CMS Directs Insurers to Cover Biogen's ALS Drug Qalsody

(Reuters) – The Centers for Medicare & Medicaid Services (CMS) has mandated private insurers providing Medicare Advantage plans to include Biogen's amyotrophic lateral sclerosis (ALS) drug, Qalsody, in their coverage. This decision follows reports of coverage denials from various Medicare Advantage plans.

Qalsody received accelerated approval from the U.S. Food and Drug Administration (FDA) last year. However, CMS noted that many plans were denying coverage by classifying the drug as "experimental and investigational."

The FDA's accelerated approval process allows earlier access to drugs for serious conditions, although companies must conduct confirmatory trials to demonstrate clinical benefits to achieve traditional approval afterward.

CMS stated that it does not differentiate between drugs approved via the accelerated pathway and those with traditional approval. A memo dated December 9 instructed insurers to cease denial policies regarding Qalsody coverage.

Additionally, the agency expects insurers to reach out to patients who were wrongly denied coverage to communicate the updated policies.

The ALS Association, a patient advocacy group, announced on Wednesday that it is collaborating with CMS to address the "unjust denials" of Qalsody by insurers that labeled the treatment "experimental." They encourage individuals previously denied Qalsody by Medicare Advantage to contact their ALS specialists for access to the drug.