Economic impact of recombinant activated factor VII in the control of bleeds associated with abdominal prostatectomy

Summary

Trans-abdominal prostatectomy—often the treatment of choice for otherwise healthy patients with clinically localised prostate cancer—is associated with considerable bleeding. This can result in the need for blood transfusion. However, the increasing cost of blood, safety fears, and the pressure on available blood stock are leading to efforts to reduce or eliminate blood transfusion, where possible, in elective surgery settings.

The objective of this study was to explore the economic impact of a recent double-blind placebo-controlled dose-escalating, randomised clinical trial, which showed that a single injection of recombinant factor VIIa (rFVIIa; NovoSeven®) could reduce perioperative blood loss and eliminate the need for transfusion in patients undergoing abdominal prostatectomy.

NovoSeven® is a registered trademark of Novo Nordisk, Copenhagen, Denmark.

We modelled the clinical outcomes of the three patient groups in the original trial and applied unit costs from the Netherlands (where the trial took place) to the mean resource use associated with the treatment groups. The mean cost of abdominal prostatectomy for the placebo group, a lower dose rFVIIa group (20 ug/kg) and a higher dose rFVIIa group (40 ug/kg) was €9,602 (US$11,527), €9,958 (US$11,954) and €9,522 (US$11,430), respectively. The model was sensitive to the number of packed cells for the placebo group, unit cost of packed cells and the unit cost of rFVIIa.

Our study concludes that, compared with placebo, the use of rFVIIa at 40 ug/kg as a haemostatic agent in abdominal prostatectomy lowers overall treatment costs and reduces surgery time by conferring transfusion freedom. The potential for such clinical and economic outcomes in other surgical settings should be explored in more extensive studies.

Keywords: :

• prostatectomy
• rFVIIa
• NovoSeven®
• economics
• resource use
• Netherlands