CurrentViva HealthPolicy IC-0850

Kresladi (marnetegragene autotemcel) — Medical Necessity Criteria for Leukocyte Adhesion Deficiency‑I

Medical necessity criteria and prior authorization requirements for Kresladi (marnetegragene autotemcel) for treating severe Leukocyte Adhesion Deficiency-I (LAD‑I) in covered members; affects providers requesting prior authorization and utilization management staff.

Policy Summary

PayerViva Health

PolicyKresladi (marnetegragene autotemcel) — Medical Necessity Criteria for LAD‑I

Policy CodePolicy IC-0850

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization (granted for a single dose only) and submit required supporting clinical documentation via the PA portal or fax.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 doseinitial authorization quantity (single dose only)

2.8 x10^6recommended minimum infusion dose

CD18 <2%neutrophil marker threshold

D71.1covered ICD-10

J3590, C9399HCPCS codes listed

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Coverage Criteria for Kresladi (marnetegragene autotemcel)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Diagnosis and laboratory/genetic confirmation: Member has a confirmed diagnosis of severe LAD‑I defined by neutrophil CD18 expression <2% or CD11a and/or CD11b expression <2% (if CD18 ≥2%); documented biallelic ITGB2 mutations; and clinical history consistent with severe LAD‑I or a known family history.CD18 <2% or CD11a/CD11b <2%

Treatment candidacy and donor/HSCT status: Member is a candidate for autologous hematopoietic stem cell transplant (HSCT), has not had prior HSCT, and does not have a known and available suitable 10/10 HLA‑matched related donor willing to participate in an allogeneic HSCT.no prior HSCT; no suitable 10/10 HLA‑matched related donor

Pre‑procedural and safety requirements: Member will undergo mobilization with G‑CSF and plerixafor prior to apheresis; has no active or clinically significant systemic infection; will be monitored for infection and receive prophylactic antimicrobials per institutional guidelines; will be monitored for veno‑occlusive disease (including liver function tests during the first month post‑infusion); will be monitored for LVV‑mediated insertional oncogenic hematologic malignancies; will be monitored and managed for DMSO hypersensitivity during and after infusion; and has been screened and found negative for HIV using non‑PCR assays prior to mobilization and apheresis.HIV screening negative (non‑PCR); no active systemic infection

No prior gene therapy: Member has not received prior gene therapies for the treatment of LAD‑I, including marnetegragene autotemcel; retreatment with marnetegragene autotemcel is considered investigational and will be reviewed on a case‑by‑case basis.no prior gene therapy for LAD‑I

Dose and product restrictions: Authorization is limited to a single intravenous infusion for autologous use only; recommended minimum dose 2.8 × 10^6 CD34+ cells/kg, with a maximum of 1 dose up to 3.22 × 10^8 CD34+ cells per dose.single infusion; autologous only; ≤3.22 × 10^8 CD34+ cells per dose

Retreatment (repeat administration) with marnetegragene autotemcel is considered investigational and is not routinely authorized. Prior authorization is granted initially for ONE dose total and renewal is not permitted. Limited retreatment was reported for a single patient in the pivotal study, but available evidence is insufficient to establish safety and effectiveness of repeat administration; requests for retreatment will be reviewed on a case‑by‑case basis with supporting clinical documentation.

Members who have received prior gene therapy for LAD‑I, including prior administration of marnetegragene autotemcel, are excluded from routine coverage for an additional administration. Such retreatment is considered investigational and will be evaluated individually, taking into account the clinical circumstances and submitted documentation.

Coding and Billing

HCPCS CodesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals (Hospital Outpatient Use Only)

NDCNDC

83537-0034-xx

Kresladi 50 mL infusion bag and metal cassette (supplied in one or two infusion bags containing a frozen suspension of genetically modified autologous cells enriched for CD34+ cells with each infusion bag containing approximately 30 mL and is individually packed within an overwrap in a metal cassette for protection)

Covered Diagnosis CodesICD-10Covered

D71.1

Leukocyte adhesion deficiency

inv-07: Maximum units per dose — single dose maximum up to specified CD34+ cell count

Maximum units per doseAuthorization limited to a single dose with a cap of 1 dose up to 3.22 x 10^8 CD34+ cells per dose

Dose timingOne-time single intravenous infusion only (no repeat dosing authorized routinely)

Product useAutologous use only

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Validity

Prior authorization validity will be provided initially for ONE dose total. Renewal of prior authorization is NOT permitted. Retreatment with marnetegragene autotemcel is considered investigational; requests for retreatment will be reviewed on a case-by-case basis with full supporting documentation.

Initial authorization: ONE dose only
Renewal: NOT permitted
Retreatment: investigational; case-by-case review

Documentation Required

Documentation Submission Required

Submission of supporting clinical documentation (including but not limited to medical records, clinic notes, laboratory results, genetic/mutation testing, apheresis reports, and diagnostic reports) is REQUIRED for all prior authorization requests. Records must be uploaded via the prior authorization web portal or faxed. Failure to submit required documentation may result in denial due to inability to establish medical necessity.

Key Definitions

inv-14: Severe LAD‑I definition — neutrophil marker thresholds and genetic documentation requirements

Neutrophil marker thresholdsSevere LAD‑I defined by neutrophil CD18 expression <2% OR CD11a and/or CD11b expression <2% (if CD18 ≥2%)

Genetic documentationDocumented biallelic ITGB2 mutations are required

Clinical contextClinical history consistent with severe LAD‑I or a known family history must be present

inv-15: Recommended minimum single infusion dose — 2.8 × 10^6 CD34+ cells/kg

Recommended minimum infusion dose2.8 × 10^6 CD34+ cells/kg (single intravenous infusion)

Use restrictionsAutologous use only; one-time single-dose intravenous use only

Background

Leukocyte Adhesion Deficiency‑I (LAD‑I) is a rare, inherited disorder caused by biallelic ITGB2 mutations that result in markedly reduced neutrophil integrin expression and recurrent, potentially life‑threatening infections. Kresladi (marnetegragene autotemcel) is an autologous, lentiviral vector–modified CD34+ cell therapy intended as a one‑time intravenous infusion to correct the underlying defect in severe LAD‑I. Eligibility for therapy requires laboratory and genetic confirmation of severe LAD‑I, adherence to pre‑procedural mobilization and safety monitoring, and no prior gene therapy for LAD‑I; because evidence for repeat dosing is limited, use is restricted to a single autologous infusion with defined dosing parameters.

Policy Summary

PayerViva Health

PolicyKresladi (marnetegragene autotemcel) — Medical Necessity Criteria for LAD‑I

Policy CodePolicy IC-0850

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization (granted for a single dose only) and submit required supporting clinical documentation via the PA portal or fax.

SourceLink

On This Page

Include documentation of diagnosis and clinical course
Provide genetic and mutational testing results when applicable
Include lab results and apheresis/mobilization records
Upload via PA web portal or fax

Documentation Required

Pre‑ and Post‑Procedure Monitoring Documentation

For members with LAD‑I who meet clinical criteria, provide documentation of pre‑ and post‑procedure monitoring plans and results: mobilization with G‑CSF and plerixafor prior to apheresis (document dosing and dates); apheresis collection details including CD34+ cell yield (max 3.22 x10^8 CD34+ cells per dose); HIV screening results (use non‑PCR methods if prior LVV exposure possible); plan for withholding prophylactic ART for at least one month prior to mobilization when applicable; monitoring and management plans for infection, veno‑occlusive disease (including liver function tests during first month post‑infusion), DMSO hypersensitivity, and surveillance for LVV‑mediated insertional oncogenic hematologic malignancies.

Document G‑CSF and plerixafor mobilization (doses, dates)
Apheresis collection and CD34+ cell count (max 3.22 x10^8 CD34+ cells per dose)
HIV screening method and results (avoid PCR if prior LVV exposure)
Plan for holding prophylactic ART when applicable
Monitoring plans for infection, VOD (LFTs), DMSO reactions, and LVV surveillance

Documentation Required

Precedence of HSCT and Donor Availability

Member must be a candidate for autologous HSCT and have not had prior HSCT; AND there must be no known and available suitable 10/10 HLA‑matched related donor willing to proceed with allogeneic HSCT. Also document that the member has not received prior gene therapies for LAD‑I (including marnetegragene autotemcel).

Candidate for autologous HSCT and no prior HSCT
No available suitable 10/10 HLA‑matched related donor willing to proceed with allogeneic HSCT
No prior gene therapy for LAD‑I (e.g., marnetegragene autotemcel)

Pre-procedure confirmationConfirm autologous hematopoietic stem cell transplantation is appropriate before mobilization, apheresis, and conditioning