Real-World Evidence for Drug Value Assessment in China: Learning from International Experiences.

Abstract

In China, the national medical insurance system has undergone rapid development over the past two decades. The National Healthcare Security Administration was established to manage the growing healthcare expenditure. Since then, this administration has maintained the drug formulary, known as the National Reimbursement Drug List. The list comprises Category A (essential and cost-effective drugs) and Category B (effective drugs with relatively higher cost profiles), with the Commercial Insurance Innovative Drug list (referred to as Category C) added in 2025. China has made progress in adopting real-world evidence into healthcare decision making. Real-world evidence helps address key uncertainties related to safety, effectiveness, and long-term outcomes to complement clinical trial findings using real-world data from routine clinical practice. Evolving international experiences provide practical insights into the use of real-world evidence to support drug reimbursement and reassessment decisions. This paper proposes practical strategies supporting the integration of real-world evidence into China's drug value assessment to better inform national formulary management and reimbursement pathways.