BOSTON, April 24, 2018 – The Institute for Clinical and Economic Review (ICER) today announced plans to develop a review assessing the comparative clinical effectiveness and value of biologic therapies for moderate-to-severe asthma. The report is set to be reviewed during a November 2018 public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), one of ICER’s three independent evidence appraisal committees.
ICER’s report is expected to include five therapies: 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.
An Open Input period begins today and is intended to allow stakeholders to share key information relevant to the development of the evidence reports. Comments will be accepted from all interested stakeholders on either topic until 5 PM ET on May 10, 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 these conditions.
For more information about the Open Input period, visit ICER’s website. ICER’s Manufacturer Engagement Guide, Patient 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 email@example.com and must be received by 5 PM ET on May 10, 2018 to be considered.
Draft scoping documents for each review will be available on or about May 15, 2018 and will provide more detail on ICER’s planned analyses. The documents will be open to public comment for three weeks.
ICER’s website provides a timeline of key posting dates and public comment periods for the review process.
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.