Last Updated on July 20, 2023 by BVN
The U.S. Food and Drug Administration (FDA) granted full approval to the Alzheimer’s drug Leqembi (lecanemab) on July 6, after the drug was initially given accelerated approval in January.
Leqembi is the first Alzheimer’s drug that has shown a significant reduction in the growth of amyloid-beta plaques from the brain of people in the early stages of Alzheimer’s. Following the FDA’s approval, the Centers for Medicare & Medicaid Services (CMS) agreed to cover a substantial portion of the medication after they initially declined to do so until the drug received traditional approval.
“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.
Roughly 6.5 million Americans 65 years of age and older were living with Alzheimer’s disease in 2022, according to a report by the Alzheimer’s Association.
Tia Delaney-Stewart, director of Diversity, Equity, and Inclusion for the Alzheimer’s Association, California Southland Chapter, explained that the FDA’s approval of Leqembi will positively impact patient access, especially where access to barriers continue to exist. Eighty percent of the Black population reports access barriers to health care and support for Alzheimer’s and other dementias, while 33% of Hispanic populations report experiencing discrimination related to health care access, Delaney-Stewart noted.
“While we know this is not a cure, Leqembi addresses the underlying biology of Alzheimer’s and substantially changes the course of the disease by delaying its progression,” Delaney-Stewart said in an email.
The FDA’s approval was permitted after a clinical trial verified that the drug has clinical benefits. With the approval comes a boxed warning that informs patients and caregivers of the potential risks associated with Leqembi, namely amyloid-related imaging abnormalities (ARIA), which can present as temporary swelling in some areas of the brain and may also appear with small spots of bleeding in or on the surface on the brain.
Alzheimer’s remains an incurable cognitive disease and while Leqembi will not stop Alzheimer’s from getting worse, a clinical trial showed promising results of slowing the progression of the disease. In a group study of 1,795 patients with Alzheimer’s disease, Leqembi administered every two weeks through intravenous infusion resulted in the slowing of cognitive and functional decline by 27% over the course of 18 months.
While some experts acknowledge the limitations of Leqembi, the drug has much more approval than another Alzheimer drug, Aduhelm, which was granted accelerated approval in 2021 by the FDA. In one trial the drug showed evidence to have slowed the progression of the disease, but in another trial showed no slowing of the disease.
A 2022 congressional investigation into the FDA’s approval of Aduhelm noted that the FDA’s approval process was “rife with irregularities.” Medicare also declined to cover the costs for patients. Biogen priced Aduhelm at $56,000 per year.
Japanese pharmaceutical company Eisai and U.S. manufacturer Biogen, maker of Alzheimer’s drug Aduhelm, have partnered to produce and market the drug. Leqembi will cost $26,500 a year — 80% of which Medicare will cover for individuals with “Original Medicare” who will pay a 20% coinsurance of the Medicare-approved amount for Leqembi, once they meet their Part B deductible. For other Medicare coverage plans, costs may differ.
“For people not enrolled in Medicare, including many treatment-eligible individuals under age 65, we expect other payers to ensure burden free access. It is time for all payers to deliver broad access,” said Joanne Pike, Alzheimer’s Association president and CEO in a statement.
CMS plans to add a requirement that providers prescribing Leqembi submit medical information about each patient before and during treatment. The collection of information will be kept in a registry. Researchers will have access to the information to conduct future studies regarding how the drug can help people with Medicare.
This article is published as part of the Commonwealth Health Equity Reporting Fellowship.