National Health (Trastuzumab) Special Arrangement 2011 (No. PB 94 of 2011)

EXPLANATORY STATEMENT

National Health Act 1953

National Health (Trastuzumab) Special Arrangement 2011

PB 94 of 2011

Purpose

This legislative instrument provides for a special arrangement under subsection 100(1) of the National Health Act 1953 (“the Act”) for the supply of pharmaceutical benefits with the listed drug trastuzumab to patients receiving treatment in public hospitals for early stage breast cancer.

This instrument also revokes the previous special arrangement for this program, the National Health (Trastuzumab) Special Arrangement 2010 (PB 115 of 2010).

Subsection 100(1) of the Act enables the Minister to make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available to persons:

(a)   who are living in isolated areas; or

(b)   who are receiving treatment in circumstances in which generally available pharmaceutical benefits are adequate for that treatment; or

(c)   if the pharmaceutical benefits covered by the arrangements can be more conveniently or efficiently supplied under this arrangements.

Subsection 100(3) provides that Part VII of the Act, and regulations and other legislative instruments made for the purposes of Part VII, have effect, subject to a special arrangement made under subsection 100(1). A section 100 special arrangement may thus modify the operation of Part VII, the regulations and other relevant instruments made under Part VII.

This section 100 special arrangement

This Special Arrangement provides for supply of pharmaceutical benefits with the listed drug trastuzumab to eligible patients. The relevant medicines are referred to throughout the Special Arrangement as trastuzumab pharmaceutical benefits and are set out in Schedule 1 to the Special Arrangement. Each trastuzumab pharmaceutical benefit is a brand of the listed drug trastuzumab in a determined form and manner of administration.

This Special Arrangement provides for matters relating to the prescribing and supplying of trastuzumab pharmaceutical benefit to eligible patients. Under this Special Arrangement, a trastuzumab pharmaceutical benefit may be prescribed by a medical practitioner and may be supplied by 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 as a patient on discharge.

The Special Arrangement also specifies how claims for payment for the supply of a trastuzumab pharmaceutical benefit may be made, the amount of reimbursement that the supplier is entitled to receive from the Commonwealth for each supply, and the amount that the patient may be required to pay for each supply of a trastuzumab pharmaceutical benefit.

Changes from the previous Special Arrangement

This Special Arrangements makes changes from the previous special arrangement (PB 115 of 2010) by removing all references to the following suppliers:

• approved pharmacists;
• approved medical practitioners; and
• approved hospital authorities for private hospitals
• hospital authorities for public hospitals that are not approved under either the Act or the Highly Specialised Drugs Program (non-approved public hospital authorities).

Under PB 115 of 2010 the above mentioned suppliers were able to supply trastuzumab pharmaceutical benefits, along with approved hospital authorities for public hospitals.

However, from 1 December 2011, approved pharmacists, approved medical practitioners, approved hospital authorities for private hospitals and non-approved public hospital authorities, will only be able to supply pharmaceutical benefits with the listed drug trastuzumab in accordance with the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

PB 79 of 2011 is the new special arrangement that deals with the supply of chemotherapy medicines, including trastuzumab. It was intended that all suppliers (including approved public hospital authorities) would commence supplying chemotherapy medicines under PB 79 of 2011 from 1 December 2011. It was also intended that both PB 115 of 2010 and the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 (PB 117 of 2010) (which deals with the supply of chemotherapy medicines that are not trastuzumab) would be revoked on that day.

However, software delays have meant that some public hospitals are unable to transition to PB 79 of 2011 on 1 December 2011. Accordingly, this Special Arrangement will remain in force for supplies of trastuzumab pharmaceutical benefits made by approved hospital authorities for public hospitals until all public hospitals are able to transition to PB 79 of 2011.

Under both PB 115 of 2010 and PB 79 of 2011 non-approved public hospital authorities can only make an off-line claim, so the software delays do not affect these public hospitals.

Transitional provisions in this Special Arrangement ensure that prescriptions written prior to 1 December 2011 under PB 115 of 2010 are able to be supplied after 1 December 2011 by any of the suppliers listed in PB 115 of 2010.

Consultation

An ongoing and formal process of consultation in relation to matters relevant to this instrument includes the involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (PBAC). PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. 

PBAC members are appointed following nomination by prescribed organisations and associations 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 PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC.  When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), 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.

Pharmaceutical companies were consulted throughout the process for additions and changes to listings on the PBS and for the Special Arrangement. This includes consultation through the PBAC process, and agreement to final listing details.

Medical and pharmacy professional groups, key stakeholder groups representing oncologists and pharmacists, State and Territory health departments, as well as the Department of Human Services and the Medical Software Industry Association, were also consulted throughout the process of developing all legislative instruments under the Act necessary to implement the section 100 special arrangement for the Efficient Funding of Chemotherapy.

This Instrument

An item by item description of this Special Arrangement is at Attachment 1.

This Special Arrangement commences on 1 December 2011.

This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

ATTACHMENT 1

ITEM BY ITEM DESCRIPTION OF THE NATIONAL HEALTH (TRASTUZUMAB) SPECIAL ARRANGEMENT 2011 (PB 94 of 2011)

Part 1  Preliminary

Division 1 General

Section 1 Name of Special Arrangement

This section provides that the Special Arrangement is the National Health (Trastuzumab) Special Arrangement 2011 and that it may also be cited as PB 94 of 2011.

Section 2 Commencement

This section provides that the Special Arrangement commences on 1 December 2011.

Section 3 Revocation

This section revokes instrument PB 115 of 2010 which was the previous special arrangement concerning the supply of pharmaceutical benefits with the listed drug Trastuzumab.

Section 4 Definitions

A number of expressions are defined in section 4, including the terms ‘trastuzumab pharmaceutical benefit’ and ‘eligible patient’. A new definition of ‘Human Services Department’ has also been inserted.

Division 2 Trastuzumab pharmaceutical benefit

Section 5 Pharmaceutical benefits covered by this Special Arrangement

This section provides for the pharmaceutical benefits that are covered by this Special Arrangement. The Special Arrangement covers the trastuzumab pharmaceutical benefits set out in Schedule 1 to the Special Arrangement.

Section 6 Application of Part VII of the Act

Subsection 100(3) of the Act provides that Part VII of the Act, and regulations or other instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).

Subsection 6(1) provides that each trastuzumab pharmaceutical benefit supplied under this Special Arrangement is supplied under Part VII. This is the situation under the Act and the subsection confirms that this is not intended to be modified by the Special Arrangement. Subsection 6(2) confirms that the provisions of Part VII, and regulations and other instruments made for Part VII apply, subject to the Special Arrangement.

Section 7 Responsible person

This section provides for the responsible persons for the brands of pharmaceutical items covered by this Special Arrangement. The responsible persons have been determined by the Minister to be the responsible persons under section 84AF of the Act in another legislative instrument and are included in this Special Arrangement for transparency.

The Note under section 7 explains that each trastuzumab pharmaceutical benefit is a brand of a pharmaceutical item under the Act. This is because each trastuzumab pharmaceutical benefit has a listed drug declared as such under subsection 85(2) of the Act and a form for the listed drug, a manner of administration for the form and a brand that have been determined under subsections 85(3), 85(5) and 85(6) of the Act respectively.

Section 8 Authorised prescriber

This section provides for the authorised prescribers for the trastuzumab pharmaceutical benefits covered by this Special Arrangement.

The authorised prescribers under this Special Arrangement are medical practitioners. Medical practitioners are authorised to prescribe pharmaceutical benefits by subsection 88(1) of the Act, and are included in this Special Arrangement for transparency.

Section 9 Prescription circumstances

This section provides for the circumstances in which a prescription for the supply of a trastuzumab pharmaceutical benefit under this Special Arrangement may be written.

Section 10 Section 100 only supply

This section provides for matters relating to the section 100 only supply of the pharmaceutical benefits covered by this Special Arrangement. These matters have been determined by the Minister under relevant provisions of the Act in another legislative instrument and are included in this Special Arrangement for transparency.

The letter ‘D’ in the column in Schedule 1 headed ‘Section 100 only’ indicates that the listed drug trastuzumab is a section 100 only drug declared as such under subsection 85(2A) of the Act. All pharmaceutical benefits that have the listed drug trastuzumab may only be supplied under this or another special arrangement made under section 100 of the Act. They are not available for general supply on the PBS.

Division 3 Trastuzumab modified Authority Required procedures

Section 11 Trastuzumab modified Authority Required procedures

Section 12 Trastuzumab modified Authority Required procedures –

                        submission of prescription

Section 13 Trastuzumab modified Authority Required procedures –

                        authorisation

These sections set out matters relevant to prescriptions where authorisation from the Chief Executive Medicare is required (‘authority prescriptions’). The requirements and procedures for authority prescriptions under this Special Arrangement modify the Authority Required procedures set out in the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (‘the listing instrument’).

Section 11 provides that where a circumstance determined for a trastuzumab pharmaceutical benefit includes ‘Compliance with modified Written Authority Required procedures’ or ‘Compliance with Telephone Authority Required procedures’:

• a prescription for the trastuzumab pharmaceutical benefit must be submitted to the Chief Executive Medicare in accordance with section 12; and
• the prescription must be authorised by the Chief Executive Medicare in accordance with section 13.

Section 12 sets out the procedures for submission of prescriptions to the Chief Executive Medicare in writing or by telephone. Where the circumstance includes compliance with a particular type of Authority Required procedures, the prescription must be submitted by the corresponding method, eg. in writing for ‘Compliance with modified Written Authority Required procedures’ or by telephone for ‘Compliance with Telephone Authority Required procedures’.

This Special Arrangement modifies the Authority Required procedures set out in the listing instrument by:

• adding additional requirements in subsection 12(2) for prescriptions submitted in accordance with ‘modified Written Authority Required procedures’; and
• removing the option of electronic submission of prescriptions.

Section 13 sets out the methods by which the Chief Executive Medicare may authorise the prescription which has been submitted.

Division 4 Maximum quantity and maximum repeats

Section 14 Maximum quantity

This section provides for the maximum quantity or number of units of a trastuzumab pharmaceutical benefit that may, in one prescription, be directed to be supplied on the one occasion under this Special Arrangement.

Paragraph 14(a) provides that, for a 3 weekly course of treatment, the maximum quantity or number of units that may be directed to be supplied on one occasion is 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 the trastuzumab pharmaceutical benefit approved by the Therapeutic Goods Administration (“TGA”).

Paragraph 14(b) provides that, for a weekly course of treatment, the maximum quantity or number of units that may be directed to be supplied on one occasion is 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 the trastuzumab pharmaceutical benefit approved by the TGA.

Section 15 Maximum number of repeats

This section provides for the maximum number of occasions an authorised prescriber may, in one prescription, direct the supply of a trastuzumab pharmaceutical benefit to be repeated under this Special Arrangement.

Paragraph 15(a) provides that no repeats may be prescribed for a prescription for the initial treatment of a patient not previously treated with a trastuzumab pharmaceutical benefit for HER2 positive early stage breast cancer.

Paragraph 15(b) provides that 3 repeats may be prescribed for a prescription for the continuing treatment with a trastuzumab pharmaceutical benefit for HER2 positive early stage breast cancer.

Paragraph 15(c) provides that no repeats may be prescribed for a prescription for a new loading dose in a patient previously treated with a trastuzumab pharmaceutical benefit for HER2 positive early stage breast cancer.

Section 16 No repeats for visitors

This section provides that a medical practitioner must not write a prescription for a trastuzumab pharmaceutical benefit 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 the Act.

Part 2  Supply of trastuzumab pharmaceutical benefits

Section 17 Entitlement to trastuzumab pharmaceutical benefit

This section provides that an eligible patient is entitled to receive a trastuzumab pharmaceutical benefit under this Special Arrangement without payment or consideration, other than a charge made in accordance with Part 4 (which sets out the applicable patient contributions that a supplier may charge an eligible patient), subject to other provisions of this Special Arrangement.

The term ‘eligible patient’ is defined in section 4 of this Special Arrangement.

Section 18 Supply of trastuzumab pharmaceutical benefit under this Special

                        Arrangement

Section 18 provides that a trastuzumab pharmaceutical benefit may be supplied under this Special Arrangement by an approved hospital authority for a public hospital to an eligible patient.

Under this Special Arrangement, an approved hospital authority for a public hospital includes a public hospital authority that has been approved under either the Act or the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2011 (PB 116 of 2010).

Part 3  Claiming procedures and payment amounts

Part 3 sets out the manner in which an approved hospital authority may make a claim for the supply of a trastuzumab pharmaceutical benefit under this Special Arrangement. It also specifies the amounts which may be claimed by an approved hospital authority for such supplies.

Section 19 Application

This section provides that Part 3 applies if an approved hospital authority for a public hospital supplies a trastuzumab pharmaceutical benefit to an eligible patient under this Special Arrangement and makes a claim for payment under this Special Arrangement.

Section 20 Claim for payment by approved hospital authority for a public

                        hospital

This section sets out the manner in which an approved hospital authority for a public hospital may make a claim for payment for the supply of a trastuzumab pharmaceutical benefit.

Subsection 20(1) provides that an approved hospital authority for a public hospital may make a claim for payment for the supply of a trastuzumab pharmaceutical benefit in accordance with the rules made by the Minister under subsection 99AAA(8) of the Act, subject to subsection 20(2) and section 22.

Subsection 20(2) provides that for claims under this Division:

• a reference in the rules to an approved supplier or an approved hospital authority includes a reference to a hospital authority that was approved by the Chief Executive Medicare under the special arrangement for the Highly Specialised Drugs program; and

• a reference in the rules to a number allotted to an approval under regulation 8A includes a reference to a number allotted to an approval under section 52 of the current special arrangement for the Highly Specialised Drugs program or under section 52 of the previous special arrangement for the Highly Specialised Drugs program; and

• a reference in the rules to an authority prescription includes a reference to a prescription for a trastuzumab pharmaceutical benefit under this Special Arrangement.

Section 21 Payment for supply of trastuzumab pharmaceutical benefit to

                        approved hospital authority for public hospital where claim for

                        payment is made

This section sets out the amount which may be claimed by an approved hospital authority for a public hospital that makes a claim for payment under the rules made by the Minister under subsection 99AAA(8) as modified by section 20.

This section does this by incorporating relevant provisions of PB 116 of 2010, which is the special arrangement concerning the Highly Specialised Drugs program. The relevant sections of PB 116 of 2010 relate to the amount that an approved hospital authority for a public hospital may claim for payment and the dispensed price for the supply of an HSD pharmaceutical benefit by an approved hospital authority for a public hospital under that arrangement.

An approved hospital authority for a public hospital is entitled to be paid the amount worked out in accordance with section 35 and paragraph 37(a) of PB 116 of 2010 as if a reference in those provisions to an HSD pharmaceutical benefit were a reference to a trastuzumab pharmaceutical benefit.

The effect of this section is that an approved hospital authority for a public hospital that makes a claim payment for supply of a trastuzumab pharmaceutical benefit in accordance with this Division is entitled to claim the dispensed price for the supply of the trastuzumab pharmaceutical benefit less any amount that the approved hospital authority was entitled to charge under section 23.

Section 22 Limit on number of prescriptions in one claim

This section provides that a claim for payment submitted by an approved hospital authority for a public hospital under this Division must not contain more than 3 500 prescriptions.

Part 4  Patient Contributions

Part 4 sets out the amounts that a patient may be charged for the supply of a trastuzumab pharmaceutical benefit under this Arrangement.

Section 23 Patient contributions in relation to approved hospital authorities

                        for public hospitals

This section sets out the amount that an approved hospital authority for a public hospital may charge a patient for the supply of a trastuzumab pharmaceutical benefit where a claim for payment is made under Part 3 of this Special Arrangement.

An approved hospital authority for a public hospital may charge the patient an amount equivalent to the amount that may be charge under subsection 87(2) of the Act for the supply of a pharmaceutical benefit to the patient.

Part 5  Miscellaneous

Section 24 PBS Safety Net

This section provides that any payment made by an eligible patient for the supply of a trastuzumab pharmaceutical benefit will count towards that patient’s safety net.

The Note following this section refers to the relevant provisions concerning safety net concession cards and entitlement cards.

Part 6  Transitional arrangements

Section 25 Prescriptions written prior to 1 December 2011

This section provides for transitional arrangements that deal with prescriptions written under PB 115 of 2010, but for which no supply of a trastuzumab pharmaceutical benefit was made to an eligible patient prior to the commencement of this Special Arrangement.

Subsection 25(2) provides that the trastuzumab pharmaceutical benefit may be supplied:

(a)   by:

•  an approved pharmacist;
•  an approved medical practitioner;
•  an approved hospital authority for a private hospital; or
•  a hospital authority for a public hospital that is not an approved hospital,

under this Special Arrangement, in accordance with PB 115 of 2010 as in force on 30 November 2011; or

(b)   by a hospital authority for a public hospital under and in accordance with this Special Arrangement.

Subsection 25(3) provides that if a supply is made under paragraph 25(2)(a), a claim may be lodged and processed under PB 115 of 2010, as in force on 30 November 2011.

Subsection 25(4) provides that paragraph 25(2)(a) stops having effect on 1 April 2012.

In accordance with section 15 of the Legislative Instruments Act 2003, a trastuzumab pharmaceutical benefit supplied under the old Arrangements prior to 1 December 2011 may be claimed and processed under the old Arrangements.

Section 26 Old Arrangements

This section explains that a reference in this Part to the ‘old Arrangements’ is a reference to PB 115 of 2010.

Schedule 1 Pharmaceutical benefits to which this Special Arrangement applies and related information

This Schedule sets out the pharmaceutical benefits covered by the Special Arrangement and a number of related matters. Some of the matters have been declared or determined in other legislative instrument and are included in this Arrangements for reasons of transparency.

The pharmaceutical benefits covered by the Special Arrangement have been determined in this Special Arrangement (section 5) even though the declarations and determinations which define those medicines as pharmaceutical benefits have been made in another instrument.

The matters dealt with in the various columns in the Schedule, the corresponding provisions of the Act and the related sections of the Special Arrangement are set out in the table below.

Schedule 2 Responsible person codes

This Schedule relates to section 7 of the Special Arrangement. The responsible person for each brand of a pharmaceutical item is identified by a two letter code in the column in Schedule 1 headed ‘Responsible Person’. Schedule 2 sets out, for each code mentioned in Schedule 1, the name of the responsible person and their ABN, if any.

Schedule 3 Circumstances

This Schedule relates to sections 9 and 11-13 of the Special Arrangement.

The prescription circumstances mentioned in section 9 of the Special Arrangement are the circumstances that are set out in this Schedule.