EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 4)
PB 34 of 2016
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 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 entitled ‘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 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:
- adds new pharmaceutical benefit, ‘Bendamustine’, new brand ‘Ribomustin’, the associated circumstances maximum amounts and number of repeats;
- adds new pharmaceutical benefit, ‘Nivolumab’, new brand ‘Opdivo’, the associated circumstances maximum amounts and number of repeats;
- adds the brand ‘IRINOTECAN ACT’ and removes the brand ‘Tecan’ for the listed drug ‘Irinotecan’;
- removes the brand ‘Fludara’ and adds the brand ‘Fludarabine ACT’ for the listed drug ‘Fludarabine’;
- amends the circumstance codes, associated circumstances and purposes for the listed drugs ‘Paclitaxel, nanoparticle albumin‑bound’, ‘Pembrolizumab’ and ‘Trastuzumab emtansine’;
- removes the brand ‘Ondaz’ and ‘Ondaz Zydis’ for the listed drug ‘Ondansetron’;
- remove the Responsible Person sanofi‑aventis Australia Pty Ltd (GZ).
Additionally, from 1 May 2016, the Department of Human Services will have an automated authority system which will enable authorised prescribers to seek and obtain authority approvals via their desktop software, in real time. Changes to this instrument have been made to provide for the electronic authority approval. Section 22 (1A) has been inserted to override out of date authority tags which appear in Schedule 4, column headed Authority Requirements - Part of Circumstances. The override is necessary to allow for electronic authority methods. Technical amendments to sections 11 to 14 of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) have been made to allow authorised prescribers to submit details of a prescription by means of electronic communication to obtain an electronic authority.
A provision by provision description of this instrument is contained in Attachment.
Consultations
An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement 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.
On 15 January 2014 the Minister for Human Services endorsed a number of efficiency measures that was inclusive of the Automated PBS authority approvals measure. Consultation with the Department of Human Services and the PBAC has occurred in relation to policy matters regarding the implementation of automated electronic authority decision making.
This instrument commences on 1 May 2016.
This instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
PROVISION BY PROVISION DESCRIPTION OF THE NATIONAL HEALTH (EFFICIENT FUNDING OF CHEMOTHERAPY) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2016 (No. 4)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2016 (No. 4) and that it may also be cited as PB 34 of 2016.
Section 2 Commencement
This section provides that this Instrument commences on 1 May 2016.
Section 3 Amendments to PB 79 of 2011
This section amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (the Special Arrangement).
Item 1 and 2 inserts into section 22 (1) a new subsection (1A) and (2A), that allows for an authority approval to be obtained via electronic authority methods where ‘Compliance with Telephone Authority Required Procedures’ or ‘Compliance with Written or Telephone Authority Required Procedures’ was previously required. That is, where a medicine is listed with the words ‘Compliance with Written or Telephone Authority Required procedures’ in schedule 3, column headed ‘Authority Requirements – Part of Circumstances’, it is intended that the prescriber may seek authority approval via an automated electronic approval process.
Item 3 inserts a new pharmaceutical benefit ‘Bendamustine’ into Schedule 1, Part 1 of the Special Arrangement by inserting a new listed drug ‘Bendamustine’ in the forms ‘Powder for injection containing bendamustine hydrochloride 25 mg’ and ‘Powder for injection containing bendamustine hydrochloride 100 mg’ with the manner of administration ‘Injection’ and brand ‘Ribomustin’
Item 4 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Irinotecan’ in the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL’ by adding the brand ‘IRINOTECAN ACT’.
Item 5 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Irinotecan’ in the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL’ by adding the brand ‘IRINOTECAN ACT’.
Item 6 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Irinotecan’ in the form ‘I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL’ by adding the brand ‘IRINOTECAN ACT’ and removing the brand ‘Tecan’.
Item 7 inserts a new pharmaceutical benefit ‘Nivolumab’ into Schedule 1, Part 1 of the Special Arrangement by inserting a new listed drug ‘Nivolumab’ in the forms ‘Injection concentrate for I.V. infusion 40 mg in 4 mL’ and ‘Injection concentrate for I.V. infusion 100 mg in 10 mL’ with the manner of administration ‘Injection’ and brand ‘Opdivo’.
Item 8 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Paclitaxel, nanoparticle albumin‑bound’ by removing the circumstance code ‘C3955’ and ‘C3956’ and associated circumstance and adding the new circumstance codes ‘C4657’ ‘C6106’ and ‘C6119’ and the associated circumstance.
Item 9 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Pembrolizumab’ by removing the circumstance code ‘C5293’ ‘C5334’ ‘C5361’ ‘C5362’ and associated circumstance and adding the new circumstance codes ‘C5362’ ‘C6093’ ‘C6094’ ‘C6103’ ‘C6104’ and the associated circumstance.
Item 10 amends the entry in Schedule 1 Part 1 of the Special Arrangement for the listed drug ‘Trastuzumab emtansine’ by removing the circumstance code ‘C4987’ and associated circumstance and adding the new circumstance codes ‘C6096’ and ‘C6129’ and the associated circumstance.
Item 11 inserts a new pharmaceutical benefit ‘Bendamustine’ into Schedule 1, Part 2 of the Special Arrangement by inserting a new listed drug ‘Bendamustine’ and the associated maximum amounts and number of repeats.
Item 12 inserts a new pharmaceutical benefit ‘Nivolumab’ into Schedule 1, Part 2 of the Special Arrangement by inserting a new listed drug ‘Nivolumab’ and the purpose codes ‘P6070’ ‘P6083’ ‘P6095’ ‘P6116’ and ‘P6111’ and the associated maximum amounts and number of repeats.
Item 13 amends the entry in Schedule 1 Part 2 of the Special Arrangement for the listed drug ‘Paclitaxel, nanoparticle albumin‑bound’ by adding the new purpose codes ‘P4657’ ‘P6106’ and ‘P6119’ and the associated maximum amounts and number of repeats.
Item 14 amends the entry in Schedule 1 Part 2 of the Special Arrangement for the listed drug ‘Pembrolizumab’ by removing the purpose codes ‘P5293’ ‘P5334’ ‘P5361’ and adding the new purpose codes ‘P6093’ ‘P6094’ ‘P6103’ and ‘P6104’ and the associated maximum amounts and number of repeats.
Item 15 amends the entry in Schedule 2 of the Special Arrangement for the listed drug ‘Ondansetron’ in the forms ‘Tablet 4 mg (as hydrochloride dihydrate)’ and ‘Tablet 8 mg (as hydrochloride dihydrate)’ by removing the brand ‘Ondaz’.
Item 16 amends the entry in Schedule 2 of the Special Arrangement for the listed drug ‘Ondansetron’ in the forms ‘Wafer 4 mg’ and ‘Wafer 8 mg’ by removing the brand ‘Ondaz Zydis’.
Item 17 amends the entry in Schedule 3 of the Special Arrangement by removing the responsible person sanofi‑aventis Australia Pty Ltd (GZ).
Item 18 inserts a new related pharmaceutical benefit ‘Bendamustine’ into Schedule 4 of the Special Arrangement by inserting a new listed drug ‘Bendamustine’ and adding the new circumstances ‘C6075’ and ‘C6124’ and the associated circumstances.
Item 19 inserts a new related pharmaceutical benefit ‘Nivolumab’ into Schedule 4 of the Special Arrangement by inserting a new listed drug ‘Nivolumab’ and adding the new circumstances ‘C6070’ ‘C6083’ ‘C6095’ ‘C6111’ and ‘C6116’ and the associated circumstances.
Item 20 amends the entry in Schedule 4 of the Special Arrangement for the listed drug ‘Paclitaxel, nanoparticle albumin-bound’ by removing the circumstance code ‘C3955’ and ‘C3956’ and the associated circumstances and adding the new circumstance codes ‘C4657’ ‘C6106’ and ‘C6119’ and the associated circumstance.
Item 21 amends the entry in Schedule 4 of the Special Arrangement for the listed drug ‘Pembrolizumab’ by removing the circumstance code ‘C5293’ ‘C5334’ ‘C5361’ and ‘C5362’ and the associated circumstances and adding the new circumstance codes ‘C5362’ ‘C6093’ ‘C6094’ ‘C6103’ and ‘C6104’ and the associated circumstance.
Item 22 amends the entry in Schedule 4 of the Special Arrangement for the listed drug ‘Trastuzumab emtansine’ by removing the circumstance code ‘C4987’ and the associated circumstance and adding the new circumstance codes ‘C6096’ and ‘C6129’ and the associated circumstance.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2013 (No. 4)
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
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:
- adds 4 new listed brands for the listed drugs ‘Doxorubicin’, and ‘Gemcitabine’;
- adds 1 new listed form for the listed drug ‘Aprepitant’;
- removes 2 listed brands for the listed drug ‘Docetaxel’; and
- adds new circumstance codes and the associated circumstances for the listed drug ‘Aprepitant’.
Human rights implications
This legislative instrument engages Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.
Conclusion
This Legislaive Instrument is compatible with human rights because it advances the protection ohuman rights.