ICER Meets With FDA, EMA, and FDA to Discuss RWE Procedures

In a recent meeting, members of the Institute for Clinical and Economic Review (ICER), the Food and Drug Administration (FDA), and the European Medicines Agency (EMA) discussed how to address real world evidence (RWE) studies. ICER discussed its recent RWE framework and its interest in incorporating RWE studies into its value assessments by partnering with Aetion. ICER also discussed results from its RWE study on hereditary angioedema treatments.

Aetion CEO Carolyn Magill remarked, “For this RWE study, our researchers supplemented clinical trial findings by analyzing real-world data on the Aetion Evidence Platform to further clarify baseline attack rates, cost, and utilization. This initiative demonstrates the value of transparent and reproducible RWE to inform important decisions that impact patient care.” Read more here.

(Source: ICER, 8/24/21)