CurrentUnitedHealthcarePolicy 2025 1473-1

Hympavzi (marstacimab-hnca) prior authorization policy

Defines UnitedHealthcare prior authorization and reauthorization criteria for Hympavzi (marstacimab-hnca) for routine prophylaxis to prevent bleeding in patients ≥12 years with hemophilia A or B without inhibitors, authorization durations, and use of automated approval processes.

Policy Summary

PayerUnitedHealthcare

PolicyHympavzi (marstacimab-hnca) prior authorization policy

Policy CodePolicy 2025 1473-1

Change TypeNew program (Prior Authorization/Notification)

Effective DateJul 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Hympavzi; initial approvals issued for 12 months when all initial criteria met.

POLICY UPDATE CHANGES

New program for Hympavzi added with P&T approval March 2025 and effective date 7/1/2025.

2Covered Indications (hemophilia A and B)

12 monthsApproval duration (initial and reauthorization)

>=12Minimum patient age

Coverage Summary

Defines UnitedHealthcare prior authorization and reauthorization criteria for Hympavzi (marstacimab-hnca) for routine prophylaxis to prevent bleeding in patients ≥12 years with hemophilia A or B without inhibitors. Policy number: 2025 1473-1. Effective date: 2025-07-01. Coverage stance: covered_with_criteria for the indication of routine prophylaxis to prevent or reduce bleeding episodes in patients ≥12 years with hemophilia A or B without inhibitors.

Initial Therapy Criteria

Initial Authorization - Hemophilia A

Hympavzi will be approved based on ALL of the following criteria

Diagnosis of hemophilia A
Age: Patient is 12 years of age or older>= 12 years
Indication: Prescribed for the prevention of bleeding episodes (i.e., routine prophylaxis)
See 'Routine prophylaxis' definition.
Inhibitor status: Patient does not have a history of inhibitors to factor VIII

Authorization duration: Authorization of therapy will be issued for 12 months12 months

Initial Authorization - Hemophilia B

Hympavzi will be approved based on ALL of the following criteria

Diagnosis of hemophilia B
Age: Patient is 12 years of age or older>= 12 years
Indication: Prescribed for the prevention of bleeding episodes (i.e., routine prophylaxis)
See 'Routine prophylaxis' definition.
Inhibitor status: Patient does not have a history of inhibitors to factor IX

Continuation / Reauthorization Criteria

Reauthorization - Hemophilia A

Reauthorization criteria

Reauthorization - Hemophilia A: Documentation of positive clinical response to Hympavzi therapy

Reauthorization duration: 12 months.

Reauthorization - Hemophilia B

Reauthorization criteria

Reauthorization - Hemophilia B: Documentation of positive clinical response to Hympavzi therapy

Reauthorization duration: 12 months.

Unproven / Exclusions

Inhibitor History Exclusion

Denial conditions (exclusions)

Inhibitor history exclusion

Hemophilia A inhibitor: History of inhibitors to factor VIII (Hemophilia A)
Hemophilia B inhibitor: History of inhibitors to factor IX (Hemophilia B)

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Hympavzi; initial approvals are issued for 12 months when all initial criteria are met.

Initial approval duration = 12 months

Documentation Required

Reauthorization documentation

For reauthorization, the provider must document a positive clinical response to Hympavzi therapy; reauthorizations are issued for 12 months.

Billing Rule

Automated approval allowance

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; use of automated approval and re-approval processes varies by program.

Denial Risk

Inhibitor exclusion

Claims may be denied if the patient has a history of inhibitors to factor VIII (hemophilia A) or factor IX (hemophilia B).

Background

Hympavzi (marstacimab-hnca) is a TFPI antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years and older with hemophilia A (congenital factor VIII deficiency) or hemophilia B (congenital factor IX deficiency) without inhibitors. Policy number: 2025 1473-1. Effective date: 2025-07-01. Last review date: 2025-03-01.

Routine prophylaxis: Prescribed for the prevention of bleeding episodes (as stated in policy).