EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2013 (No. 9)
PB 64 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:
- removes three listed brands for the listed drug ‘Gemcitabine’, three listed brands for the listed drug ‘Oxaliplatin’, three listed brands for the listed drug ‘Paclitaxel’ and two listed brands for the listed drug ‘Vinorelbine’;
- updates the responsible person for listed brands of multiple listed drugs from Willow Pharmaceuticals Pty Ltd (WQ) to Actavis Pty Ltd (GN); and
- removes the responsible persons Ascent Pharma Pty Ltd (GM) and Willow Pharmaceuticals Pty Ltd (WQ) and adds the responsible person Actavis Pty Ltd (GN).
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 October 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. 9)
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. 9) and that it may also be cited as PB 64 of 2013.
Section 2 Commencement
This section provides that this Instrument commences on 1 October 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 ‘Bleomycin’ in the form ‘Powder for injection containing bleomycin sulfate 15,000 I.U.’ and brand ‘Bleo 15K’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Item 2 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Carboplatin’ in each of the forms ‘Solution for I.V. injection 150 mg in 15 mL’; ‘Solution for I.V. injection 450 mg in 45 mL’ and ‘Solution for I.V. injection 50 mg in 5 mL’ and brand ‘Carbaccord’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Items 3 and 4 amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Doxorubicin’ in each of the forms ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 ml single dose vial’ and ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 ml single dose vial’ and brand ‘Accord Doxorubicin’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Items 5 and 6 amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Epirubicin’ in each of the forms ‘Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL’; ‘Solution for injection containing epirubicin hydrochloride 20 mg in 10 mL’; ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’; and ‘Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL’ and brand ‘Epiccord’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Item 7 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 ‘Farine’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Item 8a 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 1 g (as hydrochloride)’ with manner of administration ‘Injection’ and brand ‘AS-Gemcitabine’.
Items 8b, c and d amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Gemcitabine’ in the form ‘Powder for I.V. infusion 1 g (as hydrochloride)’ and brands ‘Gemaccord’; ‘Gemcitabine Actavis’ and ‘Gemplan’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Item 9a 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 ‘AS-Gemcitabine’.
Item 9b amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Gemcitabine’ in the form ‘Powder for I.V. infusion 2 g (as hydrochloride)’ and brand ‘Gemcitabine Actavis 2000’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Item 10a 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 200 mg (as hydrochloride)’ with manner of administration ‘Injection’ and brand ‘AS-Gemcitabine’.
Items 10b, c and d amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Gemcitabine’ in the form ‘Powder for I.V. infusion 200 mg (as hydrochloride)’ and brands ‘Gemaccord’; Gemcitabine Actavis’ and ‘Gemplan’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Items 11, 12 and 13 amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Irinotecan’ in each of the forms ‘I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 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’ and brands ‘Irinoccord’ and ‘Tecan’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Item 14 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Methotrexate’ in each of the forms ‘Injection 50 mg in 2 mL vial’ and ‘Solution concentrate for I.V. infusion 1000 mg in 10 mL vial’ and brand ‘Methaccord’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Item 15 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 ‘Xalox’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Items 16a, 17 and 18a amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Oxaliplatin’ by removing the pharmaceutical benefits, which are the listed drug ‘Oxaliplatin’ in the each of forms ‘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 manner of administration ‘Injection’ and brand ‘AS-Oxaliplatin’.
Items 16b and 18b amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Oxaliplatin’ in each of the forms ‘Solution concentrate for I.V. infusion 100 mg in 20 mL’; and ‘Solution concentrate for I.V. infusion 50 mg in 10 mL’ and brand ‘Oxaliccord’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Items 19a, 21a and 22a amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Paclitaxel’ by removing the pharmaceutical benefits, which are the listed drug ‘Paclitaxel’ in the each of forms ‘Solution concentrate for I.V. infusion 100 mg in 16.7 mL’; ‘Solution concentrate for I.V. infusion 30 mg in 5 mL’; and ‘Solution concentrate for I.V. infusion 300 mg in 50 mL’ with manner of administration ‘Injection’ and brand ‘GN-Paclitaxel’.
Items 19b, 20, 21b and 22b amend 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 ‘Plaxel’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Items 23 and 24 amend the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Vinorelbine’ by removing the pharmaceutical benefits, which are the listed drug ‘Vinorelbine’ in each of the forms ‘Solution concentrate for I.V. infusion 10 mg (as tartrate) in 1 mL’; and ‘Solution concentrate for I.V. infusion 50 mg (as tartrate) in 5 mL’ with manner of administration ‘Injection’ and brand ‘AS-Vinorelbine’.
Item 25 amends the entry in Schedule 2 of the Special Arrangement for ‘Ondansetron’ in the form ‘Tablet (orally disintegrating) 4 mg’ and brand ‘Onsetron ODT 4’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Item 26 amends the entry in Schedule 2 of the Special Arrangement for ‘Ondansetron’ in the form ‘Tablet (orally disintegrating) 8 mg’ and brand ‘Onsetron ODT 8’ by changing the responsible person code from ‘WQ’ to ‘GN’.
Item 27a amends the entry in Schedule 3 of the Special Arrangement by removing the responsible person code ‘GM’ and the associated responsible person, ‘Ascent Pharma Pty Ltd’.
Item 27b amends Schedule 3 of the Special Arrangement by adding a new responsible person code ‘GN’ and associated responsible person, ‘Actavis Pty Ltd’.
Item 28 amends the entry in Schedule 3 of the Special Arrangement by removing the responsible person code ‘WQ’ and the associated responsible person ‘Willow Pharmaceuticals Pty Ltd’.