OBJECTIVES: Sunitinib is an oral multi-targeted tyrosine kinase inhibitor approved globally for the first- and second-line treatment of metastatic renal cell carcinoma (mRCC). The purpose of this study was to assess the budget impact of using sunitinib as first-line therapy in urban Chinese patients from a Chinese payer perspective. METHODS: A user friendly budget impact model was constructed to compare the overall budget impact with and without sunitinib incorporated in the formulary. An up to 3-year time horizon with 6 weekly cycle treatment was used to estimate the overall budget impact for mRCC patients from a third-party payer perspective. The analysis was conducted with the following 3 comparators based on China treatment pattern included in the model: sunitinib, INF-a, and sorafenib. Epidemiology data, drug costs, adverse events information, and health care resources associated with the treatments and adverse events (AE) were obtained from the literature. Costs were expressed in 2013 prices. The analysis used Shanghai population as the base case. Budgetary impact for other large cities in China can be estimated by substituting the various city populations. RESULTS: In Shanghai, patients eligible for first line treatment were estimated at 892. If Sunitinib is added into the formulary with the current retail price, the estimated net budgetary impact for 3 years total is RMB82,369,048.84. This is equivalent to about RMB0.10 budget impact per member per month (PMPM) with significantly improved clinical efficacy. A sensitivity analysis indicated that the increased budget impact is a direct result of patients on Sunitinib treatment experienced superior Mean progression free survival time over competitors. CONCLUSIONS: The results suggested that the addition of Sunitinib in the formulary as first-line therapy for mRCC in urban China would improve patient clinical outcomes with moderate impact on the overall payer budget.