EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2013 (No. 6)
PB 36 of 2013
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 Act, is to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (the Special Arrangement), to make changes to the special arrangement relating to the efficient funding of chemotherapy.
The Special Arrangement achieves greater efficiency in payment for the supply of injected or infused chemotherapy medicines (“chemotherapy pharmaceutical benefits”) to eligible patients being treated for cancer, to reflect the 2010 budget measure titled ‘Revised arrangements for the efficient funding of chemotherapy drugs’. This Special Arrangement also relates to the supply of medicines associated with the side-effects of cancer and cancer treatment (“related pharmaceutical benefits”) at certain public hospitals.
This instrument makes changes to the pharmaceutical benefits available under the section 100 special arrangement for the efficient funding of chemotherapy. These changes reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act, which commence on the same day.
This Instrument removes two listed brands for the listed drugs ‘Epirubicin’, and ‘Irinotecan’.
The instrument also amends the definitions for ‘diluent fee’, ‘dispensing fee’, ‘distribution fee’ and ‘preparation fee’ to reflect the indexation of these fees for 1 July 2013. These fees are indexed annually (WCI9) in conformity with the indexation of other fees provided for in the Fifth Community Pharmacy Agreement.
As announced by the Minister for Health, on 5 May 2013, an additional $60 is also being added to the current preparation fee after indexation, as a part of the ‘Increased Funding for Chemotherapy Services’ initiative. The additional funding will be provided for each chemotherapy infusion supplied between 1 July 2013 and 31 December 2013, while a review of chemotherapy funding arrangements is undertaken. This interim funding is being provided to support the ongoing viability of the provision of chemotherapy medicines.
If a Government decision is made, following the review of chemotherapy funding arrangements, that the additional increase to the Preparation fee will not continue after 31 December 2013 then amendment would need to be made to the Special Arrangement, registered in December 2013, to commence on 1 January 2014 to remove the additional $60 from the preparation fee. The effect of such an amendment would be that Approved Suppliers would not receive the additional $60 per infusion for supplies made on and from 1 January 2014.
A provision by provision description of this Instrument is contained in the Attachment.
Consultations
An ongoing and formal process of consultation in relation to matters relevant to this instrument includes the involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (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.
In relation to additional interim funding under the ‘Increased Funding for Chemotherapy Services’ initiative, the Department of Health and Ageing has consulted widely with a range of stakeholders and groups. These include hospitals and pharmacies, the Australian Private Hospitals Association, the Society of Hospital Pharmacists of Australia and the Pharmacy Guild of Australia. Senior staff from the Department of Health and Ageing also visited a number of chemotherapy suppliers, third party chemotherapy compounders, and private hospitals with chemotherapy services across Australia.
This Instrument commences on 1 July 2013.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2013 (No. 6)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 6) and that it may also be cited as PB 36 of 2013.
Section 2 Commencement
This section provides that this Instrument commences on 1 July 2013.
Section 3 Amendments to PB 79 of 2011
This section provides that Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (the Special Arrangement).
Schedule 1
Item 1 revises the diluent fee to reflect that due to indexation the fee is $4.91 on and from 1 July 2013.
Item 2 revises the dispensing fee to reflect that due to indexation the fee is $6.63 on and from 1 July 2013.
Item 3 revises the distribution fee to reflect that due to indexation the fee is $24.79 on and from 1 July 2013.
Item 4 revises the preparation fee to reflect that due to indexation and a decision to add $60 to the fee, the fee is $101.33 on and from 1 July 2013.
Item 5 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Epirubicin’ by removing a pharmaceutical benefit, which is the listed drug ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’ with manner of administration ‘Injection/intravesical’ and brand ‘Epirubicin SZ’.
Item 6 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Irinotecan’ by removing a pharmaceutical benefit, which is the listed drug ‘Irinotecan’ in the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL’ with manner of administration ‘Injection’ and brand ‘Irinotecan SZ’.