Institute for Clinical and Economic Review Releases Draft Evidence Report on Elagolix for Endometriosis

– Public comment period now open until May 31st; Requests to make oral comment during public meeting also being accepted –

BOSTON, May 4, 2018 – The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of elagolix (AbbVie/Neurocrine Biosciences) for the management of endometriosis and associated pain. The review will be open to public comment until May 31, 2018. Findings contained in this report are preliminary and subject to change based on additional stakeholder input and further analysis of data.

Elagolix is currently under review by the FDA. An approval decision was initially scheduled for the second quarter of 2018; however, the FDA has extended this date by three months to allow time for review of additional information. The report will be subject to deliberation during a public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC), one of ICER’s three independent evidence appraisal committees, in July of 2018.

ICER is committed to engaging with all stakeholders in a thorough and transparent manner. During this review, ICER spoke with key patient groups and advocates, clinical experts, and manufacturers. Public comments were also accepted on a Draft Scoping Document. The current draft report incorporates input received from patients, clinicians, and other stakeholders during each of these opportunities for engagement.

Submit a Public Comment: The Draft Evidence Report and Draft Voting Questions are now open to public comment until 5 PM ET on May 31, 2018. All stakeholders are invited to submit formal comments by email to publiccomments@icer-review.org.Guidelines for submitting public comments, including formatting specifications, are available on ICER’s website. ICER’s Manufacturer Engagement Guide and Patient Participation Guide provide additional detail on what types of information may be most informative to the report.

ICER will review all comments and incorporate any necessary changes in the Evidence Report and Revised Voting Questions that will be posted on or about June 15, 2018. All comments and ICER’s response to comments will be posted publicly along with the Evidence Report.

Register for the Public Meeting: The Evidence Report will be the subject of a public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) on July 12, 2018 in Burlington, VT. During the meeting, the independent council will vote on key questions raised in the report.

Registration for the public meeting and live webcast is now open.

Register to Make an Oral Comment: During the public meeting, there will be a limited amount of time available for interested stakeholders to make an oral comment on the report. Requests to submit oral comments must be emailed to publiccomments@icer-review.org by 5 PM ET on May 31, 2018. Individuals who wish to deliver oral comments must separately register to attend the meeting.

For more information about registering for oral comment, please visit our website.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.