Objective: The major aim of this study was to describe changes in the use of TKIs for CML after listing of nilotinib in the Chinese national reimbursement formulary (National Reimbursement Drug List; NRDL).

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 patients with TKI-treated CML was based on standard daily treatment dosages and the annual total use of TKIs. Reimbursement of nilotinib for CML was implemented across China in January 2019.

Results: One year before the nilotinib reimbursement policy had been implemented, the estimated annual distribution of patients with CML who received imatinib, dasatinib, or nilotinib (N=15,968) was 84.1%, 12.1%, and 3.8%, respectively. One year after institution of the nilotinib NRDL, the estimated annual distribution of patients with CML who received imatinib, dasatinib, or nilotinib (N=24,467) changed to 78.7%, 11.3%, and 9.9%, respectively. In addition, the annual use of imatinib, dasatinib, and nilotinib increased by 43.4%, 43.9%, and 302% (>3-fold), respectively. In total, the annual patient number receiving all three first-generation and second-generation TKIs increased by 53.2% after the nilotinib NRDL policy had been instituted. The increased use of nilotinib in tier 3A tertiary hospitals accounted for 91.6% of the total increased nilotinib use after implementation of the new NRDL.

Conclusions: Reimbursing nilotinib substantially augmented the use of nilotinib in Chinese hospitals (mainly through tier 3A hospitals). Nilotinib reimbursement policy did not reduce the market volume of existing TKIs with reimbursement coverage (imatinib and dasatinib) but slightly reduced their market shares.