The Institute for Clinical and Economic Review released a revised Evidence Report Thursday for their review the oral suspension of edaravone recently approved by the FDA and AMX0035, which is currently under review by FDA.
The revised report comes after we submitted formal objections to ICER’s earlier draft, which we pointed out relied on discriminatory measures to place a value on life and inappropriate data that fails to fully include the experiences and costs of Americans living with ALS.
The revised draft fails to address the fundamental flaws in ICER’s approach to evaluating treatments for ALS as it still relies on inappropriate, outdated and discriminatory data to create a cost-effectiveness model that could be used to erect barriers to accessing approved treatments for ALS.
ICER’s review process now moves to a public hearing of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), which ICER defines as a core program comprised of health care officials from throughout the Midwest.
That hearing is scheduled for August 19 and will be available to watch here.
Calaneet Balas, President and CEO of The ALS Association, and Scott Kauffman, Chair of the Association’s Board of Trustees will be providing public comment during that hearing and will share the impact a flawed value assessment will have on the ALS community. ALS advocates Sunny Brous and Steve Kowalski will also tell their personal stories about living with ALS and the benefit of drug therapies on their quality of life.
For more on the ICER review of ALS therapies, please visit www.als.org/icer.
And listen to a conversation about the flaws in ICER’s methodology on Connecting ALS.