Health Department launches consultation on cost recovery fees for medicines and vaccines

Pharma News: The Department of Health and Aged Care has announced a consultation on the draft 2024-25 Cost Recovery Implementation Statement (CRIS) for listing medicines on the Pharmaceutical Benefits Scheme (PBS) and designated vaccines on the National Immunisation Program (NIP). Stakeholders are invited to contribute their feedback by 15 May, shaping the path forward for the upcoming fiscal year.

Amendments to the National Health (Pharmaceutical and Vaccines – Cost Recovery) Regulations 2022 came into effect on 1 July 2023 to support the annual indexation of cost recovery fees.

Embedded within the draft 2024-25 CRIS are the fee structures slated for implementation in 2024-25, shedding light on how the Department navigates cost recovery for various processes, including submissions to the Pharmaceutical Benefits Advisory Committee (PBAC) or NIP, and applicant-driven listing activities. Notable among the updates are provisions for the annual review of indexation for PBS/NIP cost recovery fees and enhanced disclosure regarding depreciation costs for IT assets related to PBS/NIP operations.

Previous engagement with stakeholders has revealed a call for greater clarity surrounding fee increments and the utilisation of additional government funding earmarked for this purpose. Stakeholders stress the importance of early engagement to facilitate smooth transitions and advocate for expanded opportunities for fee exemptions, particularly concerning submissions pertaining to TGA designated orphan medicines.

Moreover, there’s a palpable desire for flexible waiver provisions and alternative fee structures to accommodate lower-value medicines, vaccines, or smaller companies. Transparency emerges as a central theme, with stakeholders pushing for publicly available metrics to gauge improvements in the PBS evaluation and listing process. They seek a clear delineation of how cost recovery fees improve departmental resources and staffing, demanding accountability and efficiency in resource allocation.

The final CRIS will be published before the fee changes take effect on 1 July 2024.

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