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Qfitlia — Blue Cross Blue Shield of Texas

Hemophilia B (factor IX deficiency)

Preferred products

  • Hemlibra
  • antihemophilic factor VIII agents
  • antihemophilic factor IX agents

Initial criteria

  • Requested agent is eligible for continuation of therapy AND patient has been treated with the requested agent (not samples) within the past 90 days AND is at risk if therapy is changed OR meets all applicable criteria below.
  • For Hemophilia A: diagnosis of congenital factor VIII deficiency confirmed by blood coagulation testing AND requested agent used for routine prophylaxis to prevent or reduce frequency of bleeding episodes AND used for primary prophylaxis in patients with severe factor VIII deficiency (factor VIII level <1%) OR secondary prophylaxis in patients with ≥2 episodes of spontaneous joint bleeding.
  • For Hemophilia A: if patient has factor VIII inhibitors, must have previous prophylaxis therapy AND (tried/inadequate response to Immune Tolerance Induction (ITI) OR inhibitor level ≥200 BU OR rationale for not a candidate for ITI).
  • For Hemophilia A without inhibitors: patient has (inadequate response to TWO prerequisite agents [Hemlibra AND antihemophilic factor VIII agent]) OR (inadequate response to ONE prerequisite agent AND intolerance/hypersensitivity to ONE prerequisite agent [Hemlibra AND antihemophilic factor VIII agent]) OR (intolerance/hypersensitivity to TWO prerequisite agents [Hemlibra AND antihemophilic factor VIII agent]) OR has an FDA labeled contraindication to BOTH Hemlibra AND ALL antihemophilic factor VIII products.
  • For Hemophilia B: diagnosis of congenital factor IX deficiency confirmed by blood coagulation testing AND requested agent used for routine prophylaxis to prevent or reduce frequency of bleeding episodes AND used for primary prophylaxis in patients with severe factor IX deficiency (factor IX level ≤2%) OR secondary prophylaxis in patients with ≥2 spontaneous joint bleeds.
  • For Hemophilia B with inhibitors: must have previous prophylaxis therapy AND (tried/inadequate response to Immune Tolerance Induction OR inhibitor level ≥200 BU OR rationale why not a candidate for ITI).
  • For Hemophilia B without inhibitors: (inadequate response OR intolerance OR hypersensitivity to an antihemophilic factor IX agent) OR has an FDA labeled contraindication to ALL antihemophilic factor IX agents.
  • If the patient has an FDA labeled indication, then patient’s age is within FDA labeling for the indication OR there is support for use in that age group.
  • Patient does NOT have co-existing thrombophilic disorder or history/risk factors predisposing to thrombosis.
  • Requested agent will NOT be used for treatment of breakthrough bleeding.
  • Prescriber is a hematologist or working in a hemophilia treatment center or has consulted with such a specialist.
  • Requested agent will NOT be used in combination with immune tolerance induction with clotting factor products (factor VIII or IX concentrates), hemophilia bypassing agent prophylaxis (factor VIIa or anti-inhibitor coagulant complex), or emicizumab for hemophilia A with inhibitors.
  • Factor VIII or IX products may be used only for breakthrough bleeds occurring >7 days after initiation of Qfitlia.
  • Patient has antithrombin activity ≥60% at baseline and AT-activity will be monitored regularly per FDA labeling.
  • Patient does NOT have hepatic impairment (Child-Pugh Class A, B, or C).
  • Rare disease compendia exception: For NM fully insured or NM HIM member – no FDA contraindications, indication is rare disease, and either FDA labeled indication for same route OR compendia supported indication.
  • Ohio exception: Member resides in Ohio, plan is Fully Insured or HIM Shop (SG), no FDA contraindications, and indication supported by (FDA-labeled indication OR compendia listing OR two major journal articles with supportive evidence).

Approval duration

BCBSIL/BCBSMT/BCBSTX 12 months; other plans 6 months; NM and OH exceptions 12 months