EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2012 (No. 10)
PB 106 of 2012
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:
- revises the explanation for calculating the additional patient contribution and makes consequential changes to other provisions reflecting that revision;
- amends the number of repeats allowable for 1 drug;
- increases the maximum quantity for 2 drugs;
- amends the brand name for 2 brands of a drug;
- adds 4 new brands;
- adds 1 responsible person for a new brand to be supplied under the Special Arrangement; and
- amends the circumstances for two drugs.
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 December 2012.
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 2012 (No.10)
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 2012 (No.10) and that it may also be cited as PB 106 of 2012.
Section 2 Commencement
This section provides that this Instrument commences on 1 December 2012.
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
Items [1] – [3]
These items updates the reference to section 48 in sections 45(2)(b), 46(3) and 47(3) to reflect the amendment made by Item 4 of Schedule 1 of this instrument.
Item [4] section 48
This item amends the wording to more accurately reflect how the additional patient contribution is calculated.
Item [5] – Schedule 1, entry for Apomorphine
This item amends the number of repeats allowable for all forms of Apomorphine from ‘0’ to ‘5’.
Items [6] – [8]
These items increase the maximum quantity available for Apomorphine in the form Injection containing apomorphine hydrochloride 20 mg in 2 mL from ‘5’ to ‘360’, and forms Injection containing apomorphine hydrochloride 50 mg in 5 mL and Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg in 10 mL pre‑filled syringe from ‘5’ to ‘180’.
Items [9] – Schedule 1, entry for Clozapine in the forms Tablet 25 mg, Tablet 50 mg, Tablet 100 mg and Tablet 200 mg, under in the column headed ‘Maximum Quantity’
This item increases the maximum quantity for Clozapine in the forms Tablet 25 mg, Tablet 50 mg, Tablet 100 mg and Tablet 200 mg from ‘100’ to’ 200’.
Item [10] – Schedule 1, entry for Lamivudine in the forms Tablet 150 mg and Tablet 300 mg with manner of administration Oral and brand Alphapharm Lamivudine
This item amends the brand name from ‘Alphapharm Lamivudine’ to ‘Lamivudine Alphapharm' for Lamivudine in the forms of 150 mg and 300 mg tablets.
Item [11] Schedule 1, entry for Lenalidomide in the column headed ‘Circumstances’
This item replaces the circumstance codes C3205 and C3821 with C4090 and C4091 to reflect the new circumstances set out in Item 19 of Schedule 1 of this instrument.
Items [12] and [13]
These items replace the circumstance codes C1650 and C3355 with C4108, C4146, C4084 and C4095 to reflect new circumstances for Mycophenolic Acid in the forms Tablet (enteric coated) containing mycophenolate sodium equivalent to 180 mg mycophenolic acid and Tablet (enteric coated) containing mycophenolate sodium equivalent to 360 mg mycophenolic acid set out in Item 20 of Schedule 1 of this instrument.
Item [14] Schedule 1, entry for Nevirapine in the form Tablet 200 mg
This item inserts a new brand, Nevirapine Alphapharm, for the drug Nevirapine in the form of a 200 mg tablet.
Items [15] to [17]
These items add new brands, Octreotide (SUN), for Octreotide 50 micrograms, 100 micrograms and 500 micrograms injections (as acetate) in 1 mL.
Item [18] Schedule 2, after entry for XA
This item adds a responsible person for a new brand to be supplied under the Special Arrangement, Sun Pharmaceutical Industries (Australia) Pty Ltd.
Item [19] Schedule 3, entry for Lenalidomide
This item inserts new circumstances for the prescribing of Lenalidomide.
Item [20] Schedule 3, entry for Mycophenolic Acid
This item inserts new circumstances for the prescribing of Mycophenolic Acid.