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.  

An FDA advisory committee voted overwhelmingly (7-2) to support approval of AMX0035 for the treatment of ALS. A phase 3 clinical trial will continue to test the effectiveness of AMX0035.

Today, we filed comments with the FDA imploring them to ask the right question when it reconvenes its advisory committee in September to consider a new drug application (NDA) for AMX0035.

A committee convened by the Institute for Clinical and Economic Review voted overwhelmingly on August 19 that oral edaravone and AMX0035 provide meaningful clinical benefit to people with ALS and have a positive impact on quality of life, but that neither drug provides sufficient value to justify the presumed cost to insurers.

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.

We filed comments with the FDA asking for clarity and heightened urgency in the agency’s Action Plan for Rare Degenerative Diseases, including ALS.

The ALS Association 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.

This morning we joined other ALS organizations releasing an open letter urging the FDA to quickly approve AMX0035.

Today, ICER (the Institute of Clinical and Economic Review) issued its initial draft report on the cost-effectiveness of AMX0035 and oral edaravone.

We submitted a letter to the FDA signed by 37 clinicians who specialize in treating people with ALS calling on the FDA to swiftly approve AMX0035.

Every year, hundreds of people with ALS, their caregivers, friends and family come together to discuss progress in the fight against ALS and how we advance ALS research, accelerate the drug development process and make it possible for people with ALS to live their lives as they want by engaging policymakers to support the ALS community. Registration is now open for our annual advocacy conference, which will be held June 14 -16 from 3:00-4:30 p.m. ET. Due to visitor restrictions at the U.S. Capitol Complex, the event will be virtual again this year.

The ALS Association endorses the strengthened Accelerating Access to Critical Therapies for ALS Act (ACT) for ALS Act (H.R.8662/ S. 4867) as an important step in bringing promising new treatments to people with ALS as quickly as possible. The bill accelerates the fight against ALS by authorizing $100 million for ALS research and creating the first federal entity explicitly charged with developing treatments for neurodegenerative diseases.

Historic changes in telehealth were made in response to COVID-19 that marked a big step forward in the use of digital technology to deliver health care. We need Congress to pass legislation to ensure expanded use of this vital health care tool is permanent. Send a letter to your members of Congress today urging them to support permanent access to telehealth.

The ALS Association strongly supports initiatives to enable people with ALS to access promising treatments as soon as possible, including prior to FDA approval. Our primary goal is to facilitate the development of effective treatments and help support delivery to everyone with ALS as soon as possible.