Leqembi (lecanimab-irmb): What Traditional Approval Means for Early Onset Alzheimer’s Disease Treatment

by Robert C. Accetta, RPh, BCGP, FASCP, Sr. Pharmacist, HCQIP, IPRO

The FDA granted traditional approval of Leqembi (lecanimab-irmb), a monoclonal antibody drug which may help reduce the progression of early onset Alzheimer’s Disease. The indications for use include those with a diagnosis of mild cognitive impairment or mild dementia stage of disease. The FDA press release may be found here.

With FDA traditional approval, Medicare Part B will provide coverage for those who have been diagnosed with Alzheimer’s Disease and are evaluated by their provider to meet clinical criteria. CMS has provided guidance on its requirements for participating Medicare beneficiaries and their providers, which includes providers enlisting in a national registry.

A boxed warning discusses the medication class risk of amyloid-related imaging abnormalities (ARIA), which are associated with rare asymptomatic episodes of abnormal swelling or bleeding in the brain. The FDA recommended (but did not require) patients undergo genetic testing for the specific Alzheimer’s genes which increase the risks for ARIA and may help with informed decision making for the provider and the patient.

This medication is administered by intravenous infusion over 1 hour at a dosage of 10mg/kg, once every two weeks. Adverse events include allergic reactions and infusion related side effects. Medications which should be continued with caution include antithrombotics, such as aspirin, antiplatelets, and anticoagulants.

CMS Resource:

A July 6, 2023, CMS press release about broader coverage of Leqembi can be found here.