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. 3)
PB 28 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 adds a new Complex Authority Required (CAR drug) and related circumstances, maximum quantities and maximum number of repeats for pharmaceutical benefits that have that CAR drug. It also removes another CAR drug as that drug will no longer be listed on the Pharmaceutical Benefits Scheme (PBS) from 1 April 2011.
This instrument also amends the circumstances for, and forms of, various pharmaceutical benefits and amends the additional patient contributions payable for supplies of two pharmaceutical benefits.
Details of the amendments made by this instrument are set out 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 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 April 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.3)
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. 3) and that it may also be cited as PB 28 of 2011.
Section 2 Commencement
This section provides that this Instrument commences on 1 April 2011.
Section 3 Amendments to PB 116 of 2010
Section 3 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 definition of a Complex Authority Required (CAR) drug in section 4 of the Principal Instrument to:
- add the newly listed drug Romiplostin; and
- remove the drug Sitaxentan.
Item 2 amends paragraph 24(2)(a) of the Principal Instrument to remove the limitation on the maximum quantity that may be supplied on one occasion for HSD pharmaceutical benefits that have the drug Sitaxentan.
Item 3 amends subsection 24(2) of the Principal Instrument to provide for limitations on the maximum quantity that may be supplied on one occasion for HSD pharmaceutical benefits that have the drug Romiplostin.
Item 4 amends paragraph 25(2)(l) of the Principal Instrument to remove the limitation on the maximum number of repeat supplies that may be authorised in one prescription for HSD pharmaceutical benefits that have the drug Sitaxentan.
Item 5 amends subsection 25(2) of the Principal Instrument to provide for limitations on the maximum number of repeat supplies that may be authorised in one prescription for HSD pharmaceutical benefits that have the drug Romiplostin.
Item 6 amends the entry for the listed drug Ambrisentan in Schedule 1 of the Principal Instrument to remove the circumstance code C3213.
Item 7 amends the entry for the listed drug Filgrastim in Schedule 1 of the Principal Instrument to:
- add new HSD pharmaceutical benefits with the listed drug Filgrastim and the forms Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim) and Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim); and
- amend the forms Injection 300 micrograms in 0.5 mL single use pre-filled syringe and Injection 480 micrograms in 0.5 mL single use pre-filled syringe to incorporate the brand name Neupogen as part of the form.
Item 8 amends the entry for the listed drug Infliximab in Schedule 1 of the Principal Instrument to replace the Circumstances Codes C3452, C3453, C3454 and C3455 with the Circumstance Codes C3691, C3692, C3693, C3694.
Item 9 amends Schedule 1 of the Principal Instrument to add a new entry for the newly listed drug Romiplostin.
Item 10 amends Schedule 1 of the Principal Instrument to remove the entry for the drug Sitaxentan.
Item 11 amends the entry for the listed drug Valaciclovir in Schedule 1 of the Principal Instrument to add a new brand APO-Valaciclovir for the form Tablet 500 mg (as hydrochloride).
Item 12 amends the entry for the listed drug Ambrisentan in Schedule 3 of the Principal Instrument to remove the circumstance C3213.
Item 13 amends the entry for the listed drug Infliximab in Schedule 3 of the Principal Instrument to replaces circumstances C3452, C3453, C3454 and C3455 with circumstances C3691, C3692, C3693, and C3694.
Item 14 amends Schedule 3 of the Principal Instrument to add a new entry for the newly listed drug Romiplostin.
Item 15 amends Schedule 3 of the Principal Instrument to remove the entry for the drug Sitaxentan.
Item 16 amends the entry for the listed drug Cyclosporin in Schedule 4 of the Principal Instrument to:
- amend the value of the Approved ex-manufacturer price and the Claimed ex-manufacturer price for the remaining forms.