The FDA is expected to decide today whether it will grant traditional approval to the first-ever medicine proven to slow the course of Alzheimer’s disease, according to WKOW.
Approval of the drug, Leqembi, could spur a change in how the Centers for Medicare and Medicaid Services (CMS) covers the drug, expanding access to up to a million people with early forms of the disease.
Leqembi received accelerated approval in January. Evidence shows it clears amyloid plaque buildups in the brain associated with Alzheimer’s disease; however, due to an earlier coverage decision by CMS, which provides insurance coverage for many elderly patients with the disease through Medicare, the drug has not been widely used. Its cost is $26,500 before insurance.
The drug was approved only for people with early forms of Alzheimer’s disease; people with more advanced forms may not benefit from it. Additionally, it does not cure the disease. In an 18-month trial Leqembi was shown to slow declines in cognitive ability and function by 27%.
Health care systems are preparing for broader use of the medicine, with infusion centers gearing up for a potential new patient surge.
CMS plans this year to provide broader coverage for Leqembi if the drug receives traditional FDA approval, among other qualifications.
