— Report will be subject of New England CEPAC meeting in September 2021; Draft Scoping Document open to public comment until April 2nd, 2021 —
BOSTON, March 15, 2021 – The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of efgartigimod (argenx, Halozyme Therapeutics, and Zai Lab) and eculizumab (Soliris®, Alexion Pharmaceuticals, Inc.) for the treatment of myasthenia gravis. An FDA decision on efgartigimod is expected in late 2021. Eculizumab was approved in October 2017.
The assessment will be publicly discussed during a meeting of the New England CEPAC (New England CEPAC) in September 2021, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
Consistent with ICER’s updated process for announcing new assessments, we have spent the past five weeks engaging with targeted stakeholders, including relevant patient groups, the manufacturers of the treatments being assessed, clinical specialists, as well as public and private payers. Based on this preliminary cross-stakeholder engagement, today ICER has posted a Draft Scoping Document outlining how we plan to conduct this assessment.
All interested stakeholders are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. Comments can be submitted by email to email@example.com and must be received by 5 PM ET on April 2, 2021. All comments submitted must meet ICER’s formatting specifications.
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 April 12, 2021.
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.