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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