Medicine supply of patients with CML is provided by means of federal state reimbursement program (FSRP) of high-cost nosologies and by regional budgets.  Now, the reimbursement  list of high-cost drugs includes only first generation tyrosine kinase inhibitor (TKI) – imatinib. However, there is a problem with access of patients with CML to second generation TKI because regional budgets are limited. Therefore, it’s important to provide pharmacoeconomic assessment of including second generation TKI into FSRP. OBJECTIVES: To provide budget impact analysis (BIA) of including second generation TKI (nilotinib) into reimbursement list of high-cost drugs of FSRP for second line treatment of patients with CML. METHODS: BIA, as a part of this healtheconomic research was developed on the basis of decision tree and Markov model.The perspective of the study was FSRP of high-cost drugs, so direct costs for imatinib and nilotinib were considered.Real consumption of medicine was used.Tender prices of FSRP for imatinib and regional tender prices for nilotinib were used. Exchange rate 1Euro = 50Rub. RESULTS: Annual cost per patient for imatinib for the first line CML patient in chronic phase was 6336Euro, while patients in accelerated phase and the second line treatment patients needed high dose imatinib treatment that costs 12672Euro.Annual cost per patient for nilotinib was 35040Euro.Total expenditures for first line treatment of CML with imatinib and the second line treatment with nilotinib for all CML patients were 82,2  mln Euro.FSRP budget for CML in 2014 was 46 mln Euro, regional expenditures for the second line treatment with second generation TI of CML were above 44 mln Euro.Therefore, including of nilotinib into FSRP leads to budget increase, but doesn’t exceed total current expenditures for CML of 90 mln Euro. CONCLUSIONS: Inclusion of nilotinib into FSRP does not exceed total current expenditures for CML and may improve patient access for effective treatment.