Presentation (CTI)

OBJECTIVES: Timely public reimbursement determines whether regulatory approval translates into patient access. We assessed reimbursement coverage, approval-to-reimbursement time, and healthcare costs for new medicines in Taiwan and benchmarked Taiwan’s access timelines against published international estimates.
METHODS: New active ingredients approved by the Taiwan Food and Drug Administration during 2016-2025 were identified after excluding new formulations, routes, strengths, fixed-dose combinations, and indication expansions. Medicines were exclusively classified as orphan, cancer, or other subgroups. National Health Insurance reimbursement status was followed through December 31, 2025. Outcomes included reimbursement coverage, cumulative reimbursement over time, and time from regulatory approval to reimbursement. Analyses were stratified by medicine type and calendar year. For contextual benchmarking, Taiwan’s estimates were compared with published Organization for Economic Cooperation and Development (OECD) estimates using local launch as the starting point.
RESULTS: Among 308 new active ingredients, 182 (59.1%) were reimbursed by the end of 2025. Up to 10 years of follow-up, cumulative reimbursement reached 74.4% overall and 91.7% for orphan medicines. Among reimbursed medicines in earlier approval cohorts, mean approval-to-reimbursement time ranged from 1.48 to 2.23 years overall, 1.49 to 2.83 years for cancer medicines, and 2.62 to 3.66 years for orphan medicines. Approximately half of cancer and orphan medicines were reimbursed within 3 years, increasing to about 75% within 5 years. Overall timelines were close to the published OECD average of approximately 2 years after local launch but remained longer and more variable for selected subgroups.
CONCLUSIONS: Taiwan achieved high long-term reimbursement coverage, particularly for orphan medicines, but coverage did not consistently translate into timely access. Routine monitoring of standardized approval-to-reimbursement indicators could identify bottlenecks and inform accelerated review, managed access, and other life-cycle reimbursement policies. Ongoing expenditure analyses will complement these access indicators.