Addressing Evidence Gaps in the Expedited Review Process: Payer Perspectives
Drug development is expensive, time consuming and risky. To address these factors, clinical and regulatory experts in pharmaceutical companies design drug development programs and clinical trials with a focus on meeting the FDA requirements. Especially with drugs approved via expedited pathways, the payer's 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. Participants outlined payer needs, barriers, and solutions for products approved through an expedited approval process regarding evidence for new drug products.
This forum identified payer needs and current barriers that payer currently face regarding evidence for therapies approved through an expedited approval process. In addition, participants helped identify potential solutions to address evidence gaps.
- Forum Program [PDF]
- Press Release
- Executive Summary [PDF]
- Forum Proceedings - Q4 2022 or Q1 2023
- Forum Webinar - September 22, 2022