Efanesoctocog alfa (1) – Altuvoct®

Recombinant blood coagulation factor VIII, group 1, in stage 2

• The legal consequence of the company’s decision not to submit a dossier at the relevant time is a finding that the additional benefit is not proven.
• The pharmaceutical manufacturer has not claimed any therapeutic improvement, including due to minor side effects, or pharmacological-therapeutic non-comparability.
• In its deliberations on establishing the additional benefit of Efanesoctocog alfa and on updating the fixed-amount group ‘Blood coagulation factor VIII, recombinant, Group 1’ to Level 2, that the additional benefit of Efanesoctocog alfa is deemed not proven in accordance with Section 35a(1), fifth sentence, of SGB V.
• Overall assessment
  • Consequently, in the present Stage 2 fixed-amount group classification pursuant to Section 35(1), second sentence, number 2 of SGB V, there is pharmacological and therapeutic comparability between the active ingredients to be grouped, as required by Section 35a(4) of SGB V.
  • Treatment options are not restricted and medically necessary alternative prescriptions are available.
  • The marketing authorisation under pharmaceutical law does not allow the conclusion that any of the finished drugs included has a unique therapeutic indication.

Courtesy translation only, please refer to the German original.