(C-185) A Learning Healthcare Initiative: Real Time Medication Use Evaluation of Lecanemab-irmb and Donanemab-azbt - Surveillance of Mild Cognitive Impairment/Alzheimer’s Disease in the Veterans Health Administration

Background: Nearly one-half million Veterans are living with Alzheimer’s disease (AD) with prevalence expected to rise. The US Food and Drug Administration approved IgG1 monoclonal antibody therapies, lecanemab-irmb (7/2023) and donanemab-azbt (8/2024), for treatment of mild cognitive impairment or during the mild dementia stage of AD. The Veterans Health Administration (VHA) implemented a real-time pharmacovigilance Medication Use Evaluation (MUE) to assess and monitor safety and appropriateness of these medications.

Objectives: To assess utilization, safety and appropriateness of use of lecanemab-irmb through a real-time MUE. To apply lessons learned from evaluation to improve the MUE for lecanemab-irmb and donanemab-azbt.

Methods: Using SQL databases, Microsoft PowerApps and PowerBI, we designed a real-time MUE as a mandatory pharmacovigilance process for Veterans enrolled from October 2023 to present treated with lecanemab-irmb and donanemab-azbt. We measured patients meeting Criteria for Use (CFU), appropriate dose/administration, MRIs and adverse drug event (ADE) reporting during and between infusions. Enhancements were applied from lessons learned with the initial lecanemab-irmb model. Additional beta-tests of the tool used the donanemab-azbt model to inform of comprehensive and efficient improvements. We used descriptive statistical analysis of characteristics, CFU compliance, dose, infusions and ADEs.

Results: As of 2/10/2025, the lecanemab-irmb MUE includes 14 registered sites, and 8 actively administered at least one infusion of lecanemab-irmb to 46 patients, 13 (28%) experienced an ADE: infusion related reaction 8(62%), amyloid-related imaging abnormalities (ARIA) 4(30%). MUE data was automated in conjunction with the dashboard for ease of reporting and summary analysis. Biweekly internal meetings, monthly community of practice calls, subject matter expert feedback were used for continuous improvement and enhancement. Resulting enhancements were to ensure patients were not lost to follow-up, improve documentation of ADE resolution and follow-up, improve traveling Veteran care and update dose titration regimens. Using the lecanemab MUE tool design, the donanemab-azbt MUE was developed and launched in 14 existing MUE-registered sites. To date, one site has 3 patients with at least 2 donanemab-azbt infusions and no ADEs.

Conclusions: The real-time lecanemab-irmb MUE offers a user-friendly and robust monitoring and enhanced oversight tool for drug administration and safety. Continuous learning and feedback made the lecanemab-irmb MUE a more comprehensive and efficient tool. Enhancements have been incorporated in the new donanemab-azbt MUE.