UPDATE – APRIL 2024: Relyvrio was voluntarily withdrawn from the market by Amylyx following a phase 3 trial that failed to show it was effective.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 ALS Association filed a formal objection to health insurer CIGNA for the company’s decision to exclude Relyvrio from its formulary as part of our continued fight to ensure access to approved treatments.

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.

“Failure to do so will result in the reduction of quality and quantity of life – an avoidable and unacceptable outcome,” Dr. Neil Thakur, chief mission officer of The ALS Association said.

The letter laid out five reasons why CIGNA’s decision was wrong and discriminatory.

• First, this policy is in direct conflict to CIGNA’S initial coverage of the drugs for people living with ALS made in October of 2022 that provided Recommended Authorization Criteria. Under the earlier criteria patients were approved for 6 months after which their neurologist can seek reauthorization for a new 12-month period. Under CIGNA’s new policy patients must go through the medical exception process which significantly delays and sometimes denies access and places a heavy paperwork burden on already busy ALS physicians.  
• Second, this decision discriminates against people on CIGNA’s commercial plans given that Medicare, the Veteran’s Administration, and all major insurers cover RELYVRIO™. 
• Third, this decision conflicts with FDA’s approval of RELYVRIO™ for the treatment of amyotrophic lateral sclerosis for adults.   
• Fourth, this decision takes away the opportunity for someone living with ALS for a survival advantage of about six months along with longer functional independence.  
• Fifth, regarding CIGNA’s statement that “ Referral to a specialized multidisciplinary clinic should be considered for patients with ALS to optimize health care delivery, prolong survival, and enhance quality of life.,” please see the attached May 24, 2022, letter from 38 clinicians, who direct care at these clinics, calling on the FDA to approve RELYVRIO™ so that they can prescribe it for their patients.  

Read the full letter here.

The Association will be sending copies to state insurance commissioners in the coming weeks as part of the fight to make sure approved treatments are made available.