https://www.cnn.com/2023/07/06/health/leqembi-alzheimers-fda-approval-medicare/index.html
The US Food and Drug Administration is expected to decide on Thursday whether to grant traditional approval to the Alzheimer’s drug Leqembi, the first medicine proven to slow the course of the memory-robbing disease.
An approval decision would also be expected to trigger a change in how the Centers for Medicare and Medicaid Services covers the drug, broadening access for up to an estimated million people with early forms of the disease.
Leqembi, from drugmakers Eisai and Biogen, received accelerated approval in January based on evidence that it clears amyloid plaque buildups in the brain that are associated with Alzheimer’s disease. But because of an earlier coverage decision by CMS, which provides insurance coverage for many elderly patients with Alzheimer’s through Medicare, the drug hasn’t been widely used. It costs $26,500 before insurance coverage.
“You had this treatment at your fingertips, and suddenly you had Medicare saying, ‘Yeah, but you can’t quite get access to that yet,’ ” said Joe Montminy, 59, who was diagnosed with younger-onset Alzheimer’s in his early 50s. “Getting that insurance coverage is incredibly significant … because having a treatment is awesome, but I can’t afford to pay the $26,000 cost.”
The drug was approved only for people with early forms of Alzheimer’s disease, those with mild cognitive impairment or mild dementia who have been confirmed to have amyloid plaques in their brains. Dr. Lawrence Honig, a professor of neurology at Columbia University Irving Medical Center, estimates that group constitutes about a sixth of the more than 6 million Americans currently diagnosed with Alzheimer’s.
People with more advanced forms of the disease may not benefit from the drug, he said, and may face increased safety risks.
“It’s not that we know it’s not good for people with moderate or severe disease; it’s just that we don’t know,” said Honig, who has consulted for drug companies working on Alzheimer’s medicines.
Even for those who may benefit from the drug, Honig noted, it’s not a cure; Leqembi was shown in an 18-month clinical trial to slow declines in cognitive ability and function by 27%.
“The treatments we have right now are just the beginning of a new era,” Honig said. “We hope that we will have treatments that are more efficacious.”
The drug also comes with side effects and requires monitoring through regular brain imaging. About 13% of participants in the trial experienced brain swelling or bleeding, and those risks could be higher for certain groups based on their genetics or if they take blood-thinning medications.