EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2013 (No.6)
PB 63 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 the Act, is to amend the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement), to make changes to the special arrangement relating to the highly specialised drugs program for hospitals.
The pharmaceutical benefits supplied under the Special Arrangement are for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving treatment at or from a public or private hospital having access to appropriate specialised facilities.
The amendments made by this Instrument reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.
This instrument inserts two new restrictions for the 5 mg and 10 mg forms of the drug Lenalidomide, removes the brand Pamidronate Strides for the drug Pamidronic Acid, amends the responsible person for the drug Valaciclovir from Ascent Pharma Pty Ltd to Actavis Pty Ltd and updates the schedule of Responsible Person Codes.
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), 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 and for this Instrument. This includes consultation through the PBAC process, and agreement to final listing details.
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 (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2013 (No.6)
Section 1 Name of Instrument
This section provides that this Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No.6) and that it may also be cited as PB 63 of 2013.
Section 2 Commencement
This section provides that this Instrument commences on 1 October 2013.
Section 3 Amendments to PB 116 of 2010
This section provides that Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010) (the Special Arrangement).
Schedule 1 Amendments
Item 1 Section 24, HSD pharmaceutical benefits that have CAR drugs—quantity exceptions
This item amends the existing section 24 to clarifythat the existing quantity exception for lenalidomide is specific to the treatment of multiple myeloma. It also inserts the new quantity exception for the treatment of myelodysplastic syndrome to be limited to up to 21 tablets.
Item 2 Section 25, HSD pharmaceutical benefits that have CAR drugs—repeat exceptions
This item amends the existing section 25 to clarify that the existing repeat exception for lenalidomide is specific to the treatment of multiple myeloma. It also inserts the new quantity exception for the treatment of myelodysplastic syndrome to be limited to up to three repeats.
Item 3 Schedule 1, entry for Lenalidomide in the form Capsule 5 mg, manner of administration Oral
This item replaces the existing entry and inserts two new circumstance codes, C4282 and C4287, in relation to the treatment of myelodysplastic syndrome for the 5mg capsule form of the drug lenalidomide.
Item 4 Schedule 1, entry for Lenalidomide in the form Capsule 10 mg, manner of administration Oral
This item replaces the existing entry and inserts two new circumstance codes, C4282 and C4287, in relation to the treatment of myelodysplastic syndrome for the 10mg capsule form of the drug lenalidomide.
Item 5 Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL, manner of administration injection
This item deletes the brand Pamidronate Strides for the drug Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL with the manner of administration injection.
Item 6 Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL, manner of administration injection
This item deletes the brand Pamidronate Strides for the drug Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL with the manner of administration injection.
Item 7 Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) with the manner of administration Oral and brand Zelitrex
This item deletes the current responsible person code GM, (Ascent Pharma Pty Ltd), and inserts the new responsible person code of UA, (Actavis Pty Ltd).
Item 8 Schedule 2 – Responsible Person Codes
This item replaces the existing schedule with an updated table of Responsible Person Codes for the Highly Specialised Drugs program. It amends typographical errors, includes the new listing of UA, Actavis Pty Ltd, and lists all entries in alphabetical order by manufacturer code.
Item 9 Schedule 3, entry for Lenalidomide
This item inserts the new restriction text for initiation and maintenance treatment for the condition myelodysplastic syndrome.