On Tuesday, the Institute for Clinical and Economic Review (ICER) issued its final report and policy recommendations on AMX0035 and oral edaravone.

We strongly disagree with ICER’s final report on new ALS drugs, which may result in people living with ALS being unable to access life-extending treatments. ICER’s flawed conclusions were based on their discriminatory methodology, as the National Council on Disability has documented.  

Throughout this process, The ALS Association has vigorously advocated against the release of this report because of its use of international, incomplete and irrelevant data and methodology. Research has clearly proven that both oral edaravone (and by extension IV edaravone) and AMX0035 extend life for people living with ALS. 

ICER’s ultimate determination that the expected cost of these drugs outweighs any potential benefit to people living with ALS is unfounded and unfair.

ICER purports to be an independent organization that is concerned about access for patients, but this report could serve to propagate the very system that continuously deprives patients with opportunities to slow the progression of disease and/or extend life.

We continue to urge insurers to include oral edaravone and AMX0035 in their formularies as quickly as possible and to ensure affordable and speedy access to these drugs.