Real-World Evidence for Drug Value Assessment in China: Learning from International Experiences
Abraham G Hartzema1, Adel Gehchan2, Jennifer D Guo3
1College of Pharmacy, University of Florida, Gainesville, FL, USA. hartzema@ufl.edu.
Drugs - Real World Outcomes
|June 4, 2026
Summary
China
Area of Science:
- Health economics
- Pharmaceutical policy
- Real-world evidence
Background:
- China's national medical insurance system has rapidly evolved.
- The National Healthcare Security Administration manages healthcare expenditure and maintains the National Reimbursement Drug List (Categories A and B).
- A new Category C (Commercial Insurance Innovative Drug list) will be added in 2025.
Purpose of the Study:
- To propose strategies for integrating real-world evidence (RWE) into China's drug value assessment.
- To inform national formulary management and reimbursement pathways.
- To leverage international experiences in RWE for drug reimbursement decisions.
Main Methods:
- Review of China's healthcare system development and drug formulary management.
- Analysis of the role of real-world evidence in complementing clinical trial data.
- Examination of international best practices in utilizing RWE for reimbursement.
Main Results:
- Real-world evidence addresses uncertainties in drug safety, effectiveness, and long-term outcomes.
- International experiences offer insights into RWE application for drug reimbursement.
- Integration of RWE can enhance China's drug value assessment processes.
Conclusions:
- Integrating real-world evidence is crucial for informed drug value assessment in China.
- Strategic implementation of RWE can optimize national formulary management.
- This approach supports evidence-based reimbursement decisions for improved healthcare outcomes.
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