National Reimbursement Drug List in China: Changing Dynamics and Trend and Price Determination of Formulation Innovation Drugs

OBJECTIVES: To explore the factors influencing the success of listing the National Reimbursement Drug List (NRDL) and price determination of formulation innovation drugs.

METHODS: A literature review on academic literature from PubMed, CNKI and official documents from government agencies to identify relevant studies. Interviews were conducted with experts who have NRDL experience in the past two years. Quantitative analysis of the NRDL's success rate and price reductions was performed using official data and price information published by the medical insurance authorities, as well as the price determining factors of formulation innovation drugs.

RESULTS: From 2017 to 2023, the success rate of NRDL negotiations has steadily increased, averaging 78.7%, with rates around 80% in both 2022 and 2023. The average reduction in negotiated prices compared to launch prices was 56.5%, with reductions maintaining around 60% since 2021. In 2023, the effectiveness, safety, innovativeness, and fairness of the products applied for were key dimensions in assessing product’s value. The degree of clinical value and substitutability compared to NRDL listed products were critical factors in determining whether a product could pass the shortlisting stage. The approval rate for compound formulations was lower in 2022 and 2023 (6.02% and 5.26% of included varieties respectively). Based on the results of the four-dimensional scoring and four-quadrant classification from the comprehensive evaluation, the key price determination of formulation innovation drugs was the lowest price among the reference drug price, international reference price or bidding procurement price. Case studies showed that if both components of a compound formulation were on the Volume-based Procurement (VBP) list, the reimbursement standard was typically the sum of the VBP prices, averaging 87.43% lower than catalog prices.

CONCLUSIONS: The NRDL evaluation process is continuously improving. For products with innovative dosage forms, the reimbursement standard is relatively low in a highly competitive environment.