Abstract
OBJECTIVE: China has formulated the National Drug Price Negotiation ("Policy") to promote the availability and use of innovative medicine for alleviating the financial burden on patients. As of 2024, China has conducted nine rounds of negotiations. This study is a comprehensive nationwide evaluation to assess the impact of the six rounds that took place between 2016 and 2021 on the availability, cost, use, and price of negotiated drugs in the hospital setting in China. METHODS: Data on negotiated drugs, spanning the years 2015-2022, were obtained from the China Medicine Economic Information (CMEI) database. Our dataset included information from 698 hospitals and 155 negotiated drugs. T-tests and interrupted time series analysis were performed to evaluate the impact on the targeted medicines. FINDINGS: The Policy significantly increased the use and availability rate of the negotiated drugs. After inclusion in the National Reimbursement Drug List (NRDL), the average defined daily doses (DDDs) of drugs in each of the six negotiation rounds were 3-12 times higher than before, and their availability was 1.5-4.5 times higher. The Policy had significant immediate effects on defined daily dose cost (DDDc) and prices across all negotiation rounds, with average DDDc decreasing by up to 77.8% and price indices by as much as 51.7%. The Policy's effects varied across negotiation rounds, with stronger immediate impacts on all four outcome measures for drugs negotiated after 2018. However, the rate of decline in both price indices and DDDc slowed over time. CONCLUSIONS: Evidence supports the claim that the Policy achieved its desired objectives, although there is a valid case for increasing the availability of medicines and establishing availability assessment criteria for innovative drugs. We recommend that the government be more sensitive to abnormal changes in drug prices and patient costs after the end of the negotiated agreement period.