Independence Blue Cross (IBX) provides coverage for drugs, biologics, and gene therapies that have received FDA-accelerated approval when research findings demonstrate direct evidence of their clinical effectiveness. Starting January 1, 2025, IBX is clarifying its continued non-coverage position for certain drugs, biologics, and gene therapies that have received FDA-accelerated approval without demonstrating clinical findings that show effectiveness. In these cases, it is typical for the FDA to require continued research studies to demonstrate clinical effectiveness and proven safety of the treatment.