CurrentColorado Rocky Mountain Health PlansPolicy N/A

Hympavzi (marstacimab-hncq) prior authorization — routine prophylaxis for hemophilia A and B

Criteria and authorization rules for Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce bleeding episodes in patients aged 12 years and older with hemophilia A or B without high-titer inhibitors; applies to Colorado Rocky Mountain Health Plans clinical pharmacy program.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyHympavzi (marstacimab-hncq) prior authorization — routine prophylaxis for hemophilia A and B

Policy CodePolicy N/A

Change TypeMaterial clinical and operational updates

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit documentation confirming diagnosis of hemophilia A or B without high‑titer inhibitors (>=5 BU) and that patient is ≥12 years for initial authorization.

SourceLink

POLICY UPDATE CHANGES

Added criteria for hemophilia A without inhibitors.

Removed criteria that patient is not to receive extended half-life factor VIII replacement products for treatment of breakthrough bleeding episodes.

Removed criteria of failure to meet clinical goals after a trial of prophylactic factor IX replacement products.

Clarified high titer inhibitor criteria (>= 5 Bethesda units).

>=12Minimum age

>=5 BUHigh-titer inhibitor threshold

12 moAuthorization duration

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Coverage Criteria for Hympavzi (marstacimab-hncq)

inv-01: Initial Authorization - Hemophilia A

Covered when ALL of the following are met

Initial authorization (hemophilia A): (1) Diagnosis of hemophilia A; (2) Patient has not developed high-titer factor VIII inhibitors (>= 5 BU); (3) Patient is 12 years of age or older; (4) Hympavzi is prescribed for routine prophylaxis (prevention of bleeding episodes)

Authorization issued for 12 months

inv-02: Initial Authorization - Hemophilia B

Covered when ALL of the following are met

Initial authorization (hemophilia B): (1) Diagnosis of hemophilia B; (2) Patient has not developed high-titer factor IX inhibitors (>= 5 BU); (3) Patient is 12 years of age or older; (4) Hympavzi is prescribed for routine prophylaxis (prevention of bleeding episodes)

Authorization issued for 12 months

inv-03: Reauthorization

Reauthorization covered when the following is met

Reauthorization: Documentation of positive clinical response to Hympavzi therapy

Authorization will be issued for 12 months

Coverage is NOT provided for patients who have developed high-titer factor VIII or IX inhibitors. For this policy the threshold for a high-titer inhibitor is defined as ≥ 5 Bethesda units (BU) for either factor VIII or factor IX. Presence of an inhibitor at or above this threshold excludes the patient from meeting the stated approval criteria for Hympavzi.

Key Coding & Age/Inhibitor Thresholds

inv-05: High-titer inhibitor threshold

High-titer inhibitor threshold>= 5 Bethesda units (BU)

Effect on coveragePatients with inhibitor titers >= 5 BU are excluded from authorization under these criteria

Referenced in criteria forBoth hemophilia A and B initial authorization requirements

inv-06: Minimum age

Minimum age for coverage>= 12 years

Applies toAdult and pediatric patients aged 12 years and older for hemophilia A and B indications

Authorization duration

Provider Authorization & Documentation Requirements

Prior Authorization

Prior Authorization Required

Initial authorization criteria — provider actions summary and required documentation. Providers must confirm diagnosis, age, inhibitor status, and prophylaxis intent before requesting prior authorization. Authorization issued for 12 months when criteria met.

Confirm diagnosis of hemophilia A or hemophilia B as applicable
Document absence of high-titer factor VIII (for hemophilia A) or factor IX (for hemophilia B) inhibitors (i.e., < 5 Bethesda units)
Patient age ≥ 12 years
Indication: routine prophylaxis for prevention of bleeding episodes
Authorization duration: 12 months

Documentation Required

Documentation Required for Reauthorization

Reauthorization documentation — providers must submit objective documentation of a positive clinical response to continued Hympavzi therapy. Examples include reduced bleeding frequency, decreased infusion or replacement therapy use, improved joint health, or other clinician-documented clinical benefit.

Background on Therapy

Hympavzi (marstacimab-hncq) is a tissue factor pathway inhibitor antagonist indicated for routine prophylaxis to reduce the frequency of bleeding episodes in patients with hemophilia A or B who do not have high-titer inhibitors. Under this policy, therapy is intended for patients aged ≥ 12 years and is authorized for 12 months when criteria are met.

Definitions

inv-12: high-titer inhibitor

DefinitionHigh-titer inhibitor = inhibitor titer greater than or equal to 5 Bethesda units (BU)

ImplicationPresence of high-titer factor VIII or IX inhibitors (>= 5 BU) excludes patients from coverage under these criteria

Used inInitial authorization criteria for hemophilia A and B

inv-13: routine prophylaxis

DefinitionRoutine prophylaxis: prescription of Hympavzi for the prevention of bleeding episodes (ongoing preventive therapy)

Indication contextIndicated for routine prophylaxis in patients 12 years and older with hemophilia A or B without respective inhibitors

Initial Therapy Criteria

inv-14: Initial therapy

Covered when ALL of the following are met

Initial therapy: Diagnosis of hemophilia A or B without respective high-titer inhibitors (>= 5 BU); patient is 12 years of age or older; Hympavzi is prescribed for routine prophylaxis (prevention of bleeding episodes)

Authorization issued for 12 months

Continuation / Reauthorization Criteria

inv-15: Reauthorization

Reauthorization covered when the following is met

Continuation/Reauthorization: Documentation of positive clinical response to Hympavzi therapy is required for renewal

Authorization periods are 12 months

Step Therapy / Policy History

Change date	Change summary
8/2025
Removed requirement for trial of prophylactic factor IX replacement products (prior step); added criteria for hemophilia A without inhibitors and clarified high‑titer inhibitor definition.

Site of Care Considerations

Note

Infusion center — site‑of‑care and plan mandates may apply

State mandates, member benefit plan provisions, and other utilization management programs may affect coverage or site‑of‑care decisions for infusion center administration; verify applicable state and member plan requirements before authorizing or scheduling therapy.

Confirm any state‑level mandates that impact infusion center coverage.
Check the member's benefit plan for site‑of‑care restrictions or required prior authorizations.
Be aware that separate utilization management programs or policies may also apply.