OBJECTIVES The objective of the study was to develop a cost-effectiveness analysis of sorafenib associated to BSC versus BSC alone in the second line treatment of advanced renal cell carcinoma (RCC) under the Brazilian public health care system perspective. METHODS A Markov model was developed to project the lifetime costs and outcomes associated with the disease progression of patients receiving sorafenib/BSC or BSC alone. The cycle duration was three months and the corresponding transition probabilities were obtained from the TARGET study. The model considered three health states: progression free survival, disease progression and death. The outcomes were expressed as life years gained. Only direct medical costs were considered in the analysis, including drugs, physician visits, monitoring and treatment of adverse events. Unit costs for drugs were obtained from the Brazilian Health Prices Database (BPS) and procedure costs were extracted from the National Database of Ambulatory Costs (SIA/DATASUS). Costs and outcomes were discounted at an annual 5% discount rate. Main parameters were evaluated in a sensitivity analysis. RESULTS In a lifetime horizon, total costs per patient were R$48,285 for sorafenib/BSC and R$7,356 for BSC alone. Mean progression free survival for patients treated with both alternatives were 2066 years and 1243 years, respectively, resulting in an incremental cost-effectiveness ratio of R$49,751 (US$21,553) per life year gained. Varying the time horizon of the analysis increased the ICER for values above R$70,000 in time horizons below 5 years. Varying the discount rate between 0% and 10% led to ICERs between R$46.589 and R$61,302, respectively. CONCLUSIONS There's no defined threshold for the accepted ICER in Brazil. Considering international standards, the incremental cost-effectiveness ratio would be around 3 times the Brazilian per capita Gross Domestic Product. Therefore, sorafenib/BSC appears to be cost-effective in the management of advanced RCC.