P201: Addressing Access Disparities From a REMS Lens: A Qualitative Analysis of the SPRAVATO, TYSABRI, and iPLEDGE REMS Programs
Poster Presenter
Esther Borteye
Risk Management Fellow
Pfizer United States
Objectives
To evaluate how operational requirements across three Risk Evaluation and Mitigation Strategies (REMS) SPRAVATO, TYSABRI, and iPLEDGE impact patient access.
Method
Utilizing US FDA REMS documents and peer-reviewed literature, a mapping of REMS requirements for SPRAVATO, TYSABRI, and iPLEDGE was undertaken to identify relevant access-related characteristics that stratify health opportunities and outcomes of the Cochrane PROGRESS framework domains.
Results
Applying the PROGRESS framework, analysis identified characteristics associated with access disparities linked to REMS operational requirements across all three programs. Place-of-residence disparities were evident for SPRAVATO, TYSABRI, and iPLEDGE, driven by the geographic concentration of certified prescribers, pharmacies, and treatment sites required under REMS. For SPRAVATO, mandatory onsite administration with post-dose monitoring and limited availability of certified sites increased travel, time, and resource burden, particularly for patients in rural or lower socioeconomic settings. For TYSABRI, access variability was associated with the distribution of certified infusion centers and complex coordination across prescribers, infusion sites, and laboratory services, contributing to administrative burden and potential treatment delays in lower-resource health systems. For iPLEDGE, access barriers were primarily related to provider availability and geographic distribution, with certification requirements intersecting with dermatology workforce shortages in rural and underserved regions. Across all three programs, socioeconomic status, occupation, and education-related disparities were exacerbated by frequent in-person visits, laboratory testing, monitoring demands, appointment cadence, and extensive documentation—burdens that disproportionately affect individuals with limited financial resources, inflexible work schedules, or lower health literacy. No race-related access disparities were identified. However, within iPLEDGE, religion and gender-related disparities persist. Contraceptive and pregnancy-prevention requirements may conflict with some religious beliefs, limiting adherence. Despite gender-neutral REMS language updates, continued reliance on reproductive-capacity classifications still creates challenges for transgender and gender-diverse patients.
Conclusion
This qualitative analysis suggests that REMS operational requirements, including prescriber certification, restricted dispensing settings, frequent monitoring, and patient administrative tasks, interact with existing health system constraints to exacerbate place of residence, occupation, gender, religion, education, and socioeconomic disparities in access. While REMS are essential for risk mitigation, their implementation may unintentionally create variability in treatment initiation and continuity across patient populations. Incorporating access considerations into REMS implementation, such as alignment with regional provider capacity and care delivery models, may support more equitable access while maintaining safety objectives. Further pragmatic evaluations are warranted to assess whether targeted REMS modifications can reduce operational burden without compromising risk mitigation outcomes.
