OBJECTIVES: The aim of this study was to estimate cost/utility of infliximab for treatment of Chron’s disease in Serbia and to calculate impact on national health budget if it is used according to evidence-based guidance for treatment of inflammatory bowel diseases. METHODS: Cost/utility of biological therapy of Chron’s disease (infliximab in the first line, adalimumab for the patients unresponsive to infliximab) vs. azathioprine was estimated by Markov model written in Excel 2007. The model has 9 health states, with 30 two-month cycles. The model was populated from the perspective of Serbian society, taking into account both direct and indirect costs expressed in Serbian dinars (1 Euro = 120 RSD). Both costs and quality-adjusted life years (QALYs) were discounted at uniform rate of 3%. The model outputs were generated by Monte Carlo microsimulation, and further used for budget impact analysis. Conclusions of the model were challenged by probabilistic sensitivity analysis. RESULTS: Biological therapy was cost effective in comparison with standard therapy, with ICER value of 2,091,348.98 ± 1,156,213.78 RSD per QALY gained (99% CI), and Neto monetary benefit of 90,183.84 ± 135,055.30 RSD (99% CI). About 62% of virtual patients generated by the model simulation were below the willingness of pay of 3 GDP per capita per QALY gained. Price of infliximab was the most influential variable on Neto monetary benefit in the sensitivity analysis. If infliximab and adalimumab are 100% reimbursed by Serbian health insurance fund for 3,927 patients with Chron’s disease in Serbia who need biological therapy, additional annual burden on health budget in Serbia would be 180,248,853.03 ± 333,531,117.81 RSD (99% CI), or about 0.29% of total drug budget. CONCLUSIONS: Biological therapy of Chron’s disease in Serbia is cost/effective option, which would impose moderate burden on national health budget after full implementation according to recommendations of evidence-based international guidelines for treatment of inflammatory bowel diseases.