Access to Medicines Working Group – 6 March 2025
Page last updated: 28 May 2025
The Access to Medicines Working Group (AMWG) met on 6 March 2025. Attendees included representatives from Medicines Australia (MA), the pharmaceutical industry and the Department of Health and Aged Care (the Department).
The AMWG noted the formation of the Health Technology Assessment (HTA) Review Implementation Advisory Group (IAG) to advise Government on recommendations in the HTA Policy and Methods Review report. The IAG has been established for at least 12 months and will co-design a draft Government response to the HTA review and a final report to the Minister on the group’s work.
The AMWG was presented with an overview of progress with PBS cost recovery activities including the annual indexation of PBS cost recovery fees for the 2025-26 financial year and an update on the PBS Time and Motion Study to refresh staffing inputs for the PBS cost model. The AMWG noted the work undertaken by the Department to refresh the PBS cost model throughout 2025 for implementation in the 2026-27 financial year, subject to Government approval through the budget process. The Department will provide indicative 2026-27 cost recovery advice to the AMWG by December 2025 and undertake public consultation on the 2026-27 PBS Cost Recovery Implementation Statement in early 2026.
The AMWG further discussed MA’s proposal on Risk Sharing Arrangements (RSA) policy development including feedback provided by the Department and outstanding issues from an industry perspective. The AMWG noted that RSAs are a tool to support decision-makers and acknowledged the role of the PBAC as an independent adviser to the Minister consistent with the legislation. MA and the Department agreed to further progress RSA policy development work out-of-session, as outlined in the Strategic Agreement.
The AMWG also discussed the TGA’s Medicines Repurposing Program (MRP) and noted industry continues to be engaged through MA’s Regulatory Affairs Working Group. The Department advised that reimbursement issues are being closely considered as part of advice on individual submissions for the TGA’s Advisory Committee on Medicines and at the overall program level. MA and the Department agreed to engage further on providing appropriate guidance for sponsors on structuring PBAC submissions for medicines repurposing and other aspects of reimbursement of these medicines.
The Metrics and KPI Subgroup provided advice to the AMWG on proposed measures to support KPI 1 in the Strategic Agreement: to reduce time to PBS listing, including time from TGA registration to PBS listing. The AMWG agreed or agreed-in-principle to a range of metrics and statistics to be implemented starting from 2025-26. Further advice will be provided to AMWG on implementation and reporting at its next meeting.
The AMWG will reconvene in August 2025.
