(B-105) Assessment of Utilization Patterns of New Molecular Entities Approved in 2022 using the Sentinel Distributed Database

Background: Understanding the uptake and utilization of new molecular entities (NMEs) in real-world clinical practice is essential for continued monitoring of their safety; an important reason being the variability of post-approval users compared to the trial population. The Sentinel System routinely assesses NMEs to provide US FDA information about utilization patterns and availability of sufficient users for potential future safety assessments using the Active Risk Identification and Analysis (ARIA) System.

Objectives: To characterize the utilization patterns of 37 NMEs approved by the FDA in 2022 in the Sentinel Distributed Database (SDD).

Methods: The study was conducted in five Data Partners (DPs) included in the SDD with data available for a minimum of one year after December 31, 2022 (overall study period January 2022 to May 2024). We identified individuals initiating NMEs, defined using first observed dispensing or administration code with ≥183 days of prior medical and pharmacy coverage. We described demographic and clinical characteristics recorded in the six months prior to treatment initiation and characterized utilization patterns by examining number of dispensing/administration codes with their days’ supply, duration of treatment episodes, cumulative duration of treatment episodes, and gaps between subsequent treatment episodes.

Results: The indications for the NMEs of interest varied widely, including different cancers, autoimmune disorders, diabetes mellitus and its complications, infectious diseases, and neurological disorders. Of the 37 NMEs, five had >10,000 users, seven between 10,000 and >1,000 users, 13 between 1,000 and >100 users, and 12 had 100 or fewer users over the study period. Tirzepatide, approved for the treatment of type 2 diabetes mellitus, had the highest number of users (438,820 users; 62.3% female) with an average of five dispensings per user, and median days’ supply and cumulative treatment duration of 28 and 112 days respectively. Faricimab-svoa, indicated for neovascular age-related macular degeneration and diabetic macular edema, was the next most commonly used (114,321 users; mean age 78.7 years), with an average of five dispensings/administrations per user, followed by gadopiclenol, an intravenous radiological contrast agent (22,748 users; mean age 62.6 years) with an average of one dispensing/administration per user.

Conclusions: Of the NMEs approved in 2022, the two most utilized were tirzepatide and faricimab-svoa, both with indications for diabetes mellitus and its complications. Having insight into the use of NMEs can help the FDA determine the next steps for assessing any safety concerns.