Reuters story
LOS ANGELES, July 6 (Reuters) - Eisai (4523.T) and Biogen's (BIIB.O) Leqembi won a coveted standard approval nod from the U.S. Food and Drug Administration on Thursday, the first Alzheimer's treatment to achieve that goal, clearing the way for wider insurance coverage of the drug.
The FDA decision marks a new milestone for a fatal disease that has eluded drugmakers' efforts for decades. Trial data showed that the treatment slows progression of the brain-wasting disease by 27% for patients in the earliest stages of Alzheimer's.
Standard approval means that Leqembi will now be covered, although the Centers for Medicare and Medicaid Services (CMS) is linking reimbursement to patient participation in a health agency database, known as a registry. Since Alzheimer's is a disease of aging, most U.S. patients are insured by Medicare.
"With FDA's decision, CMS will cover this medication broadly while continuing to gather data that will help us understand how the drug works," CMS Administrator Chiquita Brooks-LaSure said in a statement.
The downside?
The FDA also put a strong warning on the drug box, that a potential risk of brain swelling exists for Alzheimer’s drugs in this class.
Yearly cost of the drug? $26,500
We won’t know if there is an upside to Medicare covering this drug, until we find out how much Medicare will cover of the price for a monthly Rx of it.