Impact of China's NRDL Value-Rating System on Reimbursement and Pricing of Innovative Therapies
Author(s)
Wenting Zhang, PhD1, Allen Liu, Master2, Ningrui Zhang, Master2.
1Trinity Life Sciences, San Francisco, CA, USA, 2Trinity Life Sciences, Waltham, MA, USA.
1Trinity Life Sciences, San Francisco, CA, USA, 2Trinity Life Sciences, Waltham, MA, USA.
Presentation Documents
OBJECTIVES: This research aims to explore the newly implemented value-rating system of China’s National Reimbursement Drug List (NRDL) to assess its impact on innovative products’ reimbursement & pricing outcomes.
METHODS: An in-depth analysis of the 2024 NRDL Negotiation results was performed to evaluate how the value ratings of participating drugs may influence their pricing outcomes. Our analysis employs a three-step approach: 1) Identify key successful drug candidates from the 2024 NRDL negotiation, focusing on oncology, rare diseases, and chronic conditions; 2) Evaluate the added clinical benefit compared to standard of care/NRDL-listed competitor(s) and estimate their likely value ratings; 3) Examine the potential relationship between value ratings and pricing outcomes for these therapies.
RESULTS: The value-rating system is designed to objectively evaluate a product’s clinical benefits during the expert review process, categorizing drugs into one of four tiers to determine their eligibility for negotiation. This framework has significantly raised the threshold for entering negotiations, with 63% of products failing to pass the expert review—likely due to low value ratings assigned. Among the 117 new products that advanced through the expert review, 88 were successfully added to the NRDL, reflecting a 75% success rate. Our analysis indicates that products with higher value ratings (e.g., "breakthrough") are more likely to achieve favorable pricing outcomes than those with lower ratings (e.g., "equivalent"). As a result, the value tiering system may indirectly influence NRDL pricing outcomes.
CONCLUSIONS: While no official guidelines delineate its role in NRDL pricing, the value rating system provides a practical and directional framework for assessing pricing and access outcomes for innovative medicines in China. Although budget impact and pricing thresholds remain critical to NRDL negotiations, the increasing significance of the value rating system has revealed emerging pricing trends tied to product value.
METHODS: An in-depth analysis of the 2024 NRDL Negotiation results was performed to evaluate how the value ratings of participating drugs may influence their pricing outcomes. Our analysis employs a three-step approach: 1) Identify key successful drug candidates from the 2024 NRDL negotiation, focusing on oncology, rare diseases, and chronic conditions; 2) Evaluate the added clinical benefit compared to standard of care/NRDL-listed competitor(s) and estimate their likely value ratings; 3) Examine the potential relationship between value ratings and pricing outcomes for these therapies.
RESULTS: The value-rating system is designed to objectively evaluate a product’s clinical benefits during the expert review process, categorizing drugs into one of four tiers to determine their eligibility for negotiation. This framework has significantly raised the threshold for entering negotiations, with 63% of products failing to pass the expert review—likely due to low value ratings assigned. Among the 117 new products that advanced through the expert review, 88 were successfully added to the NRDL, reflecting a 75% success rate. Our analysis indicates that products with higher value ratings (e.g., "breakthrough") are more likely to achieve favorable pricing outcomes than those with lower ratings (e.g., "equivalent"). As a result, the value tiering system may indirectly influence NRDL pricing outcomes.
CONCLUSIONS: While no official guidelines delineate its role in NRDL pricing, the value rating system provides a practical and directional framework for assessing pricing and access outcomes for innovative medicines in China. Although budget impact and pricing thresholds remain critical to NRDL negotiations, the increasing significance of the value rating system has revealed emerging pricing trends tied to product value.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HTA57
Topic
Health Technology Assessment
Topic Subcategory
Systems & Structure, Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas