Consultation on the revised PBS Post-market Review (PMR) Framework

Overview

PBS Post-market Review Framework

The Department of Health and Aged Care is inviting stakeholders to provide feedback on a revised draft of the Pharmaceutical Benefits Scheme (PBS) Post-market Review (PMR) Framework.

Stakeholders will have the opportunity to engage and provide feedback on the revised draft of the 2022 PMR Framework. The diverse perspectives, experience and knowledge of all stakeholders is highly valued and will contribute to the finalisation of the 2022 PMR Framework. Following this consultation period, the revised Framework will need to be endorsed by Government.

The revised draft of the 2022 PBS PMR Framework is available as a related document at the bottom of this page.

The Department of Health and Aged Care has received a request from a stakeholder to extend the consultation on the revised draft PMR Framework to 16 December 2022. 

The consultation will remain open for approximately eight weeks from 20 October 2022 until 16 December 2022 at 11:59 pm AEDT.

After the consultation closing date, the Department will communicate next steps in this process to all stakeholders via this website.

For enquiries about the PBS PMR Framework consultation please contact the Post-market Review Secretariat.

Background

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 aim to provide the Pharmaceutical Benefits Advisory Committee (PBAC) with the available evidence to support decision making on the continued access, investment, or disinvestment in PBS-listed medicines.

PMRs are conducted under the 2011-12 Budget measure ‘improving sustainability of the PBS through enhanced post-market surveillance.’

Currently PMRs follow the PMR Framework developed in consultation with industry in 2014 and announced by the Minister for Health on 18 March 2015. The PMR Framework has not been altered since it was first implemented. Since 2015, PMRs have resulted in the implementation of significant changes to the PBS. Examples of outcomes of PMRs include PBS restriction changes, pricing changes and education activities. These changes support the ongoing sustainability of the PBS and improve quality use of medicines.

In 2019, the Department contracted a 'Systematic literature review on international approaches to post-market reviews and technology re-assessment' to identify international best practice. The report found that Rapid Reviews have been conducted internationally by organisations such as the Canadian Agency for Drugs and Technologies in Health (CADTH). Rapid assessments typically focus on clinical evidence and often utilise existing secondary data (i.e., clinical practice guidelines, health technology assessments [HTAs] and systematic reviews); an economic analysis is not always included.

From a subsequent internal review of PMRs undertaken under the current PMR Framework, the Department found that the current PMR Framework was no longer fit for purpose and that some processes in the Framework result in significant delays. The analysis found that:

• PMRs take over two years to complete with some Reviews taking between 3-4 years.
• The number of PMRs requested by the PBAC has decreased in recent years as the PBAC is seeking more timely advice on post-market concerns.
• The full PMR process, according to the Framework, is too prescriptive and not sufficiently agile to accommodate the range of evidence requests from the PBAC.
• Several steps in the Framework delay the time taken to complete a PMR but add little value to the quality of information provided to the PBAC.

The Department has identified changes that can be implemented to streamline and expedite PMRs without impacting on the standard of the reports and PMR outcomes.

The key differences between the revised draft PMR Framework and the current PMR Framework are summarised below:

• Public consultation on the draft Terms of Reference (ToRs) has been removed from the revised Framework. This step was found to make no material difference to the wording of the final ToRs.
• Under the revised Framework a Review Reference Group will only be established when deemed appropriate by the PBAC. For example, when there is insufficient clinical expertise in the membership of the PBAC or its sub-committees to provide advice on the research and stakeholder input relevant to the Review.
• In the revised draft PBS PMR Framework, information on the Reference Group membership will be published on the Post-market Review webpage at the beginning of the Review.

Further feedback has indicated that there are additional differences between the current and revised Frameworks, and that it would be helpful to outline these more clearly for stakeholders. These points have been added to the differences identified above:

• The current PMR Framework indicates that new topics for review are likely to originate from a drug utilisation review of PBS medicine(s) and the revised PMR Framework more explicitly describes how new PMR topics may originate from a variety of sources including: the PBAC, stakeholder requests and other areas of government.
• The revised PMR Framework more explicitly describes how PBAC advice may be shared with other areas of the Department of Health and Aged Care or State and Territory Health Departments, and specifically refers to the areas responsible for the National Health and Medical Research Council and the Medical Research Future Fund.
• More detail is provided in the revised PMR Framework relating to the continued focus of PMRs on PBS sustainability.
• More explicit detail is provided in the revised PMR Framework to clarify factors influencing prioritisation of PMR topics.

Note: No changes have been made to the revised draft PMR Framework that was originally published when this consultation opened on 20 October 2022.

Why we are consulting?

In 2022, the PBS PMR Framework was reconsidered in the context of the new Strategic Agreements between the Commonwealth, Medicines Australia (MA) and the Generic and Biosimilar Medicines Association (GBMA).

Under clause 7.5 of the new Strategic Agreements, 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.”

Consultation scope

In scope

• Improvements to streamline, expedite and provide for more flexible approaches to conducting PBS PMRs through a revised Framework
• The impacts and ramifications of any change(s) to stakeholders

Out of scope

• The PMR Program
• The Health Technology Assessment Policy and Methods Review
• A review or change of previous PBAC recommendations made as a result of a PMR

About the consultation survey

The consultation survey includes the following sections:

• Section 1. Privacy and consent (2 questions) [Required]
• Section 2. Contact details (5 questions) [Required]
• Section 3. Proposed change no. 1 - Public consultation on the draft Terms of Reference (1 question)
• Section 4. Proposed change no. 2 - Review Reference Group (1 question)
• Section 5. Proposed change no. 3 - Publication of Review Reference Group membership (1 question)
• Section 6. Proposed change no. 4 - Removal of references to internal working groups and other wording updates (1 question)
• Section 7. General comments (1 question)

Sections 3-6 of the survey includes a preamble highlighting amendments to the PMR Framework made by the Department, with an example of what has changed, followed by an invitation for comment. Any additional comments you would like the Department to consider relating to the revised PBS PMR Framework can be provided under Section 7 - General comments.

If you wish, you can complete the survey in stages by using the ‘save and return’ feature. At the bottom of each survey page, you can select the 'Save and come back later...' button. You will then be asked to provide an email address. A unique link will be emailed to you that will allow you to return to where you left off. Email addresses entered for this purpose are not saved with your responses to the consultation.

You can also choose the order in which you complete the sections of the survey. You will be returned to the Contents page after you have responded to each section. You will need to answer 'required' questions before you can submit your response. 

How will responses be used?

The feedback gained through this consultation process will be collated and used to support finalisation of the 2022 PBS PMR Framework.