CurrentUnitedHealthcarePolicy 2025 P 1454-2

Xolremdi (mavorixafor) prior authorization

UnitedHealthcare prior authorization and notification program detailing coverage and authorization criteria for Xolremdi (mavorixafor) for members age 12 and older with WHIM syndrome.

Policy Summary

PayerUnitedHealthcare

PolicyXolremdi (mavorixafor) prior authorization

Policy CodePolicy 2025 P 1454-2

Change TypeProgram createdreference added

Effective DateNov 1, 2025

Next Review Date

Key ActionSubmit prior authorization documenting WHIM syndrome diagnosis for initial approval; approvals issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Program created as a prior authorization/notification program for Xolremdi (mavorixafor).

Reference to Xolremdi package insert (September 2024) added.

12 monthsInitial authorization duration

12 monthsReauthorization duration

>=12Indicated minimum patient age

WHIM syndromeRequired diagnosis

Coverage Criteria for Xolremdi (mavorixafor)

Initial Authorization

Covered when ALL of the following are met

Initial Authorization for Xolremdi: Diagnosis of WHIM (warts, hypogammaglobulinemia, infections and myelokathexis) syndrome

Authorization issued for 12 months

Reauthorization

Covered when ALL of the following are met

Reauthorization for Xolremdi: Documentation of positive clinical response to Xolremdi therapy

Authorization issued for 12 months

Coverage for Xolremdi (mavorixafor) is subject to applicable state mandates, federal requirements, and the member’s specific benefit plan. In addition, coverage decisions may be affected by other UnitedHealthcare policies and utilization management programs; UnitedHealthcare may apply automated approval processes that rely on prior claim or medication history, diagnosis codes, or claim logic. Medical necessity determinations and applicable supply limits may also limit coverage.

Policy Summary

PayerUnitedHealthcare

PolicyXolremdi (mavorixafor) prior authorization

Policy CodePolicy 2025 P 1454-2

Change TypeProgram createdreference added

Effective DateNov 1, 2025

Next Review Date

Key ActionSubmit prior authorization documenting WHIM syndrome diagnosis for initial approval; approvals issued for 12 months.

SourceLink

On This Page

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Initial Therapy

Initial therapy coverage

Initial therapy requirement: Patient has diagnosis of WHIM syndrome; patient is 12 years of age or older

Authorization for 12 months

Continuation / Reauthorization Criteria

Continuation Therapy

Reauthorization for continued therapy

Reauthorization requirement: Documentation of positive clinical response to Xolremdi therapy

12-month reauthorization

Provider Actions & Authorization Details

Prior Authorization

Prior Authorization Required

Prior authorization/notification is required for Xolremdi (mavorixafor). Initial approvals are granted for 12 months when documentation confirms a diagnosis of WHIM syndrome. Reauthorizations are granted for 12 months when documentation shows a positive clinical response to Xolremdi therapy.

Initial authorization requires documentation confirming diagnosis of WHIM syndrome (authorization duration: 12 months).
Reauthorization requires documentation of positive clinical response to Xolremdi (authorization duration: 12 months).

Step Therapy

No step therapy requirements are specified for Xolremdi in this policy. Providers should not assume step edits apply unless noted elsewhere in the member’s benefit plan or other program-specific documents.

Documentation Required

Reauthorization Documentation Required

For reauthorization, providers must supply documentation demonstrating a positive clinical response to Xolremdi therapy. This documentation should be included with the reauthorization request to support continued coverage.

Documentation Required

Initial Authorization Documentation

Initial authorization requests must include documentation confirming the diagnosis of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis). Approval is contingent on this documentation and will be issued for 12 months when criteria are met.

Denial Risk

Potential Denial Triggers

Potential denial triggers include: limits based on medical necessity or supply limits; variability from automated approval processes that may approve/deny based on prior claim or diagnosis code history; and claim-based determinations that could result in denial if documentation is insufficient or inconsistent with medical necessity rules.

Medical necessity and supply limits may restrict approval.
Automated approvals/re-approvals vary by program and may rely on prior claims, medication history, and diagnosis codes (ICD-10).
Claims may be denied if submitted documentation is insufficient or conflicts with benefit/medical necessity rules.

Definitions

WHIM syndrome definition

DefinitionWHIM syndrome is an acronym for warts, hypogammaglobulinemia, infections and myelokathexis — a congenital immunodeficiency disorder.

Core featuresWarts, hypogammaglobulinemia (low immunoglobulins), recurrent infections, and myelokathexis (retention of neutrophils in the bone marrow).

Clinical relevanceWHIM syndrome is the required diagnosis for coverage of Xolremdi (mavorixafor) in patients 12 years of age and older.

Typical patient age for indicationPatients 12 years of age and older as specified in the Xolremdi indication.

Pathophysiology noteAssociated with impaired neutrophil and lymphocyte circulation leading to recurrent infections; targeted by CXCR4 antagonists like mavorixafor.

Background

Xolremdi (mavorixafor) is a CXCR4 antagonist indicated to increase circulating mature neutrophils and lymphocytes in patients with WHIM syndrome. The indication in this policy applies to patients 12 years of age and older with a diagnosis of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis). Authorization criteria in this policy govern initial and continued use of Xolremdi for this rare congenital immunodeficiency.