OBJECTIVES: In the last 25 years, the number of clinical conditions Stem Cell Transplantation (SCT) is used as a therapeutic intervention has been growing remarkably. The emphasis in this study is on the management, resources and economics of bleeding associated with SCT in Germany and the United States, and the understanding of the potential economic impact of NovoSeven(r) in the management of such bleed. METHODS: A detailed literature review was undertaken on bleeds associated with SCT. Additional data were obtained from clinicians at two leading SCT centres in Germany and one in the United States. Resource utilisation, outcomes and cost data were obtained from multiple sources including the participating clinicians, local economists and personal communications. Economic modelling techniques were used to assess the potential impact of the addition of NovoSeven(r) on current management practices. RESULTS: In Germany, autologous, allogenic (family related), and allogenic (un-related) SCT cost on average €83,302, €115,954 and €172,522, respectively. The corresponding costs in the United States are: $84,583, $202,474, and $303,159. Costs in the United States are generally higher than in Europe. The additional costs of bleeds depend on bleed site and severity. In Germany the baseline costs of gastrointestinal and intracranial bleeds are €32,085 and €8,684 respectively, with the addition of NovoSeven(r) and associated reduction in the use of other health care resources costs were €32,431 and €14,057. In the USA, the costs of bleeds vary from $5,718 to $209,910. The additional cost of NovoSeven(r) may be compensated for by a reduction in the use of blood products and inpatient hospitalisation. CONCLUSIONS: Our results suggest that NovoSeven(r) might lead to cost savings in certain bleeds. However, given the limited number of bleeds managed with NovoSeven(r) in the present study these results should be interpreted with caution.