BOSTON, August 25, 2021 – The Institute for Clinical and Economic Review (
ICER) announced today that it will assess the comparative clinical effectiveness and value of plinabulin (BeyondSpring Pharmaceuticals) and trilaciclib (Cosela™, G1 Therapeutics) for the prevention of chemotherapy-induced neutropenia. BeyondSpring Pharmaceuticals announced the submission of a New Drug Application (NDA) for plinabulin, and the FDA is expected to respond by late 2021. Trilaciclib received FDA approval in February 2021.
The assessment will be publicly discussed during a meeting of the California Technology Assessment Forum (
CTAF) in April 2022, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
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
publiccomments@icer.org and must be received by 5 PM ET on September 14, 2021. 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)
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 September 22, 2021.