Last week’s on-time opening of a government portal for collecting real-world evidence on Alzheimer’s drugs may have surprised some. But the timely roll-out has done little to staunch criticism of a requirement that patients and their doctors need to be part of the registry to qualify for Medicare coverage.
The data-collection requirement was just one of a number of factors that analysts expect will weigh on the sales of newly arriving antibody drugs that target amyloid for treating Alzheimer’s disease and temper the drugs’ initial uptake.
The Food and Drug Administration granted traditional approval to Eisai and Biogen’s Leqembi this month in patients with mild cognitive impairment (MCI) or the mild dementia stage of Alzheimer’s disease, following a unanimous vote by outside advisors that a confirmatory study conducted by Eisai had verified Leqembi’s clinical benefit. Further FDA decisions on additional therapies in the same class are on the way. …