The Institute for Clinical and Economic Review (ICER) has released the revised draft report: PCSK9 Inhibitors for Treatment of High Cholesterol: Effectiveness, Value, and Value-Based Price Benchmarks that reflects revisions made following a public comment period. The revised draft includes a comprehensive review of currently available evidence on the newly approved PCSK9 inhibitors alirocumab (Praluent®, Regeneron/Sanofi) and evolocumab (Repatha™, Amgen), and also provides analyses of cost-effectiveness and potential budget impact under different utilization assumptions.

ICER is committed to a transparent public engagement process to ensure that all stakeholders have the opportunity to provide input to our evidence reports. After the initial draft ICER report was released, drug manufacturers and other stakeholders had a two week period to provide comments. These comments have been considered by ICER staff as part of the development of a revised draft report that will be used to support deliberations and voting at the October 27, 2015 meeting of the New England Comparative Effectiveness Public Advisory Council (CEPAC).

More information on our methods for public engagement can be found here: Drug Assessment and Meeting Overview.

Based on comments received, the revised draft contains additional information and updates to several analyses.  You can read a detailed description of our response to comments, including the impact those comments had on the revision of the draft report, here.  You can access the revised draft report, as well as revised voting questions and public comments received, here.

Seats are currently full for in-person attendance at the CEPAC meeting that will be held in Boston on October 27, 2015. If you are interested in attending and have not yet registered, you can join the waitlist here. Those unable to attend the meeting in-person may register for a live webcast of the event by clicking here. A video recording will be available on the website following the meeting.

About CEPAC

The New England Comparative Effectiveness Public Advisory Council (CEPAC) – a core program of the Institute for Clinical and Economic Review (ICER) — is an independent panel that reviews objective evidence reports and holds public meetings to develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about CEPAC, please visit www.cepac.icer-review.org.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit health care research organization dedicated to improving the interpretation and application of evidence in the health care system. ICER directs two core programs: the California Technology Assessment Forum (CTAF), and the New England Comparative Effectiveness Public Advisory Council (CEPAC). For more information about ICER, please visit ICER’s website, www.icer-review.org.