C10020

P10020

CN10020

Risperidone

Behavioural disturbances

Initial treatment

The condition must be characterised by psychotic symptoms and aggression; AND

Patient must have dementia of the Alzheimer type; AND

Patient must have failed to respond to non-pharmacological methods of treatment; AND

Patient must not receive more than 12 weeks of treatment under this restriction.

A patient may only qualify for 12 weeks of PBS-subsidised treatment under this restriction once in a 12 month period.

Compliance with Authority Required procedures - Streamlined Authority Code 10020

C10021

P10021

CN10021

Risperidone

Behavioural disturbances

Continuing treatment, trial of dose reduction or cessation of treatment

The condition must be characterised by psychotic symptoms and aggression; AND

Patient must have dementia of the Alzheimer type; AND

Patient must have responded to an initial course of treatment with this drug for this condition; AND

Patient must have failed to respond to non-pharmacological methods of treatment; AND

The treatment must be for dose tapering purposes as part of a trial of treatment reduction or cessation; or

Patient must have trialled a period of treatment reduction or cessation with this drug for this condition and experienced worsening or re-emergence of symptoms during this trial, and retrials are considered periodically; AND

Patient must be optimised on non-pharmacological methods of treatment.

The patient's response to treatment and a trial of treatment reduction or cessation must be discussed formally with a psychiatrist or geriatrician or in a documented clinical review process involving a least one other medical practitioner, or be reviewed by a psychiatrist or geriatrician.

Response to treatment is defined as a significant reduction in symptoms of psychosis or aggression.

Patients must cease treatment if there is no improvement in symptoms of psychosis and aggression, or worsening of symptoms with therapy.

Patients must be monitored for adverse effects such as falls, drowsiness leading to reduced self-care, incontinence, reduced nutrition, reduced ability to communicate needs/wishes and take part in activities. Therapy must be ceased if harms of therapy outweigh benefits.

Trials of reduction or cessation of therapy should be considered periodically with the intention of maintaining symptom control through non-pharmacological measures wherever possible and/or lowest effective dose therapy.

Evidence of patient benefit from therapy, failure of non-pharmacological approaches to manage symptoms in the absence of therapy, and recurrence of symptoms following reduction or cessation of therapy, trialled on at least 1 occasion, must be documented in the patient's medical records.

Compliance with Authority Required procedures

C10023

P10023

CN10023

Avelumab

Stage IV (metastatic) Merkel Cell Carcinoma

Continuing treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while being treated with this drug for this condition; AND

The treatment must not exceed a maximum dose of 10 mg per kg every 2 weeks under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 10023

C10033

P10033

CN10033

Cobimetinib

Unresectable Stage III or Stage IV malignant melanoma

Initial treatment

Patient must be receiving PBS subsidised vemurafenib concomitantly for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10033

C10051

P10051

CN10051

Trametinib

Unresectable Stage III or Stage IV malignant melanoma

Initial treatment

Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10051

C10061

P10061

CN10061

Lanreotide

Octreotide

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be the sole PBS-subsidised therapy for this condition;

Patient must be aged 18 years or older.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10061

C10063

P10063

CN10063

Cinacalcet

Secondary hyperparathyroidism

Continuing treatment

Must be treated by a nephrologist; AND

Patient must have chronic kidney disease; AND

Patient must be on dialysis; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition.

During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.

During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.

Compliance with Authority Required procedures - Streamlined Authority Code 10063

C10067

P10067

CN10067

Cinacalcet

Secondary hyperparathyroidism

Continuing treatment

Must be treated by a nephrologist; AND

Patient must have chronic kidney disease; AND

Patient must be on dialysis; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition.

During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.

During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.

Compliance with Authority Required procedures - Streamlined Authority Code 10067

C10068

P10068

CN10068

Cinacalcet

Secondary hyperparathyroidism

Continuing treatment

Patient must have chronic kidney disease; AND

Patient must be on dialysis; AND

Patient must have achieved a decrease of at least 30% in intact parathyroid hormone (iPTH) concentrations after 6 months treatment.  or

Patient must have an intact parathyroid (iPTH) concentration greater than 15 pmol/L and an (adjusted) serum calcium concentration of less than 2.6 mmol/L after 6 months.

During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.

During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.

Compliance with Authority Required procedures - Streamlined Authority Code 10068

C10073

P10073

CN10073

Cinacalcet

Secondary hyperparathyroidism

Initial treatment

Must be treated by a nephrologist; AND

Patient must have chronic kidney disease; AND

Patient must be on dialysis; AND

Patient must have failed to respond to conventional therapy; AND

Patient must have sustained hyperparathyroidism with iPTH of at least 50 pmol per L.  or

Patient must have sustained hyperparathyroidism with iPTH of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L.

During the titration phase, intact PTH (iPTH) should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved.

During the titration phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient's response and tolerability.

Compliance with Authority Required procedures

C10075

P10075

CN10075

Lanreotide

Octreotide

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be the sole PBS-subsidised therapy for this condition;

Patient must be aged 18 years or older.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10075

C10076

P10076

CN10076

Sapropterin

Hyperphenylalaninaemia

Initial treatment

Must be treated by a metabolic physician; AND

Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.

Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.

Compliance with Authority Required procedures

C10077

P10077

CN10077

Lanreotide

Octreotide

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

The condition must be unresectable locally advanced disease or metastatic disease; AND

The condition must be World Health Organisation (WHO) grade 1 or 2; AND

The treatment must be the sole PBS-subsidised therapy for this condition;

Patient must be aged 18 years or older.

WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.

WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.

Compliance with Authority Required procedures - Streamlined Authority Code 10077

C10093

P10093

CN10093

Fingolimod

Multiple sclerosis

Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND

The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not show continuing progression of disability while on treatment with this drug; AND

Patient must have demonstrated compliance with, and an ability to tolerate this therapy;

Patient must weigh 40 kg or less.

Compliance with Authority Required procedures - Streamlined Authority Code 10093

C10095

P10095

CN10095

Prednisolone with phenylephrine

Severe eye inflammation

Patient must have had a cataract removed in the treated eye; or

Patient must be scheduled for cataract surgery in the treated eye;

Patient must identify as Aboriginal or Torres Strait Islander.

C10116

P10116

CN10116

Dolutegravir with abacavir and lamivudine

HIV infection

Continuing treatment

Patient must have previously received PBS-subsidised therapy for HIV infection.

Compliance with Authority Required procedures - Streamlined Authority Code 10116

C10119

P10119

CN10119

Nivolumab

Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma

Initial treatment

The treatment must be adjuvant to complete surgical resection; AND

Patient must have a WHO performance status of 1 or less; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not have received prior PBS-subsidised treatment for this condition; AND

The treatment must commence within 12 weeks of complete resection; AND

Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.

Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures

C10120

P10120

CN10120

Nivolumab

Resected Stage IIIB, IIIC, IIID or Stage IV malignant melanoma

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND

Patient must not have experienced disease recurrence; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.

Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.

Compliance with Authority Required procedures

C10121

P10121

CN10121

Budesonide with formoterol

Fluticasone furoate with vilanterol

Fluticasone propionate with salmeterol

Chronic obstructive pulmonary disease (COPD)

Patient must have significant symptoms despite regular beta-2 agonist bronchodilator therapy; AND

Patient must have experienced at least one severe COPD exacerbation, which required hospitalisation, or two or more moderate exacerbations in the previous 12 months.

Compliance with Authority Required procedures - Streamlined Authority Code 10121

C10125

P10125

CN10125

Atezolizumab

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment 2

Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy; AND

The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND

Patient must have a WHO performance status of 0 or 1; AND

Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material; AND

Patient must have progressive disease following treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) OR an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI); AND

Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer.

Compliance with Authority Required procedures - Streamlined Authority Code 10125

C10126

P10126

CN10126

Durvalumab

Unresectable Stage III non-small cell lung cancer

Initial treatment

Patient must have received platinum based chemoradiation therapy; AND

The condition must not have progressed following platinum based chemoradiation therapy; AND

Patient must have a WHO performance status of 0 or 1; AND

Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10126

C10130

P10130

CN10130

Dabrafenib

Trametinib

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma

Continuing treatment

Patient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection; AND

Patient must not have experienced disease recurrence; AND

Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.

Compliance with Authority Required procedures

C10138

P10138

CN10138

Levodopa with carbidopa

Advanced Parkinson disease

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND

The treatment must be commenced in a hospital-based movement disorder clinic.

Compliance with Authority Required procedures - Streamlined Authority Code 10138

C10139

P10139

CN10139

Dimethyl fumarate

Multiple sclerosis

Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND

The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not show continuing progression of disability while on treatment with this drug.

Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 10139

C10140

P10140

CN10140

Dimethyl fumarate

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND

The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND

Patient must be ambulatory (without assistance or support).

Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 10140

C10148

P10148

CN10148

Dabrafenib

Trametinib

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma

Initial treatment

The treatment must be adjuvant to complete surgical resection; AND

The condition must be positive for a BRAF V600 mutation; AND

Patient must have a WHO performance status of 1 or less; AND

Patient must be receiving PBS-subsidised trametinib and dabrafenib concomitantly for this condition; AND

Patient must not have received prior PBS-subsidised treatment for this condition; AND

The treatment must commence within 12 weeks of complete resection; AND

Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.

Compliance with Authority Required procedures

C10150

P10150

CN10150

Teriflunomide

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND

The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND

Patient must be ambulatory (without assistance or support).

Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 10150

C10157

P10157

CN10157

Dabrafenib

Vemurafenib

Unresectable Stage III or Stage IV malignant melanoma

Initial treatment

The condition must be positive for a BRAF V600 mutation; AND

The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; or

Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND

Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND

Patient must have a WHO performance status of 2 or less.

Compliance with Authority Required procedures - Streamlined Authority Code 10157

C10161

P10161

CN10161

Levodopa with carbidopa

Advanced Parkinson disease

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND

The treatment must be commenced in a hospital-based movement disorder clinic.

Compliance with Authority Required procedures - Streamlined Authority Code 10161

C10162

P10162

CN10162

Fingolimod

Ofatumumab

Ozanimod

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND

The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND

Patient must be ambulatory (without assistance or support).

Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 10162

C10170

P10170

CN10170

Cladribine

Relapsing remitting multiple sclerosis

Initial treatment

The condition must be diagnosed by a neurologist; AND

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND

The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND

Patient must be ambulatory (without assistance or support).

Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

The prescriber should write authority prescriptions for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1.

Compliance with Authority Required procedures - Streamlined Authority Code 10170

C10171

P10171

CN10171

Cladribine

Relapsing remitting multiple sclerosis

Continuing treatment

Must be treated by a neurologist; AND

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; AND

The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not show continuing progression of disability while on treatment with this drug; AND

Patient must have demonstrated compliance with, and an ability to tolerate, this therapy.

The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1.

Compliance with Authority Required procedures - Streamlined Authority Code 10171

C10172

P10172

CN10172

Fingolimod

Ofatumumab

Ozanimod

Multiple sclerosis

Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND

The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not show continuing progression of disability while on treatment with this drug; AND

Patient must have demonstrated compliance with, and an ability to tolerate this therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 10172

C10197

P10197

CN10197

Levodopa with carbidopa

Advanced Parkinson disease

Maintenance therapy

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND

Patient must have been commenced on treatment in a hospital-based movement disorder clinic.

Compliance with Authority Required procedures - Streamlined Authority Code 10197

C10198

P10198

CN10198

Fingolimod

Multiple sclerosis

Initial treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND

The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND

Patient must be ambulatory (without assistance or support);

Patient must weigh 40 kg or less.

Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 10198

C10199

P10199

CN10199

Teriflunomide

Multiple sclerosis

Continuing treatment

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or

The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND

The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not show continuing progression of disability while on treatment with this drug.

Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.

Compliance with Authority Required procedures - Streamlined Authority Code 10199

C10206

P10206

CN10206

Atezolizumab

Durvalumab

Extensive-stage small cell lung cancer

Initial treatment

The condition must be previously untreated; AND

Patient must have a WHO performance status of 0 or 1; AND

The treatment must be in combination with etoposide and a platinum-based antineoplastic drug.

Compliance with Authority Required procedures - Streamlined Authority Code 10206

C10208

P10208

CN10208

Brivaracetam

Intractable partial epileptic seizures

Continuing treatment

Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND

The treatment must not be given concomitantly with levetiracetam.

Compliance with Authority Required procedures - Streamlined Authority Code 10208

C10210

P10210

CN10210

Brivaracetam

Intractable partial epileptic seizures

Initial treatment

Must be treated by a neurologist; AND

The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND

The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents; AND

The treatment must not be given concomitantly with levetiracetam, except for cross titration.

Compliance with Authority Required procedures - Streamlined Authority Code 10210

C10212

P10212

CN10212

Trastuzumab

Early HER2 positive breast cancer

3 weekly treatment regimen

Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND

Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.  or

Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10212

C10213

P10213

CN10213

Trastuzumab

Early HER2 positive breast cancer

Continuing treatment (weekly regimen)

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND

Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.  or

Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.

Compliance with Authority Required procedures - Streamlined Authority Code 10213

C10215

P10215

CN10215

Atezolizumab

Locally advanced or metastatic non-small cell lung cancer

Continuing treatment - 4 weekly treatment regimen

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 10215

C10216

P10216

CN10216

Atezolizumab

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing first-line treatment of metastatic disease - 3 weekly treatment regimen

Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated; AND

Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND

Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 10216

C10223

P10223

CN10223

Omalizumab

Uncontrolled severe allergic asthma

Balance of supply in a patient aged 6 to 12 years

Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND

Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 28 weeks treatment; or

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND

The treatment must provide no more than the balance of up to 28 weeks treatment available under the Initial restriction or up to 24 weeks treatment available under the Continuing restriction.

Compliance with Authority Required procedures

C10226

P10226

CN10226

Omalizumab

Uncontrolled severe allergic asthma

Continuing treatment

Patient must have a documented history of severe allergic asthma; AND

Patient must have demonstrated or sustained an adequate response to treatment with this drug; AND

Patient must not receive more than 24 weeks of treatment under this restriction; AND

Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician.

An adequate response to omalizumab treatment is defined as 

(a) a reduction in the Asthma Control Questionnaire (ACQ-5) or ACQ-IA score of at least 0.5 from baseline, OR

(b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 or ACQ-IA score from baseline, OR

(c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline.

All applications for continuing treatment with omalizumab must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate must be made at around 20 weeks after the first dose of PBS-subsidised omalizumab so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.

The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab. This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with omalizumab.

A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks of therapy.

The authority application must be made in writing and must include 

(a) a completed authority prescription form; and

(b) a completed Paediatric Severe Allergic Asthma Continuing PBS Authority Application - Supporting Information form which includes details of 

(i) maintenance oral corticosteroid dose; and

(ii) Asthma Control Questionnaire (ACQ-5) score; or

(iii) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.

Compliance with Written Authority Required procedures

C10248

P10248

CN10248

Sofosbuvir with velpatasvir and voxilaprevir

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND

Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND

The treatment must be limited to a maximum duration of 12 weeks.

The application must include details of the prior treatment regimen containing an NS5A inhibitor.
The application must include details of the prior treatment regimen containing an NS5A inhibitor.

Compliance with Authority Required procedures

C10250

P10250

CN10250

Tolvaptan

Autosomal dominant polycystic kidney disease (ADPKD)

Initial treatment

Must be treated by a nephrologist; AND

Patient must have an estimated glomerular filtration rate (eGFR) between 30 and 89 mL/min 1.73 m2 at the initiation of treatment with this drug for this condition; AND

Patient must have or have had rapidly progressing disease at the time of initiation of this drug for this condition.

Rapidly progressing disease is defined as either of the following 

A decline in eGFR of greater than or equal to 5 mL/min/1.73 m2 within one year;

OR

An average decline in eGFR of greater than or equal to 2.5 mL/min/1.73 m2 per year over a five year period.

Compliance with Authority Required procedures

C10251

P10251

CN10251

Brivaracetam

Intractable partial epileptic seizures

Initial treatment

Must be treated by a neurologist; AND

The treatment must be in combination with two or more anti-epileptic drugs which includes one second-line adjunctive agent; AND

The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs, which includes at least one first-line anti-epileptic agent and at least two second-line adjunctive anti-epileptic agents; AND

Patient must be unable to take a solid dose form of this drug; AND

The treatment must not be given concomitantly with levetiracetam, except for cross titration.

Compliance with Authority Required procedures - Streamlined Authority Code 10251

C10252

P10252

CN10252

Trifluridine with tipiracil

Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction

Initial treatment

Patient must have a WHO performance status of 1 or less; AND

Patient must have previously received at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum and either a taxane or irinotecan; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 10252

C10257

P10257

CN10257

Atezolizumab

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing first-line treatment of metastatic disease, as monotherapy, where concomitant bevacizumab has ceased due to intolerance - 4 weekly treatment regimen

Patient must have experienced intolerance to combination treatment with bevacizumab; AND

Patient must have previously received PBS-subsidised treatment with this drug in this line of treatment; AND

Patient must have stable or responding disease; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10257

C10265

P10265

CN10265

Omalizumab

Uncontrolled severe allergic asthma

Initial treatment

Patient must have a diagnosis of asthma confirmed and documented by a paediatric respiratory physician, clinical immunologist, or allergist; or paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by the following standard clinical features:
 forced expiratory volume (FEV1) reversibility or airway hyperresponsiveness or peak expiratory flow (PEF) variability; AND

Patient must have a duration of asthma of at least 1 year; AND

Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE; AND

Patient must have total serum human immunoglobulin E greater than or equal to 30 IU/mL; AND

Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 6 to less than 12 years;

Must be treated by a paediatric respiratory physician, clinical immunologist, allergist; or paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician; AND

Patient must be under the care of the same physician for at least 6 months.

Optimised asthma therapy includes 

(i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative;

(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.

AND

(ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated.

If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application.

The initial IgE assessment must be no more than 12 months old at the time of application.

The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application 

(a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used),

(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.

(a) a completed authority prescription form; and

(b) a completed Paediatric Severe Allergic Asthma Initial PBS Authority Application - Supporting Information form,

(i) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and

(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and

(iii) the IgE result; and

(iv) Asthma Control Questionnaire (ACQ-5) score; or

(v) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.

AND

(b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician.

(a) a completed authority prescription form; and

(b) a completed Paediatric Severe Allergic Asthma Initial PBS Authority Application - Supporting Information form,

(i) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and

(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and

(iii) the IgE result; and

(iv) Asthma Control Questionnaire (ACQ-5) score; or

(v) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.

The Asthma Control Questionnaire (5 item version) or ACQ-IA assessment of the patient's response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 24 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed.

This assessment, which will be used to determine eligibility for continuing treatment, should be submitted within 4 weeks of the date of assessment, and no later than 2 weeks prior to the patient completing their current treatment course, to avoid an interruption to supply. Where a response assessment is not undertaken and submitted, the patient will be deemed to have failed to respond to treatment with omalizumab.

A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased.

At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks.

The authority application must be made in writing and must include 

(a) a completed authority prescription form; and

(b) a completed Paediatric Severe Allergic Asthma Initial PBS Authority Application - Supporting Information form,

(i) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and

(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and

(iii) the IgE result; and

(iv) Asthma Control Questionnaire (ACQ-5) score; or

(v) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.

which includes the following 

(i) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and

(ii) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and

(iii) the IgE result; and

(iv) Asthma Control Questionnaire (ACQ-5) score; or

(v) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score.

Compliance with Written Authority Required procedures

C10268

P10268

CN10268

Glecaprevir with pibrentasvir

Chronic hepatitis C infection

Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND

Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND

The treatment must be limited to a maximum duration of 16 weeks.

The application must include details of the prior treatment regimen containing an NS5A inhibitor.
The application must include details of the prior treatment regimen containing an NS5A inhibitor.

Compliance with Authority Required procedures

C10271

P10271

CN10271

Encorafenib

Unresectable Stage III or Stage IV malignant melanoma

Initial treatment

The condition must be positive for a BRAF V600 mutation; AND

The condition must not have been treated previously with PBS-subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; or

Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND

Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND

Patient must have a WHO performance status of 2 or less.

Compliance with Authority Required procedures - Streamlined Authority Code 10271

C10293

P10293

CN10293

Trastuzumab

Early HER2 positive breast cancer

Initial treatment (3 weekly regimen)

Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND

Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.  or

Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.

HER2 positivity must be demonstrated by in situ hybridisation (ISH).

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10293

C10294

P10294

CN10294

Trastuzumab

Early HER2 positive breast cancer

Continuing treatment (3 weekly regimen)

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND

Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.  or

Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.

Compliance with Authority Required procedures - Streamlined Authority Code 10294

C10295

P10295

CN10295

Trastuzumab emtansine

Early HER2 positive breast cancer

Continuing adjuvant treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while being treated with this drug for this condition; AND

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND

The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.

Compliance with Authority Required procedures

C10296

P10296

CN10296

Trastuzumab

Early HER2 positive breast cancer

Initial treatment (weekly regimen)

Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND

Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.  or

Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.

HER2 positivity must be demonstrated by in situ hybridisation (ISH).

Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10296

C10297

P10297

CN10297

Atezolizumab

Locally advanced or metastatic non-small cell lung cancer

Continuing treatment - 3 weekly treatment regimen

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND

Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 10297

C10306

P10306

CN10306

Binimetinib

Unresectable Stage III or Stage IV malignant melanoma

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug; AND

Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition; AND

Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 10306

C10309

P10309

CN10309

Trifluridine with tipiracil

Metastatic colorectal cancer

Initial treatment

Patient must have a WHO performance status of 1 or less; AND

Patient must have previously received treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-vascular endothelial growth factor (anti-VEGF) agent and an anti-epidermal growth factor receptor (anti-EGFR) agent for this condition; or

Patient must not be a suitable candidate for treatment with fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, an anti-VEGF agent and an anti-EGFR agent for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 10309

C10310

P10310

CN10310

Trifluridine with tipiracil

Metastatic (Stage IV) adenocarcinoma of the stomach or gastro-oesophageal junction

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10310

C10317

P10317

CN10317

Darunavir with cobicistat, emtricitabine and tenofovir alafenamide

HIV infection

Continuing treatment

Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner; AND

Patient must have previously received PBS-subsidised therapy for HIV infection; AND

The treatment must not be in combination with ritonavir.

Compliance with Authority Required procedures - Streamlined Authority Code 10317

C10324

P10324

CN10324

Darunavir with cobicistat, emtricitabine and tenofovir alafenamide

HIV infection

Initial treatment

Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner; AND

Patient must be antiretroviral treatment naive; or

Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen; AND

The treatment must not be in combination with ritonavir.

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.

Compliance with Authority Required procedures - Streamlined Authority Code 10324

C10328

P10328

CN10328

Binimetinib

Unresectable Stage III or Stage IV malignant melanoma

Initial treatment

Patient must be receiving PBS-subsidised encorafenib concomitantly for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10328

C10330

P10330

CN10330

Brivaracetam

Intractable partial epileptic seizures

Continuing treatment

Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND

Patient must be unable to take a solid dose form of this drug; AND

The treatment must not be given concomitantly with levetiracetam.

Compliance with Authority Required procedures - Streamlined Authority Code 10330

C10355

P10355

CN10355

Sapropterin

Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency

Continuing treatment

Must be treated by a metabolic physician; or

Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND

Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition.

Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.

Compliance with Authority Required procedures

C10362

P10362

CN10362

Tenofovir

Chronic hepatitis B infection

Patient must be in the third trimester of pregnancy; AND

Patient must have elevated HBV DNA levels greater than 200,000 IU/mL (1,000,000 copies/mL), in conjunction with documented hepatitis B infection.

Compliance with Authority Required procedures - Streamlined Authority Code 10362

C10363

P10363

CN10363

Levodopa with carbidopa

Advanced Parkinson disease

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND

The treatment must be commenced in a hospital-based movement disorder clinic; AND

Patient must require continuous administration of levodopa without an overnight break.  or

Patient must require a total daily dose of more than 2000 mg of levodopa.

Compliance with Authority Required procedures - Streamlined Authority Code 10363

C10375

P10375

CN10375

Levodopa with carbidopa

Advanced Parkinson disease

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND

The treatment must be commenced in a hospital-based movement disorder clinic; AND

Patient must require continuous administration of levodopa without an overnight break.  or

Patient must require a total daily dose of more than 2000 mg of levodopa.

Compliance with Authority Required procedures - Streamlined Authority Code 10375

C10384

P10384

CN10384

Brigatinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment

The treatment must be as monotherapy; AND

The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND

Patient must have a WHO performance status of 2 or less;

Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.

Compliance with Authority Required procedures

C10386

P10386

CN10386

Levodopa with carbidopa

Advanced Parkinson disease

Maintenance therapy

Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND

Patient must have been commenced on treatment in a hospital-based movement disorder clinic; AND

Patient must require continuous administration of levodopa without an overnight break.  or

Patient must require a total daily dose of more than 2000 mg of levodopa.

Compliance with Authority Required procedures - Streamlined Authority Code 10386

C10388

P10388

CN10388

Evolocumab

Familial homozygous hypercholesterolaemia

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be in conjunction with dietary therapy and exercise.

Compliance with Authority Required procedures - Streamlined Authority Code 10388

C10390

P10390

CN10390

Sapropterin

Hyperphenylalaninaemia

Continuing treatment

Must be treated by a metabolic physician; or

Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND

Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition.

Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.

Compliance with Authority Required procedures

C10391

P10391

CN10391

Sapropterin

Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency

Initial treatment

Must be treated by a metabolic physician; AND

Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.

Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured.

Compliance with Authority Required procedures

C10402

P10402

CN10402

Amoxicillin

Infection

Patient must be a male with acute cystitis.  or

Patient must have pyelonephritis.  or

Patient must have a tooth avulsion.  or

Patient must have salmonella enteritis.  or

Patient must have community acquired pneumonia.  or

Patient must have a condition requiring prolonged oral antibiotic therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 10402

C10404

P10404

CN10404

Amoxicillin

Roxithromycin

Infection

Patient must have a condition requiring prolonged oral antibiotic therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 10404

C10405

P10405

CN10405

Amoxicillin with clavulanic acid

Infection

Patient must be a male with acute cystitis.  or

Patient must have a condition requiring prolonged oral antibiotic therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 10405

C10410

P10410

CN10410

Cefalexin

Infection

Patient must have a pin-site infection.  or

Patient must have an infection following cardiac device insertion.  or

Patient must have acute otitis externa.  or

Patient must have streptococcal pharyngitis or tonsillitis.  or

Patient must have mastitis.  or

Patient must have periorbital (preseptal) cellulitis.  or

Patient must have acute rheumatic fever.  or

Patient must have a diabetic foot infection.  or

Patient must have a widespread infection of dermatitis.

Patient must require treatment for prophylaxis for invasive group A streptococcal (iGAS) infection.  or

Patient must have impetigo.  or

Patient must have pyelonephritis.  or

Patient must have a condition requiring prolonged oral antibiotic therapy.  or

Midwives may prescribe under this item for the treatment of mastitis only.

Compliance with Authority Required procedures - Streamlined Authority Code 10410

C10412

P10412

CN10412

Cefalexin

Infection

Patient must have impaired renal function; AND

Patient must have a pin-site infection.  or

Patient must have an infection following cardiac device insertion.  or

Patient must have acute otitis externa.  or

Patient must have streptococcal pharyngitis or tonsillitis.  or

Patient must have mastitis.  or

Patient must have periorbital (preseptal) cellulitis.  or

Patient must have acute rheumatic fever.  or

Patient must have a diabetic foot infection.  or

Patient must have a widespread infection of dermatitis.

Patient must require treatment for prophylaxis for invasive group A streptococcal (iGAS) infection.  or

Patient must have impetigo.  or

Patient must have pyelonephritis.  or

Patient must have a condition requiring prolonged oral antibiotic therapy.  or

Midwives may prescribe under this item for the treatment of mastitis only, where the patient has impaired renal function.

Compliance with Authority Required procedures - Streamlined Authority Code 10412

C10413

P10413

CN10413

Amoxicillin with clavulanic acid

Infection

Patient must have periorbital (preseptal) cellulitis.  or

Patient must have postpartum endometritis.  or

Patient must have an exacerbation of bronchiectasis.  or

Patient must have pyelonephritis.  or

Patient must have pneumonia acquired in hospital or aged care.  or

Patient must have a diabetic foot infection.  or

Patient must have a condition requiring prolonged oral antibiotic therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 10413

C10414

P10414

CN10414

Pertuzumab

Metastatic (Stage IV) HER2 positive breast cancer

Continuing treatment

Patient must have previously been issued with an authority prescription for this drug for this condition; AND

Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND

The treatment must be in combination with trastuzumab; AND

The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.

A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.

The treatment must not exceed a lifetime total of one course. However, treatment breaks are permitted. A patient who has a treatment break in PBS-subsidised treatment with this drug for reasons other than disease progression is eligible to continue to receive PBS-subsidised treatment with this drug.

Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.

Compliance with Authority Required procedures

C10416

P10416

CN10416

Amoxicillin

Community acquired pneumonia

Patient must have community acquired pneumonia.

Compliance with Authority Required procedures - Streamlined Authority Code 10416

C10431

P10431

CN10431

Certolizumab pegol

Secukinumab

Non-radiographic axial spondyloarthritis

Continuing treatment

Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND

Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND

The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND

Must be treated by a rheumatologist.  or

Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.

An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following 

(a) a CRP measurement no greater than 10 mg per L; or

(b) a CRP measurement reduced by at least 20% from baseline.

If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.

The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.

Compliance with Authority Required procedures

C10434

P10434

CN10434

Golimumab

Upadacitinib

Non-radiographic axial spondyloarthritis

Continuing treatment - balance of supply

Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND

The treatment must provide no more than the balance of up to 24 weeks treatment; AND

Must be treated by a rheumatologist.  or

Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.

Compliance with Authority Required procedures

C10436

P10436

CN10436

Golimumab

Non-radiographic axial spondyloarthritis

Initial 1 (New patient), Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply

Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND

The treatment must provide no more than the balance of up to 16 weeks treatment; AND

Must be treated by a rheumatologist.  or

Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.

Compliance with Authority Required procedures

C10459

P10459

CN10459

Certolizumab pegol

Non-radiographic axial spondyloarthritis

Initial 1 (New patient), Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply

Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 18 to 20 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 18 to 20 weeks treatment; AND

The treatment must provide no more than the balance of up to 20 weeks treatment; AND

Must be treated by a rheumatologist.  or

Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.

Compliance with Authority Required procedures

C10464

P10464

CN10464

Budesonide with formoterol

Mild asthma

Patient must have asthma and require an anti-inflammatory reliever therapy; AND

Patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA).

Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.

Compliance with Authority Required procedures - Streamlined Authority Code 10464

C10482

P10482

CN10482

Budesonide with formoterol

Mild asthma

Patient must have asthma and require an anti-inflammatory reliever therapy; AND

Patient must not be on a concomitant single agent long-acting-beta-2-agonist (LABA);

Patient must be aged 12 years or over.

Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine.

Compliance with Authority Required procedures - Streamlined Authority Code 10482

C10498

P10498

CN10498

Granisetron

Nausea and vomiting

The condition must be associated with radiotherapy being used to treat malignancy.  or

The condition must be associated with oral chemotherapy being used to treat malignancy.

Compliance with Authority Required procedures - Streamlined Authority Code 10498

C10509

P10509

CN10509

Atezolizumab

Durvalumab

Extensive-stage small cell lung cancer

Continuing treatment - 4 weekly treatment regimen

The treatment must be as monotherapy; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while being treated with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10509

C10521

P10521

CN10521

Atezolizumab

Extensive-stage small cell lung cancer

Continuing treatment - 3 weekly treatment regimen

The treatment must be as monotherapy; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while being treated with this drug for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 10521

C10538

P10538

CN10538

Budesonide with formoterol

Asthma

Patient must have failed PBS-subsidised fluticasone proprionate and salmeterol as a fixed dose combination for this condition; AND

Must be treated by a respiratory physician.  or

Must be treated by a paediatrician.

Compliance with Authority Required procedures - Streamlined Authority Code 10538

C10560

P10560

CN10560

Tocilizumab

Systemic juvenile idiopathic arthritis

Balance of supply for Initial treatment - Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months) - in a patient of any weight being administered a subcutaneous form of this biological medicine

Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under Initial 3 (recommencement of treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; AND

The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; AND

Must be treated by a rheumatologist.  or

Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.

Compliance with Authority Required procedures

C10570

P10570

CN10570

Tocilizumab

Systemic juvenile idiopathic arthritis

Balance of supply for Initial treatment - Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months)

Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under Initial 3 (recommencement of treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; AND

The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; AND

Must be treated by a rheumatologist.  or

Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.

Compliance with Authority Required procedures

C10676

P10676

CN10676

Pembrolizumab

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma

Continuing treatment - 6 weekly treatment regimen

Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND

Patient must not have experienced disease recurrence; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.

Compliance with Authority Required procedures

C10688

P10688

CN10688

Pembrolizumab

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma

Initial treatment - 6 weekly treatment regimen

The treatment must be adjuvant to complete surgical resection; AND

Patient must have a WHO performance status of 1 or less; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not have received prior PBS-subsidised treatment for this condition; AND

The treatment must commence within 12 weeks of complete resection; AND

Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.

Compliance with Authority Required procedures

C10701

P10701

CN10701

Pembrolizumab

Unresectable Stage III or Stage IV malignant melanoma

Continuing treatment - 6 weekly treatment regimen

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have previously been issued with an authority prescription for this drug for this condition; AND

Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 10701

C10705

P10705

CN10705

Pembrolizumab

Unresectable Stage III or Stage IV malignant melanoma

Continuing treatment - 3 weekly treatment regimen

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have previously been issued with an authority prescription for this drug for this condition; AND

Patient must have stable or responding disease.

Compliance with Authority Required procedures - Streamlined Authority Code 10705

C10717

P10717

CN10717

Methylphenidate

Attention deficit hyperactivity disorder

Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive;

Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND

Patient must require continuous coverage over 12 hours; AND

The treatment must not exceed a maximum daily dose of 72 mg with this drug.

Compliance with Authority Required procedures

C10742

P10742

CN10742

Guselkumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 20 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as 

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following 

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

C10743

P10743

CN10743

Guselkumab

Severe chronic plaque psoriasis

Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)

Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 20 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

The most recent PASI assessment must be no more than 4 weeks old at the time of application.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C10745

P10745

CN10745

Fentanyl

Methadone

Chronic severe disabling pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months

The condition must require daily, continuous, long term opioid treatment; AND

Patient must not be opioid naive; AND

Patient must have cancer pain.  or

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics.  or

Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.

Compliance with Authority Required procedures - Streamlined Authority Code 10745

C10747

P10747

CN10747

Fentanyl

Methadone

Chronic severe disabling pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months

The condition must require daily, continuous, long term opioid treatment; AND

Patient must not be opioid naive; AND

Patient must have cancer pain.  or

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics.  or

Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.

Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.

Compliance with Authority Required procedures - Streamlined Authority Code 10747

C10748

P10748

CN10748

Buprenorphine

Morphine

Oxycodone

Oxycodone with naloxone

Tapentadol

Tramadol

Chronic severe pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months

The condition must require daily, continuous, long term opioid treatment; AND

Patient must have cancer pain.  or

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics.  or

Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.

Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.

Compliance with Authority Required procedures - Streamlined Authority Code 10748

C10751

P10751

CN10751

Fentanyl

Methadone

Chronic severe disabling pain

Continuing PBS treatment after 1 June 2020

Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.

Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.

Compliance with Authority Required procedures - Streamlined Authority Code 10751

C10752

P10752

CN10752

Buprenorphine

Morphine

Oxycodone

Oxycodone with naloxone

Tapentadol

Tramadol

Chronic severe pain

Continuing PBS treatment after 1 June 2020

Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.

Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.

Compliance with Authority Required procedures - Streamlined Authority Code 10752

C10755

P10755

CN10755

Buprenorphine

Morphine

Oxycodone

Oxycodone with naloxone

Tapentadol

Tramadol

Chronic severe pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months

The condition must require daily, continuous, long term opioid treatment; AND

Patient must have cancer pain.  or

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics.  or

Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.

Compliance with Authority Required procedures - Streamlined Authority Code 10755

C10756

P10756

CN10756

Morphine

Chronic severe disabling pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months

The condition must require daily, continuous, long term opioid treatment; AND

Patient must have cancer pain.  or

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics.  or

Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.

Compliance with Authority Required procedures

C10758

P10758

CN10758

Hydromorphone

Severe pain

The treatment must be for short term therapy of acute severe pain; AND

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics.  or

Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.

C10762

P10762

CN10762

Morphine

Severe pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics.  or

Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.  or

The treatment must be part of pre-operative care.  or

The treatment must be used as an analgesic adjunct in general anaesthesia.

Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.

C10764

P10764

CN10764

Codeine

Codeine with paracetamol

Hydromorphone

Morphine

Oxycodone

Tramadol

Severe pain

Continuing PBS treatment after 1 June 2020

Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.

Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.

C10765

P10765

CN10765

Morphine

Severe pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics.  or

Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.  or

The treatment must be part of pre-operative care.  or

The treatment must be used as an analgesic adjunct in general anaesthesia.

C10766

P10766

CN10766

Codeine

Codeine with paracetamol

Oxycodone

Tramadol

Severe pain

The treatment must be for short term therapy of acute severe pain; AND

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics.  or

Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.

C10768

P10768

CN10768

Codeine

Codeine with paracetamol

Oxycodone

Tramadol

Severe pain

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics.  or

Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.

C10770

P10770

CN10770

Hydromorphone

Morphine

Severe pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics.  or

Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.

Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.

C10771

P10771

CN10771

Codeine

Codeine with paracetamol

Oxycodone

Tramadol

Severe pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics.  or

Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.

C10772

P10772

CN10772

Codeine

Codeine with paracetamol

Oxycodone

Tramadol

Severe pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics.  or

Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.

Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.

C10775

P10775

CN10775

Morphine

Cancer pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months

Patient must have cancer pain; AND

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics.  or

Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.

Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.

C10777

P10777

CN10777

Hydromorphone

Morphine

Severe pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics.  or

Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.

C10792

P10792

CN10792

Lisdexamfetamine

Attention deficit hyperactivity disorder

Patient must require continuous coverage over 12 hours; AND

The treatment must not exceed a maximum daily dose of 70 mg with this drug;

Patient must be aged between the ages of 6 and 18 years inclusive.  or

Patient must have had a diagnosis of ADHD prior to turning 18 years of age if PBS-subsidised treatment is continuing beyond 18 years of age.  or

Patient must have a retrospective diagnosis of ADHD if PBS-subsidised treatment is commencing after turning 18 years of age.  or

Patient must have had a retrospective diagnosis of ADHD if PBS-subsidised treatment is continuing in a patient who commenced PBS-subsidised treatment after turning 18 years of age.

A retrospective diagnosis of ADHD for the purposes of administering this restriction is 

(i) the presence of pre-existing childhood symptoms of ADHD (onset during the developmental period, typically early to mid-childhood); and

(ii) documentation in the patient's medical records that an in-depth clinical interview with, or, obtainment of evidence from, either a (a) parent, (b) teacher, (c) sibling, (d) third party, has occurred and which supports point (i) above.

Compliance with Authority Required procedures

C10802

P10802

CN10802

Risankizumab

Tildrakizumab

Severe chronic plaque psoriasis

Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)

Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

The most recent PASI assessment must be no more than 4 weeks old at the time of application.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C10806

P10806

CN10806

Guselkumab

Tildrakizumab

Severe chronic plaque psoriasis

Continuing treatment, Whole body

Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND

Patient must have demonstrated an adequate response to treatment with this drug; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 24 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as 

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.

The most recent PASI assessment must be no more than 4 weeks old at the time of application.

Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.

An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

C10807

P10807

CN10807

Bimekizumab

Guselkumab

Tildrakizumab

Severe chronic plaque psoriasis

Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply

Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; or

Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND

Must be treated by a dermatologist.

Compliance with Authority Required procedures

C10814

P10814

CN10814

Morphine

Chronic severe disabling pain

Continuing PBS treatment after 1 June 2020

Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.

Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.

Compliance with Authority Required procedures

C10830

P10830

CN10830

Apomorphine

Parkinson disease

Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND

The treatment must be commenced in a specialist unit in a hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 10830

C10836

P10836

CN10836

Morphine

Chronic severe disabling pain

The condition must require daily, continuous, long term opioid treatment; AND

Patient must have cancer pain.  or

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics.  or

Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.

Compliance with Authority Required procedures

C10837

P10837

CN10837

Morphine

Cancer pain

Continuing PBS treatment after 1 June 2020

Patient must have previously received PBS-subsidised treatment with this form of this drug for this condition after 1 June 2020.

Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.

C10839

P10839

CN10839

Morphine

Severe pain

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics.  or

Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.  or

The treatment must be part of pre-operative care.  or

The treatment must be used as an analgesic adjunct in general anaesthesia.

C10844

P10844

CN10844

Apomorphine

Parkinson disease

Maintenance therapy

Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND

Patient must have been commenced on treatment in a specialist unit in a hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 10844

C10853

P10853

CN10853

Risankizumab

Tildrakizumab

Severe chronic plaque psoriasis

Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)

Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
 (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

The most recent PASI assessment must be no more than 4 weeks old at the time of application.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C10858

P10858

CN10858

Morphine

Chronic severe disabling pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months

The condition must require daily, continuous, long term opioid treatment; AND

Patient must have cancer pain.  or

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid or other opioid analgesics.  or

Patient must be unable to use non-opioid or other opioid analgesics due to contraindications or intolerance.

Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.

Compliance with Authority Required procedures

C10859

P10859

CN10859

Hydromorphone

Morphine

Severe pain

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics.  or

Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.

C10860

P10860

CN10860

Oxycodone

Severe pain

The treatment must be for post-operative pain following a major operative procedure; AND

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics.  or

Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.

C10863

P10863

CN10863

Apomorphine

Parkinson disease

Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND

The treatment must be commenced in a specialist unit in a hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 10863

C10889

P10889

CN10889

Guselkumab

Tildrakizumab

Severe chronic plaque psoriasis

Continuing treatment, Face, hand, foot

Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND

Patient must have demonstrated an adequate response to treatment with this drug; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 24 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing 

(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.

The most recent PASI assessment must be no more than 4 weeks old at the time of application.

Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

C10890

P10890

CN10890

Oxycodone

Severe pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months

Patient must have cancer pain; or

The treatment must be for post-operative pain following a major operative procedure; AND

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics.  or

Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.

Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.

C10891

P10891

CN10891

Morphine

Cancer pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months

Patient must have cancer pain; AND

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics.  or

Patient must be unable to use non-opioid and other opioid analgesics due to contraindications or intolerance.

C10901

P10901

CN10901

Guselkumab

Severe chronic plaque psoriasis

Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)

Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
 (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 20 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

The most recent PASI assessment must be no more than 4 weeks old at the time of application.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C10910

P10910

CN10910

Oxycodone

Severe pain

Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months

Patient must have cancer pain; or

The treatment must be for post-operative pain following a major operative procedure; AND

Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics.  or

Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.

C10917

P10917

CN10917

Atezolizumab

Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma

Continuing treatment of hepatocellular carcinoma - 3 weekly treatment regimen

Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while being treated with this drug for this condition.

PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time

Compliance with Authority Required procedures - Streamlined Authority Code 10917

C10935

P10935

CN10935

Armodafinil

Modafinil

Narcolepsy

Initial 2 - treatment of narcolepsy with cataplexy

Must be treated by a qualified sleep medicine practitioner or neurologist; AND

The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; or

The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND

Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND

Patient must have a definite history of cataplexy documented in their medical records for auditing purposes; AND

Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.

The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk 

(a) a psychiatric disorder;

(b) a cardiovascular disorder;

(c) a history of substance abuse;

(d) glaucoma;

(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.

Compliance with Authority Required procedures

C10939

P10939

CN10939

Atezolizumab

Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma

Initial treatment

Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated; AND

Patient must have a WHO performance status of 0 or 1; AND

Patient must not be suitable for transarterial chemoembolisation; AND

Patient must have Child Pugh class A; AND

The condition must be untreated with systemic therapy.  or

Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal.

Compliance with Authority Required procedures - Streamlined Authority Code 10939

C10953

P10953

CN10953

Siponimod

Multiple sclerosis

Continuing treatment (including recommencement of treatment)

The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not show continuing progression of disability while on treatment with this drug; AND

Patient must be ambulatory, with/without assistance/support; AND

Patient must have demonstrated compliance with, and an ability to tolerate this therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 10953

C10955

P10955

CN10955

Siponimod

Multiple sclerosis

Initial treatment

The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of at least one of the brain/spinal cord; or

The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis supported by written certification, which is documented in the patient's medical records, from a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND

The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND

Patient must be ambulatory, with/without assistance/support; AND

Patient must have mild disability in at least 3 functional systems.  or

Patient must have moderate disability in at least 1 functional system.

Functional systems referred to in this restriction are the visual, brain stem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral/cognitive systems.

Select a dose and pack size appropriate for the patient's CYP2C9 metabolising enzyme status.

Compliance with Authority Required procedures - Streamlined Authority Code 10955

C10967

P10967

CN10967

Armodafinil

Narcolepsy

Continuing or change of treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition.  or

Patient must have previously received PBS-subsidised treatment with modafinil for this condition.

Compliance with Authority Required procedures

C10968

P10968

CN10968

Modafinil

Narcolepsy

Continuing or change of treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition.  or

Patient must have previously received PBS-subsidised treatment with armodafinil for this condition.

Compliance with Authority Required procedures

C10970

P10970

CN10970

Armodafinil

Modafinil

Narcolepsy

Initial 1 - treatment of narcolepsy without cataplexy

Must be treated by a qualified sleep medicine practitioner or neurologist; AND

The treatment must be for use when therapy with dexamfetamine sulfate poses an unacceptable medical risk; or

The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND

Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND

Patient must have a mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); or

Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; AND

Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.

The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk 

(a) a psychiatric disorder;

(b) a cardiovascular disorder;

(c) a history of substance abuse;

(d) glaucoma;

(e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.

The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration.

The authority application must be made in writing and must include the following 

(a) a completed authority prescription form; and

(b) a completed Narcolepsy Initial PBS authority application and Supporting information form; and

(c) details of the contraindication or intolerance to dexamfetamine sulfate; and

(d) either 

(i) the result and date of the polysomnography test and Multiple Sleep Latency Test (MSLT) conducted by, or under the supervision of, a qualified sleep medicine practitioner; or

(ii) the result and date of the electroencephalograph (EEG), conducted by, or under the supervision of, a neurologist.

The polysomnography, MSLT or EEG test reports must be provided with the authority application.

Compliance with Written Authority Required procedures

C10971

P10971

CN10971

Methoxsalen

Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma

Initial treatment

Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; or

Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or

The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND

Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND

Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND

Must be treated by a haematologist; or

Must be treated by a medical physician working under the supervision of a haematologist;

Patient must be aged 18 years or over.

Compliance with Authority Required procedures - Streamlined Authority Code 10971

C10972

P10972

CN10972

Atezolizumab

Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma

Continuing treatment where bevacizumab is discontinued - 4 weekly treatment regimen

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while being treated with this drug for this condition.

PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time

Compliance with Authority Required procedures - Streamlined Authority Code 10972

C10985

P10985

CN10985

Methoxsalen

Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma

Initial treatment

Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; or

Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or

The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND

Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND

Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication; AND

Must be treated by a haematologist; or

Must be treated by a medical physician working under the supervision of a haematologist;

Patient must be aged 18 years or over.

Compliance with Authority Required procedures - Streamlined Authority Code 10985

C10988

P10988

CN10988

Methoxsalen

Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma

Continuing treatment

Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND

Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or

The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND

Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule; AND

Must be treated by a haematologist.  or

Must be treated by a medical physician working under the supervision of a haematologist.

A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment

Compliance with Authority Required procedures - Streamlined Authority Code 10988

C10989

P10989

CN10989

Methoxsalen

Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma

Continuing treatment

Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND

Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; or

The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND

Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule; AND

Must be treated by a haematologist.  or

Must be treated by a medical physician working under the supervision of a haematologist.

A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment

Compliance with Authority Required procedures - Streamlined Authority Code 10989

C10992

P10992

CN10992

Rivaroxaban

Chronic stable atherosclerotic disease

Continuing treatment

Patient must have received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be in combination with aspirin, but not with any other anti-platelet therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 10992

C10995

P10995

CN10995

Venetoclax

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

Dose modification

The treatment must be for dose titration purposes.

Compliance with Authority Required procedures

C11013

P11013

CN11013

Rivaroxaban

Chronic stable atherosclerotic disease

Initial treatment

The treatment must be in combination with aspirin, but not with any other anti-platelet therapy; AND

Patient must have a diagnosis of coronary artery disease in addition to at least one of the following risk factors:
 (i) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (ii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iii) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; or

Patient must have a diagnosis of peripheral artery disease in addition to at least one of the following risk factors:
 (i) concomitant coronary artery disease (ii) diagnosed heart failure (left ventricular ejection fraction of at least 30% but less than 50%) (iii) diagnosed kidney disease classified by an eGFR in the range of 15-60 mL/min (iv) diabetes mellitus combined with at least one of the following: (a) age at least 60 years (b) concomitant microalbuminuria (c) Aboriginal/Torres Strait Islander descent; AND

Patient must have at least one of the following if coronary artery disease is present:
 (i) a previous multi-vessel coronary revascularisation procedure (ii) significant stenosis in at least 2 coronary arteries (iii) a previous single vessel coronary revascularisation procedure with significant stenosis in more than 1 coronary artery; or

Patient must have at least one of the following if peripheral arterial disease is present:
 (i) a previous peripheral/carotid artery revascularisation intervention (ii) intermittent claudication with an ankle-brachial index less than 0.9 (iii) asymptomatic carotid artery stenosis greater than 50%; AND

The condition must be diagnosed by at least one of:
 (i) invasive (selective) angiography (ii) non-invasive imaging (i.e. CT scan, ultrasound) (iii) ankle-brachial index measurement in the case of peripheral arterial disease with intermittent claudication; AND

Patient must have clinical findings/observations by the treating physician that exclude each of the following:
 (i) high risk of bleeding (ii) prior stroke within one month of treatment initiation (iii) prior haemorrhagic / lacunar stroke (iv) severe heart failure with a known ejection fraction less than 30% (v) New York Heart Association class III to IV heart failure symptoms (i.e. symptoms corresponding to moderate to severe limitation on physical activity, whereby any of fatigue/palpitations/dyspnoea occur upon zero to minimal activity) (vi) an estimated glomerular filtration rate less than 15 mL/minute (vii) a requirement for dual antiplatelet therapy (viii) a requirement for non-acetylsalicylic acid antiplatelet therapy (ix) a requirement for a higher dose of oral anticoagulant therapy; AND

Must be treated by a specialist physician.  or

Must be treated by a physician who has consulted a specialist physician.

Compliance with Authority Required procedures - Streamlined Authority Code 11013

C11015

P11015

CN11015

Obinutuzumab

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

For combination use with venetoclax treatment cycles 1 to 6 inclusive in first-line therapy

The condition must be untreated; AND

The treatment must be in combination with PBS-subsidised venetoclax.

Compliance with Authority Required procedures - Streamlined Authority Code 11015

C11017

P11017

CN11017

Venetoclax

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

First continuing treatment (treatment cycles 2 to 6 inclusive) of first-line therapy

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND

The treatment must cease upon disease progression.

Compliance with Authority Required procedures

C11018

P11018

CN11018

Rifampicin

Mycobacterium ulcerans infection (Buruli ulcer)

The treatment must be used in combination with another antibiotic for the treatment of Buruli ulcer.

Compliance with Authority Required procedures

C11057

P11057

CN11057

Beclometasone with formoterol

Asthma

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids;

Patient must be aged 18 years or older.

Compliance with Authority Required procedures - Streamlined Authority Code 11057

C11066

P11066

CN11066

Dolutegravir with lamivudine

HIV infection

Continuing or change of treatment

Patient must have previously received PBS-subsidised therapy for HIV infection.

Compliance with Authority Required procedures - Streamlined Authority Code 11066

C11069

P11069

CN11069

Venetoclax

Chronic lymphocytic leukaemia (CLL)

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND

The treatment must be ceased on disease progression or on completion of 24 months of PBS-subsidised treatment under this restriction with this drug for this condition, whichever comes first.

Compliance with Authority Required procedures

C11070

P11070

CN11070

Protein formula with vitamins and minerals, and low in potassium, phosphorus, calcium, chloride and vitamin A

Chronic renal failure

Patient must be a child aged 3 years or older;

Patient must require treatment with a low protein and a low phosphorus diet.  or

Patient must require treatment with a low protein, low phosphorus and low potassium diet.

Compliance with Authority Required procedures - Streamlined Authority Code 11070

C11073

P11073

CN11073

Venetoclax

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

Second and final continuing treatment prescription (treatment cycles 7 to 12 inclusive) of first-line therapy

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must cease upon disease progression.  or

The treatment must cease upon completion of 12 cycles of treatment with this drug for this condition, whichever comes first.

Compliance with Authority Required procedures

C11077

P11077

CN11077

Levetiracetam

Partial epileptic seizures

The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or

Patient must be a woman of childbearing potential; AND

Patient must be unable to take a solid dose form of levetiracetam; AND

The treatment must not be given concomitantly with brivaracetam, except for cross titration.

Compliance with Authority Required procedures - Streamlined Authority Code 11077

C11081

P11081

CN11081

Lamotrigine

Epileptic seizures

The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs.  or

Patient must be a woman of childbearing potential.

Compliance with Authority Required procedures - Streamlined Authority Code 11081

C11089

P11089

CN11089

Ixekizumab

Secukinumab

Severe chronic plaque psoriasis

Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)

Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
 (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 16 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

The most recent PASI assessment must be no more than 4 weeks old at the time of application.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C11090

P11090

CN11090

Tildrakizumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as 

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following 

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.

Compliance with Written Authority Required procedures

C11096

P11096

CN11096

Ixekizumab

Secukinumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 16 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as 

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following 

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

C11099

P11099

CN11099

Bortezomib

Multiple myeloma

C11107

P11107

CN11107

Adalimumab

Etanercept

Ixekizumab

Severe chronic plaque psoriasis

Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply

Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions; AND

Must be treated by a dermatologist.

Compliance with Authority Required procedures

C11116

P11116

CN11116

Levetiracetam

Partial epileptic seizures

The condition must have failed to be controlled satisfactorily by other anti-epileptic drugs; or

Patient must be a woman of childbearing potential; AND

The treatment must not be given concomitantly with brivaracetam, except for cross titration.

Compliance with Authority Required procedures - Streamlined Authority Code 11116

C11119

P11119

CN11119

Ustekinumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing 

(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following 

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

C11120

P11120

CN11120

Risankizumab

Tildrakizumab

Ustekinumab

Severe chronic plaque psoriasis

Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply

Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction; AND

Must be treated by a dermatologist.

Compliance with Authority Required procedures

C11123

P11123

CN11123

Tildrakizumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing 

(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following 

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter.

Compliance with Written Authority Required procedures

C11124

P11124

CN11124

Risankizumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as 

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following 

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.

Compliance with Written Authority Required procedures

C11130

P11130

CN11130

Guselkumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 20 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing 

(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following 

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

C11138

P11138

CN11138

Ixekizumab

Secukinumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 16 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing 

(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following 

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

C11143

P11143

CN11143

Tenofovir with emtricitabine

Pre-exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection

Patient must have at least one of the following prior to having the latest PBS-subsidised prescription issued:
 (i) a negative HIV test result no older than 4 weeks, (ii) evidence that an HIV test has been conducted, but the result is still forthcoming.

C11145

P11145

CN11145

Ustekinumab

Severe chronic plaque psoriasis

Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)

Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
 (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

The most recent PASI assessment must be no more than 4 weeks old at the time of application.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C11153

P11153

CN11153

Ustekinumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as 

A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.

An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following 

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

Compliance with Written Authority Required procedures

C11154

P11154

CN11154

Ixekizumab

Secukinumab

Severe chronic plaque psoriasis

Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)

Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 16 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

The most recent PASI assessment must be no more than 4 weeks old at the time of application.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C11158

P11158

CN11158

Infliximab

Severe chronic plaque psoriasis

Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) - balance of supply

Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 22 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 22 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 22 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 22 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions; AND

Must be treated by a dermatologist.

Compliance with Authority Required procedures

C11160

P11160

CN11160

Sorafenib

Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma

Initial treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have a WHO performance status of 2 or less; AND

Patient must have Child Pugh class A; AND

The condition must be untreated with systemic therapy.  or

Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following:
 (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 11160

C11161

P11161

CN11161

Ustekinumab

Severe chronic plaque psoriasis

Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years)

Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND

Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND

The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

The most recent PASI assessment must be no more than 4 weeks old at the time of application.

At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

Compliance with Written Authority Required procedures

C11168

P11168

CN11168

Lenvatinib

Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma

Initial treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not be suitable for transarterial chemoembolisation; AND

Patient must have a WHO performance status of 2 or less; AND

Patient must have Child Pugh class A; AND

The condition must be untreated with systemic therapy.  or

Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following:
 (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy.

Compliance with Authority Required procedures - Streamlined Authority Code 11168

C11171

P11171

CN11171

Risankizumab

Severe chronic plaque psoriasis

Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)

Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND

Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must not receive more than 28 weeks of treatment under this restriction;

Patient must be aged 18 years or older;

Must be treated by a dermatologist.

An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing 

(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or

(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.

An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.

To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.

Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.

The authority application must be made in writing and must include 

(a) a completed authority prescription form(s); and

(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following 

(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and

(ii) details of prior biological treatment, including dosage, date and duration of treatment.

The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.

If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.

A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.

At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.

Compliance with Written Authority Required procedures

C11178

P11178

CN11178

Osimertinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment as second-line EGFR tyrosine kinase inhibitor therapy

Patient must not have previously received this drug for this condition; AND

The treatment must be as monotherapy; AND

Patient must have a WHO performance status of 2 or less; AND

The condition must have progressed on or after prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy as first line treatment for this condition; AND

Patient must have evidence of EGFR T790M mutation in tumour material at the point of progression on or after first line EGFR TKI treatment.

Compliance with Authority Required procedures

C11181

P11181

CN11181

Osimertinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing treatment of second-line EGFR tyrosine kinase inhibitor therapy

The treatment must be as monotherapy; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND

Patient must be undergoing continuing treatment with this drug as second-line therapy (i.e. there are 2 Continuing treatment listings for this drug - ensure the correct Continuing treatment restriction is being accessed).

Compliance with Authority Required procedures

C11183

P11183

CN11183

Osimertinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing treatment of first-line EGFR tyrosine kinase inhibitor therapy

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND

Patient must be undergoing continuing treatment with this drug as first-line therapy (i.e. there are 2 Continuing treatment listings for this drug - ensure the correct Continuing treatment restriction is being accessed).

Compliance with Authority Required procedures

C11185

P11185

CN11185

Osimertinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment as first-line epidermal growth factor receptor tyrosine kinase inhibitor therapy

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have a WHO performance status of 2 or less; AND

Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); or

Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal;

Patient must have evidence in tumour material of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors.

Compliance with Authority Required procedures

C11193

P11193

CN11193

Selexipag

Pulmonary arterial hypertension (PAH)

Continuing treatment

Patient must have received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND

The treatment must form part of triple combination therapy consisting of:
 (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); or

The treatment must form part of dual combination therapy consisting of either:
 (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND

The treatment must not be as monotherapy; AND

Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.

For the purposes of PBS subsidy, an endothelin receptor antagonist is one of (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.

For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred 

(i) Hospitalisation due to worsening PAH;

(ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with worsening of WHO functional class status;

(iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6-Minute Walk Distance from baseline, combined with the need for additional PAH-specific therapy;

(iv) Initiation of parenteral prostanoid therapy or long-term oxygen therapy for worsening of PAH;

(v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH.

Compliance with Authority Required procedures

C11195

P11195

CN11195

Selexipag

Pulmonary arterial hypertension (PAH)

Initial treatment following dose titration

Patient must have WHO Functional Class III PAH at treatment initiation with this drug; or

Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND

The treatment must form part of triple combination therapy consisting of:
 (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); or

The treatment must form part of dual combination therapy consisting of either:
 (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND

Patient must have completed the dose titration phase; AND

The treatment must not be as monotherapy; AND

Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH;

Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.

Select one appropriate strength (determined under the 'Initial treatment - dose titration' phase) and apply under this treatment phase (Initial treatment following dose titration) once only. Should future dose adjustments be required, apply under the 'Continuing treatment' restriction.

A prior PAH agent is any of ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.

For the purposes of PBS subsidy, an endothelin receptor antagonist is one of (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.

PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.

PAH (WHO Group 1 pulmonary hypertension) is defined as follows 

(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or

(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.

Compliance with Authority Required procedures

C11229

P11229

CN11229

Ambrisentan

Bosentan

Macitentan

Sildenafil

Tadalafil

Pulmonary arterial hypertension (PAH)

Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag

The treatment must form part of triple combination therapy consisting of:
 (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); or

The treatment must form part of dual combination therapy consisting of either:
 (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND

Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.

The authority application for selexipag must be approved prior to the authority application for this agent.

For the purposes of PBS subsidy, an endothelin receptor antagonist is one of (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.

PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.

PAH (WHO Group 1 pulmonary hypertension) is defined as follows 

(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or

(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.

The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.

The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information.

A maximum of 5 repeats may be requested.

Compliance with Authority Required procedures

C11261

P11261

CN11261

Selexipag

Pulmonary arterial hypertension (PAH)

Initial treatment - dose titration

Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy; AND

Patient must have WHO Functional Class III PAH at treatment initiation with this drug; or

Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND

The treatment must be for dose titration purposes with the intent of completing the titration within 12 weeks; AND

The treatment must form part of triple combination therapy consisting of:
 (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); or

The treatment must form part of dual combination therapy consisting of either:
 (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND

The treatment must not be as monotherapy; AND

Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH;

Patient must have had at least one PBS-subsidised PAH agent prior to this authority application.

A prior PAH agent is any of ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.

For the purposes of PBS subsidy, an endothelin receptor antagonist is one of (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil.

PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.

PAH (WHO Group 1 pulmonary hypertension) is defined as follows 

(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or

(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.

Compliance with Authority Required procedures

C11310

P11310

CN11310

Esomeprazole

Lansoprazole

Omeprazole

Pantoprazole

Rabeprazole

Complex gastro-oesophageal reflux disease (GORD)

One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control

Must be treated by a gastroenterologist; or

Must be treated by a surgeon with expertise in the upper gastrointestinal tract; or

Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialists in relation to this current PBS benefit being sought, with the specialist's name documented in the patient's medical records for auditing purposes; or

Must be treated by a medical practitioner who has not consulted a specialist, but only if treatment continues therapy initiated under this restriction with involvement by a specialist (i.e. continuing treatment initiated for non-complex GORD does not meet this criterion), with the specialist's name documented in the patient's medical records for auditing purposes; AND

The treatment must be:
 (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND

Patient must must have symptoms inadequately controlled with each of:
 (i) a standard dose proton pump inhibitor (PPI) administered once daily, (ii) a low dose PPI administered twice daily; treatment is for: (1) establishment of symptom control.  or

Patient must be assessed for the risks/benefits of a step-down in dosing from standard dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for:
 (2) maintenance treatment.  or

Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for:
 (3) re-establishment of symptom control.  or

Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for:
 (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.

Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.

Compliance with Authority Required procedures

C11360

P11360

CN11360

Indacaterol with mometasone

Asthma

Patient must have previously had frequent episodes of asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids;

Patient must be aged 12 years or over.

Compliance with Authority Required procedures - Streamlined Authority Code 11360

C11370

P11370

CN11370

Esomeprazole

Complex gastro-oesophageal reflux disease (GORD)

One of: (1) establishment of symptom control, (2) maintenance treatment, (3) re-establishment of symptom control

Must be treated by a gastroenterologist; or

Must be treated by a surgeon with expertise in the upper gastrointestinal tract; AND

The treatment must be:
 (i) the sole PBS-subsidised proton pump inhibitor (PPI) for this condition, (ii) the sole strength of this PPI, (iii) the sole form of PPI; AND

Patient must have symptoms inadequately controlled with each of:
 (i) a high dose proton pump inhibitor (PPI) administered once daily, (ii) a standard dose PPI administered twice daily; treatment is for: (1) establishment of symptom control.  or

Patient must be assessed for the risks/benefits of a step-down in dosing from a high dose PPI administered twice daily, with the determination being that the risks outweigh the benefits; treatment is for:
 (2) maintenance treatment.  or

Patient must have trialled a step-down in dosing, yet symptoms have re-emerged/worsened; treatment is for:
 (3) re-establishment of symptom control.  or

Patient must have trialled a step-down in dosing, with symptoms adequately managed with once daily dosing; treatment is for:
 (2) maintenance treatment, but with the quantity sought in this authority application being up to 1 pack per dispensing.

Check patient adherence to any preceding PPI treatment regimen. Exclude non-adherence as a cause of inadequate control before accessing treatment under this restriction.

Compliance with Authority Required procedures

C11374

P11374

CN11374

Dupilumab

Chronic severe atopic dermatitis

Continuing or resuming treatment of the whole body

Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the whole body; AND

Patient must have achieved an adequate response within the first 16 weeks of treatment; or

Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; or

Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND

The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND

Must be treated by a dermatologist.  or

Must be treated by a clinical immunologist.

For the purposes of this restriction, an adequate response to treatment is defined as 

(a) An improvement/maintenance in the Eczema Area and Severity Index (EASI) score of at least 50% compared to baseline; and

(b) An improvement/maintenance in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline

Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above.

State each of the current EASI and DLQI scores for this authority application.

Compliance with Authority Required procedures

C11377

P11377

CN11377

Dupilumab

Chronic severe atopic dermatitis

Continuing or resuming treatment of the face and/or hands

Patient must have received PBS-subsidised treatment with this biological medicine for the treatment of chronic severe atopic dermatitis affecting the face/hands; AND

Patient must have achieved an adequate response within the first 16 weeks of treatment; or

Patient must have maintained an adequate response to their most recent course of PBS-subsidised treatment with this biological medicine for this PBS indication if this is the second or subsequent Continuing treatment authority application; or

Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse-effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application; AND

The treatment must be the sole PBS-subsidised biological medicine for this PBS indication; AND

Must be treated by a dermatologist.  or

Must be treated by a clinical immunologist.

For the purposes of this restriction, an adequate response to treatment of the face/hands is defined as 

(a) (i) A rating of either mild (1) to none (0) on at least 3 of the assessments of erythema, oedema/papulation, excoriation and lichenification mentioned in the Eczema Area and Severity Index (EASI); or

(ii) At least a 75% reduction in the skin area affected by this condition compared to baseline; and

(b) An improvement in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline

Where an initial baseline (post-topical corticosteroid, pre-biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non-PBS-subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above.

Document each qualifying response measure in the patient's medical records for PBS compliance auditing purposes

Compliance with Authority Required procedures

C11385

P11385

CN11385

Apomorphine

Parkinson disease

Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND

The treatment must be commenced in a specialist unit in a hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 11385

C11390

P11390

CN11390

Secukinumab

Non-radiographic axial spondyloarthritis

Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply

Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patients) restriction to complete 20 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND

The treatment must provide no more than the balance of up to 20 weeks treatment; AND

Must be treated by a rheumatologist.  or

Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.

Compliance with Authority Required procedures

C11391

P11391

CN11391

Ipilimumab

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing combination treatment (with nivolumab) of first-line drug therapy

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND

The treatment must not exceed 24 months in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND

The treatment must be in combination with nivolumab.

Compliance with Authority Required procedures - Streamlined Authority Code 11391

C11445

P11445

CN11445

Apomorphine

Parkinson disease

Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND

The treatment must be commenced in a specialist unit in a hospital setting.

Compliance with Authority Required procedures - Streamlined Authority Code 11445

C11468

P11468

CN11468

Nivolumab

Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing combination treatment (with ipilimumab) of first-line drug therapy

The condition must be squamous type non-small cell lung cancer (NSCLC); AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND

The treatment must not exceed 24 months in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND

The treatment must be in combination with ipilimumab.

Compliance with Authority Required procedures - Streamlined Authority Code 11468

C11473

P11473

CN11473

Fulvestrant

Locally advanced or metastatic breast cancer

The condition must be hormone receptor positive; AND

The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND

The condition must be inoperable;

Patient must not be premenopausal.

A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.