EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2014 (No. 3)
PB 21 of 2014
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 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 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 entitled ‘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 makes changes to the pharmaceutical benefits available under the Special Arrangement for the efficient funding of chemotherapy. These changes 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.
This instrument:
- amends the circumstances for the listed drug, ‘Cetuximab’;
- removes the circumstances for the listed drugs, ‘Irinotecan’ and ‘Oxaliplatin’;
- amends the name for two listed brands for the listed drug ‘Doxorubicin-Pegylated Liposomal’;
- adds a pharmaceutical benefit ‘Panitumumab’ and the associated circumstances;
- removes one listed form and two listed brands for the listed drug ‘Tropisetron’; and
- adds the responsible person Amgen Australia Pty Ltd (AN) and removes the responsible person Novartis Pharmaceuticals Australia Pty Limited (NV).
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.
This instrument commences on 1 April 2014.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2014 (No. 3)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 3) and that it may also be cited as PB 21 of 2014.
Section 2 Commencement
This section provides that this Instrument commences on 1 April 2014.
Section 3 Amendments to 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
Item 1 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Cetuximab’ in the forms ‘Solution for I.V. infusion 100 mg in 20 mL’ and ‘Solution for I.V. infusion 500 mg in 100 mL’ with the manner of administration ‘Injection’ by removing the circumstances codes ‘C3843’, ‘C3844’, ‘C3903’ and ‘C3904 and adding the circumstances codes ‘C4468’, ‘C4477’, ‘C4511’ and ‘C4532’.
Item 2 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Doxorubicin-Pegylated Liposomal’ in the form ‘Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL’ with manner of administration ‘Injection’ and brand ‘Lipodox’, by changing the listed brand to ‘Liposomal Doxorubicin SUN’.
Item 3 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Doxorubicin-Pegylated Liposomal’ in the form ‘Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 50 mg in 25 mL’ with manner of administration ‘Injection’ and brand ‘Lipodox 50’ by changing the listed brand to ‘Liposomal Doxorubicin SUN’.
Item 4 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Irinotecan’ the forms ‘I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL’; ‘I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL’; ‘I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL’ and; ‘I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL’ with manner of administration ‘Injection’ by removing the circumstances code ‘C3184’.
Item 5 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Oxaliplatin’ in the forms ‘Powder for I.V. infusion 100 mg’; ‘Powder for I.V. infusion 50 mg’; ‘Solution concentrate for I.V. infusion 100 mg in 20 mL’; ‘Solution concentrate for I.V. infusion 200 mg in 40 mL’ and; ‘Solution concentrate for I.V. infusion 50 mg in 10 mL’ with the manner of administration ‘Injection’ by removing the circumstances codes ‘C3900’, ‘C3901’, ‘C3930’ and ‘C3939’.
Item 6 inserts a new listed drug ‘Panitumumab’ into Schedule 1 Part 1 of the Special Arrangement by adding a new pharmaceutical benefit, which is the listed drug ‘Panitumumab’ in the form ‘Solution concentrate for I.V. infusion 100 mg in 5 mL’ with the manner of administration ‘Injection’ and brand ‘Vectibix’.
Item 7 amends Schedule 1 Part 2 of the Special Arrangement by removing the purpose codes, ‘P3844’, ‘P3904’, ‘P2715’, ‘P3921’, ‘P2713’, ‘P2714’, ‘P3843’, ‘P3903’, ‘P3919’, and ‘P3920’ and adding the purpose codes ‘P4511’, ‘P4532’, ‘P2715’, ‘P3921’, ‘P2713’, ‘P2714’, ‘P3919’, ‘P3920’, ‘P4468’ and ‘P4477’ for the listed drug ‘Cetuximab’.
Item 8 amends Schedule 1 Part 2 of the Special Arrangement by adding the maximum amount and number of repeats for the listed drug ‘Panitumumab’.
Item 9 amends the entry in Schedule 2 of the Special Arrangement for ‘Tropisetron’ by removing a pharmaceutical benefit, which is the listed drug ‘Tropisetron’ in the form ‘Capsule 5 mg (as hydrochloride)’ with manner of administration ‘Oral’ and brand ‘Navoban’.
The item also amends the entry in Schedule 2 of the Special Arrangement for ‘Tropisetron’ by removing a pharmaceutical benefit, which is the listed drug ‘Tropisetron’ in the form ‘I.V. injection 5 mg (as hydrochloride) in 5 mL’ with manner of administration ‘Injection’ and brand ‘Navoban’.
Item 10 amends Schedule 3 of the Special Arrangement by adding a new responsible person ‘Amgen Australia Pty Ltd’.
Item 11 amends the entry in Schedule 3 of the Special Arrangement by removing responsible person ‘Novartis Pharmaceuticals Australia Pty Limited’.
Item 12 amends the entry in Schedule 4 of the Special Arrangement by removing circumstance codes, purpose codes and the associated circumstances and purposes; and adding the new circumstance codes, purpose codes and the associated circumstances and purposes for pharmaceutical benefits with the listed drug ‘Cetuximab’.
Item 13 amends the entry in Schedule 4 of the Special Arrangement by removing the circumstance code and the associated circumstance for pharmaceutical benefits with the listed drug ‘Irinotecan’.
Item 14 amends the entry in Schedule 4 of the Special Arrangement by removing circumstance codes and the associated circumstances for pharmaceutical benefits with the listed drug ‘Oxaliplatin’.
Item 15 amends Schedule 4 of the Special Arrangement by adding circumstance codes and the associated circumstances for pharmaceutical benefits with the listed drug ‘Panitumumab’.
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 Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Kim Bessell
Assistant Secretary
Pharmaceutical Access Branch
Principal Pharmacy Advisor
Pharmaceutical Benefits Division
Department of Health and Agein