CurrentHAP CareSource MI Coordinated HealthPolicy N/A

Immune Disorders - Gene Therapy - Kresladi Utilization Management Medical Policy

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This policy governs prior authorization and medical-benefit coverage for Kresladi (marnetegragene autotemcel) intravenous gene therapy in pediatric patients with severe leukocyte adhesion deficiency-I due to biallelic ITGB2 variants. It applies to one-time, single-dose treatment when the stated clinical, donor, prescribing-specialist, infection, and dosing requirements are met.

Policy Summary

PayerHAP CareSource MI Coordinated Health

PolicyKresladi Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAdministrative update

Effective DateN/A

Last ReviewAug 5, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with patient-specific documentation confirming all coverage criteria and the weight-based dose.

SourceLink

POLICY UPDATE CHANGES

Added administrative instructions for clients with Embarc Benefit Protection.

1 doseMaximum treatment course per lifetime

2.8 × 10^6 CD34+ cells/kgMinimum required dose

<18 yearsRequired patient age

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CurrentHAP CareSource MI Coordinated HealthPolicy N/A

Immune Disorders - Gene Therapy - Kresladi Utilization Management Medical Policy

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Sign up for all hap_caresource_mi_coordinated_health policy alerts

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Policy Summary

PayerHAP CareSource MI Coordinated Health

PolicyKresladi Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAdministrative update

Effective DateN/A

Last ReviewAug 5, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with patient-specific documentation confirming all coverage criteria and the weight-based dose.

SourceLink

POLICY UPDATE CHANGES

Added administrative instructions for clients with Embarc Benefit Protection.

1 doseMaximum treatment course per lifetime

2.8 × 10^6 CD34+ cells/kgMinimum required dose

<18 yearsRequired patient age

1 yearApproval duration

LAD-II/IIINot recommended indications

Coverage Criteria

Initial therapy for severe LAD-I

Covered for the FDA-approved indication when ALL criteria A through I are met.

FDA-approved indication

Patient and treatment requirements
- Age: Patient is younger than 18 years of age.<18 years
- No prior Kresladi: Patient has not previously received Kresladi.No prior dose
  Verification in claims history is required when available.
- HSCT appropriateness: According to the prescribing physician, hematopoietic stem cell transplantation is appropriate for the patient.
- HLA-matched sibling donor status
  - No matched sibling donor: Patient does not have an HLA-matched sibling donor.
  - Matched donor unavailable: Patient has an HLA-matched sibling donor, but the individual is unable or unwilling to donate.
Confirmed severe LAD-I
- ITGB2 variants: Documented biallelic pathogenic or likely pathogenic variants in the ITGB2 gene.Biallelic pathogenic or likely pathogenic ITGB2 variants
  Documentation required.
- Flow-cytometry severity
  - CD18 criterion: Patient has less than 2% of normal CD18-expressing polymorphonuclear neutrophils as assessed by flow cytometry.<2% of normal CD18-expressing polymorphonuclear neutrophils
    Documentation required.
  - CD18 plus CD11a/CD11b criterion
    CD18 level: Patient has at least 2% of normal CD18-expressing polymorphonuclear neutrophils.
Infection status: According to the prescribing physician, patient does not have an active bloodstream infection or other serious, untreated infection.No active bloodstream infection or serious untreated infection
Qualified prescriber: Medication is prescribed by a hematologist, stem cell transplant physician, or pediatric immunologist with expertise in inborn errors of immunity.
Recent body weight: Current patient body weight has been obtained within the past 30 days.Weight obtained within 30 days
Documentation required.
Dose and administration: Approve one dose of Kresladi by intravenous infusion to provide a one-time, per-lifetime single dose containing a minimum of 2.8 × 10^6 CD34+ cells/kg of body weight.Minimum 2.8 × 10^6 CD34+ cells/kg
Dose verification required.

Coverage of Kresladi is not recommended for patients who have received prior gene therapy, for leukocyte adhesion deficiency type II or III, or for circumstances not listed in the Recommended Authorization Criteria.

Kresladi is not recommended for LAD-II or LAD-III because these disorders are caused by genetic variants other than ITGB2 and result in leukocyte migration defects unrelated to CD18; they are not expected to respond to Kresladi therapy.

Kresladi is not recommended after prior gene therapy because it has not been studied in patients who have undergone prior gene therapy.

Initial Therapy

Initial therapy

Approve one-time, per-lifetime, single-dose Kresladi when all FDA-approved indication criteria are met.

Initial Kresladi therapy

Age and prior treatment
- Age: Patient is younger than 18 years of age.<18 years
- No prior Kresladi: Patient has not previously received Kresladi.No prior dose
  Verification in claims history is required when available; otherwise, the prescribing physician must confirm no prior treatment.
HSCT and donor status

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for medical-benefit coverage of Kresladi. Approval requires that the patient meet the applicable authorization criteria and that Kresladi be prescribed by a physician specializing in the condition being treated.

Billing Rule

One-Time Approval

Approvals are limited to one administration per lifetime as a single dose. The approval window is one year to allow time to prepare and administer the therapy.

Billing Rule

Medical Director and Embarc Review

Disease and Therapy Background

Leukocyte adhesion deficiency-I (LAD-I) is a rare autosomal recessive inborn error of immunity involving defective leukocyte adhesion and migration during infection and inflammation.

Definitions

Leukocyte adhesion deficiency-I (LAD-I)

DefinitionA rare, autosomal recessive inborn error of immunity characterized by defective leukocyte adhesion, migration, and tissue recruitment during infection and inflammation.

Genetic causeCaused by pathogenic loss-of-function variants in the ITGB2 gene, which encodes the beta 2 integrin subunit CD18.

Disease characteristicsCommon clinical features include recurrent severe bacterial and fungal infections, impaired wound healing, and absence of pus at infection sites due to defective neutrophil recruitment.

Severe LAD-I

CD18 criterionLess than 2% of expected polymorphonuclear neutrophil CD18 expression.

Combined expression criterionAt least 2% of expected polymorphonuclear neutrophil CD18 expression together with less than 2% of expected CD11a and/or CD11b expression.

Lifetime Quantity Limit

Kresladi quantity limit

Lifetime quantity limitOne dose per lifetime.

AdministrationA single intravenous infusion.

Minimum dose2.8 × 10^6 CD34+ cells/kg of body weight.

Administration Site

Billing Rule

Administer the one-time intravenous infusion

Administer Kresladi by intravenous infusion as a one-time, single dose. The policy does not specify a required facility setting.

Policy Summary

PayerHAP CareSource MI Coordinated Health

PolicyKresladi Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeAdministrative update

Effective DateN/A

Last ReviewAug 5, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with patient-specific documentation confirming all coverage criteria and the weight-based dose.

SourceLink

On This Page

≥2% of normal CD18-expressing polymorphonuclear neutrophils

Documentation required.

CD11a or CD11b level: Patient has less than 2% of normal CD11a- or CD11b-expressing polymorphonuclear neutrophils.<2% of normal CD11a- or CD11b-expressing polymorphonuclear neutrophils

Documentation required.

HSCT appropriateness: According to the prescribing physician, hematopoietic stem cell transplantation is appropriate for the patient.
HLA-matched sibling donor status
- No matched sibling donor: Patient does not have an HLA-matched sibling donor.
- Matched donor unavailable: Patient has an HLA-matched sibling donor, but the individual is unable or unwilling to donate.

Severe LAD-I diagnosis

ITGB2 variants: Documented biallelic pathogenic or likely pathogenic variants in the ITGB2 gene.Biallelic pathogenic or likely pathogenic ITGB2 variants
Documentation required.
Flow-cytometry severity
- CD18 criterion: Patient has less than 2% of normal CD18-expressing polymorphonuclear neutrophils as assessed by flow cytometry.<2% of normal CD18-expressing polymorphonuclear neutrophils
  Documentation required.
- CD18 plus CD11a/CD11b criterion
  - CD18 level: Patient has at least 2% of normal CD18-expressing polymorphonuclear neutrophils.≥2% of normal CD18-expressing polymorphonuclear neutrophils
  - CD11a or CD11b level: Patient has less than 2% of normal CD11a- or CD11b-expressing polymorphonuclear neutrophils.<2% of normal CD11a- or CD11b-expressing polymorphonuclear neutrophils

Clinical, prescriber, and dosing requirements

Infection status: According to the prescribing physician, patient does not have an active bloodstream infection or other serious, untreated infection.No active bloodstream infection or serious untreated infection
Qualified prescriber: Medication is prescribed by a hematologist, stem cell transplant physician, or pediatric immunologist with expertise in inborn errors of immunity.
Recent body weight: Current patient body weight has been obtained within the past 30 days.Weight obtained within 30 days
Documentation required.
Dose and administration: Administer one intravenous dose containing a minimum of 2.8 × 10^6 CD34+ cells/kg of body weight.Minimum 2.8 × 10^6 CD34+ cells/kg
Dose verification required.

All approvals and denials are forwarded to the Medical Director for evaluation. For clients with Embarc Benefit Protection, incomplete Embarc reviews must be routed to Embarc@EviCore.com before the Medical Director completes the review; forward approvals and denials as required.

Documentation Required

Required Clinical Documentation

Submit patient-specific documentation supporting the applicable coverage criteria. Documentation may include chart notes, laboratory or other medical test results, claims records, prescription receipts, and other relevant information.

All documentation must include patient-specific identifying information.

Documentation Required

Genetic and Flow-Cytometry Evidence

Document the genetic and flow-cytometry findings confirming severe leukocyte adhesion deficiency-I.

Biallelic pathogenic or likely pathogenic variants in the ITGB2 gene.
Less than 2% of normal CD18-expressing polymorphonuclear neutrophils; or at least 2% CD18-expressing cells with less than 2% of normal CD11a- or CD11b-expressing cells, as assessed by flow cytometry.

Documentation Required

Recent Body Weight

Document the patient's current body weight obtained within the preceding 30 days.

Documentation Required

Dose Verification

Provide documentation supporting the weight-based dose and the required minimum cell dose for the one-time intravenous infusion.

Minimum dose: 2.8 × 10⁶ CD34+ cells/kg of body weight.
Weight-based dosing requires Medical Director verification.

Denial Risk

Noncovered Circumstances

Coverage is not recommended for the following circumstances: prior receipt of gene therapy, leukocyte adhesion deficiency-II or -III, or circumstances not listed in the Recommended Authorization Criteria.

LAD-II and LAD-III are caused by genetic variants other than ITGB2 and are not expected to respond to Kresladi.
Criteria may be updated as new published data become available.

Denial Risk

Active or Untreated Infection

The prescribing physician must confirm that the patient does not have an active bloodstream infection or another serious, untreated infection.

Denial Risk

Age and Diagnostic Criteria

The patient must be younger than 18 years and have severe leukocyte adhesion deficiency-I confirmed by the required genetic and diagnostic findings.

Documented biallelic pathogenic or likely pathogenic ITGB2 variants are required.
Qualifying flow-cytometry findings must meet the CD18, CD11a, or CD11b thresholds.

Denial Risk

Prior Kresladi Use

Verify that the patient has not previously received Kresladi. If claims history is unavailable or shows no Kresladi claims, the prescribing physician must confirm that the patient has not received it previously.

Diagnostic confirmationMolecular genetic testing in conjunction with flow cytometry is considered ideal for confirming LAD-I; confirmatory ITGB2 testing is mandatory before Kresladi gene therapy.

Kresladi

Therapy typeAutologous hematopoietic stem cell-based gene therapy.

AdministrationAdministered by intravenous infusion.

Treatment scheduleOne-time, single-dose treatment for autologous use.