Comment from Academy of Managed Care Pharmacy (AMCP)
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Summary: The Academy of Managed Care Pharmacy (AMCP) supports the FDA's use of the Plausible Mechanism Framework to develop individualized therapies for ultra-rare genetic conditions. They advocate for clearer definitions of the framework's scope, standardized protocols for real-world evidence (RWE) collection, and increased transparency regarding post-marketing evidence to support coverage and reimbursement decisions.
The Academy of Managed Care Pharmacy (AMCP) thanks the Food and Drug Administration (FDA) for the opportunity to comment on Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause. Please see attached for AMCP's full comments.