Medicare Coverage for Alzheimer's Disease Treatment Available Following FDA Traditional Approval
Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) had approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use.
This approval makes LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer's disease (AD).
In a phase 3 clinical trial, LEQEMBI demonstrated clinically meaningful slowing of cognitive and functional decline in a patient group generalizable to U.S. Medicare beneficiaries, which included a mix of racial and ethnic groups, patients with common comorbid conditions, concomitant medications, and patients with mild cognitive impairment (MCI) due to AD or mild AD.
Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
Furthermore, CMS confirmed that broader coverage of LEQEMBI is now available. The CMS-facilitated registry is now available for healthcare professionals to submit required patient data to CMS.
This action will facilitate reimbursement for and access to LEQEMBI across a broad range of healthcare settings in the U.S.
As of July 7, 2023, there are no approved Alzheimer's disease vaccines in the U.S.