Volume 10 Supplement 1

26th International Symposium on Intensive Care and Emergency Medicine

Open Access

Cost-effectiveness analysis of recombinant activated factor VII as adjunctive therapy for bleeding control in severely injured trauma patients in Germany

  • R Rossaint1,
  • P Choong2,
  • K Boffard3,
  • B Riou4,
  • S Rizoli5,
  • Y Kluger6,
  • M Christensen7,
  • R Lefering8 and
  • S Morris9
Critical Care200610(Suppl 1):P169

DOI: 10.1186/cc4516

Published: 21 March 2006


Uncontrollable bleeding is a leading cause of death in trauma patients and a major cause of preventable morbidity and mortality. Recombinant activated factor VII (rFVIIa) has been shown to decrease the need for red blood cell transfusion among severely injured blunt trauma patients. A significant difference in the incidence of acute respiratory distress syndrome was also observed relative to standard care together with a nonsignificant difference in mortality. While safety and efficacy of rFVIIa in trauma patients has been demonstrated, little is known about its cost-effectiveness.


The cost-effectiveness of rFVIIa relative to standard care was measured using patient-level data on survival and treatment patterns collected prospectively in a multicenter, international, trial, and outcomes data in the German Trauma Registry on patients matching key inclusion/exclusion criteria in the trial. Differences in survival observed at the end of trial and differences in healthcare cost were projected to a lifetime for each patient to produce an estimate of costs per life-year gained with rFVIIa. Analyses were conducted from the German third-party payer perspective, limited to healthcare costs and using a discount rate of 5%. The assessment considered adults with severe blunt trauma injury who had received 8 U RBC prior to random assignment to either three intravenous injections of rFVIIa (200, 100, and 100 μg/kg) or three placebo injections.


Projected to a lifetime, the mean cost per treated patient was €86,085 for rFVIIa and €65,875 for placebo, while life-years gained (LYG) were 13.17 and 12.22, respectively. The incremental cost of €21,210 and effect of 0.944 resulted in incremental costs per LYG of €21,410 for rFVIIa. Adjusting for quality of life (QoL) in residual life-years produced incremental quality-adjusted survival of 0.763 years and incremental costs per QALY gained of €26,502. Using a conservative threshold of €30,000 for cost-effective healthcare technologies, results appeared most sensitive to assumptions about residual life expectancy and QoL.


rFVIIa is a cost-effective adjunctive therapy for control of bleeding in patients with severe blunt trauma injuries when compared with standard care in Germany.

Authors’ Affiliations

University Hospital, Aachen, Germany, University Hospital
National University Hospital
Johannesburg University, Johannesburg, South Africa, Johannesburg University,
C.H.U. Pitié Salpétrière, Paris, France, C.H.U. Pitié Salpétrière
Sunnybrooke Womens College Health Sciences Center, Toronto, Ontario, Canada, Sunnybrooke Womens College Health Sciences Center
Soursky Medical Centre, Tel-Aviv, Israel, Soursky Medical Centre
Novo Nordisk A/S, Bagsvaerd, Denmark, Novo Nordisk A/S
University of Cologne, Germany, University of Cologne
Imperial College London, UK, Imperial College London


© BioMed Central Ltd 2006