Posted by Michael Wonder on 05 May 2018
ICER releases draft evidence report on elagolix for endometriosis
4 May 2018 - Public comment period now open until 31 May; requests to make oral comment during public meeting also being accepted.
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 31 May 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.
