Title

Assessing FDA's Risk Management and Evaluation Strategies for Novel Oral Anticoagulants: A comprehensive plan for Impact Assessment of Public Health Interventions Using the RE-AIM Framework

Document Type

Presentation

Publication Date

4-2-2014

Comments

Advisor: Joseph Jackson, PhD, MS, Associate Professor at Thomas Jefferson University

Abstract

The Food and Drug Administration (FDA) has required Risk Evaluation and Mitigation Strategies (REMS) to manage the risk of stroke post treatment without bridging for the Novel Oral Anticoagulant (NOAC) drugs. REMS assessments are conducted by law to evaluate how REMS are meeting goals, ultimately for the protection of public health. The NOACs are an important addition to treatment options over difficulties with warfarin for non-valvular atrial fibrillation, a condition with increasing public health burden. This study aims to evaluate how the NOAC REMS ensure the benefits of these drugs outweigh the risks by applying the RE-AIM Framework (Reach, Efficacy, Adoption, Implementation, and Maintenance) to REMS assessment, an idea formulated by the FDA in exploring improvement to evaluation methods. Due to the confidentiality of REMS data collected by sponsors and unavailability of outcomes data, observational evidence was collected and reviewed. Based on professional judgment in consideration of the evidence, each RE-AIM dimension was scored by the author, for a total public health impact score of 0.84 (scale 0-1.0). This score shows that NOAC REMS have been appropriately carried out to prevent stroke risk and ensure a positive benefit-risk profile for the two-year period of the requirements. However, in this particular case, RE-AIM added burden by qualitative and indirect assessment. In examining the wider use of RE-AIM for REMS assessments, the FDA will need to consider how to balance potentially burdensome requirements with useful, standardized assessment methods. Although use of RE-AIM did not provide significant public health contributions to NOAC REMS assessment, overall, the NOACs’ strong efficacy make them positive additions and viable alternatives to warfarin for treating NVAF, especially with the REMS to ensure communication about stroke risk, which is important for providers and patients in addressing the considerable burdens posed by this disease.

Presentation: 30 minutes