EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

ARRANGEMENTS UNDER SECTION 100

SPECIAL AUTHORITY PROGRAM (TRASTUZUMAB)

No. PB 18 of 2007

Purpose and operation

1. The purpose of the Australian Pharmaceutical Benefits Scheme (PBS) is to provide timely, reliable and affordable access for the Australian community to necessary and cost-effective medicines.

2.      The PBS is regulated by Part VII of the National Health Act 1953 (the Act), which provides for the supply of listed drugs and medicinal preparations as pharmaceutical benefits.

3.      “Pharmaceutical benefit” is defined under subsection 84(1) of the Act as a drug or medicinal preparation in relation to which, by virtue of section 85 of the Act, Part VII of the Act applies.

4.      Subsection 100(1) of the Act provides that the Minister may make special arrangements for providing that an adequate supply of special pharmaceutical products will be available to persons:

(a)   who are living in isolated areas; or

(b)   who are receiving medical treatment in such circumstances that pharmaceutical benefits:

(i)                 cannot be conveniently or efficiently supplied in accordance with Part VII of the Act; or

(ii)               are inadequate for that medical treatment.

5.      Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).

6.      Subsection 100(3) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).

7.      The declaration made under subsection 85(2) of the Act sets out the drugs and medicinal preparations to which Part VII of the Act applies and the restrictions, if any, that apply to the prescribing of such drugs and medicinal preparations as pharmaceutical benefits.  Schedule 6 of the declaration under subsection 85(2) lists those drugs and medicinal preparations that may be made available under arrangements provided for by section 100 of the Act.

8.      The Special Authority Program (Trastuzumab) is a set of Arrangements made under subparagraph 100(1)(b)(i) of the Act for the purpose of providing that an adequate supply of special pharmaceutical products will be available to persons who require treatment with trastuzumab.

9.      The Special Authority Program (Trastuzumab) Arrangements made under subparagraph 100(1)(b)(i) of the Act on 7 November 2006, with effect from 1 December 2006           (No. PB 54 of 2006), are repealed and substituted with these Arrangements.

10.  These Arrangements were remade on 14 February 2007 to give effect from
1 March 2007, to the special arrangements for the supply of trastuzumab available under the Special Authority Program under section 100, as recommended by the Pharmaceutical Benefits Advisory Committee.

11.  This instrument is required to be remade as Paragraph 16 of the Special Authority Program (Trastuzumab) Arrangements contains reference to paragraphs 20 to 23 of the Highly Specialised Drugs Program (HSDP) Arrangements (No. PB 16 of 2007), these HSDP Arrangements being a disallowable legislative instrument in effect at the time the current SAP Arrangements were made.  Paragraph 14(1)(a) of the Legislative Instruments Act 2003 enables a legislative instrument to incorporate by reference any disallowable legislative instrument that is in force at a particular time or from time to time.

12.  The Arrangements for the HSDP will be revoked and remade with effect from                  1 March 2007.  In accordance with the requirements of the Legislative Instruments Act 2003, it is thus necessary to remake the Special Authority Program (Trastuzumab) Arrangements with effect from 1 March 2007 to amend Paragraph 16 to refer to the remade HSDP Arrangements (No. PB 16 of 2007) in force from that date.

13.  These Arrangements constitute a legislative instrument for the purposes of the Legislative Instruments Act 2003.

14.  Details of the Arrangements are set out in the Attachment.

Consultations

15.  The Pharmaceutical Benefits Advisory Committee (PBAC) is the independent expert body, established by section 100A of the Act, which makes recommendations to the Minister for Health and Ageing about which drugs and medicinal preparations should be available as pharmaceutical benefits.  Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared.  When recommending a medicine be listed on the PBS, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

16.  PBAC members are selected from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.

ATTACHMENT

The Preamble states the authority for the making of these Arrangements.

Paragraph 1 provides that these Arrangements commence on 1 March 2007.

Paragraph 2 provides that a word or phrase used in these Arrangements will be taken to have the same meaning as in the National Health Act 1953 (the Act), the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations) or a declaration, determination or other instrument made under Part VII of the Act or under the Regulations, unless the contrary intention appears.  Paragraph 2 also defines certain terms used in these Arrangements.

Paragraph 3 provides that the provisions of the Act, the Regulations, declarations,  determinations and other instruments made under the Act shall apply to the prescribing of trastuzumab under these Arrangements, except where otherwise specified in these Arrangements.

Paragraph 4 provides that a person is entitled to receive trastuzumab under these Arrangements, without payment or other consideration, other than the charges specified in paragraph 15, if that person is an eligible person within the meaning of the Health Insurance Act 1973, and if that person is receiving treatment by a medical practitioner.

Paragraph 5 provides that the supply of trastuzumab under these Arrangements is authorised only in the circumstances specified in Schedule 1 to these Arrangements..

Paragraph 6 provides that trastuzumab is available for intravenous administration under these Arrangements in the following forms marketed under the following brands:

Form (strength, type, size, etc.) Proprietary name Manufacturer

Powder for I.V. infusion 150 mg Herceptin Roche Products Pty Ltd

Paragraph 7 provides that the maximum quantity of trastuzamab that may be prescribed on a prescription is:

(a)   in respect of the 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 the 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.

Paragraph 8 provides that 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 initial PBS-subsidised treatment in a patient previously treated with non-PBS-subsidised trastuzumab for HER2 positive early breast cancer; or

(c)           3, in the case of a prescription for continuing treatment. 

Subparagraph 9(1) provides that, subject to subparagraph 9(2), when prescribing trastuzumab the medical practitioner must:

(a)          prepare and sign the prescription:

(i)       in a form approved by the Secretary, and completed in ink in the medical practitioner’s handwriting; or

(ii)     in a computer-prepared form that is accordance with the form approved by the Secretary under subsubparagraph (i); or

(iii)  in a computer-prepared form approved in writing for the purpose by the Secretary and in a format approved in writing by the Secretary; or

(iv)   by a method approved by the Secretary in writing; and

(b)               submit the prescription and where appropriate, the material specified in Schedule 1, by

(i)       sending the prescription to the specified address of Medicare Australia; or

(ii)     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).

Subparagraph 9(2)  provides that 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 9(1)(a).

Paragraph 10 provides that the Medicare Australia CEO may authorise a prescription:

(a)     by signing that prescription if it was submitted in accordance with subparagraph 9(1)(a) and:

(i)       if an alteration is required by the Medicare Australia CEO, returning the prescription to the medical practitioner for alteration before the treatment is given to the patient; or

(ii)     in any other case by returning it to the medical practitioner, or sending it to the patient; or

(b)     verbally if the prescription was submitted by telephone in accordance with subparagraph 9(1)(b)(ii).

Paragraph 11 provides that 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 that authorised prescription; and

(b)     the medical practitioner must mark the authorisation number on the prescription and retain a copy of the prescription for 1 year from the date on which the prescription was authorised.

Paragraph 12 provides that the Medicare Australia CEO must not authorise the repeat supply of trastuzumab powder for I.V. infusion 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.

Paragraph 13 provides that 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.

Paragraph 14 provides that trastuzumab may be supplied by:

(a)                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 an approved hospital that is not participating in the arrangements set out in Schedule F to the Australian Health Care Agreements, but is approved by  Medicare Australia to issue safety net concession cards and pharmaceutical benefits entitlement cards.

Paragraph 15 describes the cost to patients of the supply of trastuzumab under these Arrangements.  An approved supplier may charge the person to whom trastuzumab has been supplied an amount equal to that which may be charged under section 87 of the Act for the supply of a pharmaceutical benefit.

Paragraph 16 describes the payments that may be made to an approved supplier by the Commonwealth for the supply of trastuzumab under these Arrangements.  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 No. PB 16 of 2007 applies to trastuzumab.

The Schedules

Schedule 1 to the Arrangements lists the circumstances for which trastuzumab may be prescribed as a special pharmaceutical product for the initial and continuing treatment of patients with HER2 positive early breast cancer.  The procedures for authorising a prescription of trastuzumab as a special pharmaceutical product for the initial and continuing treatment of patients with HER2 positive early breast cancer are also detailed in this Schedule.