OBJECTIVES: To estimate the cost-effectiveness of nilotinib compared to imatinib as first-line (FL) treatment for newly diagnosed patients with Ph+ CML-CP. METHODS: A literature-based Markov model was developed to estimate the costs of Ph+ CML-CP patients initiating therapy with nilotinib or imatinib. Direct expenses associated with Ph+ CML-CP and resulting follow-up costs were calculated using general tariff agreement of Russian obligatory insurance system and official national statistics.  For reference, accepted exchange rate was 1 EUR = 40 RUB. RESULTS: Compared to FL imatinib, FL nilotinib results in increases in discounted FL drug therapy costs: 17 283 587 RUB (432 090 EUR) in imatinib group and 19 826 435 RUB (495 661 EUR) in nilotinib group per patient for life expectancy (17.3 and 18.82 respectively). The discounted incremental cost/LYG and cost/QALY are estimated at 1 672 926 RUB (41 823 EUR) and 1 829 387 RUB (45 735 EUR), respectively. CONCLUSIONS: The results of cost-effectiveness illustrate that FL nilotinib is acceptable in Russian patients with Ph+ CML-CP who are initiating tyrosine kinase inhibitors therapy and has to be recommended as first-line (FL) treatment for newly diagnosed patients with Ph+ CML-CP.