EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 12 OF 2021
NATIONAL HEALTH ACT 1953
National Health (Weighted average disclosed price – April 2021 reduction day) Amendment Determination 2021
Authority
This legislative instrument is made pursuant to subsection 99ADB(4) of the National Health Act 1953 (the Act), which provides that the Minister may, by legislative instrument, determine the weighted average disclosed price (WADP) of a brand of a pharmaceutical item (listed brand) in accordance with the National Health (Pharmaceutical Benefits) Regulations 2017 (the Regulations).
Subsection 99ADB(7) of the Act further provides that a subsection 99ADB(4) determination for a listed brand may include the adjusted approved ex-manufacturer price (AAEMP) for the listed brand.
Purpose
This legislative instrument amends the National Health (Weighted average disclosed price – April 2021 reduction day) Determination 2020 (PB 123 of 2020) (the Principal Instrument) by:
- amending the WADPs for brands of the pharmaceutical item:
- nortriptyline, tablet 10 mg (as hydrochloride), oral;
- nortriptyline, tablet 25 mg (as hydrochloride), oral;
- trastuzumab, powder for I.V. infusion 420 mg, injection;
- trasutzumab, powder for I.V. infusion 60 mg, injection; and
- trastuzumab, powder for I.V. infusion 150 mg, injection.
- removing from Schedule 1 and inserting in Schedule 2 WADPs for brands of pharmaceutical items containing:
- rituximab, solution for subcutaneous injection containing rituximab 1400 mg in 11.7 mL, injection;
- teriflunomide, tablet 14 mg, oral;
- voriconazole, tablet 200 mg, oral; and
- voriconazole, tablet 50 mg, oral.
- inserting WADPs for brands of new pharmaceutical items that listed after publication of the Principle Instrument:
- fluoxetine, capsule 20 mg as hydrochloride USP, oral;
- norethisterone with ethinylestradiol, pack containing 21 tablets 1 mg 35 micrograms and 7 inert tablets USP, oral;
- pindolol, tablet 5 mg USP, oral;
- sertraline, oral;
- tablet 50mg (as hydrochloride) USP;
- tablet 100mg (as hydrochloride) USP; and
- topotecan, solution concentrate for I.V. infusion 4 mg in 4 mL as hydrochloride, injection.
The Principal Instrument was made pursuant to subsection 99ADB(4) and paragraph 99ADH(1)(aa) of the Act for brands of pharmaceutical items with a data collection period ending 30 September 2020 (2021 April cycle).
Amendments
Revision of WADP determinations for Brands of Pharmaceutical Items
Amendments are being made following consideration of matters raised by Responsible Persons concerning the determinations in the Principal Instrument for brands of pharmaceutical items containing nortriptyline, rituximab, teriflunomide, trastuzumab, and voriconazole.
A review of determinations in response to matters raised by Responsible Persons revealed that:
- A Responsible Person for a brand of teriflunomide had submitted incorrect data. Corrected data was resubmitted. New calculations for the WADPs set out in this amending determination were completed in accordance with the Act and Regulations, moving this drug from Schedule 1 to Schedule 2;
- Responsible Persons for brands of nortriptyline and trastuzumab had submitted incorrect data. Corrected data was resubmitted. New calculations for the WADPs set out in this amending determination in Schedule 1 were completed in accordance with the Act and Regulations;
- The subcutaneous form of rituximab will not take a scheduled reduction due to the outcome of a dispute focusing on its commercial viability and patient access; and
- Voriconazole will not take a scheduled reduction due to the correct threshold for its calculations being 30 per cent, moving the drug from Schedule 1 to Schedule 2.
Insertion of WADP determinations for New Brands of New Pharmaceutical Items
WADPs need to be determined for new pharmaceutical items that listed on the F2 formulary between 30 September 2020 and 1 April 2021. Examples are s19A temporary listings (fluoxetine, pindolol, sertraline and norethisterone with ethinylestradiol) and new forms or pack sizes of drugs (topotecan).
There are six new pharmaceutical items that are included in this amending instrument, as follows:
- fluoxetine, capsule 20 mg as hydrochloride USP, oral;
- norethisterone with ethinylestradiol, pack containing 21 tablets 1 mg 35 micrograms and 7 inert tablets USP, oral;
- pindolol, tablet 5 mg USP, oral;
- sertraline, oral;
- tablet 50mg (as hydrochloride) USP;
- tablet 100mg (as hydrochloride) USP; and
- topotecan, solution concentrate for I.V. infusion 4 mg in 4 mL as hydrochloride, injection.
Basis for amendments
Subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to vary or revoke the determination made under subsection 99ADB(4) for the medicines affected by this amending instrument.
Consultation
This instrument affects companies that are Responsible Persons for all brands of all pharmaceutical items containing nortriptyline, rituximab, teriflunomide, trastuzumab, and voriconazole.
All of the affected Responsible Persons were consulted about the amendments. No additional consultation with experts was undertaken, as consultation with affected Responsible Persons drew on the knowledge of persons with relevant expertise.
This instrument commences on the day after it is registered on the Federal Register of Legislation. This instrument is a legislative instrument for the purposes of the Legislation Act 2003.