OBJECTIVES: The objective of this study was to assess the economic impact of everolimus with reduced-dose CsA in de novo renal transplant recipients in the Hungarian healthcare setting. METHODS: Analyses of the trial RADB201 found that total direct medical costs (costs without everolimus, CsA and MMF) are mostly dependent on key clinical events, i.e., number of days on dialysis (hemo- and peritoneal), inpatient length of stay (LOS) due to adverse events (AE) or infection (INF), and episodes of biopsy proven acute rejection (BPAR). A multivariate regression model was applied on the RADB-201 database to predict total direct medical costs based on these clinical events. The obtained coefficients, adjusted for patient characteristics, were applied to the clinical data of the RADA-2306 trial, hence predicting the economic consequences of the reduced CsA dose . We applied Hungarian unit costs to the entire clinical database. The time horizon of the analysis was one year. RESULTS: The model predicted that the incremental cost for one day on hemodialysis and peritoneal dialysis was HF 134,617 and HF 50,149 ,one day of hospitalization due to AE and INF was HF 41,685 and HF 45,231 and the one BPAR event reached HF 523,907, all these parameters with p<0.001. Compared to MMF, reduced-dose of CsA with everolimus decreased the one-year total direct medical cost due to major clinical events by HF 1,373,254 and HF 1,387,057 for everolimus 1.5 mg and 3.0 mg, respectively (see table) . Adjusted for patient characteristics, the cost savings become HF 940,380 for everolimus 1.5 mg and HF 838,570 for everolimus 3.0 mg. CONCLUSION: The use of reduced-dose CsA with everolimus 1.5mg in de novo kidney transplant recipients improves transplant outcomes and reduces one-year total direct medical cost compared to an MMF based strategy.