Problem Statement: Lecanemab is an IgG1 monoclonal antibody, which targets soluble aggregated amyloid beta (aβ) and works by removing amyloid plaques in the brain. While lecanemab effectively removes beta-amyloid and has full FDA approval as of July 6, 2023, the clinical benefits remain uncertain. Adverse drug events, particularly amyloid-related imaging abnormalities with hemorrhage (ARIA-H) and edema (ARIA-E), present significant safety concerns for this medication.

Description: Nearly half a million US Veterans have Alzheimer’s disease, and the prevalence is expected to rise, particularly with the increasing incidence of traumatic brain injury and posttraumatic stress disorder. The objective of the real-time medication use evaluation (MUE) is to assess the safe and appropriate use of lecanemab in the Veterans Health Administration, confirm that patients meet inclusion and exclusion criteria as outlined in the VA Pharmacy Benefits Management (PBM) Lecanemab Criteria for Use (CFU), assess and characterize any adverse drug events (ADE) experienced during the course of treatment as well as the management of ADEs, and assess reasons for discontinuation. The MUE is designed to collect information on the safe and appropriate use of lecanemab in real-time during, immediately following, and between infusion appointments. Local VA pre-screening of patient-specific inclusion and exclusion criteria are conducted per the CFU, and these data are submitted to the VA Center for Medication Safety via a web-based data collection form. Lecanemab dosing, administration, MRI screening, and adverse event reporting and management are documented on the form at each treatment infusion visit.

Lessons Learned: This web-based real-time MUE tool will enable the VA to collect lecanemab safety and appropriateness of use data to optimize Veteran care, assist decision-makers on continued guidance on use of the agent in VA, and identify potential areas for future research.

Stakeholder Perspective: National government health care system.