–Document open to public comment until February 1, 2018–
BOSTON, January 11, 2018– The Institute for Clinical and Economic Review (ICER) has posted a Draft Scoping Document outlining a planned review of elagolix (AbbVie/Neurocrine Biosciences) for the treatment of endometriosis and associated pain. The scoping document will be open to public comment for three weeks until February 1, 2018 at 5pm ET.
Elagolix is currently under review by the FDA, 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. 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.
All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered.
ICER’s Patient Participation Guide and Manufacturer Engagement Guide provide additional guidance for submitting public comments, including suggestions for what types of information may be most useful.
In addition to comments on the scope, ICER also welcomes submissions from stakeholders on examples of low-value care practices within this clinical area. These submissions will inform a report section focused on strategies to reduce waste and preserve resources for high-value, potentially higher cost treatments. More information is available in the scoping document.
Following the public comment period, a revised scoping document will be posted on or about February 9, 2018.
The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.
ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.