OBJECTIVES: Renal cell carcinoma (RCC) accounts for approximately 2% of all cancers worldwide. Many patients present with advanced or unresectable disease, and up to 30% of patients treated by nephrectomy for localized disease will relapse. Improved care for patients with metastatic RCC (mRCC), including targeted therapies have improved prognosis but have also increased drug costs. In this study, we set out to study costs and outcomes in mRCC treatment using national registries comprising all patients diagnosed with RCC in Sweden. METHODS: Two cohorts of patients diagnosed with mRCC 2002-2005 and 2006-2008, representing patients diagnosed pre- and post-TKI introduction respectively, were identified in the national Swedish Cancer Registry. A pre-defined algorithm was used to determine the presence of mRCC. Through record linkage with the national registries for drug prescriptions, hospital care, and causes of death, data on resource utilization and survival was obtained. The Kaplan-Meier method was used to estimate survival, using an exponential model to calculate the mean for 4.5 years - beyond the end of the observation period. Costs were estimated in 2010 SEK (1 SEK = USD ($) 0.14), using the Lin method to account for censoring. Sensitivity analysis was done to better incorporate the cost of hospital dispensed drugs. RESULTS: Patients diagnosed post-TKI introduction (n=1,217) had longer survival (median 1.08 compared to 0.79 years, restricted mean 1.73 compared to 1.55, both p <0.001) compared to patients diagnosed pre-TKI introduction (n=1,536). Costs were higher for patients more recently diagnosed: $52,601 versus $40,970. Pharmaceutical costs were $12,418 higher in the post period but where slightly offset by lower inpatient care costs. The cost per life-year gained (LYG) amounted to $64,616. CONCLUSIONS: The study suggests that mRCC survival has improved in recent years while costs have increased, resulting in a fairly modest cost per LYG in a Swedish setting.