One of the nation’s largest healthcare insurers has changed its policy for a new and in-demand ALS medicine, deciding not to cover it due to “a lack of clinical efficacy data.”
Cigna considers the medicine, called Relyvrio, to be “experimental, investigational or unproven” and now won’t cover it for the treatment of ALS, or amyotrophic lateral sclerosis. Relyvrio was developed by the Massachusetts-based biotechnology company Amylyx Pharmaceuticals, and approved by the Food and Drug Administration last September.
“We want people living with ALS to have affordable access to effective, safe treatments,” Cigna said in a statement to BioPharma Dive. “Right now, there is not enough clear clinical evidence to support Relyvrio’s effectiveness so it is not currently covered on our standard formularies.”
“However, patients who meet certain clinical criteria may still be able to get coverage for it, depending on their plan,” Cigna added.
Previously, the insurer had covered Relyvrio if patients met a list of eight criteria and had been prescribed the drug by a physician who specializes in ALS treatment.
Cigna’s new policy is likely to further fuel concerns among patients and healthcare providers, who have feared that insurance companies will restrict access to Relyvrio, as they have in the past for other expensive rare disease medications. Amylyx set Relyvrio’s price tag at $158,000 per year.
Delays to treatment are especially daunting in diseases that rapidly progress, as ALS does. Patients with the disorder, which is hallmarked by the progressive decaying of nerve cells, often die within two to five years after first showing symptoms.
At Duke University’s ALS clinic, several patients’ applications for Relyvrio coverage have been denied by various insurers. But compared to Cigna, “no other company is anywhere near this extreme,” according to director Rick Bedlack.
“If we don’t do something about this, I worry that others will see this and soon follow suit,” said Bedlack, who has consulted with Amylyx in the past.
Stephen Scelsa, a neurologist at Mount Sinai Health System in New York and director of its ALS center, hasn’t seen any denials from Cigna yet, though he notes that’s not a common insurance among the clinic’s patients. (Scelsa has previously advised and received grant funding from Amylyx.)
Rather, most of the denials have involved ALS patients whose disease is more advanced than those who participated in the clinical trial that led to Relyvrio’s approval. That study enrolled nearly 140 participants, and found those given Amylyx’s drug as opposed to a placebo declined a bit slower in their ability to perform essential functions like speaking, writing and walking. It also showed Relyvrio-treated patients lived a median of about five months longer.
Amylyx is now running an additional, much larger trial to confirm the benefits of its drug. The trial finished enrolling patients last week, and is expected to produce data next year.
“We will continue to closely monitor developments as Relyvrio undergoes its confirmatory clinical trial, and will reevaluate its formulary status as more data is available,” Cigna said.
In its own statement to BioPharma Dive, Amylyx said it’s aware of Cigna’s commercial policy and has been in communication with the insurer about Relyvrio’s safety and effectiveness.
“Our payer interactions to date have been highly encouraging, and Cigna’s policy is an outlier, as we have seen strong positive coverage nationally,” Amylyx added.
For many ALS patients and their caregivers, Relyvrio has become a vital source of hope. Most drugs ever developed to treat the disease have failed in clinical testing. The FDA has only approved two other medications specifically for ALS, and the effects of both are considered modest.
Amylyx, therefore, is under pressure to ensure its drug gets covered by insurers and delivered to patients in a timely fashion. Investors are also watching closely, as Amylyx’s near-term financial future rests on a successful launch of Relyvrio.