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Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care

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Introduction to Recombinant Activated Factor VII (rFVIIa)

Recombinant activated factor VII (rFVIIa) is approved by the FDA for use in patients with hemophilia A or B with inhibitors, acquired hemophilia, and congenital factor VII deficiency. In the United States, prevalence of hemophilia A and hemophilia B are 1:10,000 and 1:25,000, respectively. Relatively few of these individuals will ever require rFVIIa for treatment as a result of developing antibody inhibitors to the exogenous replacement coagulation factors they are given to replace the deficient factor. In most cases, patients with inhibitors cannot be desensitized to their factor replacement regimen and require rFVIIa to bypass the inhibiting antibodies and to promote clotting during bleeding crises or for surgery and related procedures.

The Stanford-UCSF Evidence-based Practice Center used the 2000–2008 data from the Perspective Comparative Database of Premier, Inc. (Charlotte, NC) to assess the in-hospital usage trends of rFVIIa. The Premier database includes information on 40 million annual hospitalizations occurring in 615 U.S. hospitals. Data from the Premier database indicated that in the past decade, off-label use of rFVIIa in the hospital has increased in many other nonhemophiliac bleeding situations that are unresponsive to conventional therapy to control excessive bleeding and reduce exposure to allogeneic blood.