Pharmaceutical Benefits Advisory Committee process for managing its March 2025 agenda
The Pharmaceutical Benefits Advisory Committee (PBAC) has considered the issues arising from the current notice of intent (NOI) advice of industry sponsors to the Department of Health and Aged Care for the March 2025 PBAC meeting cycle.
This process has indicated that the number of submissions requiring clinical and economic evaluation expected to be presented for the March 2025 PBAC meeting cycle significantly exceeds the capacity available to undertake the technical evaluations necessary for PBAC preparations and progression to Committee considerations.
The PBAC met Out of Session to select the submissions able to be accommodated on the March 2025 agenda, and which allows the Committee to acquit its obligations under the National Health Act 1953 (the Act).
The principles recognised by the Committee for these considerations included:
All members of the Committee were involved in this selection process;
All of the potential submissions expected to require a full technical evaluation process under the requirements of PBAC Guidelines were discussed;
Ensuring deliberations in March 2025 are able to be informed and fit for providing considered advice and recommendations as required under the Act;
The Committee referred to supporting materials made available for their considerations that captured information for each potential submission item, including that provided from applicant’s NOIs and previous PBAC outcomes where applicable;
Clinical need, additional therapeutic priorities and equity for priority populations were guiding factors.
The practical implementation of the principles above was that the Committee:
agreed that any 3-day meeting capacity includes a maximum total number of cost-effective analysis submissions which must be fully evaluated and progressed through the usual 17-week cycle steps to be acceptable for decision-making purposes;
prioritised two resubmission items for the March 2025 meeting which PBAC has previously identified as high added therapeutic value and have been on a Facilitated Resolution pathway to return to the March 2025 meeting;
considered other categories of new submissions collated by criteria that noted Therapeutic Goods Administration (TGA) Orphan Drug, Provisional and Priority status, category 1 or 2 claim (as identified by the applicant), co-dependent applications, and cost minimisation analysis applications;
provided rationale for each item in a deliberative manner and considered that the reasons that certain submissions could be delayed included no current unmet clinical need, or that a medicine or vaccine may already be publicly funded and available.
recognised that some applicants might not proceed with their submission and in that eventuality additional submissions could be accommodated to take their place.
News Item on PBS website: https://www.pbs.gov.au/info/news/2024/10/pbac-process-for-managing-its-March-2025-agenda