Aetion Researchers Discuss ICER’s Reassessment of Drugs Receiving Accelerated FDA Approval Using RWE

August 27, 2021

The Institute for Clinical and Economic Review (ICER) recently published findings from a pilot study that used real world evidence (RWE) to assess the cost-effectiveness of three drugs receiving accelerated approval from the Food and Drug Administration (FDA). The drugs are used in treating hereditary angioedema. RWE is expected to play an increasingly important role in assessing drug efficacy, cost-effectiveness, and patient coutcomes.

“Biopharma manufacturers should anticipate knowledge gaps in their clinical development programs and leverage the opportunity to conduct RWE studies to inform assessments in the future. By planning RWE studies and communicating plans with decision-makers, biopharma manufacturers can potentially help shape future evidence generation requirements from HTA bodies and payers, and influence the way RWE is incorporated into decision-making.” Read more here.

(Source: Ashley Jaksa and Mandy Patrick, Aetion, 8/26/21)

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