Presentation (CTI)

OBJECTIVES: Managed entry agreements (MEAs) are increasingly used to facilitate access to high-cost therapies under clinical and financial uncertainty. This study examined whether Taiwan’s 2018 MEA policy was associated with changes in reimbursement timing for oncologic versus non-oncologic drugs.
METHODS: A retrospective cohort study was conducted using linked Taiwan Food and Drug Administration approval records, National Health Insurance reimbursement data, Pharmaceutical Benefit and Reimbursement Scheme meeting minutes, and Health Technology Assessment reports from 2013 to 2026. Primary outcomes included reimbursement within 12 and 24 months of regulatory approval and time to reimbursement. Difference-in-differences models evaluated differential changes in reimbursement outcomes between oncologic and non-oncologic drugs before and after MEA implementation. Cox proportional hazards models examined time to reimbursement.
RESULTS: Among 5,177 drug records, MEA implementation was associated with an 11.1 percentage point increase in reimbursement within 12 months for oncologic drugs relative to non-oncologic drugs (β=0.111; P=.003). This differential effect was not sustained at 24 months. Time-to-event analyses showed no significant overall acceleration in reimbursement timing for oncologic drugs. Among Pharmaceutical Benefit and Reimbursement Scheme-reviewed drugs, those requiring MEAs had lower reimbursement hazards (HR=0.49; P=.011), indicating longer time to listing.
CONCLUSIONS: Taiwan’s MEA policy was associated with earlier reimbursement for oncologic therapies but not broader acceleration of reimbursement across all drugs. These findings suggest MEAs may function primarily as prioritization mechanisms within resource-constrained reimbursement systems.