OBJECTIVES: To estimate the budget impact of saxagliptin/metformin XR fixed-dose combination introduction as a treatment option for patients with type 2 diabetes mellitus (T2DM), compared to the present situation, in Chile. METHODS: An MS Excel-based budget impact model assuming coverage for one million people. The time horizon was three years and the analysis perspective was the National health Insurance system in Chile (FONASA). Prevalence information was obtained from published literature. Pharmaceutical expenses of oral anti-diabetic agents were analyzed excluding other medical costs. The cost of oral anti-diabetic agents was based upon list prices adjusted to co-payments, expressed in Chilean pesos 2012 (exchange rate 1US$ = 487.8 CH$). The market share of the different drugs was based upon QUALIDIAB Database, market studies and data provided by Bristol Myers Squibb. The budget impact is reported in terms of annual budget impact, per-member per-month (PMPM) and per-patient per-month (PPPM). A Monte Carlo simulation (10,000 iterations) was done as part of the sensitivity analysis. RESULTS: The net budget impact estimated for the introduction of saxagliptin/metformin XR combined was $2,772,663 for the first year, $25,680,312 for the second year and $81,609,192 for the third year; the cumulative net budget impact was $110,062,166. PMPM was $0.23, $2.14 and $6.8 for the first, second and third year respectively. PPPM was $9.2, $85.0 and $270.3 each year, respectively. The cumulative impact in the total annual budget for oral anti-diabetic agents represented an increase of 1.6%. Monte Carlo simulation showed that cumulative budget impact varied from 1.1 to 1.8%. CONCLUSIONS: This study showed that the introduction of saxagliptin/metformin XR combined, as a treatment option for patients with T2DM, into the national health insurance system of Chile (FONASA) would have a minimal budgetary impact.