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The Centers for Medicare & Medicaid Services (CMS) issued a directive telling private insurers providing Medicare Advantage (MA) plans to cover Biogen’s amyotrophic lateral sclerosis (ALS) drug Qalsody after finding instances of noncoverage.
The December 9 directive says CMS observed some MA plans “are inappropriately denying Medicare Part B drug coverage for the U.S. Food & Drug Administration (FDA) approved drug Qalsody (tofersen), used for the treatment of amyotrophic lateral sclerosis (ALS), by classifying it as ‘experimental and investigational’ for all indications. The FDA granted accelerated approval to Qalsody on April 25, 2023, for the treatment of ALS in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.”
“CMS does not make a distinction” between traditional and accelerated approval, which “relies on surrogate endpoints that can reasonably predict whether a treatment will result in clinical benefit,” the Biotechnology Innovation Organization (BIO) explained. “For more than 30 years, the pathway has successfully sped up the development of new medicines for people with life-threatening conditions and few treatment options.”
‘A victory for the entire ALS community’
“We expect that all MA plans that currently classify Qalsody as experimental and investigational for the treatment of ALS in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene will immediately discontinue use of those coverage policies and comply with the rules outlined at § 422.101 on requirements relating to basic benefits,” said CMS.
“Further, we expect MA plans to expeditiously contact enrollees that were inappropriately denied coverage of Qalsody based on its classification as experimental and investigational to inform them that coverage policies for Qalsody have changed,” continued the directive.
“This is a victory for the entire ALS community. It’s critical that FDA-approved treatments are made accessible rather than being labeled as ‘experimental,’” said ALS Association CEO Calaneet Balas.
The ALS Association worked “directly with CMS to launch an investigation into these unjust denials,” said the organization. “This new CMS directive provides precedent for state regulators to issue similar actions for other private insurers.”
