OBJECTIVES: Chronic myeloid leukemia (CML) drugs had high clinical efficacy but were costly, which placed a high disease burden on CML patients. Consequently, China attempted to reduce the price of CML drugs through national drug price negotiation (NDPN) to alleviate the economic burden of CML. This study aimed to clarify the policy effects of NDPN on the price, volume, spending, and usage share of negotiated drugs.

METHODS: All first-line tyrosine kinase inhibitors for chronic leukemia marketed in China, including Imatinib, Nilotinib, and Dasatinib, were selected as study samples. Purchasing data from an eastern province between 2018 and 2021 was used. The outcome indicators were defined daily doses (DDDs), defined daily cost (DDC) and expenditure. Descriptive statistics were used to investigate changes in price and usage share. Additionally, an interrupted time series model was developed to analyze the impact on the volume and expenditure of Nilotinib, Dasatinib, Imatinib, and the total.

RESULTS: After Nilotinib was included in the National Reimbursement Drug List through negotiation, the DDC of Nilotinib decreased from $100.51 to $35.52 (-64.66%). This reduction was greater than that of Imatinib and Dasatinib. Meanwhile, the usage share of Nilotinib has been increasing annually. The utilization of Nilotinib increased by 1,044.03 DDDs (p=0.003) immediately and by 99.33 DDDs (p<0.001) per month after the policy was implemented. The total utilization of sample drugs increased by 3,155.10 DDDs (p=0.122) immediately and by 391.60 DDDs (p=0.007) per month. The expenditure of Nilotinib dropped by $27,640.57 (p=0.020) immediately, and then increased by $1,109.93 (p=0.471) per month. The total expenditure decreased by $420,268.21 (p=0.003), and by $11,494.95 (p=0.343) per month.

CONCLUSIONS: NDPN have improved the accessibility of negotiated CML drugs and saved expenditure for medical insurance funds. Therefore, China should further implement regular NDPN to improve affordability of innovative drugs.