(Reuters) – The Centers for Medicare & Medicaid Services has directed private insurers providing Medicare Advantage plans to cover Biogen (NASDAQ:BIIB)’s amyotrophic lateral sclerosis drug Qalsody after finding instances of coverage denial.
Qalsody received the U.S. Food and Drug Administration’s accelerated approval last year, but CMS said it found many Medicare Advantage plans, which cover adults 65 years and older or those with disabilities, were denying coverage by calling the drug “experimental and investigational”.
FDA’s accelerated approval pathway allows for earlier approval of drugs that treat serious conditions. Companies still require to conduct confirmatory trials to confirm that the drug actually provides a clinical benefit, following which the FDA grants a traditional approval for the drug.
CMS does not make a distinction between drugs that are marketed under an accelerated FDA approval versus a traditional approval, the agency said in a memo dated Dec. 9, and directed insurers to immediately discontinue the policy that denied coverage for the drug.
The agency said it expects insurers to contact patients who were inappropriately denied coverage of the drug to inform that policies have changed.
The ALS Association, a patient advocacy group, late on Wednesday said it began working with CMS to investigate “unjust denials” of coverage for the drug by insurance companies, who labeled the drug as “experimental”.
The association urged people previously denied Qalsody by their Medicare Advantage plan to contact their ALS specialist to secure access to the treatment.
