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fitusiran sodium — Blue Cross Blue Shield of Montana

Hemophilia A (factor VIII deficiency)

Preferred products

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

Initial criteria

  • ONE of the following: (A) The requested agent is eligible for continuation of therapy AND the patient has been treated with the requested agent (not on samples) within the past 90 days AND is at risk if therapy is changed OR (B) meets all criteria below.
  • For Hemophilia A: ALL of the following: diagnosis of congenital factor VIII deficiency confirmed by blood coagulation testing AND used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes AND used for primary prophylaxis in severe factor VIII deficiency (factor VIII <1%) OR secondary prophylaxis after ≥2 spontaneous joint bleeds AND ONE of the following: (A) patient has factor VIII inhibitors AND previous prophylaxis therapy AND either inadequate response to immune tolerance induction (ITI) OR inhibitor level ≥200 BU OR justification why not a candidate for ITI OR (B) patient does NOT have factor VIII inhibitors AND ONE of the following: has tried and had inadequate response to TWO prerequisite agents (Hemlibra AND an antihemophilic factor VIII agent) OR tried and had inadequate response to ONE prerequisite agent AND intolerance/hypersensitivity to another prerequisite agent (Hemlibra or antihemophilic factor VIII agent) OR intolerance/hypersensitivity to BOTH prerequisite agents OR FDA-labeled contraindication to BOTH Hemlibra AND ALL antihemophilic factor VIII agents.
  • For Hemophilia B: ALL of the following: congenital factor IX deficiency confirmed by blood coagulation testing AND used for routine prophylaxis to prevent or reduce bleeding episodes AND used for primary prophylaxis in severe factor IX deficiency (≤2%) OR secondary prophylaxis after ≥2 spontaneous joint bleeds AND ONE of the following: (A) patient has factor IX inhibitors AND previous prophylaxis therapy AND either inadequate response to ITI OR inhibitor level ≥200 BU OR justification not a candidate for ITI OR (B) patient does NOT have factor IX inhibitors AND ONE of the following: inadequate response, intolerance, or hypersensitivity to an antihemophilic factor IX agent OR FDA-labeled contraindication to ALL antihemophilic factor IX agents.
  • If patient has an FDA-labeled indication, ONE of the following: (A) age within FDA labeling OR (B) justification for use outside labeled age.
  • Patient does NOT have co-existing thrombophilic disorder or predisposing risk factors for thrombosis.
  • Requested agent will NOT be used for treatment of breakthrough bleeding.
  • Prescriber is a specialist (hemophilia treatment center or hematologist with hemophilia experience) OR has consulted with a specialist.
  • Requested agent will NOT be used in combination with immune tolerance induction with clotting factor products, hemophilia bypassing agent prophylaxis, or emicizumab for hemophilia A with inhibitors (factor VIII or IX products can be given for breakthrough bleeds after 7 days from Qfitlia initiation).
  • Patient has baseline antithrombin activity level ≥60% and AT-activity monitored per FDA labeling.
  • Patient does NOT have hepatic impairment (Child-Pugh Class A, B, C).

Approval duration

12 months (BCBSIL, BCBSMT, BCBSTX); 6 months (others)