Medicare Insurers Directed to Cover ALS Drug Qalsody

The Centers for Medicare & Medicaid Services has instructed insurers to cover Biogen's ALS drug Qalsody, following reports of coverage denials. Despite its FDA accelerated approval, insurers labeled it 'experimental'. Patients previously denied are advised to contact their ALS specialist for access.

The Centers for Medicare & Medicaid Services (CMS) has mandated Medicare Advantage insurers to provide coverage for Biogen's amyotrophic lateral sclerosis (ALS) medication, Qalsody. This directive follows findings of inappropriate denials based on claims that the drug was 'experimental and investigational.'

Qalsody was granted accelerated approval by the U.S. Food and Drug Administration (FDA) last year. While this pathway allows for swifter availability of drugs treating severe illnesses, companies must still conduct further trials to confirm therapeutic benefit. CMS, however, clarified they do not distinguish between drugs with accelerated or traditional FDA approval in their policies.

The ALS Association, an advocacy group, announced collaboration with CMS to address these unjust coverage denials. They urged patients affected by the denials to seek guidance from their ALS specialists to gain access to the much-needed treatment.

(With inputs from agencies.)