OBJECTIVES: Melanoma accounts for less than 5% of skin cancers, but is responsible for 90% of skin cancer-related deaths worldwide. According to Brazilian Institute of Cancer 2012 statistics, it was estimated 6,230 cases of melanoma. BRAF mutations occur in approximately 50% of cases, being associated with poorer patient prognosis in advanced melanoma. Historically, there have been limited treatment options for advanced melanoma, resulting in a critical unmet clinical need for more effective therapies. Vemurafenib is a novel targeted therapy, effective for BRAF-V600 mutation-positive unresectable or metastatic melanoma treatment, orally administrated and available in Brazilian market since 2012. Therefore, the aim of this study was estimate the economic impact of vemurafenib reimbursement in Brazilian Private Healthcare System Budget. METHODS: Based on an epidemiologic approach, the potential number of patients for vemurafenib was estimated. Only the private market was considered, accounting for 40% of all patients and only drug costs were evaluated. The ex-factory price and labeled dose of 960mg b.i.d. were used. Average therapy duration of 6 months was assumed. Costs were reported in Brazilian Reais (BRL1.00~USD0.48 Dec. 2012). A total health assistance budget of BRL67.9 billion was considered, according to Brazilian National Agency for Supplementary Health data from 2012. RESULTS: A total of 756 cases of advanced melanoma are expected in 2013 in the private system, corresponding potentially to 378 patients harboring BRAF-V600E mutation. Treating all potential patients with vemurafenib would yield a total drug cost of BRL59.101.395, corresponding to a potential budget impact of 0.087%, considering health assistance budget. Cost savings owing to oral administration was not considered. CONCLUSIONS: By identifying the patients with BRAF-V600E mutation, therapy can be targeted to those who present a higher chance to respond to treatment, resulting in a potential low impact of vemurafenib in private healthcare system budget, mainly because of its very selected and specific eligible population.