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
• Patient has moderately severe to severe hemophilia A as evidenced by a baseline Factor VIII level ≤ 2%; AND
• ONE of the following: (a) Factor VIII inhibitor titer testing performed within past 30 days AND patient does not have a positive test for Factor VIII inhibitors ≥ 1.0 Bethesda units/mL; OR (b) patient has not received Factor VIII therapy in the past; AND
• Prophylactic use of Factor VIII products will be discontinued no later than 7 days following the initial Qfitlia dose (use for breakthrough bleeding permitted); 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 Factor VIII products will not occur while receiving Qfitlia (use for breakthrough bleeding permitted); 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