Objective: The major aim of this study was to describe changes in the use of TKIs for CML treatment after implementing an imatinib VBP policy in China.

Methods: The Chinese Medicine Information Network of the Chinese Pharmaceutical Society was used to identify the drug use of imatinib, dasatinib, and nilotinib in the sample hospitals from May 2017 to April 2021. The annual number of TKI-treated patients with CML was and the annual total use of TKIs. Data analyses were conducted for the implemented imatinib VBP policy in 11 Chinese cities in April 2019 (when only generic imatinib Xin Wei was listed, per the 2019 VBP) and expanded to the others in January 2020 (when both generic imatinib Xin Wei and Ge Ni Ke were listed, per the 2020 VBP).

Results: Patients with TKI-treated CML increased by 32.9% (from 6,498 to 8,635) after implementing the VBP policy in April 2019 and by 22.9% (from 13,351 to 16,409) in January 2020. Distribution of patients receiving the three approved TKIs changed slightly (imatinib: 78.4% vs. 77.7%; dasatinib: 11.7% vs. 11.3%; nilotinib: 9.9% vs. 10.9%) after implementing the VBP policy in January 2020. After the 2019 VBP and 2020 VBP implementations, the annual volume of Xin Wei increased by 127% and Ge Ni Ke increased by 82.1%. Concurrently, the annual volume of Novartis-originated imatinib was reduced by 5.8% and 22.9% after the 2019 VBP and the 2020 VBP, respectively.

Conclusions: The use of TKIs for CML in China increased substantially, mainly via increased use of VBP-listed generic imatinib. The imatinib VBP policy had limited impact on the market share of the three China-approved TKIs for CML but reduced the use of non-generic imatinib in China.