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Alhemo (concizumab-mtci subcutaneous injection – NovoNordisk)Cigna

Hemophilia B with Factor IX inhibitors

Initial criteria

  • Patient age ≥ 12 years; AND
  • Patient is using Alhemo for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
  • Factor IX inhibitor titer testing has been performed within the past 30 days; AND
  • Patient has a positive test for Factor IX inhibitors of ≥ 0.6 Bethesda units/mL; AND
  • According to the prescriber, prophylactic use of bypassing agents will be discontinued (use for breakthrough bleeding allowed); 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 Alhemo for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
  • According to the prescriber, prophylactic use of bypassing agents will not occur while receiving Alhemo (use for breakthrough bleeding allowed); AND
  • Patient is not undergoing immune tolerance induction therapy; AND
  • Patient experienced a beneficial response to therapy (e.g., reduced bleeding events/severity); AND
  • Medication is prescribed by or in consultation with a hemophilia specialist

Approval duration

1 year