EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 5)
PB 46 of 2016
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 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 entitled ‘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 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:
- amends the circumstance codes, associated circumstances and purposes for the listed drugs ‘Eribulin’, ‘Ondansetron’ and ‘Rituximab’;
- adds the brands ‘Ondansetron GH’ and ‘Ondansetron ODT’ GH for the listed drug ‘Ondansetron’;
- removes the brand ‘Ondaz Zydis’ for the listed drug ‘Ondansetron’;
- removes the Responsible Person Mayne Pharma International Pty Ltd (YN); and
- adds a new Responsible Person Accord Healthcare Pty Ltd (OC).
A provision by provision description of this instrument is contained in 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). 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.
This instrument commences on 1 June 2016.
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 2016 (No. 5)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 5) and that it may also be cited as PB 46 of 2016.
Section 2 Commencement
This section provides that this Instrument commences on 1 June 2016.
Section 3 Amendments to PB 79 of 2011
This section amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (the Special Arrangement).
Item 1 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’ and brand ‘Doxorubicin MYX’ by removing the responsible person YN and adding a new responsible person OC.
Item 2 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Eribulin’ by removing the circumstance code ‘C4646’ and associated circumstance.
Item 3 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’ and brand ‘Irinotecan MYX’ by removing the responsible person YN and adding a new responsible person OC.
Item 4 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Methotrexate’ in in each of the forms ‘Injection 50 mg in 2 mL vial’ and ‘Solution concentrate for I.V. infusion 1000 mg in 10 mL vial’; and brand ‘Methotrexate MYX’ by removing the responsible person YN and adding OC.
Item 5 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Premetrexed’ in in each of the forms forms ‘Powder for I.V. infusion 100 mg (as disodium)’ and ‘Powder for I.V. infusion 500 mg (as disodium); and brand ‘Pemetrexed MYX’ by removing the responsible person YN and adding OC.
Item 6 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Rituximab’ by removing the circumstance code ‘C5980’, ‘C6001’, C6040’ and ‘C6058’; and associated circumstance and adding the new circumstance codes ‘C6161’ ‘C6162’ and ‘C6187’ and the associated circumstances.
Item 7 amends the entry in Schedule 1 Part 2 of the Special Arrangement for the listed drug ‘Rituximab’ by removing the purpose code ‘P5980’, ‘P6001’, ‘P6040’ and ‘P6058’; and adding the new purpose codes ‘P6161’ ‘P6162’ and ‘P6187’ and the associated maximum amounts and number of repeats.
Item 8 amends the entry in Schedule 2 of the Special Arrangement for the listed drug ‘Ondansetron’ in the forms ‘Tablet 4 mg (as hydrochloride dihydrate)’ and ‘Tablet 8 mg (as hydrochloride dihydrate)’ by adding the brand ‘Ondansetron GH’.
Item 9 amends the entry in Schedule 2 of the Special Arrangement for the listed drug ‘Ondansetron’ in the forms ‘Tablet 4 mg (orally disintegrating)’ and ‘Tablet 8 mg (orally disintegrating’’ by adding the brand ‘Ondansetron ODT GH’.
Item 10 amends the entry in Schedule 2 of the Special Arrangement for the listed drug ‘Ondansetron’ in the forms ‘Wafer 4 mg’ and ‘Wafer 8 mg’ by removing the brand ‘Ondaz Zydis’.
Item 11 amends the entry in Schedule 2 of the Special Arrangement for the listed drug ‘Rituximab’ by removing the circumstance code ‘C5980’, ‘C6004’, and C6040’ and associated circumstance and adding the new circumstance codes ‘C6161’ ‘C6162’ and ‘C6187’ and the associated circumstances.
Item 12 amends the entry in Schedule 3 of the Special Arrangement by adding the responsible person Accord Healthcare Pty Ltd (OC).
Item 13 amends the entry in Schedule 3 of the Special Arrangement by removing the responsible person Mayne Pharma International Pty Ltd (YN).
Item 14 amends the entry in Schedule 4 of the Special Arrangement for the listed drug ‘Eribulin’ by removing the circumstance code ‘C4646’ and the associated circumstances.
Item 15 amends the entry in Schedule 4 of the Special Arrangement for the listed drug ‘Rituximab’ by removing the circumstance code ‘‘C5980’, ‘C6001’, ‘C6004’, ‘C6040’ and ‘C6058’and the associated circumstances; and adding the new circumstance codes ‘C6161’ ‘C6162’ and ‘C6187’ and the associated circumstances.
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.
The Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.
Conclusion
This Legislaive Instrument is compatible with human rights because it advances the protection ohuman rights.