marstacimab-hncq — Blue Cross Blue Shield of Texas
Hemophilia B (factor IX deficiency) without factor IX inhibitors
Preferred products
- Hemlibra
- antihemophilic factor VIII agents
- antihemophilic factor IX agents
Initial criteria
- Prescriber states the patient has been treated with the requested agent (not samples) within the past 90 days and is at risk if therapy is changed OR ALL of the following:
- Diagnosis of Hemophilia A (factor VIII deficiency) without factor VIII inhibitors AND BOTH of the following:
- Requested agent will be used for primary prophylaxis in patients with severe factor VIII deficiency (factor VIII level <1%) OR requested agent will be used for secondary prophylaxis in patients with at least two episodes of spontaneous bleeding into joints
- AND ONE of the following:
- Patient is currently being treated with Hympavzi and stable on therapy [chart notes required] OR
- Has tried and had an inadequate response to TWO prerequisite agents (Hemlibra AND an antihemophilic factor VIII agent) [chart notes required] OR
- Has tried and had an inadequate response to ONE prerequisite agent AND has intolerance or hypersensitivity to ONE prerequisite agent (Hemlibra AND an antihemophilic factor VIII agent) [chart notes required] OR
- Has intolerance or hypersensitivity to TWO prerequisite agents (Hemlibra AND an antihemophilic factor VIII agent) OR
- TWO prerequisite agents (Hemlibra AND antihemophilic factor VIII agent) discontinued due to lack of efficacy/effectiveness, diminished effect, or adverse event [chart notes required] OR
- Patient has FDA labeled contraindication to BOTH Hemlibra AND ALL antihemophilic factor VIII agents [chart notes required] OR
- TWO prerequisite agents (Hemlibra AND antihemophilic factor VIII agent) expected to be ineffective or unsafe or cause adherence barriers or worsen comorbidities etc. [chart notes required] OR
- TWO prerequisite agents not in the patient’s best interest based on medical necessity [chart notes required] OR
- Has tried another drug in same pharmacologic class or mechanism as BOTH prerequisite agents and discontinued due to lack of efficacy/effectiveness OR adverse event [chart notes required]
- OR diagnosis of Hemophilia B (factor IX deficiency) without inhibitors AND BOTH of the following:
- Used for primary prophylaxis in severe factor IX deficiency (factor IX <1%) OR secondary prophylaxis in patients with at least two episodes of spontaneous bleeding into joints
- AND ONE of the following:
- Patient is currently stable on Hympavzi [chart notes required] OR
- Has tried and had inadequate response to antihemophilic factor IX agent [chart notes required] OR
- Has intolerance or hypersensitivity to antihemophilic factor IX agent [chart notes required] OR
- Has FDA labeled contraindication to ALL antihemophilic factor IX agents [chart notes required] OR
- Antihemophilic factor IX agents discontinued due to lack of efficacy/effectiveness or adverse events [chart notes required] OR
- Antihemophilic factor IX agents expected to be ineffective or unsafe or not in patient’s best interest [chart notes required]
- Patient’s age is within FDA labeling for requested indication OR supported in medical literature
- Requested agent used as prophylaxis to prevent/reduce frequency of bleeding episodes AND not for treatment of breakthrough bleeding AND patient is not pregnant
- Prescriber is a specialist in hemophilia or has consulted one
- Requested agent is not used in combination with prophylactic factor VIII or IX concentrates (allowed for breakthrough bleeds)
- Patient does not have FDA labeled contraindications to Hympavzi
Approval duration
BCBSOK: 36 months; BCBSIL/BCBSMT/BCBSTX: 12 months; all other: 6 months