OBJECTIVES: To estimate the incremental budget impact of reimbursing efmoroctocog alfa as a therapy for children and adults with haemophilia A (HA) in Italy. METHODS: The model has been developed as a Microsoft Excel^®macro-enabled workbook and two scenarios were compared: the current environment (CE), which represents the marketplace with the available conventional recombinant products (FVIIIs) for the time period of interest, and the new environment (NE), which assumes that efmoroctocog alfa is reimbursed during the same time period. The target population size was calculated using published epidemiological national data. The analysis was performed over a 3-years time horizon from the Italian National Healthcare System (INHS) perspective. Univariate one-way sensitivity analyses and scenario analyses were performed. RESULTS: Considering a cumulative population size of 2,593 HA patients over the three years period, the total costs in the CE were estimated to be € 555,277,691, whereas costs in the NE ranged from € 535,091,489 to € 548,703,432 at the efmoroctocog price of € 0.65/IU and € 0.79/IU respectively, suggesting potential savings to the INHS between 3.6% to 1.2%The one-way sensitivity analyses results showed potential savings for most of the 7 key parameters with the exception of the illustrative scenario where efmoroctocog alfa dose per injection was increased by 50% and the price set to € 0.79/IU while decreasing conventional FVIIIs average price to € 0.55/IU. CONCLUSIONS: This is the first analysis conducted to estimate the impact on the Italian healthcare budget of including efmoroctocog alfa as a treatment option for patients with HA. The results suggest potential saving between 3.6% to 1.2 % over a 3-years period.