EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 75 OF 2019
NATIONAL HEALTH ACT 1953
National Health (Weighted average disclosed price – October 2019 reduction day)
Amendment Determination 2019
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 – October 2019 reduction day) Determination 2019 (PB 45 of 2019) (the Principal Instrument) by:
- amending the WADPs for brands of pharmaceutical items containing:
- bivalirudin for administration by injection (bivalirudin); and
- ivabradine for oral administration (ivabradine);
- removing from Schedule 1 WADPs for brands of pharmaceutical containing:
- epirubicin for administration by injection /intravesical (epirubicin); and
- pemetrexed for administration by injection (pemetrexed); and
- inserting a WADP for the first new brand of a new pharmaceutical item containing isotretinoin for oral administration (isotretinoin).
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 31 March 2019 (2019 October 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 bivalirudin, epirubicin, ivabradine and pemetrexed.
A review of determinations in response to matters raised by responsible persons revealed that for bivalirudin and ivabradine, incorrect data had been submitted by some responsible persons. Corrected data was submitted. New calculations for the WADPs set out in this amending determination were completed in accordance with the Act and Regulations.
A review of determinations in response to matters raised by responsible persons concluded that for epirubicin and pemetrexed, the implementation of price disclosure reductions on 1 October 2019 would affect supply. The brands for pharmaceutical items containing epirubicin and pemetrexed have been removed from the Principle Instrument.
Insertion of WADP determinations for New Brands of New Pharmaceutical Items
A WADP is required to be determined for new brands of pharmaceutical items listing between 31 March 2019 and 30 September 2019 that have no other existing brand of the same pharmaceutical item (including a single brand pharmaceutical item where the brand or pharmaceutical item changes, or where all existing brands change).
There is one brand of one new pharmaceutical item that is included in this amending instrument, as follows:
- the Oratane® brand of ‘isotretinoin, capsule 5 mg, oral’.
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 bivalirudin, epirubicin, ivabradine and pemetrexed.
This instrument affects the company that is the responsible person for Oratane.
All of the affected companies were consulted about the amendments. No concerns were expressed.
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.