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.