EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 5)
PB 39 of 2012
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.
On and from 1 July 2012 the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations) prescribe a new defined ‘paperless claim for payment’, which is required to include a ‘supply certification form’ (as defined in the Regulations). This Instrument makes consequential amendments to the Special Arrangement to make it clear when a claim under this Special Arrangement meets the new definition of ‘paperless claim for payment’, that the supplier does not have to include a ‘supply certification form’.
This instrument also makes changes to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (the main listing instrument) made under sections 84AF, 85, 85A, 88 and 101 of the Act, which commence on the same day.
This instrument amends the circumstances associated with the listed drug ‘Zoledronic Acid’ to provide for the use of the listed drug for the treatment of patients with bone metastases from castration-resistant prostate cancer under this Special Arrangement.
This instrument also corrects errors in the identification of section 100 only status for listed brands with the listed drugs ‘Abatacept’, ‘Clozapine’, ‘Cyclosporin’, ‘Levodopa with Carbidopa’ and ‘Pamidronic Acid’. The corrections ensure that this Special Arrangement correctly reflects the section 100 only status in the main listing instrument.
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), 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 July 2012.
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 2012 (No. 5)
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 2012 (No.5) and that it may also be cited as PB 39 of 2012.
Section 2 Commencement
This section provides that this Instrument commences on 1 July 2012.
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
SUMMARY OF CHANGES
Paperless claim for payment
Items 1-3 amend the Special Arrangement to reflect that a claim made under Part 4 Division 2 of the Special Arrangement is a ‘paperless claim for payment’ (within the meaning of the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations)), but the ‘supply certification form’ otherwise required by new regulation 31(4) of the Regulations on and from 1 July 2012 is not required.
Alteration of circumstances
Listed Drug | Alteration |
Zoledronic Acid | Circumstances amended in relation to treatment of patients with bone metastases from castration-resistant prostate cancer |
Correction to Section 100 only status
For the pharmaceutical benefit with the listed drug ‘Abatacept’ the letter indicated in the column headed ‘Section 100 only’ is amended to reflect that it is only that pharmaceutical benefit with the listed drug ‘Abatacept’ that is only available under a section 100 special arrangement.
For listed brands with the listed drugs ‘Clozapine’ and ‘Cyclosporin’ the letter indicating section 100 only status is added to the column headed ‘Section 100 only’ for some listed brands where that status has not previously been included to make it clear that the section 100 only status applies to those listed brands as well as other listed brands with the same drug, form and manner of administration.
For the pharmaceutical benefit with the listed drug ‘Levodopa with Carbidopa’ the letter indicated in the column headed ‘Section 100 only’ is amended to reflect that it is only for specific circumstances that the pharmaceutical benefit is only available under a section 100 special arrangement.
For listed brands with the listed drug ‘Pamidronic Acid’ the letter indicated in the column headed ‘Section 100 only’ is amended to reflect that the particular pharmaceutical benefits with the listed drug ‘Pamidronic Acid’ are only available under a section 100 special arrangement.