Abstract

The goal of the study was to evaluate clinical and economic feasibility of nilotinib in comparison with the imatinib usage as the first-line therapy for chronic myeloid leukaemia (CML), and implementation of nilotinib compared with imatinib in high doses in the second-line treatment. Health-economic analysis and budget impact analysis of the use of tyrosine kinase inhibitors (TKI) for CML treatment were performed in Russian economic conditions. Economic models for the first and the second lines of CML treatment were built separately. Analysis showed that use of nilotinib for patients with newly diagnosed CML as the first-line treatment and for patients with imatinib resistance or intolerability as the second-line treatment is accompanied by 36% increase of consolidated budget expenditures in 2015 compared to 2014 in theoretical consumption calculations. In terms of real consumption, use of nilotinib leads to 16% increase in consolidated budget expenditures in 2015, in comparison with 2014. Expected budget expenditure in 2015, taking into account actual consumption, is 5.8 billion RUB. The growth of state expenditure for CML treatment might be due to increase in the number of patients and the use of the second-generation TKI. In case of nilotinib use, with consideration of remission that allows therapy cancellation, the average cost of one CML patient treatment based on all lines of therapy in the registry per year will be decreased by 6% in 2018 compared to 2015, despite an increase in the number of patients in the registry. Nilotinib is characterized by greater efficiency in the both lines of therapy. Using of the second-generation TKI, including nilotinib, can lead to stable remission with possible therapy cancellation after two or three years from the moment of deep molecular response. It may lead to the stabilization of cost per patient in the registry by 2018.

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