Hympavzi (marstacimab-hncq) — Medica
Hemophilia A without Factor VIII inhibitors
Initial criteria
- age ≥ 12 years
- using Hympavzi for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
- has moderately severe to severe hemophilia A as evidenced by baseline Factor VIII level ≤ 2% (without Factor VIII replacement therapy)
- EITHER (a) Factor VIII inhibitor titer testing performed within the past 30 days AND inhibitor titer < 1.0 Bethesda units/mL OR (b) has not received Factor VIII therapy in the past
- prophylactic use of Factor VIII products will be discontinued (use for breakthrough bleeding allowed)
- prescribed by or in consultation with a hemophilia specialist
Reauthorization criteria
- using Hympavzi for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
- prophylactic use of Factor VIII products will not occur while receiving Hympavzi (use for breakthrough bleeding allowed)
- prescribed by or in consultation with a hemophilia specialist
- patient experienced a beneficial response to therapy (e.g., reduction in bleeding events, severity, or spontaneous bleeds)
Approval duration
1 year