• Rolf Rossaint, Michael C Christensen, Philip Iau Tsau Choong, Kenneth D Boffard, Bruno Riou, Sandro Rizoli, Yoram Kluger, Rolf Lefering, Stephen Morris, and NovoSeven® Trauma Study Group.
• Department of Anesthesiology, University Hospital Aachen, Aachen, Germany. Rossaint@post.rwth-aachen.de.
• Eur J Trauma Emerg S. 2007 Oct 1;33(5):528-38.

PurposeThe purpose of this study was to assess the cost-effectiveness of recombinant activated factor VII (rFVIIa) as adjunctive therapy for the control of bleeding in patients with severe blunt trauma injuries in Germany. The primary outcome measure was incremental cost per quality-adjusted life-year (QALY) gained.Materials And MethodsWe developed a cost-effectiveness model based on patient-level data from a 30 day international, randomized, placebo-controlled phase II trial. The data were supplemented with secondary data from the German Trauma Register and German life tables to estimate lifetime costs and benefits. We assumed that the non-significant difference in mortality observed in the phase II trial of 5% in favor of rFVIIa could be verified in the ongoing, much larger follow-up trauma study. We adopted the perspective of third-party payers in Germany, and included all trauma-related healthcare costs.ResultsThe incremental cost per QALY gained with rFVIIa relative to placebo was e29,451. The probability that this was below e30,000 and e40,000 was 51 and 58%, respectively. The estimates were sensitive to the differences observed in mortality and the applied discount rate.ConclusionsBased on preliminary evidence from a phase II trial, we conclude that, relative to placebo, rFVIIa may be a cost-effective therapy from the thirdparty payer perspective in Germany.

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