Alzheimer disease (AD), the most common form of dementia, affects more than 5 million US residents and progressively leads to a loss of memory and cognitive function. The advent of new therapeutic agents for AD has the potential to lessen the enormous patient, family, and societal burden of illness. In this issue of JAMA, phase 3 trial results suggest that donanemab (an infused monoclonal antibody) is efficacious in slowing disease progression based on the Integrated Alzheimer’s Disease Rating Scale in patients with mild to moderate AD with amyloid and tau pathology. Another monoclonal antibody that produced similar improvements, lecanemab, was recently awarded traditional approval by the Food and Drug Administration (FDA). While these new therapies have been welcomed by many stakeholders, they also will challenge the US system of pharmaceutical regulation and reimbursement. In particular—assuming FDA approval is granted—payers and policy makers must design rules that optimize value, affordability, and equity of AD care.
Source: JAMA Online First