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. 7)
PB 53 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.
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:
- omits a pharmaceutical benefit;
- inserts a new pharmaceutical benefit that has a currently listed drug;
- amends a pharmaceutical benefit by changing the brand; and
- changes the responsible person for various pharmaceutical benefits.
A provision by provision description of the amendments made by 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), 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 August 2011.
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 2011 (No.7)
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.7) and that it may also be cited as PB 53 of 2011.
Section 2 Commencement
This section provides that this Instrument commences on 1 August 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 ‘Epoetin Alfa’ to delete a pharmaceutical benefit that has the listed drug ‘Epoetin Alfa’, the form ‘Injection 30,000 units in 0.75 mL pre-filled syringe, and the brand ‘Eprex 30,000’.
Item 2 amends the entry in Schedule 1 of the Principal Instrument for all pharmaceutical benefits that have the listed drug ‘Etanercept’ to change the responsible person from ‘Wyeth Australia Pty Limited’ to ‘Pfizer Australia Pty Ltd’.
Item 3 amends the entry in Schedule 1 of the Principal Instrument for ‘Filgrastim’ to add a new pharmaceutical benefit that has the listed drug ‘Filgrastim’, the form ‘Injection 120 micrograms in 0.2 mL single use pre-filled syringe, and the brand ‘Nivestim’.
Item 4 amends the entry in Schedule 1 of the Principal Instrument for the pharmaceutical benefit that has the listed drug ‘Infliximab’ to change the responsible person from ‘Schering-Plough Pty Limited’ to ‘Janssen-Cilag Pty Ltd’.
Item 5 amends the entry in Schedule 1 of the Principal Instrument for all pharmaceutical benefits that have the listed drug ‘Maraviroc’ to change the responsible person from ‘Pfizer Australia Pty Limited’ to ‘ViiV Healthcare Pty Ltd’.
Item 6 amends the entry in Schedule 1 of the Principal Instrument for ‘Sirolimus’ to change the responsible person from ‘Wyeth Australia Pty Limited’ to ‘Pfizer Australia Pty Ltd’ for the pharmaceutical benefits that have the listed drug ‘Sirolimus’ and the forms ‘Tablet 1 mg’, ‘Tablet 2 mg’ and ‘Oral solution 1 mg per mL, 60 mL’. Item 6 also changes the brand for the pharmaceutical benefit that has the listed drug ‘Sirolimus’ and the form ‘Tablet 0.5 mg’ from ‘Rapamune (Pfizer Australia Pty Limited)’ to ‘Rapamune’.
Item 7 amends Schedule 2 of the Principal Instrument to omit the responsible person code ‘SH’ for the responsible person ‘Schering-Plough Pty Limited’.
Item 8 amends Schedule 2 of the Principal Instrument to omit the responsible person code ‘WX’ for the responsible person ‘Wyeth Australia Pty Limited’.