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ICER to assess cost-effectiveness of AbbVie's elagolix

December 22, 2017 7:54 PM UTC

The Institute for Clinical Effectiveness and Economic Review said it will review the comparative clinical effectiveness and value of elagolix (ABT-620, NBI-56418) from AbbVie Inc. (NYSE:ABBV) for the management of endometriosis with associated pain. ICER will release its proposed scope for the review on Jan. 11, which will be open for public comment, and the draft evidence report on May 4. The institute expects to publish the final evidence report on June 15 for discussion at a public meeting of the New England Comparative Effectiveness Public Advisory Council on July 20.

In October, FDA accepted and granted Priority Review to an NDA for elagolix to manage endometriosis with associated pain. Its PDUFA date is in 2Q18 (see BioCentury, Nov. 2)...