— Report will be subject of CTAF meeting in July 2022; Draft Scoping Document open to public comment until January 19, 2022 —
BOSTON, December 22, 2021 – The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of donanemab (Eli Lilly & Co.) and lecanemab (Eisai Inc.) for the treatment of Alzheimer’s disease, along with aducanumab (Aduhelm™, Biogen) should new clinical evidence be available.
The assessment will be publicly discussed during a meeting of the California Technology Assessment Forum (CTAF) in July 2022, 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 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 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 firstname.lastname@example.org
and must be received by 5 PM ET on January 19, 2022. Please submit public comments as a Word document in the following format:
- 12-point Times New Roman font
- Three-page maximum (not including references or appendices)
ICER’s Patient Portal 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 January 27, 2022.