EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 62 OF 2010
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (TRASTUZUMAB) SPECIAL ARRANGEMENTS INSTRUMENT 2010
Purpose
The National Health (Trastuzumab) Special Arrangements Instrument 2010 (‘the Instrument’) is a set of arrangements made under subsection 100(1) of the National Health Act 1953 (the Act) for the purpose of ensuring that an adequate supply of special pharmaceutical products will be available to persons who require treatment with the drug trastuzumab.
This Instrument revokes the existing Special Authority Program (Trastuzumab) Arrangements (PB 56 of 2009) and makes additional provision for the use of on-line claiming by approved public hospital authorities. Other changes have been made to the structure and wording of the Instrument for clarity.
Authority
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2). These are listed drugs as defined in subsection 84(1). Under paragraph 100AA(1)(c) of the Act, a special pharmaceutical product, for which special arrangements may be made under section 100, includes a drug or medicinal preparation declared under subsection 85(2) of the Act.
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.
Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Subsection 100(3) provides that Part VII of the Act has effect subject to a special arrangement made under subsection 100(1).
This instrument (No. PB 62 of 2010) is made under subsection 100(1) of the Act.
A provision-by-provision description of this instrument is contained in the Attachment.
This instrument, expressed to commence on 1 July 2010, was made on 25 June 2010.
Consultations
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.
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
DETAILS OF THE NATIONAL HEALTH (TRASTUZUMAB) SPECIAL ARRANGEMENTS INSTRUMENT 2010
Division 1 - Preliminary
Section 1 provides that this Instrument is the National Health (Trastuzumab) Special Arrangements Instrument 2010, which may also be cited as PB 62 of 2010.
Section 2 provides that this Instrument commences on 1 July 2010.
Section 3 sets out definitions of certain terms used in this Instrument.
This section contains a new definition of “approved public hospital authority”, which is defined to include a hospital authority which is approved in respect of a hospital under section 52 of the National Health (Highly specialised drugs program for public hospitals) Special Arrangements Instrument 2010 (PB 63 of 2010) (the Public HSD Arrangements), in addition to a hospital authority approved in respect of a hospital in the normal way under section 94 of the Act.
The Public HSD Arrangements are a set of arrangements made under subsection 100(1) the Act for the purpose of ensuring that an adequate supply of special pharmaceutical products will be available to persons who are receiving treatment with highly specialised drugs (‘HSDs’) at public hospitals as non-admitted patients, day admitted patients or patients on discharge. Section 52 allows hospital authorities to be approved under that arrangement in respect of hospitals which could not be approved under section 94 because of subsection 94(5). Subsection 94(5) may be read as preventing a hospital authority from being approved under section 94 in respect of a hospital where that hospital does not have a dispensary on-site.
Subsection 3(2) provides that a word or expression used in this Instrument and in the Act, the Regulations or a declaration, determination or other instrument made under Part VII of the Act has the same meaning in this Instrument as it has in the Act, the Regulations, declaration, determination or instrument.
Section 4 provides that, subject to this Instrument, the provisions of the Act, the Regulations and any declarations, determinations or other instruments made under Part VII of the Act or the Regulations, apply to the prescribing and supply of trastuzumab under this Instrument.
Section 5 provides that a person is entitled to receive trastuzumab under this Instrument, without payment or other consideration, other than a charge made under subsection 16(3), 18(3) or 21(3), 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.
Division 2 – Prescriptions for Trastuzumab
Section 6 provides that the supply of trastuzumab under this Instrument is authorised only in the circumstances mentioned in Schedule 1 and subject to the requirements in this Instrument.
Section 7 provides that trastuzumab is available for intravenous administration under this Instrument only in the following form, with the following proprietary name and manufacturer:
Powder for I.V. infusion 150 mg | Herceptin | Roche Products Pty Ltd |
Section 8 provides that the maximum quantity of trastuzumab that may be prescribed for an eligible patient is:
(a) for a 3-weekly course of treatment — a sufficient number of vials to provide for a single infusion based on the weight of the patient and the dosage recommendations in the Product Information for trastuzumab approved by the Therapeutic Goods Administration; or
(b) for a weekly course of treatment — a sufficient number of vials to provide for 3 infusions based on the weight of the patient and the dosage recommendations in the Product Information for trastuzumab approved by the Therapeutic Goods Administration.
Section 9 provides that, subject to section 13, the maximum number of repeats that may be prescribed on a prescription for trastuzumab is:
(a) for a prescription for the initial treatment in a patient not previously treated with trastuzumab for HER2 positive early breast cancer — no repeats; or
(b) for a prescription for the continuing treatment in a patient previously treated with trastuzumab for HER2 positive early breast cancer — 3 repeats; or
(c) for a prescription for a new loading dose in a patient previously treated with trastuzumab for HER2 positive early breast cancer — no repeats.
Section 10 provides that prescriptions for the supply of trastuzumab must be approved in accordance with sections 11 and 12 prior to the prescription being given to the patient or the drug being dispensed.
Section 11 sets out the manner in which a prescription for trastuzumab must be prepared. Subject to subsection 11(2), a medical practitioner who proposes to prescribe trastuzumab under this Instrument must prepare and sign an approved authority prescription form, and then submit the prescription and, if appropriate, the material mentioned in Schedule 1 to the Medicare Australia CEO.
For continuing treatment of a patient, the medical practitioner may submit the prescription by giving the Medicare Australia CEO, by telephone, details of the prescription that has been prepared and signed by the medical practitioner in accordance with paragraph 11(1)(a).
Subsection 11(2) provides that the medical practitioner does not have to complete the medical indication section of a prescription mentioned in paragraph 11(1) (a) if he or she completes the appropriate Early Breast Cancer — PBS Supporting Information Form approved by the Medicare Australia CEO.
Section 12 sets out the manner in which the Medicare Australia CEO may authorise a prescription.
Subsection 12(2) provides that a prescription which is submitted in accordance with paragraph 11 (1) (b) may be authorised by the Medicare Australia CEO writing his or her authorisation of the prescription on it and either returning it to the medical practitioner (including returning it for alterations to be made) or to the person for whom it was prepared.
Subsection 12(3) provides that if the prescription is submitted by telephone in accordance with paragraph 11 (1) (c), the prescription is authorised when the details of the prescription are given to the Medicare Australia CEO over the telephone and the following actions are completed:
- the Medicare Australia CEO tells the medical practitioner the number that has been allotted to the prescription; and
- the medical practitioner writes that number on the prescription.
Subsection 12(4) requires the medical practitioner to keep a copy of the prescription for one year commencing on the day the prescription is authorised.
Section 13 provides that the Medicare Australia CEO must not authorise the supply of trastuzumab powder for intravenous infusion for a person who is a visitor to Australia even if the person is, in accordance with section 7 of the Health Insurance Act 1973, to be treated as an eligible person within the meaning of that Act.
Division 3 – Supplying trastuzumab
Section 14 provides that trastuzumab may be supplied by:
(a) an approved pharmacist;
(b) an approved medical practitioner;
(c) an approved public hospital authority, within the limits of its approval, to an eligible patient receiving treatment at, or from, the hospital as a non-admitted patient, day admitted patient or patient on discharge;
(d) an approved private hospital authority within the limits of its approval under section 94 of the Act;
(e) a hospital authority for a public hospital to an eligible patient receiving treatment at, or from, the hospital as a non-admitted patient, day admitted patient or patient on discharge.
Division 4 – Claims and payments
Subdivision 1 – Claims and payments – approved pharmacists, medical practitioners and private hospitals authorities
Section 15 provides that this Subdivision applies if an approved private hospital authority, an approved pharmacist or an approved medical practitioner supplies trastuzumab to an eligible patient under this Instrument.
Section 16 provides that, subject to subsection 16(2), the approved private hospital authority, approved pharmacist or approved medical practitioner is entitled to be paid by the Commonwealth in accordance with section 28, paragraph 30 (a) and section 31 of PB 64 of 2010, the National Health (Highly specialised drugs program for private hospitals) Special Arrangements Instrument 2010 (the Private HSD Arrangements).
The provisions of the Private HSD Arrangement mentioned in this section set out the method of working out the amount which may be claimed by an approved pharmacist or a private hospital authority for the supply of a complete manufacturer’s pack of a highly specialised drug under those Private HSD Arrangements.
In effect, an approved private hospital authority, approved pharmacist or approved medical practitioner who supplies Trastuzumab is entitled to be paid by the Commonwealth the amount by which the dispensed price for an approved private hospital authority (worked out in accordance with paragraph 30(a) of the Private HSD Arrangements) exceeds the amount that the supplier was entitled to charge the patient under subsection 16(3), plus a mark up.
Subsection 16(2) makes appropriate adjustments to the Private HSD Arrangements in order to make them applicable to trastuzumab supplied under this Instrument.
Subsection 16(3) provides that the approved hospital authority, approved pharmacist or approved medical practitioner may also charge the person, as a co-payment, the relevant amount under section 87 of the Act, the amount of which will vary depending upon a patient’s concessional status.
Subdivision 2 – Claims and payments – hospital authorities for public hospitals using the off-line system
Section 17 provides that this Subdivision applies if:
(a) a hospital authority for a public hospital supplies trastuzumab under this Instrument; and
(b) the relevant State or Territory agency responsible for the hospital makes an off-line claim for payment.
Section 18 provides that the government of the State or Territory in which the hospital is located is entitled to be paid 99.2% of the dispensed price for the supply of trastuzumab.
The dispensed price of trastuzumab, for the purposes of this section, is to be worked out in accordance with paragraph 42 (a) of the Public HSD Arrangements (PB 63 of 2010), as if a reference in that paragraph to a “highly specialised drug” were a reference to trastuzumab. Paragraph 42(a) of the Public HSD Arrangements sets out the method of working out the dispensed price where a complete pack of a drug is ordered and supplied under those Arrangements.
The hospital authority may also charge the person, as a co-payment, the relevant amount that is specified as the maximum value of a supply of out-patient medication in the determination made under subsection 84BA (2) of the Act as in force on the date of the supply of the trastuzumab.
Section 19 provides that the relevant State or Territory agency responsible for that hospital makes an off-line claim for payment by lodging a claim with Medicare Australia containing specified information.
The responsible agency may lodge up to three claims in relation to trastuzumab dispensed in a particular calendar month (a relevant month). However, the agency may only lodge one claim for a relevant month per calendar month. The agency has three months to ensure that all claims for a relevant month are lodged.
Subdivision 3 – Claims and payments – approved public hospital authorities using on-line system
Section 20 provides that this Subdivision applies if an approved public hospital authority:
(a) supplies trastuzumab to an eligible patient; and
(b) makes an on-line claims payment.
Section 21 provides that the approved public hospital authority is entitled to be paid the amount worked out in accordance with paragraph 42 (a) of PB 63 of 2010 as if a reference in that paragraph to a “highly specialised drug” were a reference to trastuzumab – the same paragraph noted above in section 18.
Subsection 21(2) provides that the amount worked out under subsection 21(1) is to be reduced by the co-payment amount charged by the authority under subsection 21(3).
That is, the amount that may be claimed by the hospital is the dispensed price worked out under paragraph 42(a) of the Public HSD Arrangements, less the amount of the co-payment that may be charged by the hospital authority (see subsection 21(3) below).
Subsection 21(3) provides that the hospital authority may also charge the person, as a co-payment, the relevant amount under section 87 of the Act, the amount of which will vary depending upon a person’s concessional status.
Section 22 sets out the manner in which an approved hospital authority makes a claim using the on-line system. Subsection 22(1) provides that an on-line claim for payment for the supply of trastuzumab under this Subdivision may be made only by an approved public hospital authority for a public hospital.
Subsection 22(2) provides that the approved public hospital authority may, subject to subsection (3) and sections 23, 24 and 25, make the claim for payment in accordance with the rules made by the Minister under paragraph 99AAA (8) (a) of the Act (the 99AAA Rules). The 99AAA Rules set out the requirements for making a claim for payment to Medicare Australia.
Subsection 22(3) makes adjustments to the 99AAA Rules such that they apply consistently to a supply of trastuzumab under these Arrangements, and to a supply by a hospital authority approved under section 52 of the Public HSD Arrangement.
Section 23 provides that the claim for payment must not contain more than 3,500 prescriptions.
Section 24 provides that before the approved public hospital authority lodges the claim, the pharmacist, or medical practitioner, at the public hospital must ensure that each supply of trastuzumab:
(a) was supplied to an eligible patient; and
(b) was prescribed in accordance with this Instrument; and
(c) was prescribed only for the therapeutic uses approved by the Therapeutic Goods Administration for the drug.
Section 25 provides that no mark ups may be added to the cost of trastuzumab for which payment is claimed under this Subdivision.
Division 5 – Miscellaneous
Section 26 provides that a patient may seek refund of all or part of the co-payment charged by an approved hospital authority making an online claim, where they were entitled to be charged a lower amount.
Section 27 provides that any payment an eligible patient makes for the supply of trastuzumab supplied under this Instrument counts towards the patient’s PBS Safety Net.
Section 28 revokes PB 56 of 2009, the Special Authority Program (Trastuzumab) Arrangements, which are the existing arrangements made under section 100 for the supply of trastzumab.
Schedule 1 sets out the circumstances in which prescriptions for trastuzumab may be authorised.