1.  The whole of this instrument

1 November 2024

1 November 2024

BOSLEER

C11229 C12425 C13495 C13496 C13497 C13499 C13571 C13582 C13632

See Schedule 2

See Schedule 2

BOSLEER

C11229 C13495 C13496 C13497 C13499 C13571 C13582 C13632

See Schedule 2

See Schedule 2

Buprenorphine

Injection (modified release) 8 mg in 0.16 mL pre‑filled syringe

Injection

Buvidal Weekly

C16051

4

5

Injection (modified release) 16 mg in 0.32 mL pre‑filled syringe

Injection

Buvidal Weekly

C16051

4

5

Injection (modified release) 24 mg in 0.48 mL pre‑filled syringe

Injection

Buvidal Weekly

C16051

4

5

Injection (modified release) 32 mg in 0.64 mL pre‑filled syringe

Injection

Buvidal Weekly

C16051

4

5

Injection (modified release) 64 mg in 0.18 mL pre‑filled syringe

Injection

Buvidal Monthly

C16015

1

5

Injection (modified release) 96 mg in 0.27 mL pre‑filled syringe

Injection

Buvidal Monthly

C16015

1

5

Injection (modified release) 100 mg in 0.5 mL pre‑filled syringe

Injection

Sublocade

C16050

1

5

Injection (modified release) 128 mg in 0.36 mL pre‑filled syringe

Injection

Buvidal Monthly

C16015

1

5

Injection (modified release) 160 mg in 0.45 mL pre‑filled syringe

Injection

Buvidal Monthly

C16015

1

5

Injection (modified release) 300 mg in 1.5 mL pre‑filled syringe

Injection

Sublocade

C16050

1

5

Tablet (sublingual) 400 micrograms (as hydrochloride)

Sublingual

Subutex

C16009

28

5

Tablet (sublingual) 2 mg (as hydrochloride)

Sublingual

Subutex

C16009

84

5

Tablet (sublingual) 8 mg (as hydrochloride)

Sublingual

Subutex

C16009

112

5

Buprenorphine with naloxone

Film (soluble) 2 mg (as hydrochloride)‑0.5 mg (as hydrochloride)

Sublingual

Suboxone Film 2/0.5

C16009

84

5

Film (soluble) 8 mg (as hydrochloride)‑2 mg (as hydrochloride)

Sublingual

Suboxone Film 8/2

C16009

112

5

ENTECLUDE

C4993 C5036

60

5

ENTECLUDE

C5037 C5044

60

5

Lanreotide

Injection 60 mg (as acetate) in single dose pre‑filled syringe

Injection

Mytolac

C4575 C7025 C9260 C9261 C15955 C16024 C16055 C16057

2

5

Somatuline Autogel

C4575 C7025 C9260 C9261 C15955 C16024 C16055 C16057

2

5

Injection 90 mg (as acetate) in single dose pre‑filled syringe

Injection

Mytolac

C4575 C7025 C9260 C9261 C15955 C16024 C16055 C16057

2

5

Somatuline Autogel

C4575 C7025 C9260 C9261 C15955 C16024 C16055 C16057

2

5

Injection 120 mg (as acetate) in single dose pre‑filled syringe

Injection

Mytolac

C4575 C7025 C9260 C9261 C10061 C10077 C15955 C16024 C16055 C16056 C16057 C16133

2

5

Somatuline Autogel

C4575 C7025 C9260 C9261 C10061 C10077 C15955 C16024 C16055 C16056 C16057 C16133

2

5

Powder for injection 100 mg

Injection

Nucala

C15344 C15353 C15376 C15400

See Schedule 2

See Schedule 2

Methadone

Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 1 L bottle, 1 mL

Oral

Aspen Methadone Syrup

C16083

840

5

Biodone Forte

C16083

840

5

Oral liquid containing methadone hydrochloride 25 mg per 5 mL in 200 mL bottle, 1 mL

Oral

Aspen Methadone Syrup

C16083

840

5

Biodone Forte

C16083

840

5

Onasemnogene abeparvovec

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 1 vial solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 5.5 mL and 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 2 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 3 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 4 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 5 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 6 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 7 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 8 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Pack containing 9 vials solution for I.V. infusion 20 trillion vector genomes per mL, 8.3 mL

Injection

Zolgensma

C12639 C15460 C15989 C16045

See Schedule 2

See Schedule 2

Buprenorphine

C16009

Opioid dependence

The treatment must be within a framework of medical, social and psychological treatment.

The prescriber must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs.

Compliance with Authority Required procedures - Streamlined Authority Code 16009

C16015

Opioid dependence

Must be treated by a health care professional.

The treatment must be within a framework of medical, social and psychological treatment; AND

Patient must be stabilised on one of the following prior to commencing treatment with this drug for this condition: (i) weekly prolonged release buprenorphine (Buvidal Weekly) (ii) sublingual buprenorphine (iii) buprenorphine/naloxone.

The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs.

Compliance with Authority Required procedures - Streamlined Authority Code 16015

C16050

Opioid dependence

Must be treated by a health care professional.

The treatment must be within a framework of medical, social and psychological treatment; AND

Patient must be stabilised on sublingual buprenorphine or buprenorphine/naloxone prior to commencing treatment with this drug for this condition.

The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs.

Compliance with Authority Required procedures - Streamlined Authority Code 16050

C16051

Opioid dependence

Must be treated by a health care professional.

The treatment must be within a framework of medical, social and psychological treatment.

The prescriber must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs.

Compliance with Authority Required procedures - Streamlined Authority Code 16051

Buprenorphine with naloxone

C16009

Opioid dependence

The treatment must be within a framework of medical, social and psychological treatment.

The prescriber must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs.

Compliance with Authority Required procedures - Streamlined Authority Code 16009

C7509

Functional carcinoid tumour

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

The condition must be causing intractable symptoms; AND

Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti‑histamines, anti‑serotonin agents and anti‑diarrhoea agents; AND

Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND

The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 120 mg every 28 days.

Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 7509

C7532

Acromegaly

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

The condition must be active; AND

Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND

The treatment must be after failure of other therapy including dopamine agonists; OR

The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR

The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND

The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND

The treatment must cease if IGF1 is not lower after 3 months of treatment; AND

The treatment must not be given concomitantly with PBS‑subsidised pegvisomant.

In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

Compliance with Authority Required procedures ‑ Streamlined Authority Code 7532

C10075

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

C15955

Functional carcinoid tumour

Continuing treatment

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

The condition must be causing intractable symptoms; AND

Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND

Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND

The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.

Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures - Streamlined Authority Code 15955

C16024

Acromegaly

Initial treatment

Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; OR

Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting.

The condition must be active; AND

Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND

The treatment must be after failure of other therapy including dopamine agonists; OR

The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR

The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND

The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND

The treatment must cease if IGF1 is not lower after 3 months of treatment; AND

The treatment must not be given concomitantly with PBS-subsidised pegvisomant.

In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

Compliance with Authority Required procedures - Streamlined Authority Code 16024

C16055

Acromegaly

Continuing treatment

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

The condition must be active; AND

Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND

The treatment must be after failure of other therapy including dopamine agonists; OR

The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR

The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND

The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND

The treatment must cease if IGF1 is not lower after 3 months of treatment; AND

The treatment must not be given concomitantly with PBS-subsidised pegvisomant.

In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.

Compliance with Authority Required procedures - Streamlined Authority Code 16055

C16056

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

Initial treatment

Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; OR

Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting.

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 at least 18 years of age.

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 16056

C16057

Functional carcinoid tumour

Initial treatment

Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; OR

Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting.

The condition must be causing intractable symptoms; AND

Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND

Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND

The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months' therapy at a dose of 120 mg every 28 days.

Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.

Compliance with Authority Required procedures - Streamlined Authority Code 16057

C16133

Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)

Continuing treatment

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 at least 18 years of age.

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 16133

C15344

Uncontrolled severe asthma

Initial treatment - Initial 2 (Change of treatment)

Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.

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

Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND

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

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

Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR

Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; AND

Patient must not receive more than 32 weeks of treatment under this restriction; AND

The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.

Patient must be aged 12 years or older.

An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine.

An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.

This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug.

At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy.

A multidisciplinary severe asthma clinic team comprises of:

(i) A respiratory physician; and

(ii) A pharmacist, nurse or asthma educator.

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 following must be provided at the time of application and documented in the patient's medical records:

(a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and

(b) details (date and duration of treatment) of prior biological medicine treatment; and

(c) eosinophil count and date; and

(d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and

(e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).

Compliance with Written Authority Required procedures

C15400

Uncontrolled severe asthma

Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy)

Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.

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

Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND

Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR

Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND

Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR

Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; AND

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

Patient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; OR

Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND

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

Patient must not receive more than 32 weeks of treatment under this restriction; AND

The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma.

Patient must be aged 12 years or older.

Optimised asthma therapy includes:

(i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated;

AND

(ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated.

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

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

(a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND

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

The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed.

This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to 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 the same treatment cycle.

A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 4 biological medicines within the same treatment cycle.

The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle.

There is no limit to the number of treatment cycles that a patient may undertake in their lifetime.

At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of mepolizumab sufficient for up to 32 weeks of therapy.

A multidisciplinary severe asthma clinic team comprises of:

(i) A respiratory physician; and

(ii) A pharmacist, nurse or asthma educator.

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 following must be provided at the time of application and documented in the patient's medical records:

(a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and

(b) if applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and

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

(d) the eosinophil count and date; and

(e) Asthma Control Questionnaire (ACQ-5) score.

Compliance with Written Authority Required procedures

Methadone

C16083

Opioid dependence

The treatment must be within a framework of medical, social and psychological treatment.

The prescriber must request a quantity (in millilitres) sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs.

Compliance with Authority Required procedures - Streamlined Authority Code 16083

C14468

Spinal muscular atrophy (SMA)
Use in a patient untreated with disease modifying therapies for this condition
The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
The condition must be pre‑symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; AND
The treatment must not be a PBS‑subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND
The treatment must be given concomitantly with best supportive care for this condition.
Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND
Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND
Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND
Patient must not be undergoing treatment with this pharmaceutical benefit through this listing where prior treatment has occurred with any of: (i) nusinersen, (ii) risdiplam.
Patient must be no older than 9 months of age.
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).
State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.
Confirm that genetic testing has been completed to demonstrate the following in support of an SMA diagnosis:
(i) 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or
(ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.
Confirm that there is a genetic test finding that substantiates the number of SMN2 gene copies to be 3 and has been determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).
Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient.

Compliance with Written Authority Required procedures

C15458

Spinal muscular atrophy (SMA)

Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen to onasemnogene abeparvovec)

The treatment must be given concomitantly with best supportive care for this condition; AND

The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes.

Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition; AND

Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND

Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND

Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND

Patient must be undergoing treatment with this pharmaceutical benefit with the intent that treatment with the replaced disease modifying agent is/has ceased.

Patient must be no older than 9 months of age; AND

Patient must have pre-symptomatic SMA with 3 copies of the SMN2 gene.

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).

Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.

Confirm that a previous PBS authority application has been approved for pre-symptomatic SMA with 3 copies of SMN2 gene.

State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.

Adhere to any Product Information or local treatment guidelines with respect to treatment-free ('wash out') periods prior to administering this benefit.

Compliance with Written Authority Required procedures

C15989

Spinal muscular atrophy (SMA)

Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec)

The treatment must be given concomitantly with best supportive care for this condition; AND

The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes.

Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition; AND

Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND

Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND

Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND

Patient must be undergoing treatment with this pharmaceutical benefit with the intent that treatment with the replaced disease modifying agent is/has ceased.

Patient must be no older than 9 months of age; AND

Patient must have pre-symptomatic SMA with 3 copies of the SMN2 gene.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; 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).

Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.

Confirm that a previous PBS authority application has been approved for pre-symptomatic SMA with 3 copies of SMN2 gene.

State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.

Adhere to any Product Information or local treatment guidelines with respect to treatment-free ('wash out') periods prior to administering this benefit.

Compliance with Written Authority Required procedures

C16045

Spinal muscular atrophy (SMA)

Use in a patient untreated with disease modifying therapies for this condition

The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR

The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND

The condition must be pre-symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; AND

The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND

The treatment must be given concomitantly with best supportive care for this condition.

Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND

Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND

Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND

Patient must not be undergoing treatment with this pharmaceutical benefit through this listing where prior treatment has occurred with any of: (i) nusinersen, (ii) risdiplam.

Patient must be no older than 9 months of age.

The authority application must be made in writing and must include:

(1) details of the proposed prescription; 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).

State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.

Confirm that genetic testing has been completed to demonstrate the following in support of an SMA diagnosis:

(i) 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or

(ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.

Confirm that there is a genetic test finding that substantiates the number of SMN2 gene copies to be 3 and has been determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).

Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient.

Compliance with Written Authority Required procedures

C15986

Pre-symptomatic spinal muscular atrophy (SMA)

Continuing/maintenance treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene

Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; OR

Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND

Patient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy.

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

Patient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; AND

The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND

The treatment must be given concomitantly with best supportive care for this condition; AND

The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.

Patient must have been 18 years of age or younger at the time of initial treatment with this drug.

Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.

In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required.

The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.

The approved Product Information recommended dosing is as follows:

(i) 16 days to less than 2 months of age: 0.15 mg/kg

(ii) 2 months to less than 2 years of age: 0.20 mg/kg

(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg

(iv) 2 years of age and older weighing 20 kg or more: 5 mg

In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:

1 unit where (i) applies;

2 units where (ii) applies;

3 units where (iii) applies;

3 units where (iv) applies.

Compliance with Authority Required procedures

C15990

Pre-symptomatic spinal muscular atrophy (SMA)

Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene

Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; OR

Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA.

The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR

The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND

The condition must be pre-symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; AND

The treatment must be given concomitantly with best supportive care for this condition; AND

Patient must be untreated with gene therapy.

Patient must be aged under 36 months prior to commencing treatment.

Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:

(a) details of the proposed prescription; and

(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:

(i) confirmation of genetic diagnosis of SMA; and

(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)

The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.

The approved Product Information recommended dosing is as follows:

(i) 16 days to less than 2 months of age: 0.15 mg/kg

(ii) 2 months to less than 2 years of age: 0.20 mg/kg

(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg

(iv) 2 years of age and older weighing 20 kg or more: 5 mg

In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:

1 unit where (i) applies;

2 units where (ii) applies;

3 units where (iii) applies;

3 units where (iv) applies.

Compliance with Written Authority Required procedures