EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2017 (No. 6)
PB 57 of 2017
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
This is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 6) (the Amending Instrument). The purpose of the Amending Instrument is to amend the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the Special Arrangement relating to the Highly Specialised Drugs (HSD) program.
The amendment made by this Instrument reflects amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.
The amendments in PB 57 of 2017 include the addition of a new listed drug, the addition of a number of new brands and/or forms of already listed drugs, changes to the circumstances for prescribing for a number of listed pharmaceutical items, deletion of a number of duplicate entries of pharmaceutical items, and amendment of a number of transcription errors including a brand name, a number of ‘maximum quantities’ and a number of ‘number of repeats’.
These changes are summarised, by drug name, in the Attachment.
A provision by provision Description of this instrument is contained in the Attachment.
Consultation
The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).
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 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), the 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 of changes to the listings on the PBS. This includes consultation through the PBAC process. Further consultation for this Instrument was considered unnecessary due to the nature of the consultation that had already taken place in the decision to list the medication.
Details of the instrument are set out in the Attachment.
This Instrument commences on 1 August 2017.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
Details of the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 6)
PART 1 PRELIMINARY
Section 1 Name of Instrument
This section provides the name of this instrument as the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 6). It can also be cited as PB 57 of 2017.
Section 2 Commencement
This section provides that this instrument commences on 1 August 2017.
Section 3 Amendment
This section provides that the Schedule amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
SCHEDULE
Items 1 to 17 Schedule 1 and Schedule 3
Items 1 to 17 provide for the addition of a new listed drug, the addition of a number of new brands of already listed pharmaceutical items, the addition of a number of new forms of already listed drugs, changes to the circumstances for prescribing for a number of listed pharmaceutical items, deletion of duplicate entries for two listed pharmaceutical items, amendment of an incorrectly transcribed brand name of a listed pharmaceutical item, amendment of an incorrectly transcribed maximum quantity for form of a listed drug, and amendment of incorrectly transcribed maximum quantities and numbers of repeats for a number of listed drugs which should instead refer to sections 24 and 25 of the Special Arrangement. A pharmaceutical item is a listed drug in a specified form, with a specified manner of administration.
Listed Drug | Type of Change |
Azacitidine | New brand added. |
Bosentan | Seven new brands of the form ‘Tablet 62.5 mg (as monohydrate)’ added and eight new brands of the form ‘Tablet 125 mg (as monohydrate)’ added. |
Desferrioxamine | Duplicate entry for the brand ‘Hospira Pty Limited’ in the form ‘Powder for injection containing desferrioxamine mesylate 500 mg’ deleted. |
Epoprostenol | Circumstances for prescribing changed for the forms ‘Powder for I.V. infusion 500 micrograms (as sodium)’ and ‘Powder for I.V. infusion 1.5 mg (as sodium)’. Incorrectly transcribed maximum quantities and numbers of repeats amended to refer to sections 24 and 25 of the Special Arrangement. |
Etanercept | Incorrectly transcribed brand name for the form ‘Injection 50mg in 1 mL single use auto-injector, 4’ amended. |
Infliximab | New brand added. Incorrectly transcribed maximum quantities and numbers of repeats amended to refer to sections 24 and 25 of the Special Arrangement. |
Omalizumab | Incorrectly transcribed maximum quantities and numbers of repeats amended to refer to sections 24 and 25 of the Special Arrangement. |
Sirolimus | Incorrectly transcribed maximum quantity for the form ‘Oral solution 1 mg per mL, 60 mL’ amended. |
Sofosbuvir with velpatasvir | New drug added in a specified form, manner of administration and brand, and associated circumstances for prescribing added. |
Tenofovir | New forms ‘Tablet containing tenofovir disoproxil maleate 300 mg’ and ‘Tablet containing tenofovir disoproxil phosphate 291 mg’ added. Circumstances for prescribing changed for the form ‘Tablet containing tenofovir disoproxil fumarate 300 mg’. |
Tenofovir with emtricitabine | New forms ‘Tablet containing tenofovir disoproxil maleate 300 mg with emtricitabine 200 mg’ and ‘Tablet containing tenofovir disoproxil phosphate 291 mg with emtricitabine 200 mg’ added. Circumstances for prescribing changed for the form ‘Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg’. |
Tenofovir with emtricitabine, elvitegravir and cobicistat | Entry which combines the forms ‘Tablet containing elvitegravir 150 mg with cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg’ and ‘Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg’ deleted (duplicate entries). |
Valganciclovir | Three new brands of the form ‘Tablet 450 mg (as hydrochloride)’ added. |