EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2020 (No. 10)
PB 116 of 2020
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 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 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.
Schedule 1 to this Instrument provides for the addition of a brand of the listed drug arsenic, the alteration of circumstances in which a prescription may be written for the supply of the listed drug obinutuzumab, the alteration of the responsible person for a brand of the listed drug trastuzumab and the addition of a responsible person code to the list of responsible persons.
Schedule 1 also makes changes to allow for pharmaceutical benefits to be listed under the Special Arrangement without an authorised prescriber from 1 December 2020 and therefore be listed for supply only, consistent with Schedule 1 Part 2 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.
Pharmaceutical benefits will be listed for supply only for a period of up to 12 months, after which time they will be fully de-listed from the PBS (available for neither prescribing nor supply). This will provide administrative clarity for the Department, Services Australia, Approved Pharmacists and software vendors who have been relying on manual workarounds, prior to these changes taking affect, to ensure that patients receive critical medicines regardless of the administrative circumstances of a pharmaceutical benefit.
These supply only arrangements ensure that patients will not be disadvantaged as existing valid prescriptions will remain valid after the pharmaceutical benefit is removed for prescribing purposes. This removes the need for a patient to consult with their prescriber about an existing prescription which has become invalid due to the delisting of the pharmaceutical benefit.
These changes are summarised, by subject matter, 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 December 2020.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2020 (No. 10)
Section 1 Name of Instrument
This section provides the name of this Instrument as the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 10) and may also be cited as PB 116 of 2020.
Section 2 Commencement
This section provides that this Instrument commences on 1 December 2020.
Section 3 Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (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).
Schedule 1 Amendments
The amendments in Schedule 1 involve the addition of a brand, the alteration of the responsible person for a brand of a listed drug, the addition of a responsible person code to the list of responsible persons and the alteration of circumstances for prescribing a pharmaceutical benefit available on the Special Arrangement. They also involve changes to allow for pharmaceutical benefits to be available for supply only. These changes are summarised below.
SUMMARY OF CHANGES TO THE NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT 2011 MADE BY THIS INSTRUMENT
Section 7
Note amended to allow ‘supply only’ arrangements to apply to chemotherapy pharmaceutical benefits and related pharmaceutical benefits when mentioned in Part 2 of Schedule 1 to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (ready prepared pharmaceutical benefits for supply only).
Brand Added
Listed Drug | Form |
Arsenic | Injection concentrate containing arsenic trioxide 10 mg in 10 mL |
Alteration of Responsible Person
Listed Drug | Form | Brand Name | Responsible Person Code |
Trastuzumab | Powder for I.V. infusion 150 mg | Ontruzant | From: MK |
Addition of Responsible Person Code
Responsible Person and Code |
Organon Pharma Pty Ltd (OQ) |
Alteration of Circumstances in Which a Prescription May be Written
Listed Drug |
Obinutuzumab |
Document/s incorporated by reference
Listed Drug | Document incorporated | Document access |
Obinutuzumab | Cumulative Illness Rating Scale (CIRS). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003. The CIRS is one of the existing tools to measure multimorbidity (the co-occurrence of two or more chronic health conditions). This index measures the chronic medical illness burden while taking into consideration the severity of chronic diseases. | The Cumulative Illness Rating Scale is available for download for free from following website: https://www.aftermd.com/downloads/CIRS_CLL_Guide_2017.pdf |
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 2020 (No. 10)
(PB 116 of 2020)
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 subsection 100(2) of the National Health Act 1953 (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 provides for amendments to the Special Arrangement to ensure that the Special Arrangement accurately reflects 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.
The amendments in Schedule 1 involve the addition of a brand, the alteration of the responsible person for a brand of a listed drug, the addition of a responsible person code to the list of responsible persons and the alteration of circumstances for prescribing a pharmaceutical benefit available on the Special Arrangement. They also involve changes to allow for pharmaceutical benefits to be available for supply only.
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 the 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 Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Thea Connelly
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Department of Health