Alzheimer’s Drug Approval Fuels Debate on Medicare’s Decisions

Medicare is using an explicit process to set coverage rules for new drugs like those that treat Alzheimer’s, but patients with rare and chronic diseases like cancer worry the procedure will limit their access to innovative medicines.

The Food and Drug Administration’s full traditional approval of Alzheimer’s drug Leqembi, or lecanamab, widened drug access and coverage for those diagnosed with the brain disorder. Medicare promised to expand coverage if traditional approval was granted and patients participate in a registry with a prescriber or clinical team.

Eisai Co. and Biogen Inc.’s Leqembi approval was monumental for many patients, said Terry Wilcox, ...