Added benefit for SOBI's Elocta not proven, says IQWiG

The German Institute for Quality and Efficiency in Health Care (IQWiG) has completed its examination of Swedish Orphan Biovitrum’s (STO: SOBI) Elocta (efmoroctocog alfa), assessing whether this new drug offers an added benefit over the appropriate comparator therapy both in prevention and in on-demand treatment for people with hemophilia A.

Such an added benefit cannot be derived from the dossier, however, because it contained no study data adequate for the research question, the IQWiG stated.

According to the Federal Joint Committee (G-BA), the new drug was to be compared with a recombinant or human plasma-derived coagulation factor VIII drug as appropriate comparator therapy. The drug manufacturer presented no data for such a direct comparison, however.