OBJECTIVES: China’s near-universal drug coverage has limitations due to high out-of-pocket costs for patients and poor coverage of innovative, premium-priced medicines. To increase access to high-cost innovative drugs, national drug price negotiations were introduced in 2015. The objective was to describe current opportunities and challenges for innovative drugs in China based on recent evidence from the new reimbursement decision making processes.

METHODS: National Reimbursement Drug List (NRDL) related notices and articles by the Ministry of Human Resources and Social Security (MOHRSS) and National Healthcare Security Administration (NHSA) between 1^st January 2015 and 31^st May 2022 were reviewed and analysed.

RESULTS: Since 2016 when five negotiations took place with three drugs added to the NRDL, both the number of negotiations and listings have increased considerably with a total of 496 product negotiations. The success rate varied between 59% and 94% over the years and across initial and renegotiations. With the relatively high success rate, agreements have often been made with substantial discounts to drug prices. The average agreed drug price discount ranged between 44% and 62% over the years, and exceeded 50% in the last two years. Regarding key assessment criteria, initial focuses on effectiveness, safety and reasonable pricing (2016) were broadened to include new aspects of innovation and equity (2021), with new pharmacoeconomic guidelines published in 2020. This indicates that manufacturers need careful planning to demonstrate broad aspects of value to meet evolving NRDL assessment requirements.

CONCLUSIONS: Pharmaceutical companies will need to track NRDL trends, monitor actual decisions by therapeutic areas, develop tailored strategies, and demonstrate comprehensive value to achieve market access and reimbursement for innovative drugs in China.