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.