OBJECTIVES: In Romania the estimated incidence of metastatic renal cancer (mRCC) is about 1500 cases; less than 400 patients receive full reimbursement for their therapy. Our objective was to assess the cost-effectiveness of Sunitinib (SU) in the first-line treatment of mRCC patients in comparison with Bevacizumab (BEV) + IFN- and Sorafenib (SO) -at the level of 2011 year- based on the latest clinical evidence. METHODS: A Markov model (comprised of four states: 1st line treatment, 2nd line, Best Supportive Care and Death) was validated in several countries and was adapted for the Romanian jurisdiction. The model was set to 6 weekly cycles for a period of 10 years, which corresponds with a lifetime length scenario. Costs for medication and application were derived from hospital databases, expert panels and structured interviews. Experts that managed more than 60% of all local mRCC were consulted. These experts identified several scenarios related to outpatient and inpatient treatment decisions predominantly based on social reasons; all these scenarios have been tested. A WHO methodology was used to set a threshold of price per QALY (3 x local GDP)  RESULTS: Cost per cycle in 1st line was lower than both 2nd line and BSC – consistent with other international findings. Neutropenia, proteinuria and heart failure have been identified as the most costly adverse events. The QALYs for SU was 1.86 compared to BEV 1.7 and SO 1.69. Incremental cost per QALY SU vs. SO was 14.000 EURO and, respectively, -141.000 EURO vs. BEV. CONCLUSIONS: Sutent is cost effective vs. SO and dominant to BEV in the treatment of mRCC in the study settings. The model was very sensible to price of medication and cost of BSC.