EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2014 (No. 6)
PB 49 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 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 definitions for ‘diluent fee’, ‘dispensing fee’, ‘distribution fee’ and ‘preparation fee’ to reflect the indexation of these fees for 1 July 2014. These fees are indexed annually (WCI9) in conformity with the indexation of other fees provided for in the Fifth Community Pharmacy Agreement;
- removes two listed brands for the listed drugs ‘Docetaxel’, and ‘Irinotecan’;
- updates the responsible person for listed brands of multiple listed drugs from Actavis Australia Pty Ltd (TA) to Actavis Pty Ltd (GN) and Actavis Pty Ltd (UA);
- removes the responsible person Actavis Australia Pty Ltd (TA) and adds the responsible person Actavis Pty Ltd (UA).
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 July 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. 6)
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.6) and that it may also be cited as PB 49 of 2014.
Section 2 Commencement
This section provides that this Instrument commences on 1 July 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 revises the diluent fee to reflect that due to indexation the fee is $5.00 on and from 1 July 2014.
Item 2 revises the dispensing fee to reflect that due to indexation the fee is $6.76 on and from 1 July 2014.
Item 3 revises the distribution fee to reflect that due to indexation the fee is $25.26 on and from 1 July 2014.
Item 4 revises the preparation fee to reflect that due to indexation and a decision to add $60 to the fee, the fee is $102.12 on and from 1 July 2014.
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’ and brand ‘Oncotaxel 140.’ by changing the responsible person code from ‘TA’ to ‘GN’.
Item 6 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Docetaxel’ by removing a pharmaceutical benefit, which is the listed drug ‘Docetaxel’ in the form ‘Solution concentrate for I.V. infusion 20 mg in 1 mL’ with manner of administration Injection and brand ‘Oncotaxel 20’.
Items 7 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’ and brand ‘Oncotaxel 80.’ by changing the responsible person code from ‘TA’ to ‘GN’.
Items 8 amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL’ and brand ‘Epirubicin Actavis 10’ by changing the responsible person code from ‘TA’ to ‘UA’.
Item 9 amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL’ and brand ‘Epirubicin Actavis 20’ by changing the responsible person code from ‘TA’ to ‘UA’.
Item 10 amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’ and brand ‘Epirubicin Actavis 200’ by changing the responsible person code from ‘TA’ to ‘UA’.
Item 11 amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Epirubicin’ in the form ‘Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL’ and brand ‘Epirubicin Actavis 50’ by changing the responsible person code from ‘TA’ to ‘UA’.
Item 12 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Fludarabine’ in the form ‘Powder for I.V. injection containing fludarabine phosphate 50 mg’ and brand ‘Fludarabine Actavis’ by changing the responsible person code from ‘TA’ to ‘UA’.
Items 13 amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Irinotecan’ in the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL’ and brand ‘Irinotecan Actavis’ by changing the responsible person code from ‘TA’ to ‘UA’.
Item 14 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Irinotecan’ by removing a pharmaceutical benefit, which is the listed drug ‘Irinotecan’ in the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL’ with manner of administration Injection and brand ‘Irinotecan Actavis’.
Item 15 amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Irinotecan’ in the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL’ and brand ‘Irinotecan Actavis 500’ by changing the responsible person code from ‘TA’ to ‘UA’.
Items 16 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Oxaliplatin’ in each of the forms ‘Powder for I.V. infusion 100 mg’ and ‘Powder for I.V. infusion 50 mg’ and brand ‘Oxaliplatin Actavis’ by changing the responsible person code from ‘TA’ to ‘UA’.
Items 17 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Paclitaxel’ in each of the forms ‘Solution concentrate for I.V. infusion 100 mg in 16.7 mL’; ‘Solution concentrate for I.V. infusion 150 mg in 25 mL’; ‘Solution concentrate for I.V. infusion 30 mg in 5 mL’; and ‘Solution concentrate for I.V. infusion 300 mg in 50 mL’ and brand ‘Paclitaxel Actavis’ by changing the responsible person code from ‘TA’ to ‘UA’.
Item 18 amends the entry in Schedule 3 of the Special Arrangement by removing the responsible person code ‘TA’ and the associated responsible person, ‘Actavis Australia Pty Ltd’.
Item 19 amends Schedule 3 of the Special Arrangement by adding a new responsible person code ‘UA’ and associated responsible person, ‘Actavis Pty Ltd’.