CurrentUnitedHealthcarePolicy N/A

Hemlibra (emicizumab-kxwh) prior authorization

Prior authorization and medical necessity criteria for coverage of Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce bleeding episodes in patients with hemophilia A, with or without factor VIII inhibitors; applies to UnitedHealthcare pharmacy programs.

Policy Summary

PayerUnitedHealthcare

PolicyHemlibra (emicizumab-kxwh) prior authorization

Policy CodePolicy N/A

Change TypeCriteria removals and clarification

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis and, for reauthorization, evidence of positive clinical response to Hemlibra.

SourceLink

POLICY UPDATE CHANGES

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

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

Clarified high titer inhibitor criteria.

12 moauthorization period

>=5 BUhigh-titer threshold

2025 P 2154-9program id

10/01/2025effective

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Coverage Criteria — Hemlibra (emicizumab-kxwh)

inv-01: Initial Authorization — Hemophilia A with inhibitors

Covered when ALL of the following are met

Hemophilia A with inhibitors - initial: (1) Diagnosis of hemophilia A; (2) patient has developed high-titer factor VIII inhibitors (>= 5 Bethesda units [BU]); and (3) Hemlibra is prescribed for routine prophylaxis to prevent bleeding episodes.>= 5 BU

Authorization issued for 12 months

inv-02: Reauthorization — Hemophilia A with inhibitors

Covered when ALL of the following are met

Hemophilia A with inhibitors - reauthorization: Documentation of positive clinical response to Hemlibra therapy.

Authorization issued for 12 months

inv-03: Initial Authorization — Hemophilia A without inhibitors

Covered when ALL of the following are met

Hemophilia A without inhibitors - initial: (1) Diagnosis of hemophilia A; (2) patient has NOT developed high-titer factor VIII inhibitors (< 5 Bethesda units [BU]); and (3) Hemlibra is prescribed for routine prophylaxis to prevent bleeding episodes.< 5 BU

Authorization issued for 12 months

inv-04: Reauthorization — Hemophilia A without inhibitors

Covered when ALL of the following are met

Hemophilia A without inhibitors - reauthorization: Documentation of positive clinical response to Hemlibra therapy.

Authorization issued for 12 months; state mandates and member benefit plan may impact coverage.

Coverage of Hemlibra (emicizumab-kxwh) is subject to state mandates, applicable federal regulatory requirements, and the terms of the member's benefit plan. These requirements may affect whether criteria are applied or how they are implemented for a given member. Additionally, other UnitedHealthcare policies and utilization management programs may apply and can influence coverage decisions.

Definitions and Coding Thresholds

High-titer inhibitor threshold

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

Non–high-titer definition< 5 Bethesda units (BU)

Authorization noteThreshold used to determine pathway for initial authorization (with vs without inhibitors)

High-titer inhibitor — clarification

DefinitionHigh-titer factor VIII inhibitors are defined as greater than or equal to 5 Bethesda units (BU).

Context — with inhibitors pathwayPatients meeting this threshold follow the Hemophilia A with inhibitors initial authorization pathway.

Context — without inhibitors pathwayPatients below this threshold (< 5 BU) follow the Hemophilia A without inhibitors initial authorization pathway.

Policy change noteClarified high-titer inhibitor criteria in 8/2025 document updates.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Hemlibra (emicizumab-kxwh) for treatment of hemophilia A, with or without factor VIII inhibitors. Submit supporting documentation at time of request: diagnosis (ICD-10), documentation of inhibitor status (Bethesda units) when applicable, treatment intent (routine prophylaxis), and relevant prior claim/medication history. Authorizations are issued for 12 months.

Applies to Hemlibra (emicizumab-kxwh) prior authorization requests
Diagnosis: hemophilia A (see clinical criteria)
If inhibitors present: document Bethesda units ≥ 5 BU

Documentation Required

Reauthorization Documentation Required

Reauthorization requests must include documentation demonstrating a positive clinical response to Hemlibra (e.g., reduction in bleeding episodes, improved joint health, decreased factor use, clinician progress notes). Reauthorization approvals are for 12 months.

Clinical progress notes documenting improvement since initiation
Bleeding frequency or infusion/medication use comparisons to baseline
Relevant laboratory or imaging data when available

Step Therapy

Step Therapy Note

Step therapy requirements for prior prophylactic factor VIII replacement products have been removed. A history of failure on prophylactic factor VIII replacement products is no longer required prior to Hemlibra authorization.

Do not require trial/failure of prophylactic factor VIII replacement agents for Hemlibra approval
If prior medication history is submitted it may be used to support clinical decision-making but is not mandatory

Denial Risk

Denial Risk from Insufficient Documentation or Claim History

Insufficient or incomplete documentation and lack of claim/medication history may lead to denial or delay. UnitedHealthcare may also rely on prior claim/medication history and diagnosis codes to approve or deny initial and reauthorization requests.

Missing documentation of inhibitor status (when applicable) or absence of clinical response data for reauthorization increases denial risk
Claims-based automated approvals may be used; incomplete claim history can affect adjudication

Initial Therapy — Criteria

inv-13: Initial therapy — structured initial authorization criteria for Hemlibra

Initial therapy — structured criteria for initiating Hemlibra

Initial therapy pathways: Pathway 1: Hemophilia A with high-titer factor VIII inhibitors (>= 5 BU) AND Hemlibra prescribed for routine prophylaxis. Pathway 2: Hemophilia A without high-titer inhibitors (< 5 BU) AND Hemlibra prescribed for routine prophylaxis.>=5 BU or <5 BU

Authorization issued for 12 months

Reauthorization and Continuation Criteria

inv-14: Reauthorization / Continuation — structured continuation criteria and documentation requirements

Reauthorization / Continuation — documentation requirements for ongoing coverage

Continuation: Documentation of positive clinical response to Hemlibra therapy.

Authorization issued for 12 months; state mandates and member benefit plan may impact coverage.

Step	Requirement
1	No explicit step failure of prophylactic factor VIII replacement products is required in the current criteria (previous requirement to fail prophylactic factor VIII replacement products has been removed).

Policy Summary

PayerUnitedHealthcare

PolicyHemlibra (emicizumab-kxwh) prior authorization

Policy CodePolicy N/A

Change TypeCriteria removals and clarification

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis and, for reauthorization, evidence of positive clinical response to Hemlibra.

SourceLink

On This Page

OpenPayer

Hemlibra (emicizumab-kxwh) prior authorization

Coverage Criteria — Hemlibra (emicizumab-kxwh)

Definitions and Coding Thresholds

Provider Actions, Authorization & Documentation

Initial Therapy — Criteria

Reauthorization and Continuation Criteria

Background — Drug and Indication

Step Therapy / Prior Failures