OBJECTIVES: This study aimed to determine the budget impact of adding turoctocog alfa to a U.S. health plan insurer’s formulary for the treatment of hemophilia A. METHODS: A budget impact model was developed to evaluate factor replacement therapy costs, for patients with hemophilia A (without inhibitors), from the perspective of a US managed care plan.  Key model inputs included benefit plan characteristics (i.e. number of members and time frame of the model), patient characteristics (i.e. number of pediatric and adult patients; mean weight), treatment characteristics (i.e. prophylaxis, on-demand, or perioperative treatment), and disease outcomes (i.e. annual bleed rate, severity level of bleeding episode, bleed control, and major surgery).  The model compared treatment with turoctocog alfa versus marketed recombinant and plasma-derived FVIII alternatives.  For children and adults, base case weight-based dosage and frequency for prophylaxis was assumed to follow the Malmö Protocol, whereas on-demand and perioperative dosages were based on respective product package inserts.  Market share was indexed at Year 1.  All costs were based on estimated WAC drug costs (US dollars), and product information current as of January 15, 2015.  RESULTS: For a hypothetical managed care plan with 1,000,000 members, the estimated number of hemophilia A patients was 39, based on US prevalence data.  Assuming proportional adoption of turoctocog alfa from all branded rFVIII and plasma-derived FVIII, total annual treatment costs were $10,133,595 without turoctocog alfa and $10,138,671 with turoctocog alfa, resulting in a budget impact of $5,076 or $0.00042 per member per month (PMPM).  Results were sensitive to prevalence of hemophilia A, drug cost, proportion of patients on prophylaxis, and proportion of major bleeding episodes for patients treated on-demand, based on one-way sensitivity analyses. CONCLUSIONS: Inclusion of turoctocog alfa on a formulary provides a budget neutral treatment option, having a negligible budget impact on the annual pharmacy budget.