Pricing, Innovation, and Access-Determinants of Drug Reimbursement Decisions in Taiwan’s NHI System
Author(s)
Yiling Tsai, MBA, PhD1, Pei-Ling Tsai, B.B.A.2, Yi-Shan Luo, B.B.A.2, Fen-Yu Lin, B.B.A.2.
1Assistant Professor, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan, 2National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.
1Assistant Professor, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan, 2National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.
OBJECTIVES: To explore the relationship between drug characteristics and reimbursement decisions for new drugs under Taiwan’s National Health Insurance (NHI) system. The study aims to identify factors that may influence whether a drug receives reimbursement and the time required to obtain it, in the context of rising global drug prices and constrained local healthcare budgets.
METHODS: This retrospective cross-sectional study analyzed 138 new drug cases reviewed by the NHI between 2019 and 2023. Data were extracted from publicly available sources, including PBRS (Pharmaceutical Benefit and Reimbursement Scheme Joint committee) meeting records and official HTA reports. Independent variables included drug innovation classification (Categories 1, 2A, 2B), financial impact (1st and 5th-year projections), the ratio of NHI-approved price to international median and lowest prices, and the price gap between NHI and manufacturer-proposed prices. Dependent variables were: (1) reimbursement status (yes/no), and (2) reimbursement delay (days from regulatory approval to NHI coverage). Descriptive statistics, one-way ANOVA, Pearson correlation, and logistic regression were performed.
RESULTS: Of the 138 new drugs analyzed, 98.6% received NHI reimbursement, with a mean reimbursement delay of 924 days. While Category 1 drugs had the highest price-to-international median price ratio, Category 2A drugs had the highest price-to-international lowest price ratio. However, inferential statistics revealed no statistically significant association between reimbursement delay and any independent variable (all p-values > 0.05). The model faced limitations due to outliers, small sample size, and unavailable cost-effectiveness data for many drugs.
CONCLUSIONS: NHI reimbursement decisions in Taiwan appear to be based on multifactorial considerations that extend beyond measurable drug characteristics such as innovation class, financial impact, or price comparisons. While most new drugs were ultimately reimbursed, the lengthy reimbursement timeline may hinder timely patient access. To improve transparency and efficiency, the study recommends refining pricing principles, improving data completeness, and considering additional qualitative and policy-level factors in future evaluations.
METHODS: This retrospective cross-sectional study analyzed 138 new drug cases reviewed by the NHI between 2019 and 2023. Data were extracted from publicly available sources, including PBRS (Pharmaceutical Benefit and Reimbursement Scheme Joint committee) meeting records and official HTA reports. Independent variables included drug innovation classification (Categories 1, 2A, 2B), financial impact (1st and 5th-year projections), the ratio of NHI-approved price to international median and lowest prices, and the price gap between NHI and manufacturer-proposed prices. Dependent variables were: (1) reimbursement status (yes/no), and (2) reimbursement delay (days from regulatory approval to NHI coverage). Descriptive statistics, one-way ANOVA, Pearson correlation, and logistic regression were performed.
RESULTS: Of the 138 new drugs analyzed, 98.6% received NHI reimbursement, with a mean reimbursement delay of 924 days. While Category 1 drugs had the highest price-to-international median price ratio, Category 2A drugs had the highest price-to-international lowest price ratio. However, inferential statistics revealed no statistically significant association between reimbursement delay and any independent variable (all p-values > 0.05). The model faced limitations due to outliers, small sample size, and unavailable cost-effectiveness data for many drugs.
CONCLUSIONS: NHI reimbursement decisions in Taiwan appear to be based on multifactorial considerations that extend beyond measurable drug characteristics such as innovation class, financial impact, or price comparisons. While most new drugs were ultimately reimbursed, the lengthy reimbursement timeline may hinder timely patient access. To improve transparency and efficiency, the study recommends refining pricing principles, improving data completeness, and considering additional qualitative and policy-level factors in future evaluations.
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD296
Topic Subcategory
Health & Insurance Records Systems
Disease
No Additional Disease & Conditions/Specialized Treatment Areas