The Institute for Clinical and Economic Review (ICER) announced that the next report and meeting of the New England Comparative Effectiveness Public Advisory Council (CEPAC) will address drug therapies for high cholesterol, including a review of an emerging class of drugs, PCSK9 inhibitors. The drugs have shown promising clinical outcomes in early trials, and the FDA is expected to make approval decisions on the PCSK9 inhibitors alirocumab (Regeneron/Sanofi) and evolocumab (Amgen) in late summer 2015.
ICER’s report will include a systematic review of the published evidence on these new treatment options relative to existing alternatives, and will also feature a calculation of a “value-based price benchmark” for PCSK9 inhibitors based on an analysis of comparative cost-effectiveness and potential short-term budget impact. It will serve as the basis for discussion at CEPAC’s next public meeting on October 27, 2015 (meeting details and registration information included below).
During the public meeting, CEPAC will deliberate and vote on the comparative clinical effectiveness and value of the various pharmacological options for cholesterol management.The Council will discuss the implications of the votes for policy and practice with a policy roundtable of experts in the field to provide clarity and guidance to patients, clinicians, insurers, and policymakers confronted with decisions on how best to manage high cholesterol.
Date: October 27, 2015
Location: The Joseph B. Martin Conference Center at Harvard Medical School
Report Timeline and Public Comment Process
ICER has implemented a revised public comment policy for the October 27 meeting. More information on the updated policy is available on the CEPAC website. The key dates for the public comment process are outlined below. All documents will be posted no later than the dates indicated.
July 7: Scoping document posted
July 7-July 14: Public comment period on scope
September 8: Draft report and voting questions posted
September 8-September 22: Public comment period on draft report
October 6-October 27: Council reviews revised report
October 27: Public Meeting