marstacimab-hncq — Blue Cross Blue Shield of Oklahoma

Initial criteria

• Prescriber states patient has been treated with requested agent within past 90 days and is at risk if therapy changed OR all of the following:
• Diagnosis of Hemophilia A without factor VIII inhibitors AND BOTH:
• • Used for primary prophylaxis in severe factor VIII deficiency (factor VIII <1%) OR used for secondary prophylaxis with ≥2 spontaneous joint bleeds; AND
• • ONE of the following: patient stable on requested agent OR inadequate response to TWO prerequisite agents (Hemlibra AND antihemophilic factor VIII) OR inadequate response to ONE prerequisite agent AND intolerance/hypersensitivity to ONE prerequisite agent OR intolerance/hypersensitivity to TWO prerequisite agents OR discontinued TWO prerequisite agents due to lack of efficacy/effectiveness/adverse event OR has FDA labeled contraindication to BOTH prerequisite agents OR prerequisite agents expected to be ineffective or not in patient's best interest OR tried another drug in same class as prerequisite agents that failed.
• OR Diagnosis of Hemophilia B without factor IX inhibitors AND BOTH:
• • Used for primary prophylaxis in severe factor IX deficiency (factor IX <1%) OR used for secondary prophylaxis with ≥2 spontaneous joint bleeds; AND
• • ONE of the following: patient stable on requested agent OR inadequate response to antihemophilic factor IX agent OR intolerance/hypersensitivity to antihemophilic factor IX agent OR FDA labeled contraindication to all antihemophilic factor IX agents OR factor IX agents discontinued due to lack of efficacy/effectiveness/adverse event OR factor IX agents expected to be ineffective or not in patient’s best interest OR tried another drug in same class as factor IX agents that failed.
• AND patient's age within FDA labeling for requested indication OR supported by literature for use in patient’s age.
• AND requested agent used as prophylaxis to prevent/reduce bleeding; NOT for treatment of breakthrough bleeding; patient is NOT pregnant.
• AND prescriber is a hemophilia specialist (e.g., hematologist or hemophilia treatment center) OR has consulted one.
• AND requested agent NOT used in combination with prophylactic factor VIII or IX products (can be used for breakthrough bleeds).
• AND patient has no FDA labeled contraindications to requested agent.

Reauthorization criteria

• Continuation may be approved when initial criteria continue to be met and patient remains on therapy with benefit (stable or improved condition).

Approval duration

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