OBJECTIVES: To perform a cost-utility (CUA) and budget impact analysis (BIA) of oral dimethyl fumarate (DMF) in the Brazil’s Unified Health System (SUS).  METHODS: A Markov model was developed to simulate costs and outcomes of relapsing-remitting multiple sclerosis (RRMS) patients. Mutually exclusive health states were based on the Expanded Disability Status Scale (EDSS) score. Patients were initially distributed through EDSS states from 0-5 and could progress and/or relapse on yearly cycles. Treatment sequences were set in accordance with current local guidelines, starting with first-line interferon-beta 1a 22 mcg, 44 mcg or 30 mcg (IFN22, IFN44, IFN30), interferon-beta 1b 300 mcg (IFN300), glatiramer acetate (GLA) or DMF followed by second-line therapies natalizumab (NTZ) or fingolimod (FIN). Costs were obtained from SUS reimbursement lists and efficacy, safety/discontinuation parameters from a published literature systematic review. Results were expressed as incremental cost-utility ratios (ICUR). BIA was based on drug acquisition costs. Eligible population and current market-share distribution were estimated based on a public claims database (SIA/SUS). BIA’s results were presented on 3 different scenarios based on DMF market-share evolution after incorporation (low, moderate and high market penetration). RESULTS: DMF initiating sequences ending in NTZ and FIN, respectively, showed ICURs ranging from R$17,680 (US$4,568) to R$153,153 (US$39,575) and R$19,134 (US$4,947) to R$144,510 (US$37,341), respectively in comparison to other first-line options. Regarding effectiveness, DMF showed approximately 6.6 quality-adjusted life years (QALYs) compared to 6.1 (IFN22), 6.2 (IFN44), 6.2 (IFN30), 6.5 (IFN300) and 6.4 (GLA) QALYs. BIA results showed incremental cumulative costs ranging from R$2.1 to R$6.3 million (low and high market penetration scenarios, respectively) on a 5-year time horizon. CONCLUSIONS: DMF improves quality of life and is cost-effective under the Brazilian SUS perspective when compared to most of its comparators. Budget increments can be considered small (1-4%) in relation to current total MS drug expenditure in Brazil.