National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No. 9) (No. PB 93 of 2014)

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2014 (No.9)

PB 93 of 2014

Authority

Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits. 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) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).

Purpose

The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the the Act, is to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the highly specialised drugs program for hospitals.

The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving treatment at or from a public or private hospital having access to appropriate specialised facilities.

The amendment made by this Instrument reflects changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.

The amendments in PB 93 of 2014 include:

• amendments to exclude certain conditions relating to the approval of a person as an approved pharmacist from applying in circumstances relating to pharmaceutical benefits listed as highly specialised drugs;
• amendments to enable admitted patients receiving treatment at or from a public hospital to access certain HSD pharmaceutical benefits under the Special Arrangement; amendments to require eligible medical practitioners or approved hospital authorities to keep records relating to the prescription of certain HSD pharmaceutical benefits; and
• additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements).

These changes are summarised, by subject matter, in the Attachment.

A provision by provision Description of this instrument is contained in the Attachment.

Consultation

The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC). 

An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the 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), 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.

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

Jurisdictions were consulted on the amendments made by this Instrument which enable admitted patients receiving treatment at or from a public hospital to access certain HSD pharmaceutical benefits, and which require eligible medical practitioners or approved hospital authorities to keep clinical records relating to the prescription of certain HSD pharmaceutical benefits for a period of two years. This consultation involved correspondence with the jurisdictions.

This Instrument commences on 1 December 2014.

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

ATTACHMENT

PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2014 (No.9)

Section 1 Name of Instrument

This section provides that this instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2014 (No.9) and that it may also be cited as PB 93 of 2014.

Section 2 Commencement

This section provides that this instrument commences on 1 December 2014.

Section 3 Amendments to PB 116 of 2010

This section provides that Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement).

Schedule 1  Amendments

Item 1 amends the definition of ‘CAR drug’ to include the drugs Eculizumab and Ivacaftor.

Item 2 inserts a new definition of ‘eligible patient’ to clarify those patients who are eligible to be supplied pharmaceutical benefits under the Special Arrangement. This amendment expands upon the previous definition of eligible patient and enables admitted patients receiving treatment at or from a public hospital to be supplied those HSD pharmaceutical benefits referred to in section 9A under this Special Arrangement.

Item 3 inserts a new section 9A which refers to those HSD pharmaceutical benefits which may be supplied to admitted patients receiving treatment at or from a public hospital. The HSD pharmaceutical benefits are referred to in the table in section 9A.

Where there is only a drug referred to in the table in section 9A this is taken to be a reference to all HSD pharmaceutical benefits containing that drug. However:

• if there is a drug and a form referred to in the table, this is taken to be a reference to all HSD pharmaceutical benefits containing that drug in that form;
• if there is a drug and a form and a manner of administration referred to in the table, this is taken to be a reference to all HSD pharmaceutical benefits containing that drug in that form with that manner of administration; and
• if there is a drug and a form and a manner of administration and a brand referred to in the table, this is taken to be a reference to that brand of HSD pharmaceutical benefit containing that drug in that form with that manner of administration.

Additionally, where one or more circumstances and/or purposes codes are identified in the table, that HSD pharmaceutical benefit must be prescribed for one of those circumstances and or/purposes in order for it to be supplied to admitted patients receiving treatment at or from a public hospital. A reference to the circumstances and/or purposes code in this section is a reference to the circumstances/purposes code referred to in section 9 (circumstances code) or section 14 or section 15 (purposes code).

Item 4 inserts a new section 17A.  Section 17A provides that section 8 of the conditions of approval made under paragraph 92A(1)(f) of the Act, does not apply to the supply of an infusion, once prepared as a final product, when the infusion has a physical, chemical or biological stability restricting its clinically effective shelf life to 8 hours or less. This section also provides a definition for shelf life, being the period of time that a medicine can be stored and still be considered safe and effective for use.

Item 5 inserts a new section 22A which requires eligible medical practitioners prescribing certain HSD pharmaceutical benefits containing non-CAR drugs, or approved hospital authorities treating eligible patients with certain HSD pharmaceutical benefits containing non-CAR drugs, to keep a copy of any clinical records relating to that prescription, including any such records required to demonstrate the prescription was written in compliance with any relevant circumstances or purposes.

This section requires these records to be kept for a period of two years.

It is intended that eligible medical practitioners and approved hospital authorities make their own arrangements regarding how records are to be kept in compliance with this section. The obligation to keep a copy of each relevant record is on the prescriber or hospital authority i.e. it is not required that both parties to keep these records simultaneously.

Item 6 inserts a new section 23A which requires eligible medical practitioners prescribing certain HSD pharmaceutical benefits containing CAR drugs, or approved hospital authorities treating eligible patients with certain HSD pharmaceutical benefits containing CAR drugs, to keep a copy of any clinical records relating to that prescription, including any such records required to demonstrate the prescription was written in compliance with any relevant circumstances or purposes.

This section requires these records to be kept for a period of two years.

It is intended that eligible medical practitioners and approved hospital authorities make their own arrangements regarding how records are to be kept in compliance with this section. The obligation to keep a copy of each relevant record is on the prescriber or hospital authority i.e. it is not required that both parties to keep these records simultaneously.

Items 7 - 35 provide for additions, deletions and changes to drugs, forms, brands, responsible person codes, maximum quantities, the circumstances for prescribing various pharmaceutical benefits (including authority requirements).

These changes are summarised below.

SUMMARY OF CHANGES

Listed Drugs Added

Eculizumab  

Ivacaftor 

Simeprevir

Forms Deleted

Omalizumab Powder for Injection 150 mg with Diluent

Brands Added

Adefovir    Tablet containing adefovir dipivoxil 10 mg (APO-Adefovir)

Addition of Responsible Person Code

Vertex Pharmaceuticals (Australia) Pty Ltd [VR]

Alexion Pharmaceuticals Australasia Pty Ltd [XI]

Alteration of Responsible Person Code

Alteration of Circumstances