Authors' recommendations: Based on the available evidence, there is no clearly demonstrated benefit or harm from using rFVIIa relative to usual care in uncontrolled bleeding due to blunt or penetrating trauma, surgery that is unrelated to trauma, gastrointestinal bleeding, or ICH in individuals without hemophilia, inherited platelet disorders, or other coagulopathies. Dose-response relationships for the safety and efficacy of rFVIIa were inconsistent.The results of our Canadian model indicate that the economic impact of this intervention is uncertain because of the current clinical data. The potential cost-effectiveness of rFVIIa in severe blunt trauma can only be confirmed with further research. Forthcoming, but limited, phase 3 trial data of rFVIIa in severe bleeding trauma are unlikely to increase the probability of costeffectiveness that was estimated in our model, although they may add to our knowledge about efficacy. Decisions regarding reimbursement that are based on current clinical and economic findings would have a high degree of uncertainty. The value of information analysis suggests that additional clinical research may be a good investment for reducing uncertainty. The routine use of rFVIIa in severe blunt trauma could lead to substantial potential costs to Canadian Blood Services.

Project Status: Completed

URL for project: http://www.cadth.ca/media/pdf/H0457A_Recombinant_Activated_Factor_VII_Hemorrhage_Hemophilia_tr_e.pdf

Year Published: 2009

URL for published report: http://www.cadth.ca/index.php/en/hta/reports-publications/search/publication/904

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Canadian Agency for Drugs and Technologies in Health

Contact Address: 600-865 Carling Avenue, Ottawa, ON K1S 5S8 Canada. Tel: +1 613 226 2553; Fax: +1 613 226 5392;

Contact Name: requests@cadth.ca

Contact Email: requests@cadth.ca

Copyright: Canadian Agency for Drugs and Technologies in Health (CADTH)