EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM FOR HOSPITALS) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2013 (No. 2)
PB 16 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 adds two new drugs (with one listed brand per drug) and their circumstances, amends the Responsible Person for three listed brands, adds two new listed brands for a listed drug, deletes a listed brand of a listed drug, adds a new Responsible Person, amends the circumstances for listed brands of two listed drugs, and reflects the updated Ex-manufacturer and Claimed price for listed brands with additional patient contributions.
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 April 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.2)
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.2) and that it may also be cited as PB 16 of 2013.
Section 2 Commencement
This section provides that this Instrument commences on 1 April 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] Schedule 1, after entry for Baclofen
This item adds the new drug Boceprevir in the form Capsule 200 mg with manner of administration Oral and brand Victrelis. The responsible person for this brand is Merck Sharp & Dohme (Australia) Pty Ltd ABN 14 000 173 508.
Item [2] Schedule 1, entry for Lamivudine in the form Tablet 100 mg with manner of administration Oral and brand Zeffix
This item changes the responsible person for Lamivudine in the form Tablet 100 mg with manner of administration Oral and brand Zeffix from GlaxoSmithKline Australia Pty Ltd ABN 47 100 162 481 to Aspen Pharmcare Australia Pty Ltd ABN 51 096 236 985.
Item [3] Schedule 1, entry for Lamivudine in the form Oral solution 5 mg per mL, 240 mL with manner of administration Oral and brand Zeffix
This item changes the responsible person for Lamivudine in the form Oral solution 5 mg per mL, 240 mL and brand Zeffix from GlaxoSmithKline Australia Pty Ltd ABN 47 100 162 481 to Aspen Pharmcare Australia Pty Ltd ABN 51 096 236 985.
Item [4] Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL with manner of administration Injection and brand Pamisol
This item adds a new brand of the drug Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL with the manner of administration Injection and brand name Pamidronate Strides. The responsible person for this brand is Agila Australasia Pty Ltd ABN 12 154 055 339.
Item [5] Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL with manner of administration Injection and brand Pamisol
This item adds a new brand of the drug Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL with the manner of administration Injection and brand name Pamidronate Strides. The responsible person for this brand is Agila Australasia Pty Ltd ABN 12 154 055 339.
Item [6] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2a
This item substitutes new circumstance codes for the associated new circumstances for listed brands of this drug.
Item [7] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent
This item substitutes new circumstance codes for the associated new circumstances for the listed brand with this form of the drug.
Item [8] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent
This item substitutes new circumstance codes for the associated new circumstances for the listed brand with this form of the drug.
Item [9] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent
This item substitutes new circumstance codes for the associated new circumstances for the listed brand with this form of the drug.
Item [10] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent
This item substitutes new circumstance codes for the associated new circumstances for the listed brand with this form of the drug.
Item [11] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent
This item substitutes new circumstance codes for the associated new circumstances for listed brands with this form of the drug.
Item [12] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent
This item substitutes new circumstance codes for the associated new circumstances for the listed brand with this form of the drug.
Item [13] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent
This item substitutes new circumstance codes for the associated new circumstances for the listed brand with this form of the drug.
Item [14] Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 196 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent
This item substitutes new circumstance codes for the associated new circumstances for the listed brand with this form of the drug.
Item [15] Schedule 1, after entry for Tadalafil
This item adds the new drug Telaprevir in the form Tablet 375 mg with manner of administration Oral and brand Incivo. The responsible person for this brand is Janssen-Cilag Pty Ltd ABN 47 000 129 975.
Item [16] Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) with manner of administration Oral and brand Valtrex
This item changes the responsible person for Valaciclovir in the form Tablet 500 mg (as hydrochloride) with manner of administration Oral and brand Valtrex from GlaxoSmithKline Australia Pty Ltd ABN 47 100 162 481 to Aspen Pharmcare Australia Pty Ltd ABN 51 096 236 985.
Item [17] Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) with manner of administration Oral and brand Valvala
This item deletes the entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) with manner of administration Oral and brand Valvala.
Item [18] Schedule 2, after entry for XA
This item adds a new Responsible Person Agila Australasia Pty Ltd ABN 12 154 055 339.
Item [19] Schedule 3, after entry for Baclofen
This item inserts circumstances for the listed brand of the newly listed drug Boceprevir.
Item [20] Schedule 3, entry for Ribavirin and Peginterferon Alfa-2a
This item amends the circumstances associated with listed brands of the drug Ribavirin and Peginterferon Alfa-2a.
Item [21] Schedule 3, entry for Ribavirin and Peginterferon Alfa-2b
This item amends the circumstances associated with listed brands of the drug Ribavirin and Peginterferon Alfa-2b.
Item [22] Schedule 3, after entry for Tadalafil
This item inserts circumstances for the listed brand of the newly listed drug Telaprevir.
Item [23] Schedule 4, Patient contributions
This item reflect in Schedule 4 the updated Approved Ex-manufacturer Price and Claimed price to reflect the new additional patient contribution for two brands of Desferrioxamine effective 1 April 2013. For the brand Desferal 500 mg, the Approved Ex-manufacturer Price decreases from $93.14 to $81.02 and the Claimed Price decreases from $100.86 to $87.74. For the brand Desferal 2 g, the Approved Ex-manufacturer Price decreases from $37.25 to $32.40 and the Claimed Price decreases from $37.63 to $32.73.