BRIEF—ICER plans review on elagolix for endometriosis

The USA-based Institute for Clinical and Economic Review (ICER) has posted a Draft Scoping Document outlining a planned review of AbbVie and Neurocrine Biosciences’ elagolix for the treatment of endometriosis and associated pain.

The scoping document will be open to public comment for three weeks until February 1, 2018.

Elagolix is currently under review by the US Food and Drug Administration, with an approval decision expected by mid-2018.

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.

The scoping document was developed with input from key stakeholders, including clinical experts, patients, and patient advocacy groups, who provided important insights into living with endometriosis and added context to the current treatment landscape.

The ICER will continue to engage with patients, clinicians, drug manufacturers, and other stakeholders to assess appropriate outcomes and comparators for the review and to enrich the evidence available from clinical trials.