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

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

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

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

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

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

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

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

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

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

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

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

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

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

Bimekizumab

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

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

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 recommence 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

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

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.

C10802

P10802

CN10802

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

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

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

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

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 recommence 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 recommence 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 recommence 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

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 recommence 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

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 recommence 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 recommence 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 recommence 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

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

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.

Compliance with Authority Required procedures - Streamlined Authority Code 11473

C11477

P11477

CN11477

Nivolumab

Locally advanced or metastatic non-small cell lung cancer

Continuing treatment as second-line drug therapy

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.

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 - Streamlined Authority Code 11477

C11478

P11478

CN11478

Ipilimumab

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

Initial combination treatment (with nivolumab) as first-line drug therapy

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

Patient must not have previously been treated for this condition in the metastatic setting; AND

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

The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND

The treatment must be in combination with platinum-based chemotherapy for the first two cycles; AND

The treatment must be in combination with nivolumab.

The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 11478

C11482

P11482

CN11482

Amino acid formula with vitamins and minerals without lysine and low in tryptophan

Pyridoxine dependent epilepsy

Patient must be managed on a low lysine diet for pyridoxine dependent epilepsy; AND

The condition must be treated by or in consultation with a metabolic physician.

C11523

P11523

CN11523

Adalimumab

Severe psoriatic arthritis

Subsequent continuing treatment

Must be treated by a rheumatologist; or

Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

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

Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction;

Patient must be aged 18 years or older.

An adequate response to treatment is defined as 

an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and

either of the following 

(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or

(b) a reduction in the number of the following major active joints, from at least 4, by at least 50% 

(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or

(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).

The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.

The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient's medical records.

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

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 Authority Required procedures - Streamlined Authority Code 11523

C11524

P11524

CN11524

Adalimumab

Complex refractory Fistulising Crohn disease

Subsequent continuing treatment

Must be treated by a gastroenterologist (code 87); or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND

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

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

An adequate response is defined as 

(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or

(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.

The measurement of response to the prior course of therapy must be documented in the patient's medical notes.

Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.

A maximum of 24 weeks treatment will be authorised under this restriction.

Compliance with Authority Required procedures - Streamlined Authority Code 11524

C11529

P11529

CN11529

Adalimumab

Moderate to severe hidradenitis suppurativa

Subsequent continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

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

Must be treated by a dermatologist.

A response to treatment is defined as 

Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.

The measurement of response to the prior course of therapy must be documented in the patient's medical notes.

A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.

Compliance with Authority Required procedures - Streamlined Authority Code 11529

C11579

P11579

CN11579

Adalimumab

Moderate to severe ulcerative colitis

Subsequent continuing treatment

Must be treated by a gastroenterologist (code 87); or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or

Must be treated by a paediatrician; or

Must be treated by a specialist paediatric gastroenterologist; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or

Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years; AND

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

Patient must be 6 years of age or older.

Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.

The measurement of response to the prior course of therapy must be documented in the patient's medical notes.

Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

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.

If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 11579

C11604

P11604

CN11604

Adalimumab

Severe active juvenile idiopathic arthritis

Subsequent continuing treatment

Must be treated by a rheumatologist; or

Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

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

Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction;

Patient must be aged 18 years or older.

An adequate response to treatment is defined as 

an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;

AND either of the following 

(a) an active joint count of fewer than 10 active (swollen and tender) joints; or

(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or

(c) a reduction in the number of the following active joints, from at least 4, by at least 50% 

(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or

(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).

Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.

The measurement of response to the prior course of therapy must be documented in the patient's medical notes.

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

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.

If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.

Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.

Compliance with Authority Required procedures - Streamlined Authority Code 11604

C11606

P11606

CN11606

Adalimumab

Severe chronic plaque psoriasis

Subsequent continuing treatment, Face, hand, foot

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

Patient must have demonstrated an adequate response to their most recent course of 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 per subsequent continuing treatment course authorised 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 measurement of response to the prior course of therapy must be documented in the patient's medical notes.

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.

Compliance with Authority Required procedures - Streamlined Authority Code 11606

C11631

P11631

CN11631

Adalimumab

Severe Crohn disease

Subsequent continuing treatment

Must be treated by a gastroenterologist (code 87); or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or

Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by:
 (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND

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

Patient must be aged 18 years or older.

The measurement of response to the prior course of therapy must be documented in the patient's medical notes.

If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

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 Authority Required procedures - Streamlined Authority Code 11631

C11635

P11635

CN11635

Adalimumab

Severe chronic plaque psoriasis

Subsequent continuing treatment, Whole body

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; 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 per subsequent continuing treatment course authorised 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 measurement of response to the prior course of therapy must be documented in the patient's medical notes.

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 Authority Required procedures - Streamlined Authority Code 11635

C11642

P11642

CN11642

Stiripentol

Severe myoclonic epilepsy in infancy (Dravet syndrome)

Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; AND

The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs; AND

Must be treated by a neurologist if treatment is being initiated.  or

Must be treated by a neurologist if treatment is being continued or re-initiated.  or

Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued.  or

Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.

Compliance with Authority Required procedures - Streamlined Authority Code 11642

C11644

P11644

CN11644

High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

Ketogenic diet

Patient must have intractable seizures requiring treatment with a ketogenic diet; or

Patient must have a glucose transport protein defect; or

Patient must have pyruvate dehydrogenase deficiency; AND

Patient must be undergoing treatment under the strict supervision of a dietitian, together with at least one of:
 (i) a metabolic physician, (ii) a neurologist.

C11673

P11673

CN11673

Progesterone

Prevention of preterm birth

Patient must have a singleton pregnancy; AND

Patient must have at least one of:
 (i) short cervix (mid-trimester sonographic cervix no greater than 25 mm), (ii) a history of spontaneous preterm birth; AND

The treatment must be administered no earlier than at 16 weeks gestation.

Compliance with Authority Required procedures - Streamlined Authority Code 11673

C11680

P11680

CN11680

Sacubitril with valsartan

Chronic heart failure

Patient must be symptomatic with NYHA classes II, III or IV; AND

Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND

Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker:
 (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance, (iii) local treatment guidelines recommend initiation of this drug product prior to a beta-blocker; AND

Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; or

Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND

The treatment must not be co-administered with an ACE inhibitor or an angiotensin II antagonist.

Compliance with Authority Required procedures - Streamlined Authority Code 11680

C11681

P11681

CN11681

Cannabidiol

Severe myoclonic epilepsy in infancy (Dravet syndrome)

Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic-clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti-epileptic drugs; AND

The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs; AND

Must be treated by a neurologist if treatment is being initiated.  or

Must be treated by a neurologist if treatment is being continued or re-initiated.  or

Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued.  or

Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued.

Compliance with Authority Required procedures

C11683

P11683

CN11683

Clonazepam

Haloperidol

Metoclopramide

For use in patients receiving palliative care

C11696

P11696

CN11696

Fentanyl

Methadone

Severe disabling pain

Patient must not be opioid naive; 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; AND

Patient must be undergoing palliative care.

Compliance with Authority Required procedures

C11697

P11697

CN11697

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; AND

Patient must be undergoing palliative care.

Compliance with Authority Required procedures - Streamlined Authority Code 11697

C11704

P11704

CN11704

Adalimumab

Severe Crohn disease

First continuing treatment

Must be treated by a gastroenterologist (code 87); or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND

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

Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or

Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by:
 (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND

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

Patient must be aged 18 years or older.

The authority application must be made in writing and must include 

(1) a completed authority prescription form; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

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.

Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.

At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.

Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.

Compliance with Written Authority Required procedures

C11709

P11709

CN11709

Adalimumab

Severe Crohn disease

Balance of supply

Must be treated by a gastroenterologist (code 87); or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND

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; or

Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of 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.  or

The treatment must provide no more than the balance of up to 24 weeks therapy available under first continuing treatment or subsequent continuing treatment.

Compliance with Authority Required procedures

C11711

P11711

CN11711

Adalimumab

Severe Crohn disease

Subsequent continuing treatment

Must be treated by a gastroenterologist (code 87); or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or

Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by:
 (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND

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

Patient must be aged 18 years or older.

The authority application must be made in writing and must include 

(1) a completed authority prescription form; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

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 within this treatment cycle, 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

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.

Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.

At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.

Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.

Compliance with Written Authority Required procedures

C11713

P11713

CN11713

Adalimumab

Severe Crohn disease

Balance of supply for paediatric patient

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; or

Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of 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; or

The treatment must provide no more than the balance of up to 24 weeks therapy available under first continuing treatment or subsequent continuing treatment; AND

Must be treated by a gastroenterologist (code 87).  or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)].  or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].  or

Must be treated by a paediatrician.  or

Must be treated by a specialist paediatric gastroenterologist.

Compliance with Authority Required procedures

C11715

P11715

CN11715

Adalimumab

Severe Crohn disease

Initial treatment - Initial 1 (new patient)

Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND

Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including:
 (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; or

Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND

Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40 preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment and which is no more than 4 weeks old at the time of application; AND

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

Patient must be aged 6 to 17 years inclusive;

Must be treated by a gastroenterologist (code 87).  or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)].  or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].  or

Must be treated by a paediatrician.  or

Must be treated by a specialist paediatric gastroenterologist.

The authority application must be made in writing and must include 

(1) two completed authority prescription forms; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website (www.servicesaustralia.gov.au).

An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of 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.

Compliance with Written Authority Required procedures

C11716

P11716

CN11716

Adalimumab

Severe Crohn disease

Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)

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

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

Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist, consultant physician, paediatrician or specialist paediatric gastroenterologist; AND

Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40; AND

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

Patient must be aged 6 to 17 years inclusive;

Must be treated by a gastroenterologist (code 87).  or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)].  or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].  or

Must be treated by a paediatrician.  or

Must be treated by a specialist paediatric gastroenterologist.

The authority application must be made in writing and must include 

(1) two completed authority prescription forms; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

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

A PCDAI assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks therapy so that there is adequate time for a response to be demonstrated.

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.

Compliance with Written Authority Required procedures

C11717

P11717

CN11717

Adalimumab

Severe Crohn disease

Subsequent continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI

Patient must have a documented history of severe Crohn disease; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND

Patient must have a total PCDAI score of 40 points or less; AND

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

Patient must be aged 6 to 17 years inclusive;

Must be treated by a gastroenterologist (code 87).  or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)].  or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].  or

Must be treated by a paediatrician.  or

Must be treated by a specialist paediatric gastroenterologist.

The authority application must be made in writing and must include 

(1) a completed authority prescription form; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

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

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.

Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.

Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.

Compliance with Written Authority Required procedures

C11718

P11718

CN11718

Adalimumab

Severe Crohn disease

Subsequent continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI

Patient must have a documented history of severe Crohn disease; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND

Patient must have a total PCDAI score of 40 points or less; AND

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

Patient must be aged 6 to 17 years inclusive;

Must be treated by a gastroenterologist (code 87).  or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)].  or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].  or

Must be treated by a paediatrician.  or

Must be treated by a specialist paediatric gastroenterologist.

The measurement of response to the prior course of therapy must be documented in the patient's medical notes.

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

Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.

Compliance with Authority Required procedures - Streamlined Authority Code 11718

C11746

P11746

CN11746

Clonazepam

For use in patients receiving palliative care

C11753

P11753

CN11753

Buprenorphine

Morphine

Oxycodone

Oxycodone with naloxone

Severe disabling pain

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; AND

Patient must be undergoing palliative care.

Compliance with Authority Required procedures

C11755

P11755

CN11755

Obinutuzumab

Follicular lymphoma

Re-induction treatment

Patient must not have previously received PBS-subsidised obinutuzumab; AND

The condition must be CD20 positive; AND

The condition must be refractory to treatment with rituximab for this condition; AND

The condition must be symptomatic; AND

The treatment must be for re-induction treatment purposes only; AND

The treatment must be in combination with bendamustine; AND

The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition.

The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen.

A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under 

i) the previously untreated induction treatment restriction; or

ii) the rituximab-refractory re-induction restriction.

Compliance with Authority Required procedures

C11759

P11759

CN11759

Adalimumab

Severe Crohn disease

Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)

Must be treated by a gastroenterologist (code 87); or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND

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

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

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

Patient must be aged 18 years or older.

The authority application must be made in writing and must include 

(1) two completed authority prescription forms; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.

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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

C11761

P11761

CN11761

Adalimumab

Severe Crohn disease

Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)

Patient must have a documented history of severe Crohn disease; AND

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

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

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

Patient must be aged 6 to 17 years inclusive;

Must be treated by a gastroenterologist (code 87).  or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)].  or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].  or

Must be treated by a paediatrician.  or

Must be treated by a specialist paediatric gastroenterologist.

The authority application must be made in writing and must include 

(1) two completed authority prescription forms; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

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.

Compliance with Written Authority Required procedures

C11762

P11762

CN11762

Adalimumab

Severe Crohn disease

Initial treatment - Initial 1 (new patient)

Must be treated by a gastroenterologist (code 87); or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)];

Patient must be aged 18 years or older;

Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND

Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND

Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; or

Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; or

Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND

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

Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy.  or

Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.  or

Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.

The authority application must be made in writing and must include 

(1) two completed authority prescription forms; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following 

(a) patient must have evidence of intestinal inflammation;

(b) patient must be assessed clinically as being in a high faecal output state;

(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.

(i) blood higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or

(ii) faeces higher than normal lactoferrin or calprotectin level; or

(iii) diagnostic imaging demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.

Evidence of intestinal inflammation includes 

(i) blood higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or

(ii) faeces higher than normal lactoferrin or calprotectin level; or

(iii) diagnostic imaging demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.

Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.

All assessments, pathology tests and diagnostic imaging studies must be made within 4 weeks of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.

If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application.

If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.

Details of the accepted toxicities including severity can be found on the Services Australia website.

Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.

An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

C11763

P11763

CN11763

Adalimumab

Severe Crohn disease

Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)

Must be treated by a gastroenterologist (code 87); or

Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or

Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND

Patient must have received prior 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

Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND

Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; or

Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; or

Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND

Patient must have evidence of intestinal inflammation; or

Patient must be assessed clinically as being in a high faecal output state; or

Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND

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

Patient must be aged 18 years or older.

The authority application must be made in writing and must include 

(1) two completed authority prescription forms; and

(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).

Evidence of intestinal inflammation includes 

(i) blood higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or

(ii) faeces higher than normal lactoferrin or calprotectin level; or

(iii) diagnostic imaging demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.

Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.

Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.

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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.

Compliance with Written Authority Required procedures

C11767

P11767

CN11767