OBJECTIVES:  To evaluate the budget impact of axitinib, an oral angiogenesis inhibitor, in the second line treatment of metastatic renal cell carcinoma (mRCC) in the Brazilian private health system. METHODS:  A budget-impact model comparing a world with vs world without axitinib [sorafenib, everolimus, sunitinib, temsirolimus, pazopanib or best supportive care (BSC)], was calculated based on published data on incidence estimate of RCC (0,009%) and assumptions from estimate of new diagnosed cases of non-metastatic RCC (81%) [A], diagnosed non-metastatic RCC cases in progress to mRCC (40%) [A x 40% =B], new diagnosed cases of mRCC (19%) [Population estimate of RCC x 19%=C], mRCC cases receiving 1st line therapy (74%) [B+C=D] and eligible cases of 2nd line therapy (52%) [52% x D=population eligible for the analysis]. The Analysis was performed in a three year time horizon, from perspective of the Brazilian private health system, and included only direct costs of medicines. The estimates were applied considering a health plan with 2 million lives (based on average of top 10 largest Brazilian Private Health Plans). Medicines cost data were taken from MoH’s price in November 20163. RESULTS:  The total number of patients with RCC was 170 while the number of mRCC patients in 2nd line therapy was 34. Costs of treatment with axitinib were BRL 4,714,490, BRL 4,734,597 and BRL 4,877,913 in years 1, 2 and 3 versus BRL 4,475,391, BRL 4,047,948 and BRL 3,950,505 without axitinib, respectively. Over a three year time horizon, the incremental budget impact was BRL 1,853,156 (15% of RCC patients) or BRL 0.31 per member per year from total lives of the Brazilian Private Health Plan. CONCLUSIONS:  Axitinib is a targeted anticancer agent to mRCC treatment in 2nd line. Considering only the costs of drug acquisition, the treatment with axitinib were associated with low budget impact to the Brazilian Private Health System