Access to Medicines Working Group - 8 August 2024
Page last updated: 23 September 2024
The Access to Medicines Working Group (AMWG) met on 8 August 2024. Attendees included representatives from Medicines Australia (MA), the pharmaceutical industry and the Department of Health and Aged Care (the Department).
The AMWG noted the Minister has provided the HTA Policy and Methods Review Final Report to the PBAC and MSAC (and their subcommittees) for advice and is considering the timing of its release.
The AMWG was presented with an overview of progress with the PBS Time and Motion Study to refresh staffing inputs for the PBS cost model and drive efficiencies. The AMWG noted early trends and areas for further analysis. The Department will provide indicative 2025-26 cost recovery advice to the AMWG by December 2024 and undertake public consultation on the 2025-26 PBS Cost Recovery Implementation Statement in 2025.
The AMWG further discussed MA’s proposal on Risk Sharing Arrangements (RSA) reform and feedback from the Department. 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 discuss RSA policy out-of-session to progress work in this area, as outlined in the Strategic Agreement.
The Metrics and KPI Subgroup updated the AMWG on progress with identifying potential metrics to support implementation of the Strategic Agreement. The AMWG noted that the Subgroup has met three times since March and is working through MA’s prioritised list of metrics and reviewing the existing Stage 1 and 2 PBS process improvement metrics. Further advice will be provided to AMWG for consideration out-of-session as soon as available.
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.
The AMWG will reconvene in February 2025.
