The Institute for Clinical and Economic Review (ICER) on Friday 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. Findings contained in the report are preliminary and subject to change based on additional stakeholder input and further analysis of data.
Elagolix is currently under review by the U.S. Food and Drug Administration (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 for additional review.
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.
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.
To read the Draft Evidence Report, click here.