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Hympavzi — Blue Cross Blue Shield of Montana

Hemophilia B (factor IX deficiency) without factor IX inhibitors for primary or secondary prophylaxis

Preferred products

  • Hemlibra
  • antihemophilic factor VIII
  • antihemophilic factor IX

Initial criteria

  • ONE of the following:
  • A. Prescriber states the patient has been treated with the requested agent (no sample starts) within the past 90 days and is at risk if therapy is changed OR
  • B. ALL of the following:
  • 1. For Hemophilia A (factor VIII deficiency) without inhibitors:
  • • Used for primary prophylaxis in patients with severe factor VIII deficiency (factor VIII level < 1%) OR
  • • Used for secondary prophylaxis in patients with ≥ 2 episodes of spontaneous bleeding into joints
  • AND ONE of:
  • A. Patient is currently being treated and stable on the requested agent OR
  • B. Tried and had inadequate response to TWO prerequisite agents (Hemlibra AND an antihemophilic factor VIII) OR
  • C. Tried and had inadequate response to ONE prerequisite agent AND intolerance or hypersensitivity to ONE prerequisite agent (Hemlibra AND an antihemophilic factor VIII) OR
  • D. Intolerance or hypersensitivity to TWO prerequisite agents (Hemlibra AND an antihemophilic factor VIII) OR
  • E. TWO prerequisite agents discontinued due to lack of efficacy, diminished effect, or adverse event OR
  • F. FDA labeled contraindication to BOTH Hemlibra AND ALL antihemophilic factor VIII agents OR
  • G. TWO prerequisite agents expected to be ineffective, cause significant adherence barriers, worsen comorbid condition, decrease functional ability, or cause adverse reaction or harm OR
  • H. TWO prerequisite agents not in best interest based on medical necessity OR
  • I. Has tried another drug in same class/mechanism as TWO prerequisite agents and discontinued due to lack of efficacy, diminished effect, or adverse event
  • 2. For Hemophilia B (factor IX deficiency) without inhibitors:
  • • Used for primary prophylaxis in severe factor IX deficiency (factor IX level < 1%) OR secondary prophylaxis in ≥ 2 episodes of spontaneous bleeding into joints
  • AND ONE of:
  • A. Patient is currently treated and stable on requested agent OR
  • B. Tried and had inadequate response to antihemophilic factor IX agent OR
  • C. Intolerance or hypersensitivity to antihemophilic factor IX agent OR
  • D. FDA labeled contraindication to ALL antihemophilic factor IX agents OR
  • E. Antihemophilic factor IX agents discontinued due to lack of efficacy/effectiveness/diminished effect/adverse event OR
  • F. Antihemophilic factor IX agents expected ineffective, cause adherence barrier, worsen comorbid condition, reduce functional ability, or cause adverse reaction or harm OR
  • G. Antihemophilic factor IX agents not in best interest based on medical necessity OR
  • H. Tried another drug in same class/mechanism as antihemophilic factor IX and discontinued due to lack of efficacy/effectiveness/diminished effect/adverse event
  • 2. If patient has FDA indication: patient’s age within FDA labeling OR age supported for use for indication
  • 3. Requested agent used as prophylaxis to prevent/reduce bleeding episodes
  • 4. Not used for treatment of breakthrough bleeding
  • 5. Patient is not pregnant
  • 6. Prescriber is a specialist in hemophilia or has consulted with one
  • 7. Requested agent not used in combination with prophylactic factor VIII or IX concentrates (they may be used for breakthrough bleed treatment)
  • 8. Patient has no FDA labeled contraindications to the requested agent

Approval duration

12 months (BCBSMT, BCBSIL, BCBSTX); 36 months (BCBSOK); 6 months (others)