OBJECTIVES: As most innovative drugs are expensive and were not covered by social medical insurance in China, providing universal access to these drugs is a challenge. In 2017, China proposed establishing an annual price negotiation mechanism for some patented and expensive drugs. This research aims to comprehensively summarize the changes in negotiated drugs regarding quantity, coverage, availability, utilization, price, and expenditure.

METHODS: We reviewed literature, government documents, and news reports about negotiated drugs through April 30, 2024. For each literature, we recorded basic information (corresponding author, data sources, study design), details about negotiated drugs (negotiated period, disease areas), outcome indicators (accessibility, affordability), and research findings.

RESULTS: We included 26 literature, of which 17 focused on the National Drug Price Negotiation (NDPN) policy's impact on access to negotiated drugs, while the remaining 9 examined the status of access to negotiated drugs after NDPN. From 2017 to 2024, 553 drugs were newly incorporated into National Reimbursement Drug List (NRDL) via seven rounds of negotiation. Most were innovative drugs, including over 70 targeted oncology drugs and over 80 rare disease drugs. Regarding accessibility, all literature mentioned that the NDPN policy significantly increased the availability and utilization of innovative drugs. 46.1% (12/26) found uneven accessibility across regions and hospitals. Regarding affordability, 57.7% (15/26) reported a significant decrease in expenditure, and price reductions for negotiated drugs ranged from 44% to 62%. However, 26.7% (4/15) mentioned that the ratio of out-of-pocket costs for orphan drugs and anticancer drugs to catastrophic health expenditures was still greater than 1.

CONCLUSIONS: The NDPN policy effectively improved the accessibility and affordability of innovative drugs in China. These experience could provide insights for other countries. However, access to negotiated drugs needs further improvement. Additional policy efforts are required to accelerate the use of negotiated drugs and enhance health insurance treatment for low-income people.