Alhemo (concizumab-mtci) — Medica

Hemophilia A without Factor VIII inhibitors

Initial criteria

age ≥ 12 years
using Alhemo for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
moderately severe to severe hemophilia A with baseline Factor VIII level ≤ 2%
EITHER (Factor VIII inhibitor titer testing performed within 30 days AND no positive test ≥ 1.0 Bethesda units/mL) OR (no prior Factor VIII therapy)
prophylactic use of Factor VIII products will be discontinued before the initial Alhemo dose (use for breakthrough bleeding permitted)
prescribed by or in consultation with a hemophilia specialist

using Alhemo for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
prophylactic use of Factor VIII products will not occur while receiving Alhemo (use for breakthrough bleeding permitted)
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

1 year