Evaluating REMS Burden: A Comparative Time Analysis of 3 Channels for REMS Stakeholders to Perform Mandatory REMS Tasks

Background:To determine the time taken to perform 5 Risk Evaluation and Mitigation Strategy (REMS) tasks across 3 channels for the Celgene REMS programs, with an aim to better understand which channels may minimize REMS administrative burden.Methods:Five mandatory REMS tasks (new prescriber and patient enrollments, prescriber and patient surveys, and pharmacy dispenses) were performed across applicable REMS channels (online portals, telephone interactions with customer care representatives [CCRs], or an interactive voice response [IVR] system). Five REMS representatives, who had ≥1 year of experience as a CCR, simulated the completion of the same set of testing activities across REMS channels. The execution time for each task by channel was measured and averaged across the participating CCRs.Results:Using the online portal, less time was taken to enroll a new prescriber (1.3 minutes) and adult male (6.7 minutes), compared to when the CCR channel was used (21.9 and 25.9 minutes, respectively). Similarly, c...