The United States Department of Veterans Affairs has made RELYVRIO available for the treatment of ALS for veterans who are living with the disease who receive care at VA clinics or ALS specialists, becoming one of the first health care payers or insurers to provide access to the drug.
The ALS Association recently sent letters to 43 of the largest insurance companies and health care payers to make RELYVRIO, which was formerly developed as AMX0035 and approved by the FDA for use in the treatment of ALS in September, available and accessible for people living with ALS.
As the nation prepares to observe Veterans Day, the ALS Association and Paralyzed Veterans of America call on Congress to pass the Justice for ALS Veterans Act (H.R.5607/S.3483), which allows survivors of veterans who died from service-connected ALS to receive a small boost to the rate of Dependency and Indemnity Compensation (DIC), which is commonly known as the “DIC kicker.”
The ALS Association is leading a fight to increase support for The Justice for ALS Veterans Act. The bill would make sure spouses of veterans who lose their battle with ALS are not denied access to survival benefits they are owed.
The U.S. Food and Drug Administration awarded $3.7 million to three ALS research projects as part of the implementation of the Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act (ACT for ALS).
The National Academies of Sciences, Engineering, and Medicine (NAS) is undertaking a study into accelerating the development of treatments and improving quality of life for people with ALS. This is a huge win for the community. The ALS Association led an effort to get Congress to direct NAS to undertake a study on ALS and also fought for $1 million to fund the study.
We filed comments urging the U.S. Department of Health and Human Services Office of Civil Rights to finalize a proposed rule that would strengthen civil rights protections against discrimination on the basis of disability in federal health care programs.
The ALS Association, the country’s largest nonprofit committed to making ALS livable and finding a cure, today celebrated the Food and Drug Administration’s (FDA) approval of AMX0035, a new treatment for people living with amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease. The Association invested $2.2 million of funds raised through the 2014 ALS Ice Bucket Challenge into the development and trial of AMX0035, and led the years-long advocacy campaign that pushed the FDA to approve the treatment prior to completion of an ongoing phase 3 trial.
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.
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.
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.