A NOVEL APPROACH TO STUDY HEALTHCARE RESOURCE USE AND COSTS OF CARE AMONG MEDICARE-ENROLLED PATIENTS DURING AND AFTER PARTICIPATING IN CLINICAL TRIALS FOR EARLY ALZHEIMER'S DISEASE

Quantifying medical resource use (MRU) and costs for patients during and post clinical trial is challenging but would provide valuable information to the healthcare community. This study presents a novel methodology to generate patient-level health economic evidence alongside sponsor-conducted Alzheimer's Disease (AD) Phase III trials of gantenerumab (GRADUATE) trials which will extend for years beyond trial closure. Specifically, we will assess the correlation of cognitive and functional decline to health care utilization and costs. This study will link Medicare data to data from the GRADUATE studies. The GRADUATE studies are designed to assess the efficacy and safety of gantenerumab in early AD. The GRADUATE trials have a 24-month double-blind (DB) period followed by an open label extension (OLE). GRADUATE data from participants enrolled in Medicare and providing informed consent will be deterministically linked with their Medicare claims data using a HIPAA-compliant approach. Traditional Fee-For-Service Medicare (FFS) claims data will be provided by CMS via the Virtual Research Data Center (VRDC) while Medicare Advantage (MA) will be requested directly from payers. Medicare data from eligible patients will be extracted 12-months prior to GRADUATE enrollment, during the DB, OLE and for a 10-year period post-OLE completion. This study has two planned stages, with the first conducted in 30 patients to determine data linkage feasibility and site/patient acceptability, and inform the second full study stage. There are > 450 patients targeted for US GRADUATE enrollment, with 80% estimated as Medicare participants ≥66 years old. For the first study stage, 12 sites were approached for qualification, with 5–6 sites estimated to enroll 30 patients. Importantly, the study protocol and informed consent form received central IRB approval and were submitted to CMS for final approval. Initial enrollment projections indicate a higher proportion of MA participants, which necessitates approaching MA providers and developing a common data model for linkage. Initial discussions with FFS/MA providers indicate variation in data needed for linkage, linkage process, and reporting requirements. The approach developed here offers a novel, privacy-compliant, scalable approach for linking clinical trial data to Medicare claims to study the long-term economic impact of AD progression.