AMCP convened key stakeholders in managed care to address the balance between patient access and payer requirements in the FDA Accelerated Approval (AA) pathway program. Experts from various fields participated, aiming to identify gaps between FDAAA requirements and payer-valued treatment outcomes, explore evidence ecosystem opportunities, and evaluate policy options. The forum emphasized supporting drug development innovation while recognizing payer needs and promoting stakeholder trust in the AA review process. Notably, incentivizing confirmatory trials emerged as a potential impactful policy solution.
