The aim of the present report is to assess the added benefit of turoctocog alfa compared with the appropriate comparator therapy (ACT) in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
The Federal Joint Committee (G-BA) specified the ACT for the therapeutic indication as follows:
recombinant or human plasma-derived coagulation factor VIII products
The company chose the recombinant coagulation factor octocog alfa as one of the options specified as ACT by the G-BA, but limited its selection to a third-generation octocog alfa (Advate). This approach was not accepted. According to the G-BA’s specification, all products containing the drug octocog alfa would have to be considered. The ACT specified by the G-BA is therefore used for the assessment.
The assessment was conducted based on patient-relevant outcomes.
Keywords: turoctocog alfa; recombinant factor VIII N8; hemophilia A; Benefit assessment.
Copyright © 2014 by the Institute for Quality and Efficiency in Healthcare (IQWiG).