The Centers for Medicare & Medicaid Services (CMS) has issued a directive mandating that private insurers offering Medicare Advantage plans must cover Biogen's amyotrophic lateral sclerosis (ALS) drug, Qalsody (tofersen). This decision follows the discovery of multiple instances where coverage for the drug was denied by these plans.
Qalsody received accelerated approval from the U.S. Food and Drug Administration (FDA) last year. However, CMS noted that many Medicare Advantage plans, which cater to adults aged 65 and older or those with disabilities, were denying coverage by classifying the drug as "experimental and investigational." The FDA's accelerated approval pathway facilitates earlier approval for drugs targeting serious conditions, contingent upon confirmatory trials to verify clinical benefit, after which traditional approval is granted.
CMS clarified that it does not differentiate between drugs marketed under accelerated versus traditional FDA approval. In a memo dated December 9, the agency instructed insurers to immediately discontinue policies denying coverage for Qalsody. Furthermore, insurers are expected to contact patients who were inappropriately denied coverage to inform them of the policy change.
The ALS Association, a patient advocacy group, reported collaborating with CMS to investigate "unjust denials" of Qalsody coverage by insurance companies. They encourage individuals previously denied Qalsody by their Medicare Advantage plan to contact their ALS specialist to secure access to the treatment.
