CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Xolremdi (mavorixafor) for WHIM syndrome — Coverage Criteria

Policy governs coverage and authorization criteria for Xolremdi (mavorixafor) to treat WHIM syndrome in members age 12 and older; applies to Neighborhood Health Plan of Rhode Island members covered under the plan.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXolremdi (mavorixafor) for WHIM syndrome — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization for 6 months with documentation of genotype-confirmed CXCR4 variant, baseline ANC <400 cells/µL, baseline ALC, infection history, current weight, and specialty prescriber involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12+minimum covered age (years)

6 moauth duration

<400ANC requirement

≥1,000ALC target

4/dayquantity limit

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Coverage Criteria for Xolremdi (mavorixafor)

Initial Therapy for WHIM syndrome

Covered when ALL of the following are met:

Initial therapy criteria: Member is 12 years of age or older; medication is prescribed by or in consultation with a prescriber who specializes in WHIM; documentation of genotype-confirmed CXCR4 variant consistent with WHIM; documentation of baseline absolute lymphocyte count (ALC) and number of infections in the last year; documentation of baseline absolute neutrophil count (ANC) <400 cells/μL; documentation of at least one other clinical manifestation of disease at baseline (eg, warts, hypogammaglobulinemia, infections, myelokathexis, lymphopenia, monocytopenia); documentation of current weight; member will not be taking Xolremdi concomitantly with plerixafor (Mozobil); dose does not exceed 400 mg/day (4 capsules) for patients >50 kg or 300 mg/day (3 capsules) for members <50 kg.

Continuation of Therapy

Covered when ALL of the following are met:

Continuation criteria: Authorization of 6 months may be granted when member continues to meet all initial criteria and is experiencing benefit from therapy as evidenced by updated laboratory results or medical record documentation including: an absolute lymphocyte count (ALC) ≥ 1,000 cells/μL within the last 3-6 months and a reduction from baseline in infections.

All indications for Xolremdi (mavorixafor) other than those specifically listed for WHIM syndrome are considered experimental/investigational and are not a covered benefit.

Use of Xolremdi for indications other than WHIM syndrome is considered not medically necessary and will not be authorized.

Coding, Age & Laboratory Thresholds

Age

Minimum age for coverageMember must be 12 years of age or older

FDA indication age statementXolremdi is indicated in patients 12 years of age and older with WHIM syndrome

Authorization noteAuthorization may be granted for 6 months when all criteria are met

Baseline absolute neutrophil count (ANC)

Baseline ANC requirementBaseline absolute neutrophil count (ANC) must be < 400 cells/µL

Documentation requiredBaseline ANC must be documented in the medical record at initiation

Denial triggerRequest may be denied if baseline ANC is not < 400 cells/µL

Continuation absolute lymphocyte count (ALC)

Continuation ALC targetAbsolute lymphocyte count (ALC) ≥ 1,000 cells/µL within the last 3–6 months

Evidence of benefitContinuation authorization requires updated labs showing ALC ≥ 1,000 cells/µL and reduction in infections from baseline

Timing for labsALC must be documented within the last 3–6 months prior to continuation approval

Quantity limit

Daily quantity limitQuantity limited to 4 capsules per day

Dose cap for >50 kgDose does not exceed 400 mg/day (4 capsules) for patients >50 kg

Dose cap for <50 kgDose does not exceed 300 mg/day (3 capsules) for patients <50 kg

Prior Authorization, Documentation & Restrictions

Prior Authorization

Prior authorization required

Prior authorization for 6 months is required for initiation of therapy for WHIM syndrome. Authorization may be granted when all listed clinical and documentation criteria are met.

Authorization period: 6 months
Applies to members age 12 years and older

Denial Risk

Concomitant therapy restriction

Member must not be taking Xolremdi concomitantly with plerixafor (Mozobil).

Documentation Required

Required documentation

Documentation must include genotype-confirmed CXCR4 variant, baseline absolute lymphocyte count (ALC), baseline absolute neutrophil count (ANC), number of infections in the prior year, at least one other baseline clinical manifestation (e.g., warts, hypogammaglobulinemia, infections, myelokathexis, lymphopenia, monocytopenia), prescriber specialty or consultation with a WHIM specialist, and the member's current weight. Dose must be documented and not exceed limits.

Genotype-confirmed CXCR4 variant
Baseline ALC
Baseline ANC (< 400 cells/µL)
Number of infections in prior 12 months
At least one other clinical manifestation at baseline
Prescribed by or in consultation with WHIM specialist
Member's current weight
Dose documented and within limits: 400 mg/day (4 capsules) for >50 kg; 300 mg/day (3 capsules) for <50 kg

Denial Risk

Triggers for denial

Denial is likely if the member is younger than 12 years, lacks a genotype-confirmed CXCR4 variant, baseline ANC is not <400 cells/µL, required documentation or prescriber specialty/consultation is not provided, or dosing/quantity limits are exceeded.

Member age < 12 years
No genotype-confirmed CXCR4 variant
Baseline ANC ≥ 400 cells/µL
Missing required documentation (ALC, infections, clinical manifestations, prescriber specialty/consultation, weight)
Dose exceeds 400 mg/day (>50 kg) or 300 mg/day (<50 kg)
Quantity limit: more than 4 capsules per day