– Public comment period now open until October 22, 2018; Requests to make oral comment during public meeting also being accepted –
BOSTON, September 24, 2018 – The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the clinical effectiveness and value of biologic treatments for asthma associated with Type 2 inflammation and/or allergic asthma. The draft report will be open to public comment until 5pm ET on October 22, 2018.
ICER’s report assesses the effectiveness and value of dupilumab (Dupixent®, Sanofi/Regeneron), omalizumab (Xolair®, Genentech/Novartis), mepolizumab (Nucala®, GlaxoSmithKline), reslizumab (Cinqair®, Teva), and benralizumab (Fasenra™, AstraZeneca). ICER previously reviewed mepolizumab for its use in severe eosinophilic asthma and dupilumab for its use in atopic dermatitis. Dupilumab is currently under FDA review for use as add-on maintenance treatment in moderate-to-severe asthma, with an approval decision expected in October of 2018.
The report will be subject to deliberation during a public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), one of ICER’s three independent evidence appraisal committees, on November 29, 2018.
ICER is committed to engaging with all stakeholders in a thorough and transparent manner. During this review, ICER spoke with patients, clinical experts, insurers, and manufacturers. Public comments were also accepted on a Draft Scoping Document. The current draft report incorporates input received from patients, clinicians, and other stakeholders during each of these opportunities for engagement.
Submit a Public Comment: The Draft Evidence Report and Draft Voting Questions are now open to public comment until 5 PM ET on October 22, 2018. All stakeholders are invited to submit formal comments by email to email@example.com. Guidelines for submitting public comments, including formatting specifications, are available on ICER’s website. ICER’s Manufacturer Engagement Guide and Patient Participation Guide provide additional detail on what types of information may be most informative to the report.
ICER will review all comments and incorporate any necessary changes in the Evidence Report and Revised Voting Questions that will be posted on or about November 13, 2018. All comments and ICER’s response to comments will be posted publicly along with the Evidence Report.
Register for the Public Meeting: The Evidence Report will be the subject of a public meeting of the Midwest CEPAC on November 29, 2018 in St. Louis, MO. During the meeting, the independent council will vote on key questions raised in the report.
Register to Make an Oral Comment: During the public meeting, there will be a limited amount of time available for interested stakeholders to make an oral comment on the report. Requests to submit oral comments must be emailed to firstname.lastname@example.org by 5 PM ET on October 22, 2018.
Individuals who wish to deliver oral comments must separately register to attend the meeting.
For more information about registering for oral comment, please visit our website.