Institute for Clinical and Economic Review to Assess Elagolix for Management of Endometriosis

–Open Input now being accepted until January 8, 2018–

BOSTON, December 14, 2017 – The Institute for Clinical and Economic Review (ICER) will assess the comparative clinical effectiveness and value of elagolix (AbbVie) for management of endometriosis with associated pain. The FDA’s decision on whether to approve elagolix is expected during the second quarter of 2018.

An Open Input period begins today, and is intended to allow stakeholders to share key information relevant to the development of the evidence report. Comments on elagolix and on managing endometriosis will be accepted from all interested stakeholders until January 8, 2018. During this time, ICER will also contact key patient groups and clinical experts to gain further insights on the patient perspective and clinical context of treatment.

For more information about the Open Input period, visit ICER’s website. ICER’s Manufacturer Engagement GuidePatient Participation Guide, and Patient Guide to Open Input provide additional information for manufacturers and patient groups, including an explanation of what types of information may be most informative.

There are no page limits to Open Input submissions, and input received will be incorporated throughout report development. All input can be emailed to publiccomments@icer-review.org and must be received by 5 PM ET on January 8th to be considered.

The report assessing elagolix will be publicly discussed during a meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) in July of 2018, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.

During this meeting, the New England CEPAC will also review an update to a 2016 ICER assessment of therapies for plaque psoriasis. The update, announced previously as a report for review by the California Technology Assessment Forum, will instead be reviewed by the New England CEPAC and will incorporate new evidence that has emerged on the drugs included in ICER’s initial review of the subject. It will also include evidence on three additional drugs: guselkumab (Tremfya®, Johnson & Johnson), tildrakizumab (Sun Pharma/Merck), and certolizumab pegol (Cimzia®, UCB).

draft scoping document on the psoriasis update is currently open to public comment until December 22nd. A draft scoping document on the review of elagolix providing more detail on ICER’s proposed scope will be available on January 11, 2018 and will be open to public comment for three weeks.

ICER’s website provides timelines of key dates for the plaque psoriasis review and the endometriosis review.