Post-market Review of Ezetimibe
Page last updated: 20 December 2017
Disclaimer
Every effort has been made to ensure web accessibility to the Post-market Review of Ezetimibe Report and appendices, however complete web accessibility cannot be guaranteed. If you have trouble accessing information within the report or the appendices and you would like a copy to be provided to you, please direct all queries via email to PBSpostmarket@health.gov.au
Medicines included in this review | Terms of Reference | Consultation on the Review | Stakeholder Forum | Final Report to PBAC | Review Process | Further Information
Background
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 medicines for high cholesterol are 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 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 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 on 24 February 2016.
The Post-market Review of Ezetimibe was conducted 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 included in this review
The PBS listed medicines included in this Review were ezetimibe and ezetimibe co-pack/combination products.
Terms of Reference
The Terms of Reference for the Review were:
- 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 these medicines.
- Review recent clinical guidelines for the treatment of hypercholesterolaemia and compare this to how ezetimibe is currently used on the PBS.
- 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.
Consultation on the Review
Public consultation addressing the Review and final Terms of Reference closed on 22 April 2016.
Public consultation on the draft Review Report closed on 10 February 2017.
Public consultation on the revised draft Report closed on 6 June 2017.
Submissions are published on the Public Consultation page for the Post-market Review of Ezetimibe.
Stakeholder Forum
A targeted Stakeholder Forum was held in Canberra on 11 November 2016 for pharmaceutical sponsors who either have current PBS medicine listings for ezetimibe or in combination with ezetimibe, or proposed to have one in the near future.
The Outcome Statement and related submissions are published on the Public Consultation page for the Post-market Review of Ezetimibe.
The Department appreciates the valuable contributions made by stakeholders who provided submissions or comments during this review.
PBAC Consideration of the Final Report
The Report, including PBAC sub-committee advice and stakeholder comments, was provided to the PBAC for consideration in July 2017. The PBAC Minutes and Final Report for this item are now available. Parts of the PBAC Minutes have been redacted due to ‘commercial-in-confidence’ information.
PBAC Minutes for the Post-market Review of Ezetimibe
- PBAC Minutes - (PDF 896 KB) - (Word 303 KB)
Post-market Review of Ezetimibe Final Report to PBAC
- Final Report to PBAC - (PDF 1.8 MB) - (Word 303 KB)
- Appendix A – History of PBS listings - (PDF 332 KB) - (Word 22 KB)
- Appendix B – PBS ezetimibe restrictions - (PDF 1.1 MB) - (Word 157 KB)
- Appendix C – Key dates - (PDF 441 KB) - (Word 26 KB)
- Appendix D – Reference Group membership - (PDF 248 KB) - (Word 18 KB)
- Appendix E – Analysis of Utilisation Data - (PDF 2.0 MB) - (Word 753 KB)
- Appendix F – Stakeholder Forum Outcome Statement - (PDF 965 KB) - (Word 67 KB)
- Appendix G – Review of clinical guidelines - (PDF 2.4 KB) - (Word 4.2 MB)
- Appendix H – Public consultation - (PDF 488 KB) - (Word 30 KB)
- Appendix I – Systematic Literature Review - (PDF 3.8 MB) - (Word 3.8 MB)
- Appendix I – Systematic Literature Review Appendices - (PDF 1.8 MB)
Overall, the PBAC accepted the key findings presented in the Report. The PBAC noted the evidence on long- term patient outcomes was limited to one study, IMPROVE-IT, and that the eligible patient population in this study was not representative of the current PBS population eligible for subsidised ezetimibe.
The PBAC acknowledged the stakeholder comments and recognised the challenges in accurately determining the extent of statin intolerance in the Australian population. However, the PBAC was concerned with the extent of use of ezetimibe outside the PBS restriction and recommended that a price reduction was necessary to restore cost-effectiveness.
The PBAC agreed that an Authority Required (Streamlined) listing was most appropriate to maintain ezetimibe’s place as second line therapy, consistent with clinical guidelines and to direct use to the high-risk population that would derive most benefit from ezetimibe therapy.
The PBAC made a number of other recommendations in its advice to the Minister. These included the removal of the General Statement on Lipid Lowering Drugs and consequent requirement to revise the restriction for ezetimibe, the derestriction of statins and the value of Quality Use of Medicine initiatives to ensure optimal first line initiation and up-titration of statin therapy.
Review Process
This Review followed 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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