National Health (Weighted average disclosed price – October 2019 reduction day) Amendment Determination 2019 (PB 75 of 2019)

Overview

The National Health (Weighted average disclosed price – October 2019 reduction day) Amendment Determination 2019 is an instrument made under the authority of subsection 99ADB(4) of the National Health Act 1953, which empowers the Minister to determine the weighted average disclosed price (WADP) of a brand of a pharmaceutical item. This legislative instrument was enacted to address discrepancies in the data submitted for the WADPs of certain pharmaceutical brands, as well as to accommodate changes in supply due to the implementation of price disclosure reductions. The amendments made by this determination correct the WADPs for bivalirudin and ivabradine, which had been inaccurately submitted, and adjust the prices for epirubicin and pemetrexed to ensure continued supply. Additionally, the instrument introduces a new WADP for the Oratane® brand of isotretinoin, a new pharmaceutical item. The determination was developed in consultation with the relevant pharmaceutical companies, none of which expressed concerns about the amendments.

Scope and Application

The National Health (Weighted average disclosed price – October 2019 reduction day) Amendment Determination 2019 amends the weighted average disclosed prices (WADP) of certain pharmaceutical brands listed in the National Health (Weighted average disclosed price – October 2019 reduction day) Determination 2019. This legislative instrument applies to responsible persons who are companies holding relevant approvals for the listed brands of pharmaceutical items. These brands include bivalirudin for injection, ivabradine for oral administration, epirubicin for injection/intravesical, and pemetrexed for injection. Additionally, it includes a new brand of isotretinoin for oral administration. The amendment arises from considerations of data submitted by responsible persons and its impact on supply following price disclosure reductions on 1 October 2019. The Act applies nationally under the Commonwealth's authority to regulate pharmaceutical benefits. The amendment is effective from the day after its registration on the Federal Register of Legislation, and all affected companies were consulted prior to its implementation.

Key Provisions

The main operative sections of this legislative instrument (F2019L01084) are found in the National Health (Weighted average disclosed price – October 2019 reduction day) Amendment Determination 2019, which amends the October 2019 determination of weighted average disclosed prices (WADP) for certain pharmaceutical items listed in Schedule 1 of the National Health (Pharmaceutical Benefits) Regulations 2017. The amendment adjusts the WADPs for brands of pharmaceutical items containing bivalirudin for injection and ivabradine for oral administration, following the submission of corrected data. It also removes the WADPs for brands of pharmaceutical items containing epirubicin for injection/intravesical and pemetrexed for injection due to concerns about supply impacts from the October 2019 price disclosure reductions. Additionally, the amendment inserts a WADP for a new brand of a new pharmaceutical item, isotretinoin for oral administration, Oratane®. This amendment is made under subsection 99ADB(4) of the National Health Act 1953 and is based on subsection 33(3) of the Acts Interpretation Act 1901, which allows for the variation or revocation of determinations when necessary. The obligations and requirements imposed by this amendment on the parties or entities it governs primarily involve the submission of accurate data and adherence to the adjusted WADPs as determined. Responsible persons for the pharmaceutical items affected by this amendment must ensure that the data they submit is correct and up-to-date to avoid discrepancies in the WADP calculations. For the brands of pharmaceutical items where the WADPs have been adjusted, responsible persons must comply with the new WADPs set out in this amendment, which will be reflected in their pricing and supply practices. Additionally, for the brands removed from the list, responsible persons must manage their supply and pricing strategies in light of the absence of a WADP. There are no specific offences, penalties, or civil/criminal consequences outlined in this amendment for breaches of the adjusted WADPs or the removal of certain brands from the list. However, responsible persons who fail to comply with the correct WADPs or manage the supply of pharmaceutical items without a WADP could potentially face consequences under other sections of the National Health Act 1953 or the National Health (Pharmaceutical Benefits) Regulations 2017. These could include administrative actions or penalties for non-compliance with pricing regulations or supply obligations. The primary focus of this amendment is to correct data errors and address supply concerns, rather than imposing new penalties.