Partnership Forum — Addressing Evidence Gaps in the Expedited Approval Process: Payer Perspectives
Drug development is expensive, time consuming, and risky. To address these factors, clinical and regulatory experts in pharmaceutical companies must design drug development programs and clinical trials that meet FDA requirements. Especially with drugs approved via expedited pathways, the payers’ perspective typically takes a back seat to FDA approval criteria. Further, payer expectations for efficacy and safety, as well as population parameters, can differ from those established to meet FDA stipulations. However, meeting payers’ expectations is critical for patient access and commercial success. Payers increasingly demand demonstration of long-term value, especially for high investment medications or those with a high-risk safety profile. Despite the rigorous steps in the process of drug development, limitations exist due to the difference between FDA approval requirements and payer evidence needs. Forum participants will outline payer needs, barriers, and solutions for products approved through an expedited approval process regarding evidence for new drug products.
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