EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (HIGHLY SPECIALISED DRUGS PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2017 (No. 8)
PB 75 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. 8) (the Amendment Instrument). The purpose of the Amendment 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 75 of 2017 include the addition of a new brand of an already listed drug and changes to the circumstances for prescribing for a number of listed drugs (including with regard to maximum quantities and numbers of repeats) and changes to the additional patient contributions that apply to two pharmaceutical benefits. 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 October 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. 8)
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. 8). It can also be cited as PB 75 of 2017.
Section 2 Commencement
This section provides that this instrument commences on 1 October 2017.
Section 3 Amendment
This section provides that Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).
Schedule - Amendments
Item 1 Part 1, Division 1, Section 4
Amends the name of a drug included in the definition of ‘medication for the treatment of hepatitis B’.
Item 2 Part 1, Division 1, Section 4
Adds two drug names to the definition of ‘medication for the treatment of HIV or AIDS’ and amends the name of a drug already included in the definition.
Item 3 Part 2, Division 4, Section 24(2)
Amends the text detailing the maximum quantities applicable to the drug ustekinumab, to correct typographical errors.
Items 4 & 5 Part 2, Division 4, Section 25(2)
Amend the text detailing the number of repeats applicable to the drugs infliximab and pegvisomant, to correct typographical errors.
Items 6 to 10 Schedules 1 and 3
Items 6 to 10 provide for the addition of a new brand of a listed drug and changes to the circumstances for prescribing for a number of listed drugs. These changes are summarised below.
SUMMARY OF CHANGES
Brands Added
Azacitidine | Powder for injection 100 mg (AZACITIDINE DR.REDDY'S) |
Alteration of Circumstances
Pegvisomant | Injection set containing powder for injection 10 mg, 30 and diluent, 30 |
Pegvisomant | Injection set containing powder for injection 15 mg, 30 and diluent, 30 |
Pegvisomant | Injection set containing powder for injection 20 mg, 1 and diluent, 1 |
Pegvisomant | Injection set containing powder for injection 20 mg, 30 and diluent, 30 |
Item 11 Schedule 3, Part 1, Section 3(2)
Adds an alphanumeric prefix to the second drug listed for item 20 in the column ‘regimen’.
Items 12 & 13 Schedule 4
Amend the ‘Approved Ex-manufacturer or Proportional Ex-manufacturer’ prices and ‘Claimed’ prices applicable to two pharmaceutical benefits.