National Reimbursement Drug List Negotiation in China: Analysis of the Key Trends and Factors Influencing the Value Appraisal and Price Determination

OBJECTIVES: Since 2017, China’s National Health Security Administration (NHSA) has implemented a unique price negotiation mechanism for the National Reimbursement Drug List (NRDL) updates. We aim to analyze the results of the NRDL negotiations, to examine the influencing factors of the NRDL payment standards, and to understand NHSA’s value considerations in its reimbursement decisions.

METHODS: We performed a literature review on academic literature from PubMed, CNKI, Wan Fang, ISPOR website, and documents from government agencies to identify relevant studies. Quantitative analysis was conducted with the best available sales and price data before and after NRDL negotiations, and case studies to analyze and validate the key factors influencing the NRDL payment standards.

RESULTS: During the 2017-2021 negotiations, 286 drugs were added to the NRDL with average price cuts of 44 to 61.7%. The overall negotiation success rate is 70.62%, and the average time lag between regulatory approval and NRDL listing for “western drugs” has decreased from 4.6 years in 2017 to 1.1 years in 2021. We identified four key value considerations: domestic and international prices, comparator and market competition, health economic value, and clinical value considerations, and validated the potential impact of seven influencing factors (the international reference price, the Patient Assistance Program adjusted price, comparators, market competition, cost-effectiveness, budget impact, and clinical value) in the NRDL negotiation.

CONCLUSIONS: Patient access to innovative drugs in China have been significantly improved with the introduction of the NRDL negotiation mechanism. There is increasing value consideration and use of HTA methodology in the appraisal and the determination of payment standards.