1.  The whole of this instrument

1 January 2025

1 January 2025

Abacavir/
Lamivudine Mylan

C4527 C4528

60

5

Hyrimoz

C12120 C14061 C14063 C14064 C14107 C14136

See Schedule 2

See Schedule 2

Ceptolate

C5600 C5653 C9689 C9690

600

5

C14458

Pre‑symptomatic spinal muscular atrophy (SMA)
Initial treatment with this drug of pre‑symptomatic spinal muscular atrophy (SMA)
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.
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 have genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; AND
The condition must be pre‑symptomatic; 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) a completed authority prescription form; 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

C16257

Pre-symptomatic spinal muscular atrophy (SMA)

Initial treatment with this drug of pre-symptomatic spinal muscular atrophy (SMA)

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 have genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; AND

The condition must be pre-symptomatic; 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

C16170

Moderate to severe chronic pouchitis

Initial 2 treatment (Recommencement of treatment after a break in biological medicine)

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

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

Patient must not receive more than 14 weeks of treatment under this restriction.

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)].

The treatment must be initiated in combination with standard of care antibiotic.

The assessment of a patient's response to this initial course of treatment must be made after the third dose of vedolizumab so there is adequate time for a response to be demonstrated. The assessment must be made prior to obtaining a PBS authority for continuing treatment from the dose at week 14.

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.

Application for authorisation of initial treatment must be in writing and must include:

(a) details of the proposed prescription; and

(b) 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) which includes the following:

(i) the patient's baseline Modified Pouchitis Disease Activity Index (mPDAI) score and minimum endoscopic mPDAI sub-score; and

(ii) details of prior biological medicine therapy for this condition, [date of commencement and duration of therapy].

The endoscopic assessment contributing to the Modified Pouchitis Disease Activity Index score to confirm the patient's condition at baseline must have been performed no more than 4 weeks prior to the application.

Applications for treatment of this condition must be received within 4 weeks of the endoscopy to confirm diagnosis.

The prescriber must exclude secondary causes of pouchitis, for example:

(a) Ischaemia;

(b) Crohn's disease (CD) or CD of the pouch;

(c) Irritable pouch syndrome;

(d) Predominant cuffitis;

(e) Pouch stricture or pouch fistula;

(f) Active infection;

(g) NSAIDs;

(h) Coeliac disease.

Compliance with Written Authority Required procedures

C16217

Moderate to severe chronic pouchitis

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 December 2024; AND

Patient must be receiving treatment with this drug for this condition at the time of application; AND

Patient must have undergone ileal pouch anal anastomosis (IPAA) due to ulcerative colitis at least one year prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND

The condition must be confirmed based on the patient's symptoms, treatment history and baseline endoscopic examination of the pouch (pouchoscopy); AND

Patient must have had a Modified Pouchitis Disease Activity Index (mPDAI) score of at least 5 at the time of initiating treatment with this drug for this condition; AND

Patient must have had a minimum endoscopic mPDAI sub-score of at least 2 at the time of initiating treatment with this drug for this condition; AND

Patient must have had at least 3 recurrent episodes of pouchitis within the year prior to initiating treatment with this drug for this condition, each of which was treated with at least 2 weeks of antibiotic or other prescription therapy; OR

The condition must have required maintenance antibiotic therapy taken continuously for at least 4 weeks before commencing treatment with this drug; AND

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

The treatment must have been initiated in combination with standard of care antibiotic; AND

Patient must have demonstrated a partial or complete response to treatment with this drug as determined by the treating clinician, for this condition if the patient has received non-PBS-subsidised treatment for the first three doses of induction.

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)].

The assessment of a patient's response to this course of treatment must be made after the third dose of vedolizumab so there is adequate time for a response to be demonstrated. The assessment must be made prior to obtaining a PBS authority for continuing treatment from the dose at week 14.

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.

The application for authorisation of treatment must be in writing and must include:

(a) details of the proposed prescription; and

(b) 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) which includes the following:

(i) the patient's baseline Modified Pouchitis Disease Activity Index (mPDAI) score and minimum endoscopic mPDAI sub-score; and

(ii) details of prior drug therapy for the condition [dosage, date of commencement and duration of therapy]; and

(iii) the date of commencement of this drug for this condition.

The endoscopic assessment contributing to the Modified Pouchitis Disease Activity Index score to confirm the patient's condition at baseline must have been performed no more than 4 weeks prior to initiation with non-PBS-subsidised treatment with this drug.

The prescriber must have excluded secondary causes of pouchitis, for example:

(a) Ischaemia;

(b) Crohn's disease (CD) or CD of the pouch;

(c) Irritable pouch syndrome;

(d) Predominant cuffitis;

(e) Pouch stricture or pouch fistula;

(f) Active infection;

(g) NSAIDs;

(h) Coeliac disease.

Compliance with Written Authority Required procedures

C16239

Moderate to severe chronic pouchitis

Initial 2 treatment (Recommencement of treatment after a break in biological medicine)

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

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

Patient must not receive more than 14 weeks of treatment under this restriction.

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)].

The treatment must be initiated in combination with standard of care antibiotic.

The assessment of a patient's response to this initial course of treatment must be made after the third dose of vedolizumab so there is adequate time for a response to be demonstrated. The assessment must be made prior to obtaining a PBS authority for continuing treatment from the dose at week 14.

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.

Application for authorisation of initial treatment must be in writing and must include:

(a) details of the proposed prescription; and

(b) 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) which includes the details of prior biological medicine therapy for this condition [date of commencement and duration of therapy].

The prescriber must have excluded secondary causes of pouchitis, for example:

(a) Ischaemia;

(b) Crohn's disease (CD) or CD of the pouch;

(c) Irritable pouch syndrome;

(d) Predominant cuffitis;

(e) Pouch stricture or pouch fistula;

(f) Active infection;

(g) NSAIDs;

(h) Coeliac disease.

Compliance with Authority Required procedures