National Health Act 1953 Amendment special arrangements under subsection 100(1) Special Authority Program Trazstuzumab (No. PB 86 of 2007) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 86 of 2007

Amendment special arrangements under subsection 100(1) of the National Health Act 1953

I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, make this instrument under subsection 100(1) of the National Health Act 1953.

Dated 2 October 2007

STEPHEN DELLAR

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment Special Arrangements: Special Authority Program – Trastuzumab

1              Commencement

This instrument commences on 1 November 2007.

2              Amendment of PB 56 of 2007

Schedule 1 amends PB 56 of 2007.

Schedule 1        Amendments

[1]Omit subparagraph 8(b) and rename the following two subparagraphs accordingly

[2]     Schedule 1, item dealing with Trastuzumab

omit the following circumstances :

Initial treatment for HER2 positive early breast cancer in patients receiving treatment with adjuvant chemotherapy following surgery at 1 October 2006.

The total duration of PBS-subsidised treatment (initial plus continuing) that will be authorised is 52 weeks.

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

Trastuzumab must not be used in patients with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.  Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA,
prior to seeking the initial authority approval and then at
3 monthly intervals during treatment.

Authority applications for initial treatment must be made in writing and must include:

(a)        a completed authority prescription form; and

(b)        a completed Early Breast Cancer – PBS Supporting Information Form which includes:                 

(i)         a copy of the pathology report from an Approved Pathology Authority confirming the presence of HER2 gene amplification by in situ hybridisation (ISH); and

(ii)        a copy of the signed patient acknowledgement form.

The medical practitioner should request sufficient quantity based on the weight of the patient to provide for a maximum of 3 weeks’ treatment (equivalent to the loading dose for the 3-weekly regimen, and the loading dose and 2 weekly doses for the
once-weekly regimen).

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Initial PBS-subsidised treatment for HER2 positive early breast cancer where the patient was receiving treatment with trastuzumab at 1 October 2006.

The patient is eligible to receive sufficient trastuzumab to complete 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy.

Trastuzumab must not be used in patients with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.  Cardiac function must be tested by a suitable method including, for example, ECHO or MUGA, at
3 monthly intervals during treatment.

Authority applications for initial PBS-subsidised treatment must be made in writing and must include:

(a)        a completed authority prescription form; and

(b)        a completed Early Breast Cancer – PBS Supporting Information Form which includes:      

(i)         the date upon which the patient commenced non-PBS-subsidised treatment with trastuzumab and the number of weeks of treatment received; and

(ii)        a copy of the signed patient acknowledgement form.

The medical practitioner should request sufficient quantity based on the weight of the patient for 3 weeks’ supply (equivalent to 1 dose for the 3-weekly regimen, or 3 doses for the once-weekly regimen).  Up to a maximum of 3 repeats may be authorised.

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