UPDATE – APRIL 2024: Relyvrio was voluntarily withdrawn from the market by Amylyx following a phase 3 trial that failed to show it was effective. The ALS Association stands by its decision to push for early approval of Relyvrio given the promising phase 2 trial data and the safety of the treatment. At the time, we said that if it turns out to be ineffective, at worst, people living with ALS would have taken an ineffective therapy without risk of harm. If it was indeed effective, delaying access would have meant that people living with ALS would have lost two years of being able to take a life-extending therapy. In the interests of transparency and education, we are leaving this information up for future reference. People living with ALS need life-saving treatments and we are working as urgently as possible to advance the many more potential treatments in clinical trials.

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. RELYVRIO’s inclusion on the VA National Formulary as a third tier drug comes after The ALS Association urged the VA, Medicare and other health care payers to provide coverage without exclusion.

RELYVRIO, known as AMX0035 when it was undergoing clinical trials, was approved by the United States Food and Drug Administration in September. As soon as the FDA approval was achieved, the ALS Association launched its campaign to convince public and private insurers to include the drug on their formulary without restriction.

When FDA approves a drug, it also establishes guidelines on who should be able to access the drug and under what circumstances – a process commonly known as labeling. When the FDA approved RELYVRIO for the treatment of ALS it did so for treatment of all adults without exclusion.

Unfortunately, health care payers are not required to follow the FDA label and may establish other criteria for who is eligible.

To ensure that all adults with ALS have access to RELYVRIO, The ALS Association strongly advocated with the VA, Medicare and more than 30 insurance companies to:

• Provide immediate coverage for RELYVRIO that is consistent with the FDA approved indication and labeling, including in combination where appropriate. 
• Avoid unnecessary delays in access to RELYVRIO caused by prior authorization, fail first/step therapy, or other barriers to access. 

In the coming months we will continue to fight to make sure all adults living with ALS have access to approved treatments.