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The Policy VaultThe Policy Vault

fitusiran sodium — Blue Cross Blue Shield of Illinois

Hemophilia B (factor IX deficiency)

Preferred products

  • Hemlibra
  • antihemophilic factor VIII agent
  • antihemophilic factor IX agent

Initial criteria

  • ONE of the following:
  • A. Continuation of therapy: The prescriber states the patient has been treated with Qfitlia (not samples) within the past 90 days AND is at risk if therapy is changed
  • OR
  • B. ALL of the following:
  • 1. ONE of the following:
  • A. The patient has a diagnosis of Hemophilia A (factor VIII deficiency) AND ALL of the following:
  • 1. Diagnosis of congenital factor VIII deficiency confirmed by blood coagulation testing AND
  • 2. Qfitlia will be used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes AND
  • 3. Qfitlia will be used for ONE of the following:
  • A. Primary prophylaxis in severe factor VIII deficiency (factor VIII level <1%) OR
  • B. Secondary prophylaxis in patients with ≥2 spontaneous joint bleeds AND
  • 4. ONE of the following:
  • A. The patient has factor VIII inhibitors AND BOTH of the following:
  • 1. Previous prophylaxis therapy AND
  • 2. ONE of the following:
  • A. Tried and inadequate response to Immune Tolerance Induction (ITI) OR
  • B. Inhibitor level ≥200 BU (medical records required) OR
  • C. Support for why the patient is NOT a candidate for ITI
  • OR
  • B. The patient does NOT have factor VIII inhibitors AND ONE of the following:
  • 1. Tried and inadequate response to TWO prerequisite agents (Hemlibra AND antihemophilic factor VIII agent) OR
  • 2. Tried and inadequate response to ONE prerequisite agent AND intolerance or hypersensitivity to ONE prerequisite agent (Hemlibra AND antihemophilic factor VIII agent) OR
  • 3. Intolerance or hypersensitivity to TWO prerequisite agents (Hemlibra AND antihemophilic factor VIII agent) OR
  • 4. FDA labeled contraindication to BOTH Hemlibra AND ALL antihemophilic Factor VIII agents
  • OR
  • B. The patient has a diagnosis of Hemophilia B (factor IX deficiency) AND ALL of the following:
  • 1. Diagnosis of congenital factor IX deficiency confirmed by blood coagulation testing AND
  • 2. Qfitlia will be used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes AND
  • 3. Qfitlia will be used for ONE of the following:
  • A. Primary prophylaxis in severe factor IX deficiency (factor IX level ≤2%) OR
  • B. Secondary prophylaxis in patients with ≥2 spontaneous joint bleeds AND
  • 4. ONE of the following:
  • A. The patient has factor IX inhibitors AND BOTH of the following:
  • 1. Previous prophylaxis therapy AND
  • 2. ONE of the following:
  • A. Tried and inadequate response to Immune Tolerance Induction (ITI) OR
  • B. Inhibitor level ≥200 BU (medical records required) OR
  • C. Support for why the patient is NOT a candidate for ITI
  • OR
  • B. The patient does NOT have factor IX inhibitors AND ONE of the following:
  • 1. Tried and inadequate response to an antihemophilic Factor IX agent OR
  • 2. Intolerance or hypersensitivity to an antihemophilic Factor IX agent OR
  • 3. FDA labeled contraindication to ALL antihemophilic Factor IX agents
  • AND
  • 2. If the patient has an FDA labeled indication, then ONE of the following:
  • A. The patient’s age is within FDA labeling for the requested indication OR
  • B. There is support for using the requested agent for the patient’s age for the requested indication AND
  • 3. The patient does NOT have a co-existing thrombophilic disorder or risk factors predisposing to thrombosis AND
  • 4. The requested agent will NOT be used for treatment of breakthrough bleeding AND
  • 5. The prescriber is a specialist (hemophilia treatment center, hematologist with experience) or has consulted such a specialist AND
  • 6. The requested agent will NOT be used with immune tolerance induction, bypassing prophylaxis, or emicizumab for hemophilia A with inhibitors (Note: Factor VIII or IX may be used for breakthrough bleeds ≥7 days after Qfitlia start) AND
  • 7. The patient has baseline antithrombin (AT) activity ≥60% and AT activity will be monitored regularly per FDA labeling AND
  • 8. The patient does NOT have hepatic impairment (Child-Pugh Class A–C)
  • Alternative coverage for NM or OH residents: rare disease or other indication per compendia/journal evidence as specified

Approval duration

6–12 months (BCBSIL/MT/TX: 12 months; others: 6 months; additional NM/OH cases: 12 months)