Alhemo (concizumab-mtci) — Medica
Hemophilia A with Factor VIII inhibitors
Initial criteria
- age ≥ 12 years
- using Alhemo for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
- Factor VIII inhibitor titer testing performed within the past 30 days AND has a positive test ≥ 0.6 Bethesda units/mL
- prophylactic use of bypassing agents will be discontinued (use for breakthrough bleeding permitted)
- not undergoing immune tolerance induction therapy
- prescribed by or in consultation with a hemophilia specialist
Reauthorization criteria
- using Alhemo for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
- prophylactic use of bypassing agents will not occur while receiving Alhemo (use for breakthrough bleeding permitted)
- not undergoing immune tolerance induction therapy
- experienced a beneficial response to therapy (e.g., reduction in bleeding events, severity, or spontaneous bleeds)
- prescribed by or in consultation with a hemophilia specialist
Approval duration
1 year