EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Efficient Funding of Chemotherapy)
Special Arrangement Amendment Instrument 2017 (No. 3)
PB 21 of 2017
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 subsection 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 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’. The 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 amendments to Schedules 1 and 4 of the Special Arrangement to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day. The National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
This Instrument:
amends the circumstance codes and associated circumstances and purposes codes and associated purposes for the listed drugs ‘Brentuximab Vedotin’ and Pembrolizumab;
adds the brand ‘Epirubicin Accord’ for the listed drug ‘Epirubicin’ and the brand ‘Methotrexate Accord’ for the listed drug ‘Methotrexate’;
deletes the brand ‘Irinotecan Alphapharm’ for the listed drug Irinotecan; and
makes a minor machinery change to section 60(1), the transitional arrangements for existing medication chart prescribing, to allow the utilisation of previously approved medication charts until the PBS Hospital Medication Chart is available in most prescribing software packages.
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 the Special Arrangement includes the involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (PBAC). The 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. Part VII of the Act only applies to drugs or medicinal preparations recommended by the PBAC. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme, the PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia and its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
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 these interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.
Pharmaceutical companies are consulted throughout the process for additions and changes to listings on the Pharmaceutical Benefits Scheme (PBS), including consultation through the PBAC process and agreement to final listing details.
It was considered that further consultation for this Instrument was unnecessary due to the nature of the consultation that has already taken place.
This Instrument commences on 1 April 2017.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2017 (No. 3)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 3) and that it may also be cited as PB 21 of 2017.
Section 2 Commencement
This section provides that this Instrument commences on 1 April 2017.
Section 3 Amendment of 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 Amendments
Item 1 amends section 60(1) by extending the period of time, from 1 April 2017 to 1 March 2019, for which prescribers may use previously approved medication charts while software vendors complete necessary changes to facilitate the adoption of the PBS Hospital Medication Chart.
Item 2 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Brentuximab Vedotin’ in the form ‘Powder for I.V. Infusion 50 mg’ and brand ‘Adcetris’ by adding the circumstance codes ‘C6800’, ‘C6816’, ‘C6826’ and ‘C6838’.
Item 3 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’ by adding the brand ‘Epirubicin Accord’ with a responsible person code of ‘OC’.
Item 4 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Irinotecan’ in the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL’, manner of administration ‘Injection’ and brand ‘IRINOTECAN ACT’ by deleting the brand ‘Irinotecan Alphapharm’ with a responsible person code of ‘AF’.
Item 5 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Methotrexate’, in the form ‘Injection 50 mg in 2 mL vial’, and manner of administration ‘Injection’ by adding the brand ‘Methotrexate Accord’ with a responsible person code of ‘OD’.
Item 6 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Methotrexate’, in the form ‘Solution concentrate for I.V. infusion 1000 mg in 10 mL vial’ and manner of administration ‘Injection’ by adding the brand ‘Methotrexate Accord’ with a responsible person code of ‘OD’.
Item 7 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Pembrolizumab’ in the form ‘Powder for injection 50 mg’ and the manner of administration ‘Injection’, by removing the circumstance codes ‘C5362’, ‘C6093’, ‘C6103’ and ‘C6104’; and adding circumstance codes ‘C6801’, ‘C6806’, ‘C6817’, ‘C6828’ and ‘C6829’.
Item 8 amends the entry in Schedule 1, Part 2 of the Special Arrangement for the listed drug ‘Brentuximab vedotin’ by adding purpose codes ‘P6800’, ‘P6816’, ‘P6826’, and ‘P6838’.
Item 9 amends the entry in Schedule 1, Part 2 of the Special Arrangement for the listed drug ‘Pembrolizumab’ by removing purpose codes ‘P5362’, ‘P6093’, ‘P6094’, ‘P6103’ and ‘P6104’; and adding purpose codes ‘P6801’, ‘P6806’, ‘P6817’, ‘P6828’ and ‘P6829’.
Item 10 amends the entry in Schedule 4 of the Special Arrangement for the listed drug ‘Bretuximab vedotin’ by adding circumstance codes ‘C6800’, ‘C6816’, ‘C6826’ and ‘C6838’, purpose codes ‘P6800’, ‘P6816’, ‘P6826’ and ‘P6838’and their associated circumstances and purposes.
Item 11 amends the entry in Schedule 4 of the Special Arrangement for the listed drug ‘Pembrolizumab’ by:
- removing circumstance codes ‘C5362’, ‘C6093’, ‘C6094’, ‘C6103’ and ‘C6104’, and purpose codes ‘P5362’, ‘P6093’, ‘P6094’, ‘P6103’ and ‘P6104’ and their associated circumstances and purposes; and
- adding circumstance codes ‘C6801’, ‘C6806’, ‘C6817’, ‘C6828’ and ‘C6829’, and purpose codes ‘P6801’, ‘P6806’, ‘P6817’, ‘P6828’ and ‘P6829’ and their associated circumstances and purposes.
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Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 4)
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
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:
- adds 4 new listed brands for the listed drugs ‘Doxorubicin’, and ‘Gemcitabine’;
- adds 1 new listed form for the listed drug ‘Aprepitant’;
- removes 2 listed brands for the listed drug ‘Docetaxel’; and
- adds new circumstance codes and the associated circumstances for the listed drug ‘Aprepitant’.
Human rights implications
This legislative instrument engages Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.