CurrentUnitedHealthcarePolicy 2025 P 2154-9

Hemlibra® (emicizumab-kxwh) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Defines UnitedHealthcare commercial plan prior authorization and medical necessity criteria for Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent/reduce bleeding in patients with hemophilia A (with or without factor VIII inhibitors), including initial authorization, reauthorization, and additional clinical rules.

Policy Summary

PayerUnitedHealthcare

PolicyHemlibra® (emicizumab-kxwh) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 2154-9

Change TypeMaterial and non-material revisions (8/2025, 5/2025, prior clarifications)

Effective DateOct 1, 2025

Next Review Date

Key ActionHemlibra requires prior authorization for initiation; initial and reauthorizations are issued for 12 months when criteria are met and providers must document diagnosis and inhibitor status and, for reauthorization, positive clinical response.

SourceLink

POLICY UPDATE CHANGES

8/2025: Removed criteria of failure to meet clinical goals after a trial of prophylactic factor VIII replacement products. Clarified high titer inhibitor criteria.

5/2025: Removed criteria that patient is not to receive extended half-life factor VIII replacement products for the treatment of breakthrough bleeding episodes.

9/2024: Updated list of examples of extended half-life factor VIII replacement products and references.

9/2023: Modified physician attestation to prescriber attestation; updated references.

11/2019-11/2018: Program established and annual reviews with no changes to clinical criteria until later updates.

2Covered Indication Pathways (with inhibitors / without inhibitors)

Coverage Summary

Hemlibra (emicizumab-kxwh) is indicated for routine prophylaxis to prevent or reduce bleeding episodes in adult and pediatric patients (newborn and older) with hemophilia A, with or without factor VIII inhibitors. This policy defines UnitedHealthcare commercial plan prior authorization and medical necessity criteria for Hemlibra, including pathways for initial authorization and reauthorization, documentation requirements, and clinical rules effective 10/01/2025.

Key thresholds and stats

Covered Indication Pathways2 (with inhibitors / without inhibitors)

Authorization duration12 months (initial and reauthorization)

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

Initial Therapy Criteria

Hemophilia A With High-Titer Factor VIII Inhibitors - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Both of the following
- Diagnosis of hemophilia A
- Patient has developed high-titer factor VIII inhibitors (i.e., patient has developed factor VIII inhibitors greater than or equal to 5 Bethesda units [BU])>= 5 BU
  High-titer defined >= 5 BU
Prescribed for the prevention of bleeding episodes (i.e., routine prophylaxis)

Hemophilia A Without Inhibitors - Initial Authorization

Covered when ALL of the following are met:

ALL of the following

Both of the following
- Diagnosis of hemophilia A
- Patient has not developed high-titer factor VIII inhibitors (i.e., patient has NOT developed factor VIII inhibitors greater than or equal to 5 Bethesda units [BU])< 5 BU
  High-titer defined >= 5 BU
Hemlibra is prescribed for the prevention of bleeding episodes (i.e., routine prophylaxis)

Continuation (Reauthorization) Criteria

Hemophilia A With High-Titer Factor VIII Inhibitors - Reauthorization

Covered when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Hemlibra therapy
Authorization will be issued for 12 months.

Hemophilia A Without Inhibitors - Reauthorization

Covered when ALL of the following are met:

ALL of the following

Documentation of positive clinical response to Hemlibra therapy
Authorization will be issued for 12 months.

Provider Actions

Prior Authorization

Prior authorization required

Hemlibra requires prior authorization for initiation; initial approvals issued for 12 months when criteria met; reauthorizations issued for 12 months when documentation of positive clinical response provided.

Documentation Required

Document inhibitor status

Provider must document diagnosis of hemophilia A and whether patient has high-titer factor VIII inhibitors (>= 5 BU) versus not having high-titer inhibitors to support appropriate pathway.

Applicable Codes

Diagnosis codes referenced in policyICD-10

No codes listed

Clinical Evidence & Guidance

References:

1. Hemlibra [package insert]. South San Francisco, CA: Genentech, Inc., January 2024.

2. Oldenburg J, Mahlangu JN, Kim B, et al. Emicizumab Prophylaxis in Hemophilia A with Inhibitors. N Engl J Med. 2017;377:809-818.

3. Mahlangu J, Oldenburg J, Paz-Priel I, et al. Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors. N Engl J Med. 2018;379:811-822.

4. MASAC Recommendation on the Use and Management of Emicizumab-kxwh (Hemlibra®) for Hemophilia A with and without Inhibitors. MASAC Document #268, April 27, 2022.

Definitions and thresholds

High-titer factor VIII inhibitor (definition)Factor VIII inhibitor titer greater than or equal to 5 Bethesda units (BU)

Routine prophylaxis (definition)Prescribed for the prevention of bleeding episodes

Explicit threshold>= 5 Bethesda units (BU) for high-titer inhibitors

Background

Hemlibra is a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce bleeding episodes in adult and pediatric patients (newborn and older) with hemophilia A, with or without factor VIII inhibitors.

Revision History

11/2018-11/2019program_established

Program established (11/2018) and annual reviews through 11/2019 with no changes to clinical criteria; routine reviews and references updated.

9/2023terminology_change

Modified physician attestation to prescriber attestation; updated references. No change to clinical coverage.

9/2024reference_update

Updated list of examples of extended half-life factor VIII replacement products and updated references; no change to core clinical intent.