CMS Expands Medicare Coverage for Leqembi After FDA Traditional Approval
Pictured: Sign of U.S. Department of Health & Human Services at its headquarters in Washington/iStock, JHVEPhoto
The Medicare coverage expansion comes after Leqembi won the FDA’s traditional approval, making it the first anti-amyloid and disease-altering treatment to do so. Eisai and Biogen were granted accelerated approval for Leqembi in January and soon commenced their bid for full approval with data from the Phase III Clarity-AD study.
According to CMS, only patients enrolled in Medicare and with physicians participating in a qualified registry will be eligible for reimbursement—provided their doctors collect their data as real-world evidence for Leqembi and submit it to a registry. Coverage is restricted to those who are diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia, with evidence of beta-amyloid deposits in the brain.
“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. These data will be accessible to researchers for further analyses, while the CMS-facilitated registry will follow stringent security and privacy protocols, according to the announcement.
Under its coverage policy, patients will still need to pay for 20% of Leqembi’s approved pricing, once they meet their Part B deductible, while Medicare will shoulder the remaining 80% of the cost. Exact costs may differ depending on supplemental coverage or secondary insurance plans.
The list price for Leqembi in the U.S. is $26,500 per year, as set by Eisai. Prior to its traditional approval, the therapeutic antibody was only covered for patients enrolled in clinical trials.
Leqembi is a monoclonal antibody that works by binding to and removing toxic amyloid-beta plaques in the brain, which are known pathological hallmarks of Alzheimer’s disease. Its accelerated approval was based on biomarker data from a Phase II study, showing that Leqembi could indeed reduce brain levels of the amyloid-beta aggregates.
Eisai and Biogen then supported these with data from Clarity-AD, which established that Leqembi’s plaque-clearance action translated to clinical improvements, particularly a 27% reduction in cognitive decline, as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Based on these findings, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee last month unanimously backed Leqembi’s traditional approval.
According to its label, Leqembi is indicated for patients still in the early stages of the disease, such as mild cognitive impairment and mild dementia. It comes with a boxed warning for amyloid-related imaging abnormalities, which in rare instances might become serious and life-threatening.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at firstname.lastname@example.org or email@example.com.