EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2013 (No. 7)
PB 43 of 2013
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 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 makes changes to the pharmaceutical benefits available under the section 100 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 all listed brands of the listed drugs, ‘Cabazitaxel’ and ‘Docetaxel’;
- removes the listed brand ‘Gemcitabine Actavis 2000’ for the listed drug ‘Gemcitabine’;
- amends the listed drug names associated with the listed brands ImmuCyst and OncoTICE; and
- adds two pharmaceutical benefits, circumstances and purposes with the new listed drug ‘Ipilimumab’.
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 this instrument 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 August 2013.
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 2013 (No. 7)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 7) and that it may also be cited as PB 43 of 2013.
Section 2 Commencement
This section provides that this Instrument commences on 1 August 2013.
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 ‘Cabazitaxel’ in the form ‘Concentrated injection 60mg (as acetone solvate) in 1.5 mL, with diluent’, with the manner of administration ‘Injection’ by removing the circumstances codes ‘C4073’ and ‘C4138’ and adding the new circumstances codes ‘C4237’ and ‘C4262’.
Item 2 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ in the form ‘Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent’ with the manner of administration ‘Injection’ and brands ‘AS-Docetaxel’ and ‘Taxotere’ by removing the circumstances code ‘C4155’ and adding the new circumstances code ‘C4239’.
Item 3 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ in the form ‘Powder for I.V. infusion 20 mg with solvent’ with the manner of administration ‘Injection’ by removing the circumstances code ‘C4155’ and adding the new circumstances code ‘C4239’.
Item 4 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ in the form ‘Powder for I.V. infusion 80 mg with solvent’ with the manner of administration ‘Injection’ by removing the circumstances code ‘C4155’ and adding the new circumstances code ‘C4239’.
Item 5 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 140 mg in 7 mL’ with the manner of administration ‘Injection’ by removing the circumstances code ‘C4155’ and adding the new circumstances code ‘C4239’.
Item 6 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 160 mg in 16 mL’ with the manner of administration ‘Injection’ by removing the circumstances code ‘C4155’ and adding the new circumstances code ‘C4239’.
Item 7 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 20 mg in 1 mL’ with the manner of administration ‘Injection’ and brands ‘Oncotaxel 20’ and ‘Taxotere’ by removing the circumstances code ‘C4155’ and adding the new circumstances code ‘C4239’.
Item 8 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 20 mg in 2 mL’ with the manner of administration ‘Injection’ and brands ‘DBL Docetaxel Concentrated Injection’ and ‘Docetaxel Sandoz’ by removing the circumstances code ‘C4155’ and adding the new circumstances code ‘C4239’.
Item 9 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 80 mg in 4 mL’ with the manner of administration ‘Injection’ and brands ‘Oncotaxel 80’ and ‘Taxotere’ by removing the circumstances code ‘C4155’ and adding the new circumstances code ‘C4239’.
Item 10 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 80 mg in 8 mL’ with the manner of administration ‘Injection’ and brands ‘DBL Docetaxel Concentrated Injection’ and ‘Docetaxel Sandoz’ by removing the circumstances code ‘C4155’ and adding the new circumstances code ‘C4239’.
Item 11 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Gemcitabine’ by removing a pharmaceutical benefit, which is the listed drug ‘Gemcitabine’ in the form ‘Powder for I.V. infusion 2 g (as hydrochloride)’ with manner of administration ‘Injection’ and brand ‘Gemcitabine Actavis 2000’.
Item 12 inserts a new listed drug ‘Ipilimumab’ into Schedule 1 Part 1 of the Special Arrangement by adding two new pharmaceutical benefits, which are the listed drug ‘Ipilimumab’ in the forms ‘Injection concentrate for I.V. infusion 50 mg in 10 mL’ and ‘Injection concentrate for I.V. infusion 200 mg in 40 mL’ with the manner of administration ‘Injection’ and brand ‘Yervoy’.
Item 13 amends Schedule 1 Part 2 of the Special Arrangement by adding the maximum amount and number of repeats for the purposes associated with the new listed drug ‘Ipilimumab’.
Item 14 amends the entry in Schedule 2 of the Special Arrangement for "BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain) by changing the name of the listed drug to ‘Bacillus Calmette and Guerin, Connaught strain’.
Item 15 amends the entry in Schedule 2 of the Special Arrangement for "BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain) by changing the name of the listed drug to ‘Bacillus Calmette and Guerin, Tice strain’.
Item 16 amends the entry in Schedule 4 of the Special Arrangement for "BCG Immunotherapeutic" (Bacillus Calmette-Guérin/ Connaught strain) by changing the name of the listed drug to ‘Bacillus Calmette and Guerin, Connaught strain’.
Item 17 amends the entry in Schedule 4 of the Special Arrangement for "BCG-Tice" (Bacillus Calmette-Guérin/ Tice strain) by changing the name of the listed drug to ‘Bacillus Calmette and Guerin, Tice strain’.
Item 18 amends the entry in Schedule 4 of the Special Arrangement for ‘Cabazitaxel’ by removing the circumstances codes ‘C4073’ and ‘C4138’ and the circumstances associated with them and adding the new circumstances codes ‘C4237’ and ‘C4262’ and the circumstances associated with them.
Item 19 amends the entry in Schedule 4 of the Special Arrangement for “Docetaxel’ by removing circumstances code ‘C4155’ and the circumstances associated with it and inserting circumstances code ‘C4239’ and the circumstances associated with it.
Item 20 amends Schedule 4 of the Special Arrangement by adding circumstances codes, purposes codes and associated circumstances and purposes for the new pharmaceutical benefits with the listed drug ‘Ipilimumab’.