EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Efficient Funding of Chemotherapy)
Special Arrangement Amendment Instrument 2017 (No. 4)
PB 31 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 (the 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 Schedules 1, 2 and 4 of the Special Arrangement to reflect recent changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) (the Listing Instrument). The Listing Instrument is made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act.
While some of the changes to the Listing Instrument will commence on 1 May 2017, others commenced on 1 April 2017. As such, some of the amendments made by this Instrument will operate retrospectively, from 1 April 2017, to reflect the changes to the Listing Instrument that commenced on that date. This retrospectivity is discussed further below.
This Instrument:
adds a new pharmaceutical benefit, ‘Blinatumomab’, in a specified form and brand, with associated circumstances and purposes and associated maximum amounts and number of repeats;
adds a new brand of the listed drug ‘Epirubicin’, in a specified form;
amends the circumstance codes and associated circumstances and purposes for the listed drugs ‘Fludarabine’ and ‘Netupitant with Palonosetron’;
amends the authorised prescriber for the drug ‘Pembrolizumab’;
removes the pharmaceutical benefit ‘Bacillus Calmette and Guerin, Connaught strain’ and its associated circumstances;
adds a new pharmaceutical benefit, ‘Fosaprepitant’, in a specified form and brand, with associated circumstances and associated maximum quantity and number of repeats;
removes a form of the listed drug ‘Interferon alfa-2a’; and
removes a brand of the listed drug ‘Granisetron’ in the form ‘Concentrated injection 3 mg (as hydrochloride) in 3 mL’.
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.
It was considered that further consultation for this Instrument was unnecessary due to the nature of the consultation that has already taken place.
Commencement
Schedule 1 of this Instrument commences on 1 May 2017 to reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), which commence on the same day.
Schedule 2 has a retrospective commencement date of 1 April 2017 and makes changes to the pharmaceutical benefit associated with the drugs Epirubicin and Pembrolizumab. These amendments reflect changes made to the Listing Instrument, which commenced on 1 April 2017. These amendments to this Instrument will ensure that, from 1 April 2017, the pharmaceutical benefits associated with Epirubicin and Pembrolizumab are properly available to those who need them.
In accordance with subsection 12(2) of the Legislation Act 2003, the parts of the Instrument that have retrospective operation do not affect the rights of a person (other than the Commonwealth or an authority of the Commonwealth) to that person’s disadvantage, nor does it impose any liability on such a person.
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. 4)
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. 4) and that it may also be cited as PB 31 of 2017.
Section 2 Commencement
This section specifies when the Instrument commences. It provides that sections 1 to 4 of the Instrument and Schedule 1 commences on 1 May 2017. Schedule 2 of the Instrument commences on 1 April 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).
Section 4 Schedules
This section provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the Schedule concerned. It also provides that any other item in a Schedule to this instrument has effect according to its terms.
Schedule 1 Amendments commencing on 1 May 2017
Item 1 inserts the new pharmaceutical benefit ‘Blinatumomab’ into Schedule 1, Part 1 of the Special Arrangement by inserting a new listed drug ‘Blinatumomab’ in the form ‘Powder for I.V. Infusion 38.5 micrograms’, manner of administration ‘Injection’, brand ‘Blincyto’, responsible person code ‘AN’, authorised prescriber code ‘MP’ and circumstance codes ‘C6892’, ‘C6893’, ‘C6894’ and ‘C6895’.
Item 2 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Fludarabine’ in the form ‘Powder for I.V. injection containing fludarabine phosphate 50 mg’, by removing the circumstance code ‘C6248’.
Item 3 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Fludarabine’ in the form ‘Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL’, by removing the circumstance code ‘C6248’.
Item 4 inserts a new pharmaceutical benefit ‘Blinatumomab’ into Schedule 1, Part 2 of the Special Arrangement by inserting a new listed drug ‘Blinatumomab’, and purpose codes P6892, P6893, P6894, and P6895 and the associated maximum amounts and number of repeats.
Item 5 removes the pharmaceutical benefit ‘Bacillus Calmette and Guerin, Connaught strain’ from Schedule 2 of the Special Arrangement by removing the listed drug ‘Bacillus Calmette and Guerin, Connaught strain’, in the form ‘Powder for intravesical administration containing 6.6 to 19.2 x 10 8 CFU’.
Item 6 inserts a new pharmaceutical benefit ‘Fosaprepitant’ into Schedule 2 of the Special Arrangement by inserting a new listed drug ‘Fosaprepitant’, in the form ‘Powder for I.V. infusion 150 mg’, manner of administration ‘Injection’, brand ‘Emend IV’, responsible person code ‘MK’, authorised prescriber code ‘EMP’, and adding the new circumstances codes ‘C6852’, ‘C6886’, ‘C6887’ and ‘C6891’.
Item 7 amends the entry in Schedule 2 of the Special Arrangement for the listed drug ‘Granisetron’ in the form ‘Concentrated injection 3 mg (as hydrochloride) in 3 mL’, by removing the brand ‘Granisetron APOTEX’ and responsible person ‘TX’.
Item 8 amends the entry in Schedule 2 of the Special Arrangement for the listed drug ‘Interferon alfa-2a’ by removing the form ‘Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe’.
Item 9 amends the entry in Schedule 2 of the Special Arrangement for the listed drug ‘Netupitant with Palonosetron’, in the form ‘Capsule containing netupitant 300 mg with palonosetron 500 microgram (as hydrochloride)’ by adding a new circumstance code ‘C6879’.
Item 10 amends the entry in Schedule 4 of the Special Arrangement for the listed drug ‘Bacillus Calmette and Guerin, Connaught Strain’ by removing the listed drug ‘Bacillus Calmette and Guerin, Connaught Strain’, and circumstance code ‘C5598’ and its associated circumstances.
Item 11 inserts a new pharmaceutical benefit ‘Blinatumomab’ into Schedule 4 of the Special Arrangement by inserting a new listed drug ‘Blinatumomab’ and adding the new circumstance codes ‘C6892’, ‘C6893’, ‘C6894’, and ‘C6895’ and the new purpose codes ‘P6892’, ‘P6893’, ‘P6894’, and ‘P6895’ and their associated circumstances and purposes.
Item 12 amends the entry in Schedule 4 of the Special Arrangement for the listed drug ‘Fludarabine’ by removing the circumstance code ‘C6248’ and its associated circumstances and authority requirements.
Item 13 inserts a new pharmaceutical benefit ‘Fosaprepitant’ into Schedule 4 of the Special Arrangement by inserting a new listed drug ‘Fosaprepitant’ and adding the new circumstance codes ‘C6852’, C6886, C6887, and ‘C6891 and their associated circumstances and authority requirements.
Item 14 amends the entry in Schedule 4 of the Special Arrangement for the listed drug ‘Netupitant with Palonosetron’ by adding a new circumstance code ‘C6879’ and its associated circumstances and authority requirements.
Schedule 2 Amendments commencing on 1 April 2017
Item 1 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’ and after the brand ‘DBL Epirubicin Hydrochloride Injection’ by adding the brand ‘Epirubicin Accord’ with a responsible person code of ‘OC’.
Item 2 amends the entry in Schedule 1, Part 1 of the Special Arrangement for the listed drug ‘Pembrolizumab’ in the form ‘Powder for injection 50 mg’ and the manner of administration ‘Injection’, by adding the authorised prescriber code ‘MP’.
-
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.