National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 12) (PB 114 of 2016)

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 12)

PB 114 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 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.

The Instrument provides for amendments to Schedules 1, 2, 3 and 4 of the Special Arrangement to ensure that pharmaceutical benefits available under the Special Arrangement for the Efficient Funding of Chemotherapy accurately reflect changes 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:

        Adds new pharmaceutical benefits which are the listed drug ‘Doxorubicin’ in a specified form, manner of administration and brand; and the listed drug ‘Irinotecan’ in a specified form, manner of administration and brand;

        Amends the circumstance codes, purpose codes and associated circumstances and purposes for the listed drugs ‘Interferon Alfa-2a’, ‘Interferon Alfa-2b’ and ‘Ipilimumab’;

        Amends the responsible person for the listed drugs ‘Bleomycin’, ‘Carboplatin’, ‘Cisplatin’, ‘Docetaxel’, ‘Doxorubicin’, ‘Epirubicin’, ‘Fluorouracil’, ‘Folinic acid’, ‘Gemcitabine’, ‘Irinotecan’, ‘Methotrexate’, ‘Mitozantrone’, ‘Oxaliplatin’, ‘Paclitaxel’, ‘Pemetrexed’, ‘Raltitrexed’, ‘Vinblastine’, ‘Vincristine’ and ‘Vinorelbine’, each in (a) specified form(s), (a) specified manner(s) of administration and (a) specified brand(s); and

        Amends two forms of the listed drug ‘Pemetrexed’ to correct a misdescription.

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.

This Instrument commences on 1 January 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 2016 (No. 12)

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. 12) and that it may also be cited as PB 114 of 2016.

Section 2 Commencement

This section provides that this Instrument commences on 1 January 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

Items 1 to 25 and Items 27 to 29 Schedules 1 (Parts 1 and 2), 2 and 4

Items 1 to 25 and 27 to 29 provide for the amendment of manufacturer (‘responsible person’) codes, the amendment and removal of restrictions and the addition of new pharmaceutical items.  These changes are summarised below:

Item 26 Schedule 3

Item 26 amends Schedule 3 of the Special Arrangement by removing the responsible person code ‘HH’ (‘Hospira Pty Limited’) from the list of responsible person codes.

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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.

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