EXPLANATORY STATEMENT
Issued by Authority of the Minister for Health and Ageing
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No. 11)
PB 86 of 2011
Purpose
The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the National Health Act 1953 (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.
This instrument amends the circumstances associated with three pharmaceutical benefits with the listed drug ‘Ribavirin and Peginterferon Alfa-2b’, adds a new pharmaceutical benefit with the listed drug ‘Darunavir’ and changes the section 100 only status from ‘C’ to ‘D’ for ‘Doxorubicin - Pegylated Liposomal’ and ‘Rituzimab’.
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.
Section 100 special arrangements and Part VII of the Act
Subsection 100(1) 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 inadequate for that treatment; or
(c) if the pharmaceutical benefits covered by the arrangements can be more conveniently or efficiently supplied under the 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 arrangement may thus modify the operation of Part VII, the regulations and other relevant instruments.
Subsection 100(2) provides that the Minister may vary or revoke a special arrangement made under subsection (1).
Changes to the Special Arrangement made by this Instrument
This instrument makes changes to the pharmaceutical benefits available under the section 100 special arrangement for the Highly specialised drugs program for hospitals. The changes made by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument made under sections 84AF, 85, 85A, 88 and 101 of the Act, which commences on the same day.
This instrument:
- amends the prescription circumstances for which the supply of pharmaceutical benefits may be written associated with three pharmaceutical benefits;
- adds a new pharmaceutical benefit; and
- changes the section 100 status of two listed drugs to section 100 only drug status.
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), 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 prescribing circumstances for listings on the PBS and for this Instrument. This includes consultation through the PBAC process, and agreement to final listing details.
General
This Instrument commences on 1 December 2011.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
A provision by provision description of this Instrument is contained in the Attachment.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No.11)
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 2011 (No.11) and that it may also be cited as PB 86 of 2011.
Section 2 Commencement
This section provides that this Instrument commences on 1 December 2011.
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 Principal Instrument).
Schedule 1
Item 1 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Darunavir’ to add a pharmaceutical benefit, which is the listed drug ‘Darunavir’ in the form ‘Tablet 400 mg (as ethanolate)’ with manner of administration ‘Oral’ and brand ‘Prezista’.
Item 2 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Doxorubicin - Pegylated Liposomal’ by changing the section 100 only status from ‘C’ to ‘D’.
Item 3 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Ribavirin and Peginterferon Alfa-2b’ in the form Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent by omitting the circumstances codes ‘C3055’ and ‘C3413’ and inserting the circumstances codes ‘C3948’ and ‘C3949’.
Item 4 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Ribavirin and Peginterferon Alfa-2b’ in the form Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent by omitting the circumstances codes ‘C3055’ and ‘C3413’ and inserting the circumstances codes ‘C3948’ and ‘C3949’.
Item 5 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Ribavirin and Peginterferon Alfa-2b’ in the form Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent by omitting the circumstances codes ‘C3055’ and ‘C3413’ and inserting the circumstances codes ‘C3948’ and ‘C3949’.
Item 6 amends the entry in Schedule 1 of the Principal Instrument for the listed drug ‘Rituximab’ by changing the section 100 only status from ‘C’ to ‘D’.
Item 7 amends the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Darunavir’ to insert the new circumstance codes ‘C3940’ and ‘C3941’ and their associated circumstances.
Items 8 and 9 amend the entry in Schedule 3 of the Principal Instrument for the listed drug ‘Ribavirin and Peginterferon Alfa-2b’ to insert the circumstances codes ‘C3413’, ‘C3948’ and ‘C3949’ and their associated circumstances.