OBJECTIVES: Sorafenib and sunitinib are approved for patients with advanced or metastatic renal cell carcinoma after INF-a or IL-2 therapy failure or intolerance, with PS 0-1 and without CNS metastasis in defined cancer centers in the Czech Republic; sunitinib is reimbursed for first-line therapy in mRCC patients of good or intermediate risk. METHODS: We assessed the cost of sunitinib and sorafenib in patients treated in comprehensive cancer center and prepared cost-effectiveness analysis (CEA) to compare our data to CEA submitted by manufacturers to Czech authority (SUKL=State Institute for Drug Control) in reimbursement proceedings between 2008-2010. (1€=26CZK) RESULTS: CEA of sunitinib submitted to SUKL was based on cost of pharmacotherapy and clinical data of Motzer et al. study (NEJM 2007; time to PD: sunitinib 11 months, INF-a 5 months; duration of PD to death 6 months). Cost per progression-free year (PFY) was 324144CZK/12467€ in manufacturer’s analysis, CZK867,946CZK/€33,383 in SUKL analysis (after INF-a cost reduction and costs after PD removal) and CZK2,304,914/€88,651 in our analysis (cost and effects of sunitinib based on our results; INF-a data were assumed identically). CEA of sorafenib was performed for patients after cytokine intolerance or failure (Escudier et al.; NEJM 2007) in comparison with sunitinib (70% pts) or BSC (30% pts). The cost per PFY was CZK965,726/€37,143 in manufacturer’s analysis. Although sorafenib was cheaper alternative according to our results, time to progression was shortened by 18 days (ICER CZK516,820/€1,9878 per PFY). CONCLUSIONS: The cost per PFY in sunitinib was seven-times lower in manufacturer’s analysis than in CEA based on real data from cancer centre. We assume that this was mainly caused by shorter time of pharmacotherapy in original study (6 vs. 11 months in our data). CEA of sorafenib demonstrated lower costs and effects in our analysis, because the significance of comparator (70% pts sunitinib) was underestimated in manufacturer’s analysis.