EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 9)
PB 97 of 2012
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 (the main listing instrument) made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act, which commence on the same day.
This Instrument:
- adds new circumstances for the listed drugs ‘Bortezomib’, ‘Cabazitaxel’, ‘Docetaxel’, ‘Trastuzumab’ and ‘Granisetron’;
- adds new purposes for the listed drugs ‘Bortezomib’ and ‘Trastuzumab’
- adds maximum amounts and number of repeats for the new purposes associated with pharmaceutical benefits with the listed drugs ‘Bortezomib’, and ‘Trastuzumab’ and;
- amends the responsible person code and associated responsible person for two brands of the listed drug ‘Granisetron’.
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 December 2012.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
A provision by provision description of this Instrument is contained in the Attachment.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 9)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2012 (No. 9) and that it may also be cited as PB 97 of 2012.
Section 2 Commencement
This section provides that this Instrument commences on 1 December 2012.
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 ‘Bortezomib’ in the form ‘Powder for injection 3.5 mg’ with the manner of administration ‘Injection’ by removing the circumstances codes ‘C3762’, ‘C3763’, ‘C3764’, ‘C3765’, ‘C3766’ and ‘C3767’ and adding the new circumstances codes ‘C4079’, ‘C4080’, ‘C4081’, ‘C4126’, ‘C4161’ and ‘C4162’.
Item 2 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Bortezomib’ in the form ‘Powder for Injection 1mg’ with the manner of administration ‘Injection’ by removing the circumstances codes ‘C7003’, ‘C7004’, ‘C7005’, ‘C7006’ and ‘C7007’’ and adding the new circumstances codes ‘C4082’, ‘C4103’, ‘C4127’, ‘C4141’ and ‘C4163’.
Item 3 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 ‘C7000; and ‘C7001’ and adding the new circumstances codes ‘C4073’ and ‘C4138’.
Item 4 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’ by removing the circumstances codes ‘C3186’, ‘C3890’, ‘C3955’ and ‘C7002’ and adding the new circumstances codes ‘C4078’, ‘C4140’, ‘C4155’ and ‘C4160’.
Item 5 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 codes ‘C3186’, ‘C3890’, ‘C3955’ and ‘C7002’ and adding the new circumstances codes ‘C4078’, ‘C4140’, ‘C4155’ and C4160’.
Item 6 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 codes ‘C3186’, ‘C3890’, ‘C3955’ and ‘C7002’ and adding the new circumstances codes ‘C4078’, ‘C4140’, ‘C4155’ and ‘C4160’.
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 140 mg in 7 mL’ with the manner of administration ‘Injection’ by removing the circumstances codes ‘C3186’, ‘C3890’, ‘C3955’ and ‘C7002’ and adding the new circumstances codes ‘C4078’, ‘C4140’, ‘C4155’ and ‘C4160’
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 160 mg in 16 mL’ with the manner of administration ‘Injection’ by removing the circumstances codes ‘C3186’, ‘C3890’, ‘C3955’ and ‘C7002’ and adding the new circumstances codes ‘C4078’, ‘C4140’, ‘C4155’ and ‘C4160’.
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 20 mg in 1 mL’ with the manner of administration ‘Injection’ by removing the circumstances codes ‘C3186’, ‘C3890’, ‘C3955’ and ‘C7002’ and adding the new circumstances codes ‘C4078’, ‘C4140’, ‘C4155’ and ‘C4160’.
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 20 mg in 2 mL’ with the manner of administration ‘Injection’ and brands ‘DBL Docetaxel Concentrated Injection’ and ‘Docetaxel Sandoz’ by removing the circumstances codes ‘C3186’, ‘C3890’, ‘C3955’ and ‘C7002’ and adding the new circumstances codes ‘C4078’, ‘C4140’, ‘C4155’ and ‘C4160’.
Item 11 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 brand ‘Docetaxel Ebewe’ by removing the circumstances codes ‘C3186’, ‘C3890’, ‘C3955’ and ‘C7002’ and adding the new circumstances codes ‘C4078’, ‘C4140’, ‘C4155’ and ‘C4160’.
Item 12 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’ by removing the circumstances codes ‘C3186’, ‘C3890’, ‘C3955’ and ‘C7002’ and adding the new circumstances codes ‘C4078’, ‘C4140’, ‘C4155’ and ‘C4160’.
Item 13 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 codes ‘C3186’, ‘C3890’, ‘C3955’ and ‘C7002’ and adding the new circumstances codes ‘C4078’, ‘C4140’, ‘C4155’ and ‘C4160’.
Item 14 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 brand ‘Docetaxel Ebewe’ by removing the circumstances codes ‘C3186’, ‘C3890’, ‘C3955’ and ‘C7002’ and adding the new circumstances codes ‘C4078’, ‘C4140’, ‘C4155’ and ‘C4160’.
Item 15 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Trastuzumab’ in the form ‘Powder for I.V. infusion 150mg’ with the manner of administration ‘Injection’ by removing the circumstances codes ‘C3926’, ‘C3927’, ‘C3928’ and ‘C3929’ and adding the new circumstances codes ‘C4083’, ‘C4093’, ‘C4104’, ‘C4142’, ‘C4143’, ‘C4144’, ‘C4156’ and ‘C4164’.
Item 16 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Trastuzumab’ in the form ‘Powder for I.V. infusion 60mg’ with the manner of administration ‘Injection’ by removing the circumstances codes ‘C3926’, ‘C3927’, ‘C3928’ and ‘C3929’ and adding the new circumstances codes ‘C4083’, ‘C4093’, ‘C4104’, ‘C4142’, ‘C4143’, ‘C4144’, ‘C4156’ and ‘C4164’.
Item 17 amends the entry in Schedule 1 Part 2 of the Special Arrangement by providing the maximum amounts and number of repeats for the new purposes for the listed drug ‘Bortezomib’.
Item 18 amends the entry in Schedule 1 Part 2 of the Special Arrangement by providing the maximum amounts and number of repeats for the new purposes for the listed drug ‘Trastuzumab’.
Item 19 amends the entry in Schedule 2 of the Special Arrangement for ‘Granisetron’ in the forms ‘Tablet 2mg (as hydrochloride)’ and ‘Concentrated injection 3 mg (as hydrochloride) in 3 mL’ and brand ‘Kytril’ by changing the responsible person code from ‘HH’ to ‘RO’. The item also changes the circumstance code from ‘C3050’ to ‘C4139’ for all brands of ‘Granisetron’.
Item 20 amends the entry in Schedule 4 of the Special Arrangement by removing circumstances codes, purposes codes and the associated circumstances and purposes; and adding the new circumstances codes, purposes codes and the associated circumstances and purposes for pharmaceutical benefits with the listed drug ‘Bortezomib’.
Item 21 amends the entry in Schedule 4 of the Special Arrangement by removing circumstances codes and the associated circumstances; and adding the new circumstances codes and the associated circumstances for the pharmaceutical benefits with the listed drug ‘Cabazitaxel’.
Item 22 amends the entry in Schedule 4 of the Special Arrangement by removing some circumstances codes, purposes codes and the associated circumstances and purposes; and adding the new circumstances codes, and the associated circumstances for the pharmaceutical benefits with the listed drug ‘Docetaxel’.
Item 23 amends the entry in Schedule 4 of the Special Arrangement by removing the circumstances code and the associated circumstance; and adding the new circumstances code and the associated circumstance for the pharmaceutical benefits with the listed drug ‘Granisetron’.
Item 24 amends the entry in Schedule 4 of the Special Arrangement by removing circumstances codes, purposes codes and the associated circumstances and purposes; and adding the new circumstances codes, purposes codes and the associated circumstances and purposes for the pharmaceutical benefits with the listed drug ‘Trastuzumab’.