EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2014 (No.8)
PB 63 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 63 of 2014 involve the addition of drug Macitentan, removal of the drug Darunavir in the form Tablet 400 mg (as ethanolate), and amendments to the circumstances for the drugs Ambrisentan, Bosentan, Epoprostenol, Iloprost, Infliximab, Sildenafil, and Tadalafil.
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.
This Instrument commences on 1 September 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.8)
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.8) and that it may also be cited as PB 63 of 2014.
Section 2 Commencement
This section provides that this instrument commences on 1 September 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
The amendments in Schedule 1 involve the addition of a drug, addition of a brand, changes to the maximum quantities and the circumstances for prescribing various pharmaceutical benefits (including authority requirements). These changes are summarised below.
SUMMARY OF CHANGES
Alteration to Definitions
CAR drug The definition for ‘CAR drug’ provided in Part 1, Division 1, Section 4 has been amended to include the drug Macitentan.
Listed Drugs Added
Macitentan
Drugs Deleted
Darunavir In the form: Tablet 400 mg (as ethanolate).
Alteration of Circumstances
Listed Drug | Alteration |
Ambrisentan | Circumstances amended to provide more specific criteria defining response to treatment. |
Bosentan | Circumstances amended to provide more specific criteria defining response to treatment. |
Epoprostenol | Circumstances amended to provide more specific criteria defining response to treatment. |
Iloprost | Circumstances amended to provide more specific criteria defining response to treatment. |
Infliximab | Circumstances amended to include more specific criteria for prescription circumstances. |
Sildenafil | Circumstances amended to provide more specific criteria defining response to treatment. |
Tadalafil | Circumstances amended to provide more specific criteria defining response to treatment. |