EXPLANATORY STATEMENT
Issued by Authority of the Minister for Health and Ageing
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No. 6)
PB 47 of 2011
Purpose
The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 (PB 117 of 2010) (the Special Arrangement), to make changes to the special arrangement relating to the chemotherapy pharmaceuticals access program.
The Special Arrangement deals with the supply of chemotherapy pharmaceutical benefits at certain public hospitals to non-admitted patients, day admitted patients and patients on discharge.
Section 100 special arrangements and Part VII of the Act
Subsection 100(1) enables the Minister to make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available to persons:
(a) who are living in isolated areas: or
(b) who are receiving treatment in circumstances in which generally available
pharmaceutical benefits are inadequate for that treatment; or
(c) if the pharmaceutical benefits covered by the arrangements can be more
conveniently or efficiently supplied under the arrangements.
Subsection 100(3) provides that Part VII of the Act, and regulations and other legislative instruments made for the purposes of Part VII have effect subject to a special arrangement made under subsection 100(1).
Subsection 100(2) provides that the Minister may vary or revoke a special arrangement made under subsection (1).
Changes to the Special Arrangement made by this Instrument
This instrument makes changes to the pharmaceutical benefits available under the section 100 special arrangement for the chemotherapy pharmaceuticals access program. The changes made by this instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument made under sections 84AF, 85, 85A, 88 and 101 of the Act, which commences on the same day.
This instrument:
- inserts 7 new chemotherapy pharmaceutical benefits;
- removes 3 chemotherapy pharmaceutical benefits;
- makes changes to the responsible person for various chemotherapy pharmaceutical benefits;
- makes changes to the maximum number of repeats for 1 chemotherapy pharmaceutical benefit.
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.
Pharmaceutical companies were consulted throughout the process for additions and changes to listings on the PBS and for the Special Arrangement. This includes consultation through the PBAC process, and agreement to final listing details.
General
This Instrument commences on 1 July 2011.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (CHEMOTHERAPY PHARMACEUTICALS ACCESS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2011 (No. 6)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement Amendment Instrument 2011(No. 6) and that it may also be cited as PB 47 of 2011.
Section 2 Commencement
This section provides that this Instrument commences on 1 July 2011.
Section 3 Amendments to PB 117 of 2010
This section provides that Schedule 1 amends the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2010 (PB 117 of 2010) (the Principal Instrument).
Schedule 1
Item 1 amends the entry in Schedule 1 of the Principal Instrument for the chemotherapy pharmaceutical benefit with the listed drug ‘Aprepitant’ to change the number of repeats from zero to five.
Item 2 amends the entry in Schedule 1 of the Principal Instrument for the chemotherapy pharmaceutical benefit with listed drug ‘“BCG-Tice” (Bacillus Calmette-Guerin/ Tice strain)’ to change the responsible person from ‘Schering-Plough Pty Limited’ to ‘Merck Sharp & Dohme (Australia) Pty Ltd’.
Item 3 amends Schedule 1 of the Principal instrument to remove the chemotherapy pharmaceutical benefit with the listed drug ‘Bleomycin’ and the brand ‘Blenamax’.
Item 4 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Carboplatin’, the form ‘Solution for I.V. injection 50 mg in 5 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Carboplatin Ebewe’.
Item 5 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Carboplatin’ and the form ‘Solution for I.V. injection 150 mg in 15 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Carboplatin Ebewe’.
Item 6 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Carboplatin’ and the form ‘Solution for I.V. injection 450 mg in 45 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Carboplatin Ebewe’.
Item 7 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Cisplatin’ and the form ‘I.V. injection 100 mg in 10 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Cisplatin Ebewe’.
Item 8 substitutes a new entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Docetaxel’. This new entry adds:
- a new chemotherapy pharmaceutical benefit that has the existing form ‘Solution concentrate for I.V. infusion 20 mg in 1 mL’ and the new brand ‘Oncotaxel 20’; and
- a new chemotherapy pharmaceutical benefit that has the existing form ‘Solution concentrate for I.V. infusion 80 mg in 4 mL’ and the new brand ‘Oncotaxel 80’; and
- a new chemotherapy pharmaceutical benefit that has the new form ‘Solution concentrate for I.V. infusion 140 mg in 7 mL’ and the new brand ‘Oncotaxel 140’.
These 3 new chemotherapy pharmaceutical benefits have the responsible person ‘Actavis Australia Pty Ltd’. This new entry also changes the responsible person for the two chemotherapy pharmaceutical benefits that have the brand ‘Docetaxel Ebewe’ from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’.
Item 9 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Doxorubicin’ and the form ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Doxorubicin Ebewe’.
Item 10 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Doxorubicin’ and the form ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Doxorubicin Ebewe’.
Item 11 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Doxorubicin’ and the form ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 100 mg in 50 mL single dose vial’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Doxorubicin Ebewe’.
Item 12 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Doxorubicin’ and the form ‘Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Doxorubicin Ebewe’.
Item 13 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Epirubicin’ and the form ‘Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Epirubicin Ebewe’.
Item 14 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Epirubicin’ and the form ‘Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Epirubicin Ebewe’.
Item 15 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Epirubicin’ and the form ‘Solution for injection containing epirubicin hydrochloride 100 mg in 50 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Epirubicin Ebewe’.
Item 16 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Epirubicin’ and the form ‘Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Epirubicin Ebewe’.
Item 17 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Etoposide’ and the form ‘Solution for I.V. infusion 100 mg in 50 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Etoposide Ebewe’.
Item 18 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Fludarabine’ and the form ‘Solution for I.V. injection 50 mg fludarabine phosphate in 2 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Fludarabine Ebewe’.
Item 19 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Flourouracil’ and the form ‘Injection 500 mg in 10 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Flouraracil Ebewe’.
Item 20 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Flourouracil’ and the form ‘Injection 1000 mg in 20 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Flouraracil Ebewe’.
Item 21 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Flourouracil’ to add two new chemotherapy pharmaceutical benefits with the brand ‘Flouraracil Ebewe’ and the forms ‘Injection 2500 mg in 50 mL’ and ‘Injection 5000 mg in 100 mL’.
Item 22 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Folinic acid’ and the form ‘Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Calcium Folinate Ebewe’.
Item 23 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Folinic acid’ and the form ‘Injection containing calcium folinate equivalent to 100 mg folinic acid in 10 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Calcium Folinate Ebewe’.
Item 24 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Folinic acid’ and the form ‘Injection containing calcium folinate equivalent to 300 mg folinic acid in 30 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Calicum Folinate Ebewe’.
Item 25 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Gemcitabine’ and the form ‘Powder for I.V. infusion 200 mg (as hydrochloride)’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Gemcitabine Ebewe’.
Item 26 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Gemcitabine’ and the form ‘Solution Concentrate for I.V. infusion 200 mg (as hydrochloride) in 20 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Gemcitabine Ebewe’.
Item 27 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Gemcitabine’ and the form ‘Solution Concentrate for I.V. infusion 500 mg (as hydrochloride) in 50 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Gemcitabine Ebewe’.
Item 28 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Gemcitabine’ and the form ‘Powder for I.V. infusion 1 g (as hydrochloride)’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Gemcitabine Ebewe’.
Item 29 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Gemcitabine’ and the form ‘Solution Concentrate for I.V. infusion 1000 mg (as hydrochloride) in 100 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Gemcitabine Ebewe’.
Item 30 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Idarubicin’ and the form ‘Solution for I.V. injection containing idarubicin hydrochloride 5 mg in 5 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Idarubicin Ebewe’.
Item 31 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Idarubicin’ and the form ‘Solution for I.V. injection containing idarubicin hydrochloride 10 mg in 10 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Idarubicin Ebewe’.
Item 32 amends the entry in Schedule 1 of the Principal Instrument for the chemotherapy pharmaceutical benefits with listed drug ‘Interferon Alfa-2b’ to change the responsible person for both chemotherapy pharmaceutical benefits from ‘Schering-Plough Pty Limited’ to ‘Merck Sharp & Dohme (Australia) Pty Ltd’.
Item 33 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Irinotecan’ and the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Irinotecan Ebewe’.
Item 34 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Irinotecan’ and the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL’ to remove the brand ‘Irinotecan Sandoz’.
Item 35 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Irinotecan’ and the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Irinatecan Ebewe’.
Item 36 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Irinotecan’ and the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL’ to remove the brand ‘Irinotecan Sandoz’.
Item 37 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Methotrexate’ and the form ‘Solution concentrate for I.V. infusion 1000 mg in 10 mL vial’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Methotrexate Ebewe’.
Item 38 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Methotrexate’ and the form ‘Solution concentrate for I.V. infusion 5000 mg in 50 mL vial’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Methotrexate Ebewe’.
Item 39 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Mitozantrone’ and the form ‘Injection 20 mg (as hydrochloride) in 10 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Mitozantrone Ebewe’.
Item 40 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Oxiliplatin’ and the form ‘Powder for I.V. infusion 50 mg’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Oxiliplatin Ebewe’.
Item 41 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Oxiliplatin’ and the form ‘Powder for I.V. infusion 100 mg’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Oxiliplatin Ebewe’.
Item 42 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Paclitaxel’ and the form ‘Solution concentrate for I.V. infusion 30 mg in 5 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Paciltaxel Ebewe’.
Item 43 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Paclitaxel’ and the form ‘Solution concentrate for I.V. infusion 100 mg in 16.7 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Paciltaxel Ebewe’.
Item 44 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Paclitaxel’ and the form ‘Solution concentrate for I.V. infusion 150 mg in 25 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Paciltaxel Ebewe’.
Item 45 amends the entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Paclitaxel’ and the form ‘Solution concentrate for I.V. infusion 300 mg in 50 mL’ to change the responsible person from ‘InterPharma Pty Ltd’ to ‘Sandoz Pty Ltd’ for the brand ‘Paciltaxel Ebewe’.
Item 46 substitutes a new entry in Schedule 1 of the Principal instrument for the chemotherapy pharmaceutical benefits with the listed drug ‘Vinorelbine’. This new entry add a new brand ‘Vinorelbine Kabi’ to each of the forms ‘Solution for I.V. infusion 10 mg (as tartrate) in 1 mL’ and ‘Solution for I.V. infusion 50 mg (as tartrate) in 5 mL’. This new entry also changes the responsible person code for the chemotherapy pharmaceutical benefits with the brand ‘Vinorelbine Link’ from PK to FU, however there is no change in responsible person as FU is an additional code for the same responsible person (‘Fresenius Kabi Australia Pty Limited’).
Item 47 amends Schedule 2 of the Principal Instrument to insert the new responsible person code ‘FU’ for the responsible person ‘Fresenius Kabi Australia Pty Limited’.
Item 48 amends Schedule 2 of the Principal Instrument to remove the entry for the responsible person ‘InterPharma Pty Ltd’ and to replace it with an additional code for the responsible person ‘Sandoz Pty Ltd’.
Item 49 amends Schedule 2 of the Principal Instrument to remove the entry for the responsible person ‘Schering-Plough Pty Limited’.
Item 50 amends Schedule 2 of the Principal Instrument to insert a new entry for the new responsible person ‘Actavis Australia Pty Ltd’.