10.2 Post-market Reviews

The Australian Government has introduced a systematic approach to monitoring and reviewing the ongoing safety, effectiveness and cost-effectiveness of medicines listed on the PBS.

Post-market reviews of PBS-listed medicines are conducted under the 2011–12 Budget measure – ‘Improving sustainability of the Pharmaceutical Benefits Scheme (PBS) through enhanced post-market surveillance’. They fall under the quality use of medicines objective of the National Medicines Policy framework. This includes promoting the ongoing safe and effective use of medicines, with the aim to improve health outcomes for all Australians.

These reviews aim to:

  • improve patient safety through better understanding of adverse events and medicine-related harms
  • ensure the ongoing viability of the PBS through targeted medicines usage, and avoiding preventable wastage or inappropriate prescribing
  • develop a better understanding of medicines use, to review intended clinical benefit and inform medicines evaluation processes
  • ensure ongoing cost-effectiveness, including through better management of clinical and economic uncertainty
  • achieve overall improvements to the quality use of medicines and education for patients and prescribers

The Australian Government is committed to ongoing monitoring of the clinical effectiveness and cost-effectiveness of medicines after they have been listed on the PBS.

10.2.1 Ministerial approval for a post-market review

A full post-market review will only proceed following Ministerial approval.

Post-market reviews may be initiated at any time, but the main drivers are recommendations by the PBAC or issues identified through the routine monitoring processes of DUSC. Routine monitoring by DUSC occurs at 24 months after the initial listing of a medicine or major changes to the existing listings of a medicine on the PBS.

Post-market reviews may be initiated because of concerns related to the quality use of a medicine, cost-effectiveness, clinical effectiveness, higher than predicted utilisation and/or international differences. The department will seek advice from the PBAC and its subcommittees about the scope and potential sources of evidence and input for each post-market review.

10.2.2 Post-market review processes

Post-market reviews are conducted in accordance with a consultative framework that was agreed to by the pharmaceutical industry representative body (Medicines Australia) and the department.

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