VA Will Cover Lecanemab for Alzheimer Disease

The Veterans Health Administration (VHA)—the division of the US Department of Veterans Affairs (VA) that provides healthcare for veterans—announced that it is covering the drug lecanemab-irmb (Leqembi; Eisai, Tokyo, Japan; Biogen, Cambridge, MA) for the treatment of Alzheimer disease (AD). Along with this announcement, the VA issued specific criteria for reimbursement: veterans who request the drug must be over 65, sign a consent form, have been diagnosed with early stage AD, have undergone both cognitive testing and a brain MRI in the past year, have had a Functional Assessment Staging Test (FAST Scale) score that meets the criteria for mild cognitive impairment (MCI) or mild AD dementia, and have results from either an amyloid PET scan or cerebrospinal fluid (CFS) analysis that are consistent with AD.

The VA guidance excludes anyone who has other medical, neurologic, or mental health conditions that may be a cause of cognitive impairment; those who have had a stroke, transient ischemic attack, or seizure within the past year; and anyone with MRI findings that show evidence of microhemorrhages, aneurysms, lesions, or tumors.

Lecanemab is a humanized immunoglobulin gamma 1 (lgG1) monoclonal antibody directed against aggregated soluble (“protofibril”) and insoluble forms of amyloid beta (Aβ) for the treatment of those diagnosed with AD with mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology. Results from the phase 3 Clarity AD clinical trial (NCT03887455) showed a reduction in amyloid beta (Aβ) plaques in PET scans and slower cognitive decline in those who took lecanemab compared with those who took a placebo.