Post-market Review of Ezetimibe

Page last updated: 27 January 2017


Ezetimibe is listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of high cholesterol in certain patient populations. Ezetimibe is used to lower high cholesterol with the goal of reducing the risk of cardiovascular events such as heart attacks and stroke. In 2003, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing of ezetimibe on the PBS based on a comparison of data on lipid levels available at the time. Longer term studies are needed to assess whether reduction of lipid levels with ezetimibe actually results in fewer cardiovascular events.

The most commonly used treatment for high cholesterol is HMG-CoA reductase inhibitors, or statins. In November 2013, the PBAC expressed concern that the listing of ezetimibe with statin co-packs and combination products on the PBS may direct use away from optimal dose titration of statins. The PBAC also noted that in contrast to statins, there are no long term patient relevant outcome data for ezetimibe, and that PBS expenditure on the medicine was high.

On 14 August 2015, the PBAC recommended a Post-market Review of Ezetimibe. The purpose is to review the cost-effectiveness of ezetimibe, in the context of the latest available evidence and best clinical practice. The Minister for Health agreed to the Review and the draft Terms of Reference on 28 September 2015.

The Post-market Review of Ezetimibe is being carried out under the Australian Government’s post-market monitoring program, which aims to ensure the continued safe, cost-effective and quality use of, medicines listed on the PBS. Medicines to be included in this Review are ezetimibe and ezetimibe co-pack/combination products listed or considered for listing on the PBS. Medicines considered as comparators may include other lipid lowering medicines, such as statins and bile acid sequesterants.

Public Consultation on the draft Ezetimibe Post-market Review Report

The public submission process for the Report of the Ezetimibe Review opened on 30 January 2017. Interested organisations and individuals are invited to provide a submission addressing the Draft Report to the Pharmaceutical Benefits Advisory Committee (PBAC). To make a submission please go to the Public Consultation page. Submissions must be lodged by 5pm Friday 10 February 2017. Submissions received by the Department will be published on the Public Consultation page unless otherwise requested.  

Stakeholder Forum

At the request of the Reference Group of the Post-market Review of Ezetimibe, a targeted Stakeholder Forum was held in Canberra on Friday 11 November 2016. The Forum sought additional stakeholder input to further inform the Review. It was specifically targeted to pharmaceutical sponsors who either have a current Pharmaceutical Benefit Scheme medicine listing for ezetimibe or in combination with ezetimibe, or propose to have one in the near future.

The Outcome Statement (PDF 343KB) - (Word 724KB) was sent to all attending stakeholders for comment on 23 November 2016. To view the Stakeholder comments please go to the Public Consultation Page.

Consultation on Draft Terms of Reference (closed)

Public consultation on the draft Review Terms of Reference was open between 16 October and 13 November 2015.  To view submissions please go to the Public Consultation page.

Final Terms of Reference

The PBAC considered the draft Review Terms of Reference and comments from stakeholders at the December 2015 PBAC meeting.  Following the December 2015 PBAC meeting the Minister for Health approved the final Terms of Reference for the Review:

  1. Review current utilisation of Pharmaceutical Benefits Scheme (PBS) - listed ezetimibe and Ezetimibe combination products.  Any review will consider additional data sources that may inform the current utilisation of ezetimibe.
  2. Review recent clinical guidelines for the treatment of hypercholesterolaemia and compare this to how ezetimibe is currently used on the PBS.
  3. Collate and evaluate any recent clinical studies of ezetimibe that report on long term patient relevant outcomes, and use this data to review the cost-effectiveness of ezetimibe.

Public Submissions addressing the final Terms of Reference (closed)

Public consultation addressing the final Review Terms of Reference was open between 4 March and 22 April 2016. To view submissions please go to the Public Consultation page.

Review Process

This Review will follow the Post-market Review Framework available on the Reviews website. This process includes public consultation on the draft Terms of Reference, an opportunity to provide submissions to the Review, and an opportunity to comment on the draft Review Report.

Further Information

Further information on post-market reviews is available on the Reviews website.

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