marstacimab-hncq — Blue Cross Blue Shield of Illinois

Initial criteria

• ONE of the following: (A) The prescriber states the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR (B) ALL of the following criteria are met
• For Hemophilia A: ONE of the following: (A) The requested agent will be used for primary prophylaxis in patients with severe factor VIII deficiency (factor VIII level <1%) OR (B) The requested agent will be used for secondary prophylaxis in patients with ≥2 episodes of spontaneous bleeding into joints
• For Hemophilia A: ONE of the following: (A) The patient is currently being treated with and stable on the requested agent OR (B) Has tried and had an inadequate response to TWO prerequisite agents (Hemlibra AND an antihemophilic factor VIII) OR (C) Has tried and had an inadequate response to ONE prerequisite agent AND an intolerance/hypersensitivity to ONE prerequisite agent (Hemlibra AND an antihemophilic factor VIII) OR (D) Has intolerance or hypersensitivity to TWO prerequisite agents (Hemlibra AND an antihemophilic factor VIII) OR (E) TWO prerequisite agents (Hemlibra AND an antihemophilic factor VIII) were discontinued due to lack of efficacy or adverse event OR (F) Has an FDA labeled contraindication to BOTH Hemlibra AND ALL antihemophilic factor VIII agents OR (G) TWO prerequisite agents are expected to be ineffective, cause adherence barriers, worsen comorbidity, impair function, or cause harm OR (H) TWO prerequisite agents are not in best interest of patient based on medical necessity OR (I) Has tried another drug in same class as TWO prerequisite agents and discontinued due to lack of efficacy/adverse event
• For Hemophilia B: ONE of the following: (A) The requested agent will be used for primary prophylaxis in patients with severe factor IX deficiency (factor IX level <1%) OR (B) The requested agent will be used for secondary prophylaxis in patients with ≥2 episodes of spontaneous bleeding into joints
• For Hemophilia B: ONE of the following: (A) The patient is currently being treated with and stable on the requested agent OR (B) Has tried and had an inadequate response to an antihemophilic factor IX agent OR (C) Has intolerance or hypersensitivity to an antihemophilic factor IX agent OR (D) Has an FDA labeled contraindication to ALL antihemophilic factor IX agents OR (E) Antihemophilic factor IX agent was discontinued due to lack of efficacy or adverse event OR (F) Antihemophilic factor IX agents are expected to be ineffective, cause adherence barriers, worsen comorbidity, impair function, or cause harm OR (G) Antihemophilic factor IX agents are not in best interest of patient based on medical necessity OR (H) Has tried another drug in same class as antihemophilic factor IX agents and discontinued due to lack of efficacy/adverse event
• If the patient has an FDA labeled indication, then ONE of the following: (A) The patient’s age is within FDA labeling for the indication OR (B) There is support for using the requested agent for the patient’s age for the requested indication
• The requested agent will be used as prophylaxis to prevent or reduce frequency of bleeding episodes
• The requested agent will NOT be used for the treatment of breakthrough bleeding
• The patient is NOT pregnant
• The prescriber is a specialist in hemophilia or has consulted with one
• The requested agent will NOT be used in combination with prophylactic factor VIII or IX concentrates (may use factor VIII/IX for breakthrough bleeds)
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

BCBSOK: 36 months; BCBSIL/BCBSMT/BCBSTX: 12 months; Others: 6 months