OBJECTIVES: Intracerebral hemorrhage (ICH) is among the most costly and debilitating forms of stroke. Results from a recent Phase IIb clinical trial demonstrate that administration of recombinant activated factor VII (rFVIIa) reduces ICH mortality and improves functional outcome. The objective is to examine the health plan budget impact of introducing rFVIIa as a novel treatment for ICH. METHODS: A decision-analytic model was adapted to estimate the budget impact of introducing rFVIIa (40, 80, or 160 µg per kilogram) for treatment of ICH, from a US managed care perspective. The patient population was similar to that of the Phase IIb clinical trial. Model structure and inputs were obtained from published literature, clinical trial data, managed care claims databases, and expert opinion. All costs are presented in 2005 US dollars. Costs and outcomes were discounted at 3 percent annually. Univariate sensitivity analyses were conducted to assess model robustness. RESULTS: Assuming a health plan of 1,000,000 members and an initial 30% uptake of rFVIIa, the annual health plan cost is expected to increase by between $38,868 and $279,057, or between $0.003 and $0.023 per-member per-month, depending on dose of rFVIIa used. Assuming use of rFVIIa 80 µg/kg dose and an absolute 5% increase in uptake each year (i.e., 55% patients receiving rFVIIa 80 µg/kg 5 years post introduction), the change in a health plan's annual cost is expected to be -$65,778 (cost savings) compared to the current year's budget at 5 years after rFVIIa introduction. CONCLUSIONS: Treating eligible patients with rFVIIa improves survival and functional outcome. Impact to a health plan's budget is modest in the first year after introduction to market. In addition, due to expected improvements in health outcomes, a decrease in budget impact may be observed using rFVIIa 80 µg/kg as early as 3 years post introduction.