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

Slide: 9 of 36

Framework for Analyzing Outcomes of Off-Label rFVIIa Use in the Hospital Setting

This slide delineates the analytic framework for evaluating the off-label use of rFVIIa for the CER titled Comparative Effectiveness of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care. The figure represents the trajectory of a patient who receives rFVIIa at some point during inpatient medical care. The first possible time of drug administration is in the case of prophylactic use (to limit blood loss) during a potentially bloody surgery, such as liver transplantation or cardiac surgery. The second possible time of drug administration is in the case of treatment use, which occurs as an attempt to arrest ongoing bleeding and is employed in numerous clinical scenarios, including intracranial hemorrhage and trauma. The final possible time of drug administration is in the case of end-stage use, as a last-ditch effort to salvage a patient who is dying from massive hemorrhage. Repeat doses of rFVIIa are possible during any of the above applications. Thick horizontal arrows near the top of the figure represent the overlap between the clinical questions addressed in the CER and the different types of rFVIIa use described above. For example, the bar representing the overall use of rFVIIa spans the entire range of potential uses—prophylaxis, treatment, and end-stage—whereas the bar representing the off-label indication of intracranial hemorrhage encompasses only treatment use.