EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Efficient Funding of Chemotherapy)
Special Arrangement Amendment Instrument 2017 (No. 6)
PB 48 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 Section 3 Definitions and Schedules 1and 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 definitions for ‘diluent fee’, ‘dispensing fee’, ‘distribution fee’ and ‘preparation fee’ to reflect the indexation of these fees for 1 July 2017. These fees are indexed annually (WCI9) in conformity with the indexation of other fees provided for in the Sixth Community Pharmacy Agreement;
deletes the brands:
- Doxorubicin MYX for the listed drug Doxorubicin;
- Hospira Pty Limited and DBL Epirubicin Hydrochloride Injection for the listed drug Epirubicin;
- DBL Gemcitabine for Injection for the listed drug Gemcitabine;
- Irinotecan MYX for the listed drug Irinotecan;
- Methotrexate MYX for the listed drug Methotrexate;
- Hospira Pty Limited for the listed drug Mitozantrone; and
- Topotecan Agila for the listed drug Topotecan.
removes circumstance codes and purpose codes and their associated circumstances and purposes for the listed drug Pembrolizumab; and
adds a new pharmaceutical benefit for the listed drug Pembrolizumab.
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 July 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. 6)
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. 6) and that it may also be cited as PB 48 of 2017.
Section 2 Commencement
This section provides that this Instrument commences on 1 July 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).
Section 4 Schedules
This section provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the Schedule concerned. It also provides that any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1 Amendments
Item 1 revises the diluent fee to reflect that due to indexation, the fee is $5.21 on and from 1 July 2017.
Item 2 revises the dispensing fee to reflect that due to indexation, the fee is $7.15 on and from 1 July 2017.
Item 3 revises the distribution fee to reflect that due to indexation, the fee is $26.28 on and from 1 July 2017.
Item 4 revises the preparation fee to reflect that due to indexation, the fee is $83.83 on and from 1 July 2017.
Item 5 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Doxorubicin’ in the form ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial) by removing the brand ‘Doxorubicin MYX’ and responsible person ‘OC’.
Item 6 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 100 mg in 50 mL’ by removing the brand ‘Hospira Pty Limited’ and responsible person ‘PF’.
Item 7 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 removing the brand ‘DBL Epirubicin Hydrochloride Injection’ and responsible person ‘PF’.
Item 8 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 50 mg in 25 mL’, by removing the brand ‘Hospira Pty Limited’ and responsible person ‘PF’.
Item 9 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Gemcitabine’ in the forms ‘Powder for I.V. infusion 1 g (as hydrochloride)’; ‘Powder for I.V. infusion 2 g (as hydrochloride)’; and ‘Powder for I.V. infusion 200 mg (as hydrochloride)’ by removing the brand ‘DBL Gemcitabine for Injection’ and responsible person ‘PF’.
Item 10 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 100 mg in 5 mL’, by removing the brand ‘Irinotecan MYX’ and responsible person ‘OC’.
Item 11 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Methotrexate’ in the forms: ‘Injection 50 mg in 2 mL’ and ‘Solution concentrate for I.V. infusion 1000 mg in 10 mL vial’, by removing the brand ‘Methotrexate MYX’ and responsible person ‘OC’.
Item 12 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Mitozantrone’ in the form ‘Injection 20 mg (as hydrochloride) in 10 mL’ by removing the brand ‘Hospira Pty Limited’ and responsible person ‘PF’.
Item 13 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’ by removing the circumstance codes ‘C6828’ and ‘C6829’.
Item 14 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Pembrolizumab’ after the form ‘Powder for injection 50 mg’ by adding the form ‘Solution concentrate for I.V. infusion 100 mg in 4 mL’; manner of administration ‘Injection’; brand ‘Keytruda’; responsible person ‘MK’; authorised prescriber ‘MP’; and circumstance codes ‘C6801’,‘C6806’ and ‘C6817’.
Item 15 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Topotecan’ in the form ‘Powder for I.V. infusion 4 mg (as hydrochloride)’ by removing the brand ‘Topotecan Agila’ and responsible person ‘YA’.
Item 16 amends the entry in Schedule 1, Part 2 of the Special Arrangement for the listed drug ‘Pembrolizumab’ by removing the purpose codes ‘P6828’ and ‘6829’ and their associated maximum amounts and number of repeats.
Item 17 amends the entry in Schedule 4 of the Special Arrangement for the listed drug ‘Pembrolizumab’ by removing the circumstance codes ‘C6828’ and ‘C6829’ and their associated circumstances; and by removing purpose codes ‘P6828’ and ‘6829’ and their associated 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.