ALS Association Calls on CVS to Reconsider Policy on Coverage of Relyvrio

UPDATE – APRIL 2024: Relyvrio was voluntarily withdrawn from the market by Amylyx following a phase 3 trial that failed to show it was effective.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.

On behalf of everyone living with ALS and their families, the ALS Association sent a letter to CVS Caremark asking company to reconsider its current policy regarding coverage of Relyvrio.  

Relyvrio is designed to slow ALS progression by slowing or preventing motor neuron cell death, which are the cells that die in ALS. Trial data has concluded that Relyvrio can extended life by 10 months and reduce the risk of death, tracheostomy, or permanent assisted ventilation, and first hospitalization. 

The current policy requires a “documentation of clinical benefit,” interpreting this to mean evidence of stasis or improvement. This is an impossible clinical standard for people living with ALS given the nature of the disease, which creates a nonsensical and unnecessary barrier to access to Relyvrio for people living with ALS. Even if an initial denial results in a successful appeal, it is unconscionable to delay people living with ALS from receiving Relyvrio, a treatment that offers survival advantage with longer functional independence. 

We requested that CVS Caremark revise its current policy and provide immediate coverage for Relyvrio that is consistent with the FDA (Food and Drug Administration) approved indication and labeling without any prior authorization requirements.   

Read the full letter here.