OBJECTIVES: Type 1 Diabetes Mellitus (T1DM) is an endocrine autoimmune disease with onset usually in childhood and which, being chronic, affects people of working age. It affects approximately 0.3% of the population and has high personal and social impact. The National Committee for Incorporation of Technologies in Health System (CONITEC) is responsible for recommending the inclusion or not of technologies in Brazilian public health system and has drawn up a budget impact analysis (BIA) of insulin analogues for the treatment of T1DM for help the decision making. METHODS: A BIA of insulin analogues in SUS compared to human insulin (NPH and Regular) was performed. The analysis’ time horizon was 5 years, using a diabetes prevalence of 7.6% and 5% of T1DM between them (602,742), considering an annual growth rate of 0.8143% and a market share of 20%, 30%, 40%, 50% and 100%. The mean total insulin dose considered was 0.75IU/kg/day, with an average personal weight of 70kg, which means 52.5IU/day, 50% of each insulin type (basal and rapid). Unit purchase prices of insulins were obtained in the health system prices database and calculated the weighted average. For human insulins, were considered the values of last purchase of the Ministry of Health. RESULTS: The budget impact of basal analogues would be R$202.8 million in the 1st year, considering 20% of target population, reaching approximately R$1 billion in 100% of patients. For rapid analogues, the budget impact would be R$62.9 million in the 1st year, reaching R$324.9 million in 100% of patients. CONCLUSIONS: This BIA will be essential to support CONITEC’s decision about insulin analogues for T1DM patients in Brazil. Treatment costs still impressive, considering that analogues’ values reach 10 times the unit values of human insulins, fact that did not happen in other countries where they are already covered.