CMS’s Registry Proposal Raises Questions Over Uptake, Cost Burden of Alzheimer’s Drugs

After gaining accelerated approval from the FDA in January, Biogen Inc.’s Alzheimer’s treatment Leqembi (lecanemab-irmb) could receive full approval by July, thanks to a recent 6-0 advisory panel vote. And if the drug — which is subject to limited Medicare coverage per a national coverage determination (NCD) — does receive traditional approval, CMS recently vowed to “ensure availability” of new drugs that may slow the progression of Alzheimer’s disease if qualifying Medicare patients are monitored through a registry.

Leqembi would be the first drug to be covered under this type of arrangement, which has historically been reserved for new medical and diagnostic devices. But sources say uncertainty about both the registry and coverage of imaging associated with the drug makes it hard to predict uptake under the supposedly broader Medicare coverage and future costs to Medicare Advantage insurers.

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Lauren Flynn Kelly

Lauren Flynn Kelly Managing Editor, Radar on Medicare Advantage

Lauren has been covering health business issues since the early 2000s and specializes in in-depth reporting on Medicare Advantage, managed Medicaid and Medicare Part D. She also possesses a deep understanding of the complex world of pharmacy benefit management, having written AIS Health’s Radar on Drug Benefits from 2004 to 2005 and again from 2011 to 2016. In addition to her role as managing editor of Radar on Medicare Advantage, she oversees AIS Health’s publications and manages the health editorial staff. She graduated from Vassar College with a B.A. in English.

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