Plain Language Summary

What is it about?

China's healthcare system has been facing the challenge of providing access to innovative but expensive medications for its population. The National Reimbursement Drug List (NRDL) negotiation policy was implemented to address the gap between high drug prices and patient affordability. This study specifically examined how this policy affected the availability, affordability, and regional equity of negotiated drugs included in the NRDL using comprehensive nationwide and multinational data. Previous research has primarily focused on specific drug categories or regions, leaving a knowledge gap regarding the nationwide impact of this policy across multiple dimensions of drug access. The NRDL negotiation policy offers a potential solution by leveraging the consolidated purchasing power of China's national medical insurance fund to negotiate lower prices while ensuring broader insurance coverage for these medications. This study makes a notable contribution by providing a comprehensive assessment of how national drug price negotiations affect medication access across availability, affordability, and equity dimensions.

How was the research conducted?

The researchers designed a cross-sectional study examining 233 drugs included in China's NRDL through negotiations from 2018 to 2020. They applied a framework originally developed by the World Health Organization and Health Action International to assess medication accessibility across 3 key dimensions: availability, affordability, and equity. To measure these dimensions, the researchers calculated 6 specific indicators: proportion of procurement hospitals; defined daily doses for availability; defined daily dose cost; reimbursement proportion; drug price index for affordability; and Gini coefficient for equity. The study utilized 3 comprehensive databases: 2 nationwide Chinese databases covering 2018-2021 and 2019-2021, and 1 multinational database spanning 2017-2022. The researchers categorized drugs by approval time, negotiation year, and status (new versus renewed listing) to enable detailed comparative analysis of trends before and after policy implementation.

What were the results?

The implementation of China's NRDL negotiation policy significantly improved the availability of negotiated drugs, with the proportion of procurement hospitals increasing by 0.89% to 53.44%. Drug usage, measured by defined daily doses, grew substantially across all drug groups with compound annual growth rates (CAGR) ranging from 25.21% to an extraordinary 26,700%. The policy also enhanced drug affordability, as China's drug price index decreased from a mid-level position among reference countries in 2017 to become the lowest by 2022. The cost per defined daily dose declined significantly after negotiation, with CAGR ranging from 6.28% to 70.20%. Throughout the study period, the reimbursement proportion remained stable between 62.40% and 80.12%, ensuring consistent financial protection for patients. Surprisingly, regional equity also improved, with most therapeutic classifications (60.66%) achieving Gini coefficients below 0.4, indicating adequate to good equity in drug distribution across provinces.

Why are the results important?

These findings demonstrate that strategic drug price negotiations can successfully balance the competing goals of drug affordability and availability in real-world settings. The NRDL policy has concretely improved patient access to innovative medications by both increasing hospital procurement and reducing costs, potentially enabling millions of Chinese patients to receive treatments that might otherwise be financially out of reach. Healthcare providers, patients, and insurers specifically benefit from the policy through expanded treatment options, reduced financial burden, and more efficient use of healthcare resources. In the long term, this approach could serve as a model for other countries struggling with similar challenges in pharmaceutical access and affordability, particularly in middle-income countries with large populations and growing healthcare needs.

What are the strengths and weaknesses of this study?

A major strength of this study is its comprehensive nationwide scope, analyzing almost all negotiated drugs across China rather than focusing on specific medications or institutions, which provides robust evidence of policy impact at scale. However, the descriptive nature of the analysis means that results may be influenced by concurrent policies or events such as COVID-19, making it difficult to isolate the specific effects of the NRDL negotiation policy. Future research could address this limitation by conducting controlled studies that account for confounding factors and by incorporating more patient-centered metrics such as drug-specific catastrophic health expenditure. Additional studies could also explore how to optimize negotiation strategies to balance immediate access benefits with long-term innovation incentives, which remains a critical tension in pharmaceutical policy globally.

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