National Health Act 1953 Special Arrangements under subsection 100(1) Special Authority Program Trastuzumab (No. PB 81 of 2008) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 81 of 2008
Special Arrangements under subsection 100(1) of the National Health Act 1953
I, DIANA MACDONELL, Acting Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsection 100(1) of the National Health Act 1953.
Dated 9th July 2008
DIANA MACDONELL
Acting Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Special Arrangements: Special Authority Program – Trastuzumab
Commencement
1.
(a) This instrument commences on 1 August 2008.
(b) Instrument No. PB 94 of 2007 is repealed.
Definitions
2. In these Arrangements:
(a) unless the contrary intention appears, a word or phrase will be taken to have the same meaning as in the Act, the Regulations or a declaration, determination or other instrument made under Part VII of the Act or under the Regulations;
(b) “Act” means the National Health Act 1953;
(c) “approved supplier” includes a public hospital that is not participating in the arrangements set out in Schedule F to the Australian Health Care Agreements but is approved by the Medicare Australia CEO to issue safety net concession cards and pharmaceutical benefits entitlement cards;
(d) “I.V.” means intravenous;
(e) “Medicare Australia CEO” means the Chief Executive Officer of Medicare Australia;
(f) “Regulations” means the National Health (Pharmaceutical Benefits) Regulations 1960 made under the Act.
Part VII of the Act and Regulations
3. Except where otherwise specified in these Arrangements, the provisions of the Act, the Regulations and the declarations, determinations and other instruments made under Part VII of the Act and under the Regulations will apply to the prescribing and supply of trastuzumab.
Entitlement to receive trastuzumab under these Arrangements
4. Subject to these Arrangements, a person who:
(a) is, or is to be treated as, an eligible person within the meaning of the Health Insurance Act 1973; and
(b) is receiving medical treatment by a medical practitioner;
is entitled to receive trastuzumab under these Arrangements without the payment or furnishing of money or other consideration other than a charge made in accordance with paragraph 15.
Prescriptions for trastuzumab
5. The writing of a prescription for the supply of trastuzumab as a special pharmaceutical product under these Arrangements is authorised only in the circumstances specified in Schedule 1.
6. These Arrangements apply to trastuzumab for intravenous administration in the forms, marketed under the tradename, and supplied by the manufacturer specified below.
| Form (strength, type, size, etc.) | Proprietary name | Manufacturer |
| Powder for I.V. infusion 150 mg | Herceptin | Roche Products Pty Ltd |
7. The maximum quantity that may be prescribed on a prescription for trastuzumab is:
(a) in respect of a three-weekly treatment regimen, a sufficient number of vials to provide for a single infusion based on the weight of the patient and the dosage recommendations contained in the Product Information for trastuzumab approved by the Therapeutic Goods Administration;
(b) in respect of a weekly treatment regimen, a sufficient number of vials to provide for three infusions based on the weight of the patient and the dosage recommendations contained in the Product Information for trastuzumab approved by the Therapeutic Goods Administration.
8. Subject to paragraph 12, the maximum number of repeats that may be prescribed on a prescription for trastuzumab is:
(a) none, in the case of a prescription for initial treatment in a patient not previously treated with trastuzumab for HER2 positive early breast cancer; or
(b) 3, in the case of a prescription for continuing treatment; or
(c) none, in the case of a prescription for a new loading dose in a patient previously treated with trastuzumab for HER2 positive early breast cancer.
9. (1) Subject to subparagraph (2), a medical practitioner who wishes to prescribe trastuzumab under these Arrangements must:
(a) prepare and sign a prescription for trastuzumab:
(i) in a form approved by the Secretary and completed by the medical practitioner in ink in his or her own handwriting; or
(ii) in a form, prepared by means of a computer, that is in accordance with the form approved by the Secretary under subsubparagraph (i); or
(iii) in a form, prepared by means of a computer, approved in writing for the purpose by the Secretary and in the format approved in writing by the Secretary; or
(iv) by a method approved in writing by the Secretary; and
(b) submit the prescription and, where appropriate, the material specified in Schedule 1:
(i) by sending it to the following address:
(ii) Medicare Australia
Prior Written Approval of Specialised Drugs
Reply Paid 9826
GPO Box 9826
Hobart Tasmania 7001; or
(iii) in the case of continuing treatment, submit the prescription by giving the Medicare Australia CEO, by telephone, details of the prescription which has been prepared and signed by the medical practitioner in accordance with subparagraph (1)(a);
(2) Where the appropriate Early Breast Cancer – PBS Supporting Information Form approved by the Medicare Australia CEO is completed by the medical practitioner, it will not be necessary for the medical practitioner to complete the triplicate copy of the prescription referred to in subparagraph (1)(a).
Authorisation of prescriptions for trastuzumab
10. The authorisation of a prescription submitted under paragraph 9 may be made:
(a) if the prescription was submitted in accordance with subparagraph 9(1)(a) — by the Medicare Australia CEO signing his or her authorisation of the prescription on it and:
(i) if the Medicare Australia CEO requires the medical practitioner to alter the prescription — by returning it to the medical practitioner for alteration before the medical practitioner gives it to the person in respect of whom it was prepared; or
(ii) in any other case:
(A) by returning it to the medical practitioner; or
(B) by sending it to the person in respect of whom it was prepared; or
(b) if the prescription was submitted in accordance with subsubparagraph 9(1)(b)(ii) — verbally, at the time the Medicare Australia CEO is given details of the prescription.
11. If the Medicare Australia CEO authorises a prescription in accordance with subparagraph 10(b):
(a) the Medicare Australia CEO must tell the medical practitioner the number that has been allotted to the authorised prescription; and
(b) the medical practitioner must:
(i) mark that number on the prescription; and
(ii) retain a copy of the prescription for 1 year from the date on which the prescription was authorised.
12. The Medicare Australia CEO must not authorise the supply of trastuzumab powder for I.V. infusion to be repeated in respect of a prescription for a foreign person who is entitled to be treated as an eligible person within the meaning of the Health Insurance Act 1973 under section 7 of that Act.
13. Regulation 24 of the Regulations applies to the supply of trastuzumab as if the quantity or number of units of trastuzumab powder for I.V. infusion authorised by the Medicare Australia CEO under paragraph 10 or 11 were the maximum quantity or number of units applicable in relation to a pharmaceutical benefit in accordance with a determination of the Minister under paragraph 85A(2)(a) of the Act.
Supplier of trastuzumab under these Arrangements
14. Trastuzumab may be supplied:
(a) by an approved pharmacist; or
(b) by an approved medical practitioner; or
(c) by an approved hospital authority, to a patient receiving treatment at the hospital of which it is the governing body or proprietor; or
(d) by a public hospital that is not participating in the arrangements set out in Schedule F to the Australian Health Care Agreements but is approved by the Medicare Australia CEO to issue safety net concession cards and pharmaceutical benefits entitlement cards.
Cost to patient of trastuzumab under these Arrangements
15. An approved supplier that supplies trastuzumab may charge the person to whom the drug is supplied an amount equivalent to the amount that may be charged under section 87 of the Act for the supply of a pharmaceutical benefit to the person.
Payment to supplier of trastuzumab under these Arrangements
16. An approved supplier that has supplied trastuzumab is entitled to be paid by the Commonwealth as if paragraphs 20 to 23 of the arrangements made under subparagraph 100(1)(b)(i) of the Act for highly specialised drugs and set out in instrument No. PB 80 of 2008 applies to trastuzumab.
SCHEDULE 1
Initial treatment for HER2 positive early breast cancer commencing concurrently with adjuvant chemotherapy following surgery.
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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Continuing treatment for HER2 positive early breast cancer where the patient has previously received treatment with PBS-subsidised trastuzumab.
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 continuing treatment may be made by telephone.
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 dosing regimen, or 3 doses for the once-weekly dosing regimen). Up to a maximum of 3 repeats may be authorised.
Breaks in therapy.
Where a patient has a break in trastuzumab therapy of more than 1 week but less than 6 weeks from when the last dose was due, authority approval will be granted for a new loading dose. Authority applications for new loading doses may be made by telephone.
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