EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Efficient Funding of Chemotherapy)
Special Arrangement Amendment Instrument 2017 (No. 11)
PB 96 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.
The Instrument:
a) Updates references to the National Health (Pharmaceutical Benefits) Regulations 2017;
b) Introduces a new mandatory field, ‘compounder ID’, within a claim for the supply of a medicine listed under Schedule 1 of the Special Arrangement; and
c) Amends the start date for the revised payment arrangements to be introduced from 1 February 2018 to 1 December 2017 and provides that where a medicine is compounded by a TGA licensed compounder from 1 December 2017 the TGA licensed compounder is eligible to receive a direct payment of $20; and
d) Amends the transitional provisions by removing the date by which the transitional period for using infusion medication charts or medication charts apply. The Instrument also removes reference to provisions relating to the trial of the Pharmaceutical Benefits Scheme (PBS) Hospital Medication Charts Trial.
e) Amends Schedules 1 and 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. PB 71 of 2012 is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
The Schedule amendments:
add and remove circumstance codes and purpose codes and their associated circumstances and purposes for the listed drugs Brentuximab vedotin, Eribulin, and Pemetrexed; and
remove a form of the listed drug Etoposide.
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.
A separate consultation process was undertaken in regard to the program changes to the Special Arrangement. State and Territory Government Departments of Health and the Department of Human Services have been consulted regarding a suitable date for implementation of revised claiming and payment arrangements for the compounding fee. In addition, Industry was provided with three months’ notice of the implementation of the new mandatory claiming field, which beings on 1 December 2017. Industry has no objections to the revised implementation date.
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 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. 11)
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. 11) and that it may also be cited as PB 96 of 2017.
Section 2 Commencement
This section provides that this Instrument commences on 1 December 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).
Schedule 1 Amendments
The amendments in Schedule 1 involve the deletion of a form and alteration to the circumstances for prescribing various pharmaceutical benefits. These changes are summarised below.
SUMMARY OF CHANGES
Item 1 inserts a new definition ‘additional TGA licensed compounding fee’. This fee relates to the amount payable to TGA licensed compounders for the compounding of a dose of a chemotherapy drug for an infusion.
Item 2 amends the definition of ‘authority prescription’ to mean a prescription that meets the requirements of section 30 of the National Health (Pharmaceutical Benefits) Regulations 2017. This is a consequential change resulting from the repeal of the National Health (Pharmaceutical Benefits) Regulations 1960 and remaking as the National Health (Pharmaceutical Benefits) Regulations 2017.
Items 3 – 4 remove the definition of ‘compound fee’ and insert a new definition for ‘compounder ID’. The compounder ID is an identifier allocated to a compounder for the purpose of claiming supplies made under Schedule 1 of the Special Arrangement. Compounder refers to an entity that undertakes and is responsible for the compounding of an infusion. Compounder IDs are allocated by the Chemotherapy Compounding Payment Scheme Administration Agency, a role currently undertaken by Australian Healthcare Associates Pty Ltd. The ‘compound fee’ definition was removed to avoid confusion regarding the total amount payable to TGA licensed compounders and approved suppliers.
Item 5 repeals and replaces the note to the definition of ‘preparation fee’. The note explains that the preparation fee includes a $40 compounding fee paid to approved suppliers for compounding the dose of a chemotherapy drug in an infusion. Where an infusion is compounded by a TGA licensed compounder, an additional fee of $20 is paid to the TGA licensed compounder (additional TGA licensed compounding fee) as provided for in section 46B of the Special Arrangement.
Item 6 amends the definition of ‘Regulations’ to refer to the National Health (Pharmaceutical Benefits) Regulations 2017. This is a consequential change resulting from the repeal of the National Health (Pharmaceutical Benefits) Regulations 1960 and remaking as the National Health (Pharmaceutical Benefits) Regulations 2017.
Items 7 – 18 make consequential changes resulting from the repeal of the National Health (Pharmaceutical Benefits) Regulations 1960 and remaking as the National Health (Pharmaceutical Benefits) Regulations 2017.
Item 19 inserts new sub-paragraph 39(c)(iii) requiring that a claim, or provision of under-co-payment data for a supply of an infusion, must include the compounder ID of the site at which the dose of a chemotherapy drug for the infusion being claimed was compounded. That is, when claiming for a medicine listed in Schedule 1 of the Special Arrangement, approved suppliers must include a compounder ID within the claim for the pharmaceutical benefit.
Item 20 amends the reference ‘regulation 24’ to ‘section 49’. This is a consequential change resulting from the repeal of the National Health (Pharmaceutical Benefits) Regulations 1960 and remaking as the National Health (Pharmaceutical Benefits) Regulations 2017.
Item 21 amends the heading for section 46A from 31 January 2018 to 30 November 2017 to reflect the revised end date for claims based payment arrangements (item 22 refers).
Item 22 amends the end date of the claims based arrangement period relating to compounding fees for TGA licensed compounders specified in subsection 46A(1) from 31 January 2018 to 1 December 2017. This change reflects the decision, made in consultation with Industry and State and Territory Departments of Health, to bring forward the end date for claims based arrangements to 1 December 2017.
Item 23 repeals and replaces section 46B to reflect that, with the end of the claims based arrangement period, it takes effect on 1 December 2017. It also replaces the term ‘compound fee’ with ‘additional TGA licensed compounding fee’. This section sets out that on and from 1 December 2017, TGA licensed compounders will receive a direct payment of $20 per eligible EFC item claimed under the PBS that was compounded by the compounder. The inclusion of the compounder ID within a claim for a pharmaceutical benefit will enable payments to be based upon PBS data. TGA licensed compounders will no longer need to submit a claim to receive this payment.
Item 24 omits the date reference ‘before 1 March 2019’ in subsection 60(1) and as a result there will be no time limit for when the transitional arrangements in this provision apply. This will have the effect of allowing pharmaceutical benefits to be prescribed from either an infusion medication chart or a medication chart on an ongoing basis.
Item 25 repeals subsection 60(4). The instrument which was in force under Regulation 59 of the National Health (Pharmaceutical Benefits) Regulations 1960 has since been repealed and the associated PBS Hospital Medication Chart Trial has now ceased. Regulation 59 was time limited and was not included within the 2017 remake of the Regulations.
Items 26–34
Forms Deleted
Etoposide | Powder for I.V. infusion 100 mg (as phosphate) |
Alteration of Circumstances
Brentuximab vedotin |
Eribulin |
Pemetrexed |
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 2017 (No. 11)
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 Schedules 1 and 4 of 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.
This instrument also amends the start date for revised payment arrangements for the additional TGA licensed compounding fee and maintains the current level of payment to TGA licensed compounders for compounding a dose of chemotherapy. The instrument removes the end date for transitional arrangements relating to the use of infusion medication charts and medication charts. Additionally, the instrument makes a number of amendments consequential on the cessation of the National Health (Pharmaceutical Benefits) Regulations 1960 and their replacement with the National Health (Pharmaceutical Benefits) Regulations 2017.
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.
The changes made by this Instrument provide clarity and simplify the administrative processes associated with claiming the additional TGA licensed compounding fee associated with the supply of eligible pharmaceutical benefits. The Instrument maintains the amount that is to be paid for the compounding or preparation of a dose of a chemotherapy drug by a TGA licensed compounder from 1 December 2017.
The instrument does not alter the amount that an eligible patient may be charged for the supply of an infusion under the Special Arrangement.
Conclusion
This Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Julianne Quaine
Assistant Secretary
Private Health Insurance and Pharmacy Branch
Technology Assessment and Access Division
Department of Health