Turoctocog alfa (1) – NovoEight®

• Clinical trials
  • The pharmaceutical manufacturer has selected the recombinant blood clotting factor Octocog alfa as one of the alternatives designated by the G-BA as an appropriate comparator therapy.
  • However, this has no implications for the assessment, as the pharmaceutical manufacturer has not identified or submitted any relevant data suitable for assessing the additional benefit of Turoctocog alfa compared with the appropriate comparator therapy.

Haemophilia patients requiring factor VIII replacement

• There is no additional benefit compared with the appropriate comparator therapy for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
• The G-BA considers the data presented in the dossier to be unsuitable for demonstrating additional benefit.
• There are therefore no comparative data available on patient-relevant endpoints.
• The additional benefit compared with the appropriate comparator therapy is therefore not proven.
• Overall assessment
  • The G-BA considers that, taken as a whole, the considerations set out are not sufficient to allow conclusions to be drawn regarding patient-relevant effects—in terms of the benefits and harms of turoctocog alfa—compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.