Qfitlia (fitusiran subcutaneous injection – NovoNordisk) — Cigna

Initial criteria

• Patient age ≥ 12 years; AND
• Patient is using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
• Factor VIII inhibitor titer testing performed within past 30 days AND patient has a positive test for Factor VIII inhibitors ≥ 0.6 Bethesda units/mL; AND
• Prophylactic use of bypassing agents will be discontinued no later than 7 days following the initial Qfitlia dose (use for breakthrough bleeding permitted); AND
• Patient is not undergoing immune tolerance induction therapy; AND
• Medication is prescribed by or in consultation with a hemophilia specialist

Reauthorization criteria

• Patient is using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
• Prophylactic use of bypassing agents will not occur while receiving Qfitlia (use for breakthrough bleeding permitted); AND
• Patient is not undergoing immune tolerance induction therapy; AND
• Medication is prescribed by or in consultation with a hemophilia specialist; AND
• Patient experienced a beneficial response to therapy (e.g., reduction in bleeding events or severity)

Approval duration

1 year