Wednesday, we filed formal objections with the Institute for Clinical and Economic Review, commonly known as ICER, over their flawed draft report on the cost-effectiveness of AMX0035 and oral edaravone. 

“We strenuously object to the Draft Evidence Report’s seemingly definitive assessment of the non-cost-effectiveness oral edaravone (and by extension IV edaravone) and the methodology used to assess the cost-effectiveness of both oral edaravone and AMX0035,” we stated in comments submitted as part of ICER’s public comment period.

ICER’s flawed report, which is based on metrics that assess quality of life that have been called discriminatory by the National Council on Disabilities and which relies on inappropriate and outdated data that fails to capture the lives of people with ALS in the United States, could be used by health insurers to restrict access to drugs. 

“Given the complexities of the American health system, it is not appropriate to assess the burdens of ALS experienced by foreign populations, as is done in this Evidence Report. For both logical and ethical reasons, the experiences of Americans with ALS need to shape the value assessments of American drugs. Data from the United Kingdom and the Republic Korea are better suited to pricing drugs for Britons or Koreans living with ALS. The Draft Evidence Report, however, relies upon data that is a decade or more old from the United Kingdom, Korea, and the US to assess the ALS quality of life and costs,” we stated. 

Because the draft report relies on quality-of-life data that discriminates against people with disabilities and because it lacks real-world data on the medical costs of living with ALS in the United States, and because the draft report fails to account for the heterogeneity in the ALS community, we urged ICER not to finalize its report. 

Click here to sign our petition calling on insurers to ban the use of discriminatory value assessments that limit access to ALS drugs.

And listen to a recent discussion on Connecting ALS with updates on the fight for approval and access to AMX0035.