WASHINGTON DC, USA – The US Food and Drug Administration (FDA) bestowed traditional full approval upon Leqembi, an Alzheimer’s drug developed by Eisai and Biogen, making it the first medication that’s been proven to slow the progression of the crippling memory disease.
This landmark approval, announced on Thursday, June 7, 2023, is being hailed as the dawn of a new era in Alzheimer’s treatment.
Following the FDA’s approval, the Centers for Medicare and Medicaid Services (CMS) revealed that it will expand coverage of Leqembi, which is expected to widen accessibility to around one million individuals suffering from early stages of Alzheimer’s disease.
Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, stated in the announcement, “Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical benefit in this devastating disease.” She added that the confirmatory study validated that Leqembi is a “safe and effective treatment for patients with Alzheimer’s disease.”
Originally, Leqembi received accelerated approval in January based on evidence that it eliminates the buildup of amyloid plaques in the brain, which are linked to Alzheimer’s.
However, the drug hasn’t been widely adopted due to prior coverage limitations by CMS. The annual cost of Leqembi is $26,500 before insurance coverage.
Joe Montminy, who was diagnosed with Alzheimer’s in his early 50s, voiced his relief, “Getting that insurance coverage is incredibly significant … because having a treatment is awesome, but I can’t afford to pay the $26,000 cost.”
Leqembi has been approved exclusively for patients with mild cognitive impairment or mild dementia confirmed to have amyloid plaques. Dr. Lawrence Honig, a professor of neurology at Columbia University Irving Medical Center, estimated that this group represents about one-sixth of the over six million Americans diagnosed with Alzheimer’s.
Noting that Leqembi is not a cure, Dr. Honig said that an 18-month clinical trial showed that the drug slowed cognitive ability and function declines by 27%.
He remarked, “The treatments we have right now are just the beginning of a new era. We hope that we will have treatments that are more efficacious.”
The Alzheimer’s Association welcomed the news. Dr Joanne Pike, the organization’s president and CEO, said, “This treatment, while not a cure, can give people in the early stages of Alzheimer’s more time to maintain their independence and do the things they love.”
However, Leqembi is accompanied by side effects that necessitate monitoring through regular brain imaging. Approximately 13% of the trial participants experienced brain swelling or bleeding.
Infusion Centers, which administer Leqembi through IV infusion once every two weeks, have been preparing for an influx of new patients.
Sue Rottura, COO of Vivo Infusion, anticipated a 15-20% increase in patient referrals for the drug in certain areas.
CMS’s expanded coverage of Leqembi is contingent on the participation of physicians and clinical teams in the collection of real-world data, referred to as a registry.
The agency’s administrator, Chiquita Brooks-LaSure, reaffirmed CMS’s commitment to assisting people with Alzheimer’s disease in accessing innovative treatments.
However, patient groups and the pharmaceutical industry have expressed concerns that the registry requirement could act as a barrier to treatment.
According to an analysis by KFF, broad Medicare coverage of Leqembi could significantly impact the program’s spending and potentially lead to higher Medicare Part B premiums for all enrollees.
