OBJECTIVES: To analyze the budget impact of the use of nilotinib in first and second line chronic myeloid leukemia (CML), compared with imatinib and dasatinib, from the perspective of a third party payer in Colombia. METHODS: A Markov model was developed with a 5-year time horizon simulating first and second line treatment of CML patients, with treatment options including nilotinib, imatinib and dasatinib. 2013 incidence and prevalence figures were estimated from international data. Base case market share for each compound was obtained from public national medicines registry (Sismed) for the years 2012 – 2013. Resource utilization and costs of medicines, health care services and adverse events were estimated according to clinical trials data and local health care provider databases. The analysis estimated up to 80% market share for nilotinib in both lines. A univariate sensitivity analysis was developed to identify the effect of individual parameter variation on final results. RESULTS: Nilotinib inclusion as a first and second line treatment option for CML patients resulted in a cumulative impact of COP $14.961 million over 5 years, corresponding to a 0.056% per capita premium (UPC) in the Colombian care health system. Year to year, the impact was calculated from COP $1,168 million to COP $6,588 million on the fifth year. The sensitivity analysis showed the costs of technologies, health care services and disease progression as the most relevant variables. CONCLUSIONS: The budget impact analysis showed that increasing the use of nilotinib both in first and second line treatment of CML patients poses a minimal impact on the Colombian health care system, within parameters similar to those used in 2012 for the inclusion of technologies in the benefit plan. Additional benefits in lower progression rates and potential increased survival may favor this technology to be reimbursed within the premium (UPC) in Colombia.