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Post-market Reviews of Pharmaceutical Benefits Scheme Subsidised Medicines

Page last updated: 31 January 2024

What are Post-market Reviews?

In 2015, the Australian Government introduced Pharmaceutical Benefits Scheme (PBS) Post-market Reviews (PMRs) as a systematic approach to monitoring medicines following PBS listing, to inform decision making relating to ongoing access and subsidy. PMRs provide evidence and options to the Pharmaceutical Benefits Advisory Committee (PBAC) to ensure patient safety, quality use of medicines and the ongoing cost-effective use of PBS-listed medicines.

PMRs fall under the quality use of medicines objective of the National Medicines Policy. This includes promoting the safe and effective use of medicines, with the aim to improve health outcomes for all Australians.

PMRs were established under the 2011-12 Budget measure Improving sustainability of the PBS through enhanced post-market surveillance.

The PMR program was established to contribute to:

  • Ensuring the ongoing viability of the PBS through targeted medicines usage and avoiding preventable wastage or inappropriate prescribing.
  • A better understanding of medicines utilisation, to review intended clinical benefit and inform medicines evaluation processes.
  • Ongoing cost-effectiveness, including through better management of clinical and economic uncertainty.
  • Overall improvements to the quality use of medicines and education for patients and prescribers.

PMRs originally followed the 2015 PMR Framework developed in consultation with industry in 2014 and announced by the Minister for Health on 18 March 2015.

In 2022, the 2015 PMR Framework was reconsidered in the context of the Strategic Agreement between the Commonwealth and Medicines Australia (MA).

Under the new Strategic Agreement, the Commonwealth and MA agreed to:

“Work together with other relevant stakeholders to improve the current PMR Framework with the goal of reducing the timeframe from PBAC recommendation of the commencement of a Review, to completion of the Review, to a timeframe of within 12 months, subject always to the Framework not limiting PBAC independence.”

A draft revised PMR Framework was published for public consultation from 20 October 2022 to 16 December 2022. The final 2024 PMR Framework was developed by the Department of Health and Aged Care in consultation with MA and considered stakeholder comments received as part of the consultation process. The 2024 PMR Framework was endorsed by the PBAC in December 2023 and approved by the Minister for Health and Aged Care in January 2024.

How are Post-market Reviews selected?

PMRs may be initiated at any time on recommendation by the PBAC which may be as a result of considering submissions at PBAC meetings, concerns raised by stakeholders, or issues identified through the routine monitoring processes of the Drug Utilisation Sub Committee (DUSC), a sub-committee of the PBAC. New medicines on the PBS are routinely monitored by the DUSC 24 months after listing.

PMRs may be initiated due to 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 sub-committees on the scope and potential sources of evidence and input for PMRs. A PMR will only proceed following Ministerial approval.

What are the steps in a Post-market Review?

The 2024 PMR Framework is provided in DOCX and PDF formats below and outlines the usual approach to PMRs of PBS-listed medicines. A summary of changes document is also provided below which details the key changes between the 2024 PMR Framework and the 2015 PMR Framework.

When a medicine is recommended for PBS listing, the PBAC’s advice is made in the context of the treatments and evidence available at that point in time. Over time, new medicines may be developed and subsidised, more data on safety and efficacy may become available and treatment guidelines may change. As a result, the actual use and/or benefits of a medicine may change and may no longer reflect the evidence considered by the PBAC at the time of recommendation for listing.

The PMR Framework provides a mechanism for medicines to be re-considered in the current treatment context. It provides a transparent and formal approach to the ongoing evaluation of medicines subsidised by the Australian Government through the PBS. This includes consideration of actual utilisation, comparative efficacy/effectiveness, comparative safety, cost-effectiveness, treatment guidelines, health benefits and consumer experiences. As a result, the PMR Framework allows for measures to be implemented to address concerns around how a medicine is used that may have arisen since the time of PBS listing, such as improving education around medicines and their use, or revising PBS subsidy arrangements.

The PMR Framework is not intended to be prescriptive, as PMRs will differ in their complexity and focus. The Framework promotes consistency in approach, while providing the flexibility necessary to accommodate the different requirements of each Review.

How can I get involved?

PMRs follow a standard approach, which includes public consultation at various stages throughout the Review process in order to provide stakeholders with a number of opportunities to input.

Public announcements and general PMR Framework information for each PMR will be communicated on the PMR webpage and via PBS News Updates.

Stakeholders are encouraged to subscribe to PBS News Updates for the latest information and to be advised of the timing and processes for each PMR.

Information on consultation processes for medicines and vaccines can be viewed at the Office of Health Technology Assessment (OHTA) consultation hub.

Stakeholders may raise medicine related issues, potential topics for future PMRs, and suggestions for improvements to the 2024 PMR Framework by emailing PBSpostmarket@health.gov.au at any time.

Useful links

Drug Utilisation Sub-Committee Outcome Statements

These summaries provide an overview of all medicines considered by the DUSC, and highlights those which the committee recommended that no further action be taken, or recommended further consideration by the PBAC.

Pharmaceutical Benefits Advisory Committee Outcomes

This webpage provides information regarding the outcomes and brief summaries of these outcomes, grouped by meeting date. It also includes a link to the Public Summary Documents of the Committee meetings.

Current and completed Post-market Reviews

Further information regarding current and completed PMRs, as well as other Reviews relevant to the PBS, can be found here.