Hympavzi (marstacimab-hncq) — Medica
Hemophilia B without Factor IX 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 B as evidenced by baseline Factor IX level ≤ 2% (without Factor IX replacement therapy)
- EITHER (a) Factor IX inhibitor titer testing performed within the past 30 days AND inhibitor titer < 1.0 Bethesda units/mL OR (b) has not received Factor IX therapy in the past
- prophylactic use of Factor IX 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 IX 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