Today, ICER (the Institute of Clinical and Economic Review) issued its initial draft report on the cost-effectiveness of AMX0035 and oral edaravone. Basically, the organization purports to assess whether a drug has value so that payers (health insurance companies) can make decisions about whether to provide coverage and what is a fair price for the drug. The methodology that ICER uses is discriminatory to seniors, people with chronic illnesses, and disabilities.

This is the first time ICER has weighed in on ALS treatments, and we are very concerned about its flawed methodology and what it will mean for access to AMX0035, oral edaravone, and future ALS treatments.

There will be a formal comment period, in which we will provide more extensive comments, but for today, here is our initial statement on ICER’s draft report:

We are very concerned that ICER’s flawed analysis will have a chilling effect, resulting in the development of fewer ALS treatments and making it harder for people living with ALS to access any effective treatments that are approved. ICER uses two purportedly objective measures -- quality-adjusted life-year (QALY) and equal value of life years gained (evLYG) -- that the National Council on Disability has stated are discriminatory because the value of life assigned to seniors, the chronically ill, and people with ALS is deemed to be less than that of young, healthy individuals. This is discriminatory and harmful to people affected by this devastating disease. Some payers may use ICER’s analysis to deny coverage, which is unacceptable.

We are working urgently to ensure that treatments for ALS are available, accessible, and affordable, and we will strongly urge health insurance companies and other payers to ignore ICER’s flawed analysis. Many potential new treatments are currently in the pipeline and the ALS community will not stand by while outside organizations without any connection to or true understanding of ALS stifle the progress being made to make ALS livable until it is cured.