TRENDS IN REGULATORY AND REIMBURSEMENT REVIEW TIMELINES FOR NEW DRUGS IN TAIWAN, 2018-2025
Author(s)
Fang Yung Lung, BS1, Cathy SJ Fann, PhD2, Chee Jen Chang, PhD3.
1Chang Gung University, Tao Yung, Taiwan, 2Institute of Biomedical Sciences, Academia Sinica, Taipei, Taiwan, 3Distinguished Professor, Chang Gung University, Taiwan.
1Chang Gung University, Tao Yung, Taiwan, 2Institute of Biomedical Sciences, Academia Sinica, Taipei, Taiwan, 3Distinguished Professor, Chang Gung University, Taiwan.
OBJECTIVES: Timely reimbursement of innovative medicines is essential for improving patient access while sustaining national health insurance systems. This study examined recent changes in observable administrative review intervals and reimbursement category distributions within Taiwan’s new drug reimbursement process from 2018 to 2025, compared with previously reported data from 2013 to 2017.
METHODS: This retrospective observational study used publicly available data from Taiwan’s National Health Insurance Administration, including PBRS Joint Committee meeting records, HTA reports, and official reimbursement implementation announcements. New drug reimbursement cases reviewed from January 2018 to December 2025 were included. Two administrative intervals were evaluated: HTA completion to first PBRS discussion, and final PBRS decision to official reimbursement implementation. Reimbursement categories were classified as Category 1, 2A, 2B, or Other. Descriptive statistics summarized review timelines, and category distributions were compared with previously reported 2013-2017 data using Pearson’s chi-square test and t test.
RESULTS: A total of 188 new drug reimbursement cases were included. Category 2A represented the largest proportion (n=95, 50.5%), followed by Category 2B (n=58, 30.9%) and Category 1 (n=27, 14.4%). Compared with 2013-2017, Category 1 and 2A proportions increased, while Category 2B and Other categories decreased significantly (p<0.001). Among 167 eligible cases, the mean interval from HTA completion to first PBRS discussion was 63 days, versus 161 days in 2013-2017. Among 154 eligible cases, the mean interval from final PBRS decision to official reimbursement implementation was 87 days, similar to the prior period.
CONCLUSIONS: Taiwan’s new drug reimbursement process showed substantial improvement in the early administrative review stage from HTA completion to PBRS discussion. However, the post-PBRS interval remained largely unchanged, suggesting that price negotiation and implementation procedures may remain key administrative bottlenecks. Optimizing post-decision processes may further accelerate patient access to innovative medicines while supporting the financial sustainability of Taiwan’s National Health Insurance system.
METHODS: This retrospective observational study used publicly available data from Taiwan’s National Health Insurance Administration, including PBRS Joint Committee meeting records, HTA reports, and official reimbursement implementation announcements. New drug reimbursement cases reviewed from January 2018 to December 2025 were included. Two administrative intervals were evaluated: HTA completion to first PBRS discussion, and final PBRS decision to official reimbursement implementation. Reimbursement categories were classified as Category 1, 2A, 2B, or Other. Descriptive statistics summarized review timelines, and category distributions were compared with previously reported 2013-2017 data using Pearson’s chi-square test and t test.
RESULTS: A total of 188 new drug reimbursement cases were included. Category 2A represented the largest proportion (n=95, 50.5%), followed by Category 2B (n=58, 30.9%) and Category 1 (n=27, 14.4%). Compared with 2013-2017, Category 1 and 2A proportions increased, while Category 2B and Other categories decreased significantly (p<0.001). Among 167 eligible cases, the mean interval from HTA completion to first PBRS discussion was 63 days, versus 161 days in 2013-2017. Among 154 eligible cases, the mean interval from final PBRS decision to official reimbursement implementation was 87 days, similar to the prior period.
CONCLUSIONS: Taiwan’s new drug reimbursement process showed substantial improvement in the early administrative review stage from HTA completion to PBRS discussion. However, the post-PBRS interval remained largely unchanged, suggesting that price negotiation and implementation procedures may remain key administrative bottlenecks. Optimizing post-decision processes may further accelerate patient access to innovative medicines while supporting the financial sustainability of Taiwan’s National Health Insurance system.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR250
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Health Technology Assessment
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas