OBJECTIVES: The HIV and HCV epidemics of the 1980's and 1990's highlighted the vulnerability of hemophilia patients to the transmission of unknown blood-borne infections. Consequently, the pharmaceutical industry has been charged with developing recombinant concentrates with the least amount of human or animal proteins in order to reduce the chance of infection by emerging blood-borne infectious agents (e.g., viruses, prions/nvCJD). In response, Antihemophilic Factor (recombinant), Plasma/Albumin-Free Method (rAHF-PFM), was developed as an alternative treatment option for patients with hemophilia A. However, there is concern that this new technology contributes significant cost to the health care of these patients. This model was developed to delineate the economic impact of rAHF-PFM on a health care plan’s budget. METHODS: Payer perspective is utilized for the analysis under a one-year time horizon. The economic impact of the introduction of rAHF-PFM was determined using average wholesale price. Estimates of hemophilia A prevalence, factor VIII utilization, treatment regimens, and clinical outcomes were derived from published literature. Migration from previous therapies (i.e., Helixate, Kogenate, Recombinate, ReFacto, pdFVIII) to rAHF-PFM (17% of patients) was based on equivalent market shares. Numerous sensitivity analyses were performed to demonstrate the robustness of the findings. RESULTS: In a 1,000,000 member plan, following introduction of rAHF-PFM, with 82.5% on-demand use (30 IU/kg/bleed with 16.8 bleeds/year) and 17.5% prophylactic use (60 IU/kg/week with 6.6 bleeds/year), it is estimated that overall annual factor VIII treatment cost is $3,835,191, an annual increase of $39,268 ($0.003 per member per month increase). CONCLUSIONS: While there is heightened concern regarding the potential budget impact of new technologies in health care, this model demonstrates that rAHF-PFM can be provided to patients with relatively modest impact on a health care plan’s budget.