Presentation (CTI)

OBJECTIVES: This study aimed to evaluate differences in formulary inclusion and coverage decisions for oncologic therapies based on FDA-approved indications versus off-label compendia support. It focused on identifying key drivers of commercial payer decision-making, assessing how evidence type impacts access, and exploring implications for patient outcomes.
METHODS: A mixed-methods approach was used, integrating a comprehensive review of national and regional commercial payer policies. The analysis focused on the top 10 medical plans (by covered lives), comparing management strategies for on-label therapies versus off-label, compendia-supported alternatives. The study specifically examined therapies with FDA approval against those endorsed by compendia such as NCCN and Micromedex.
RESULTS: FDA-approved therapies were more likely to achieve access policies with fewer restrictions, such as prior authorization or step therapy. Off-label therapies with compendia support often faced stricter access criteria, especially when backed by lower-tier recommendations (e.g., NCCN Category 2B). Payers highly value robust clinical evidence and alignment with established guidelines but are also significantly influenced by budget constraints and anticipated patient volume when making access decisions.
CONCLUSIONS: Access policies for oncologic therapies is heavily influenced by evidence quality. FDA approval drives access, but compendia support can bridge gaps for off-label use when supported by strong data. Lower-tier compendia recommendations face greater payer scrutiny, leading to access barriers that can deter prescribing due to administrative burden and lower clinical confidence. Proactive payer engagement highlighting clinical and economic value is essential to improving access for these therapies.