EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 9)
PB 77 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 National Health Act 1953 (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).
The instrument provides for amendments to Schedule 1 of the Special Arrangement to ensure that pharmaceutical benefits available under the Special Arrangement, for the efficient funding of chemotherapy, accurately 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.
The instrument also seeks to implement revised program arrangements for the provision of pharmaceutical benefits relating to chemotherapy infusions, as agreed under the Sixth Community Pharmacy Agreement.
This instrument:
- amends the definition section, section 3, in relation to the following terms: compound fee, preparation fee, start date and TGA licensed compounder;
- formalises the process for the payment of a compound fee, following stakeholder consultations in early 2016;
- removes the brands ‘Irinotecan Actavis 500’ for the listed drug ‘Irinotecan’; ‘Plaxel’ for the listed drug ‘Paclitaxel’; and ‘Vinorelbine Kabi’ for the listed drug ‘Vinorelbine’; and
- amends the manufacturer code for the listed drug ‘Topotecan’ and brand name ‘Hycamtin’.
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). 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.
Stakeholder consultation on the chemotherapy initiative was undertaken by the Department of Health. Stakeholders consulted included representatives from peak body organisations including Australian Private Hospital Association, Pharmacy Guild of Australia and the Society of Hospital Pharmacists of Australia; community and hospital based pharmacists (both public and private), compounding organisations (both TGA licensed and non-TGA licensed) State and Territory Departments of Health and the Department of Human Services.
This instrument commences on 1 September 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. 9)
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. 9) and that it may also be cited as PB 77 of 2016.
Section 2 Commencement
This section provides that this Instrument commences on 1 September 2016.
Section 3 Authority
This section provides that this instrument is made under subsection 100(2) of the National Health Act 1953.
Section 4 Schedules
This section specifies that amendments are made to each instrument as set out in the Schedule.
Schedule 1 Amendments
Items 1 to 4 Section 3
Items 1, 2, and 4 provide for amendments to section 3 of the Special Arrangement in relation to the definitions for compound fee, preparation fee, and TGA licensed compounder.
Item 3 provide for section 3 of the Special Arrangement to be amended so that the definition for start date is repealed. This is a consequence of amendments made under Item 5.
Item 5 updates the arrangements for the payment of a compound fee in accordance with the outcomes of stakeholder consultation conducted in early 2016. Under the new arrangements, $40 of the compound fee will continue to be paid through the preparation fee. The revised Division 2A makes provision for the payment of the additional $20 component of the compound fee payable to TGA licenced compounders, which cannot be made through the preparation fee.
The new Division 2A reflects the claims based arrangements which will continue until 31 March 2017 and that new arrangements will commence from 1 April 2017. From 1 April 2017, new processes are expected to be in place to enable payment of the $20 based on PBS data.
Item 6 repeals section 61 of the Special Arrangement as it is no longer necessary given the amendments made by item 5.
Item 7 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Irinotecan’ by removing the brand ‘Ironotecan Actavis 500’for the pharmaceutical benefit which is the listed drug ‘Irinotecan’.
Item 8 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Paclitaxel’ by removing the pharmaceutical benefit which is the listed drug ‘Paclitaxel’ in the form ‘Solution concentrate for I.V. infusion 100 mg in 16.7 mL’ and brand ‘Plaxel’.
Item 9 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Paclitaxel’ by removing the pharmaceutical benefit which is the listed drug ‘Paclitaxel’ in the form ‘Solution concentrate for I.V. infusion 150 mg in 25 mL’ and brand ‘Plaxel’.
Item 10 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Paclitaxel’ by removing the pharmaceutical benefit which is the listed drug ‘Paclitaxel’ in the form ‘Solution concentrate for I.V. infusion 30 mg in 5 mL’ and brand ‘Plaxel’.
Item 11 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Paclitaxel’ by removing the pharmaceutical benefit which is the listed drug ‘Paclitaxel’ in the form ‘Solution concentrate for I.V. infusion 300 mg in 50 mL’ and brand ‘Plaxel’.
Item 12 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)’; and brand ‘Hycamtin’ by removing the responsible person NV and adding SZ.
Item 13 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Vinorelbine’ by removing the pharmaceutical benefit which is the listed drug ‘Vinorelbine’ in the form ‘Solution for I.V. infusion 50 mg (as tartrate) in 5 mL’ and brand ‘Vinorelbine Kabi’.
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.