Hympavzi (marstacimab-hncq subcutaneous injection – Pfizer) — Cigna
Hemophilia A without Factor VIII inhibitors
Initial criteria
- Patient is age ≥ 12 years; AND
- Patient is using Hympavzi for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
- Patient has moderately severe to severe hemophilia A as evidenced by a baseline (without Factor VIII replacement therapy) Factor VIII level of ≤ 2%; AND
- Patient meets ONE of the following (a or b): a) Factor VIII inhibitor titer testing has been performed within the past 30 days AND patient does not have a positive test for Factor VIII inhibitors of ≥ 1.0 Bethesda units/mL; OR b) Patient has not received Factor VIII therapy in the past; AND
- According to the prescriber, prophylactic use of Factor VIII products will be discontinued (Note: use for breakthrough bleeding is permitted); AND
- Medication is prescribed by or in consultation with a hemophilia specialist
Reauthorization criteria
- Patient is using Hympavzi for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
- According to the prescriber, prophylactic use of Factor VIII products will not occur while receiving Hympavzi (Note: use for breakthrough bleeding is permitted); AND
- Medication is prescribed by or in consultation with a hemophilia specialist; AND
- According to the prescriber, patient experienced a beneficial response to therapy (e.g., reduction in bleeding events, severity, number requiring treatment, or spontaneous bleeds)
Approval duration
1 year