Post-Market Reviews of Pharmaceutical Benefits Scheme Subsidised Medicines

Page last updated: 16 March 2015

What are Post-Market Reviews?

The Government has introduced a systematic post-market approach to monitoring medicines in use to inform decision making at all levels throughout the medicine cycle (from the registration of a medicine right through to its use by consumers).

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

Post-market reviews are conducted under the 2011-12 Budget measure Improving sustainability of the Pharmaceutical Benefits Scheme (PBS) through enhanced post-market surveillance.

Importantly, the post-market review program will contribute to:

  • Improved patient safety through better understanding of adverse events and medicine-related harms.
  • 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.

It is important for the Government to continue to monitor clinical and cost-effectiveness of medicines after they have been listed on the PBS. Reviews of cost-effectiveness ensure that the cost of medicines to the PBS appropriately reflects the health outcomes expected and subsequently produced.

These reviews are to ensure the quality use of PBS listed medicines and the ongoing sustainability of the PBS.

The full post-market review framework can be viewed here.

How are Post-Market Reviews selected?

Post-market reviews may be initiated at any time, but the main drivers for a review are recommendations by the Pharmaceutical Benefits Advisory Committee (PBAC) or issues identified through the routine monitoring processes of the Drug Utilisation Sub Committee (DUSC), a sub-committee of the PBAC. Routine monitoring occurs at 24 months post-listing for new major listings, and changes to existing listings of medicines on the PBS.

Post-market reviews 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 post-market reviews. A full post-market review will only proceed following either PBAC agreement or Ministerial approval.

What are the steps in a Review?

The full post-market reviews framework outlines the usual approach to medicines reviews:

Industry, along with consumers, are members of the DUSC (sub-committee of the PBAC) and are included in the discussion when considering medicine utilisation reports that may initiate a post-market review. This provides members significant early insights into the upcoming work-plan for the PBAC and post-market program. In addition, the DUSC publishes summaries of the DUSC meetings to improve transparency.

Once initiated, each review has an agreed Terms of Reference, and assesses appropriate evidence.

Open public consultation is undertaken for all post-market reviews. All interested stakeholders are encouraged to provide input into each review.

Stakeholder forums are also held, if required, after the public consultation process to provide a further opportunity for input. Along with the public consultation, the stakeholder forums provide a good public hearing for all stakeholders especially consumers to feed directly into the PBAC process.

An ‘issues and options paper’ and/or ‘draft report’ is made available for stakeholder input or comment along the way, depending on the type of review. This provides further opportunity for stakeholders to directly influence the PBACs consideration. A minimum of two weeks is provided for input/comment once a draft report is circulated.  This is consistent with the long standing PBAC submission process and a timeline industry has been navigating for many years.

While all reviews are conducted within the post-market review framework and provide all stakeholders the opportunity to contribute, a degree of flexibility needs to be maintained in the approach to reviews to ensure the different requirements of a review can be met.

How can I get involved?

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

The PBS website, along with the PBS subscription service, is used to keep stakeholders advised of Reviews and invite interested parties to provide input as appropriate.

For the latest news updates, you can subscribe to the PBS website.

Current PBS medicine reviews underway

There are currently a number of post-market reviews in progress, at varying stages of completion.

Links to each of the reviews, their status and supporting material is at: Reviews.

Background

Australia’s National Medicines Policy is a broad framework that aims to improve health outcomes for all Australians through access to and appropriate use of medicines.  The overall aim of the policy is to meet medication and related service needs, so that both optimal health outcomes and economic objectives are achieved.

The four central objectives of the policy are:

  • timely access to the medicines that Australians need, at a cost individuals and the community can afford;
  • medicines meeting appropriate standards of quality, safety and efficacy;
  • quality use of medicines; and
  • maintaining a responsible and viable medicines industry.

Consultation on the development of the post-market monitoring program was initiated in early 2009 under the National Medicines Policy Partnerships Forum (prior to the Budget announcement).Furthermore, post-market monitoring was the sole focus of the 2011 National Medicines Policy Partnerships Forum (post Budget announcement).Over 100 industry, consumer and professional representatives contributed to the discussion at both of these forums.

Following the Budget announcement on the post-market review framework, feedback from stakeholders at the Joint Medicines Policy Conference in August 2011 further informed the finalisation of the program. At this conference, stakeholders suggested consumers should be the focus and consultation should be conducted through a call for submissions to each review and public forums, both of which have been implemented.

Post-market reviews are not new. The PBAC and DUSC have been undertaking reviews of PBS listed medicines for many years. However, this is the first time a formal framework with the capacity to conduct these routinely has been put in place. The standard post-market review process includes consultation with all stakeholders including industry, and a strong focus on consumers.

Useful links

Drug Utilisation Sub-Committee summaries

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

Pharmaceutical Benefits Advisory Committee recommendations

This webpage provides information regarding the Pharmaceutical Benefits Advisory Committee 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 and Post-Market Reviews

Further information regarding current and completed Post-Market Reviews, as well as other reviews relevant to the Pharmaceutical Benefits Scheme, can be found here.