There is an urgent need for new and improved therapies for ALS, as there is still no cure. To help accelerate drug development and get promising treatments one step closer to regulatory evaluation, the ALS Association has committed nearly $4 million to support four early-stage clinical trials through our Hoffman ALS Clinical Trial Awards.
The ALS Association, the largest ALS organization in the world, and NuvoAir, the leading value-based specialty care provider for heart and lung conditions, announced their partnership to support virtual pulmonary care for people living with ALS and their caregivers.
The ALS Association sent formal responses to Blue Cross Blue Shield of Illinois, New Mexico, Texas, Oklahoma, and Montana challenging their draft policies regarding coverage of Qalsody, approved by the FDA earlier this year for treatment of people living with ALS caused by the SOD1 gene mutation.
We continue to press Cigna to reverse course and make Relyvrio treatment available for people living with ALS on Cigna plans. While Cigna initially revised its policy, those changes were insufficient to ensure timely access to Relyvrio for people living with ALS.
The ALS Association and the Focused Ultrasound Foundation are partnering to advance transformational treatments for people with ALS. Leveraging a $500,000 ALS Association Partnership Grant and $500,000 in matching funds from the foundation, this new collaboration will support research into diagnosing and treating ALS using focused ultrasound technology.
The ALS Association submitted comments to the FDA’s Central and Peripheral Nervous System Advisory Committee, urging it to recommend approval of tofersen for people with ALS linked to a SOD1 gene mutation. The committee will meet virtually on March 22 to review data associated with Biogen’s new drug application.
The ALS Association filed a formal objection to health insurer CIGNA for the company’s decision to exclude Relyvrio from its formulary. In a letter also shared with the Centers for Medicare and Medicaid Services and the Veterans Administration, the Association called on CIGNA to reverse its decision.
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.
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.