Analysis of Implementation and Termination Characteristics of Managed Entry Agreements for New Drugs Under Taiwan’s National Health Insurance System
Author(s)
Tzuyun Hsiao, B.B.A, Yuhua Tsai, B.B.A, Yuchen Cheng, B.B.A, Yuchieh Lin, B.B.A, Yiling Tsai, MBA, PhD.
Department of Health Care Management, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.
Department of Health Care Management, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.
OBJECTIVES: This study aims to analyze the implementation and termination characteristics of Managed Entry Agreements (MEAs) for new drugs under Taiwan’s National Health Insurance (NHI) system. MEAs are contractual arrangements between pharmaceutical companies and payers to address uncertainties in financial impact and clinical efficacy, especially for high-cost drugs targeting rare diseases or advanced-stage cancers. The research focuses on trends in MEA adoption, termination scenarios, and factors influencing agreement signing.
METHODS: A cross-sectional retrospective observational study was conducted using publicly available records from Taiwan’s NHI Pharmaceutical Benefit and Reimbursement Scheme Joint Committee Meeting between 2019 and 2023. Data on drug characteristics, financial impact estimates, clinical trial phases, and agreement types were extracted and validated by independent reviewers. Statistical analyses, including descriptive statistics and chi-square tests, were performed to identify factors affecting MEA adoption.
RESULTS: Of the 120 cases analyzed, 45.8% involved signed MEAs, while 50.8% remained undisclosed due to confidentiality. MEAs based on financial arrangements dominated (49.1%), followed by efficacy-based agreements (10.9%). Agreements were predominantly signed for two-year terms, with fixed-discount schemes being the most common financial arrangement (54.6%). Termination scenarios revealed that 23.6% of agreements were renewed at reduced prices, while 58.2% had unknown termination statuses. Factors significantly influencing MEA adoption included drug classification (p = 0.0014), clinical trial phase (p < 0.0001), therapeutic category (p < 0.0001), and estimated financial impact over three and five years (p < 0.0001).
CONCLUSIONS: MEAs have become a critical policy tool for balancing the risks of new drug reimbursement with NHI resource optimization in Taiwan. While financial-based agreements remain prevalent, efficacy-based agreements are gradually increasing due to advancements in real-world evidence collection and electronic medical records.
METHODS: A cross-sectional retrospective observational study was conducted using publicly available records from Taiwan’s NHI Pharmaceutical Benefit and Reimbursement Scheme Joint Committee Meeting between 2019 and 2023. Data on drug characteristics, financial impact estimates, clinical trial phases, and agreement types were extracted and validated by independent reviewers. Statistical analyses, including descriptive statistics and chi-square tests, were performed to identify factors affecting MEA adoption.
RESULTS: Of the 120 cases analyzed, 45.8% involved signed MEAs, while 50.8% remained undisclosed due to confidentiality. MEAs based on financial arrangements dominated (49.1%), followed by efficacy-based agreements (10.9%). Agreements were predominantly signed for two-year terms, with fixed-discount schemes being the most common financial arrangement (54.6%). Termination scenarios revealed that 23.6% of agreements were renewed at reduced prices, while 58.2% had unknown termination statuses. Factors significantly influencing MEA adoption included drug classification (p = 0.0014), clinical trial phase (p < 0.0001), therapeutic category (p < 0.0001), and estimated financial impact over three and five years (p < 0.0001).
CONCLUSIONS: MEAs have become a critical policy tool for balancing the risks of new drug reimbursement with NHI resource optimization in Taiwan. While financial-based agreements remain prevalent, efficacy-based agreements are gradually increasing due to advancements in real-world evidence collection and electronic medical records.
Conference/Value in Health Info
2025-09, ISPOR Real-World Evidence Summit 2025, Tokyo, Japan
Value in Health Regional, Volume 49S (September 2025)
Code
RWD142
Topic Subcategory
Health & Insurance Records Systems
Disease
No Additional Disease & Conditions/Specialized Treatment Areas