1.  The whole of this instrument

1 December 2024

1 December 2024

Powder for I.V. infusion 500 micrograms (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

C13491 C13505 C13506 C13510 C13512 C13577 C13634

See Schedule 2

See Schedule 2

Powder for I.V. infusion 1.5 mg (as sodium) with 2 vials diluent 50 mL

Injection

Flolan

C13491 C13505 C13506 C13510 C13512 C13577 C13634

See Schedule 2

See Schedule 2

Cipla Lenalidomide

C13782 C13785 C13786 C13787 C13791 C13801 C13803 C13804 C13805 C13810 C13811 C13812 C13813 C14362

See Schedule 2

See Schedule 2

Cipla Lenalidomide

C13782 C13785 C13786 C13787 C13791 C13803 C13804 C13805 C13811 C13812 C13813 C14362

See Schedule 2

See Schedule 2

Cipla Lenalidomide

C13782 C13785 C13786 C13787 C13803 C13805 C13811 C13812 C13813 C14362

See Schedule 2

See Schedule 2

Nevirapine Alphapharm

C4454 C4512

120

5

Zoledronate-DRLA 4

C5605 C5703 C5704 C5735 C9268 C9304 C9317 C9328 C14729 C14735

P14729 P14735

1

0

C16169

Moderate to severe chronic pouchitis

Balance of Supply - Initial 1 treatment (new patient) and Initial 2 treatment (recommencement of treatment after a break in biological medicine)

Patient must have received insufficient therapy with this drug under the Initial 1 treatment (new patient) restriction to complete 14 weeks of treatment; OR

Patient must have received insufficient therapy with this drug under the Initial 2 treatment (recommencement of treatment after a break in biological medicine) to complete 14 weeks of treatment; AND

The treatment must provide no more than the balance of up to 14 weeks treatment available under the above treatment phases.

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)].

Compliance with 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

C16181

Moderate to severe chronic pouchitis

Continuing treatment

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

Patient must have demonstrated or sustained a partial or complete response, as determined by the treating clinician, to the most recent PBS-subsidised course of treatment with this drug for this condition.

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)].

Patients who have failed to demonstrate a partial or complete response with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug for this condition

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

An application for the continuing treatment must be made following the third dose with this drug and requested no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where an application is not made within these timeframes, 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

Compliance with Authority Required procedures

C16216

Moderate to severe chronic pouchitis

Initial 1 treatment (new patient)

Patient must have undergone ileal pouch anal anastomosis (IPAA) due to ulcerative colitis (UC) at least one year previously; AND

Patient must not have previously received 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 a Modified Pouchitis Disease Activity Index (mPDAI) score of at least 5; AND

Patient must have a minimum endoscopic mPDAI sub-score of at least 2; AND

Patient must have had at least 3 recurrent episodes of pouchitis within the previous year each of which was treated with at least: (i) 2 weeks of antibiotic, (ii) 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 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 an 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 this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.

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 endoscopic mPDAI subscore; and

(ii) details of prior drug therapy for this condition [dosage, 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 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