Currentmoda_health_plan_incPolicy IC-0850

Kresladi (marnetegragene autotemcel) (Intravenous) — Coverage Criteria

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Defines prior authorization, dosing, eligibility, and monitoring requirements for coverage of Kresladi (marnetegragene autotemcel) for treatment of severe Leukocyte Adhesion Deficiency-I (LAD‑I) under Moda Health Plan Inc.

Policy Summary

Payermoda_health_plan_inc

PolicyKresladi (marnetegragene autotemcel) (Intravenous) — Coverage Criteria

Policy CodePolicy IC-0850

Change TypeNo material change

Effective Date

Last ReviewMay 5, 2026

Next Review DateMay 5, 2026

Key ActionObtain prior authorization for a single-dose administration 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 provided for

norenewal allowed

2.8 x 10^6recommended minimum dose

3.22e8maximum units per dose

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Currentmoda_health_plan_incPolicy IC-0850

Kresladi (marnetegragene autotemcel) (Intravenous) — Coverage Criteria

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Policy Summary

Payermoda_health_plan_inc

PolicyKresladi (marnetegragene autotemcel) (Intravenous) — Coverage Criteria

Policy CodePolicy IC-0850

Change TypeNo material change

Effective Date

Last ReviewMay 5, 2026

Next Review DateMay 5, 2026

Key ActionObtain prior authorization for a single-dose administration 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 provided for

norenewal allowed

2.8 x 10^6recommended minimum dose

3.22e8maximum units per dose

Coverage Criteria for Kresladi (marnetegragene autotemcel)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Confirmed diagnosis: Member has a confirmed diagnosis of severe LAD-I defined as all of the following: neutrophil CD18 expression <2% or CD11a and/or CD11b expression <2% (if neutrophil CD18 expression >=2%); documented biallelic ITGB2 mutations; clinical history consistent with severe LAD-I or known family history.

HSCT candidacy and prior treatments: Member is a candidate for autologous hematopoietic stem cell transplant (HSCT) and has not had prior HSCT; member does not have a known and available suitable 10/10 HLA-matched related donor willing to participate in an allogeneic HSCT; member has not received prior gene therapies for LAD-I including marnetegragene autotemcel.

Pre-apheresis and mobilization: Member will undergo mobilization with granulocyte-colony-stimulating factor (G-CSF) and plerixafor prior to apheresis.

Infection and monitoring: Member has no active or clinically significant systemic infection and will be monitored for signs and symptoms of infection before and after infusion, with prophylactic antimicrobials administered per institutional guidelines.

Safety monitoring: Member will be monitored for signs and symptoms of veno-occlusive disease including assessment of liver function tests during the first month following infusion; will be monitored for LVV-mediated insertional oncogenic hematologic malignancies as clinically indicated; and will be monitored and managed for severe hypersensitivity reactions to dimethyl sulfoxide (DMSO).

HIV screening & ART guidance: Member has been screened and found negative for HIV in accordance with clinical guidelines prior to mobilization and apheresis (members who have received Kresladi may test positive by PCR assays due to LVV provirus insertion and should not be screened using PCR-based assays after receipt); member will not receive prophylactic HIV antiretroviral therapy (ART) (members receiving prophylactic ART should stop therapy at least one month prior to mobilization, or for the expected duration required for elimination of the medications, until all cycles of apheresis are completed).

Renewal/Retreatment — Renewal considered only if duration of authorization has not been exceeded; routine renewals not permitted

Renewal considered only if duration of authorization has not been exceeded; routine renewals not permitted

Renewal: Duration of authorization has not been exceeded (initial authorization is for one dose); prior authorization validity may not be renewed. Retreatment is considered investigational and requests for retreatment will be reviewed on a case-by-case basis.

Members who have a known and available suitable 10/10 HLA‑matched related donor willing to participate in an allogeneic hematopoietic stem cell transplant are excluded from coverage for Kresladi (marnetegragene autotemcel). Additional exclusion criteria include prior receipt of gene therapies for LAD‑I, including prior treatment with marnetegragene autotemcel.

Retreatment with marnetegragene autotemcel is considered investigational due to insufficient evidence to establish the safety and effectiveness of repeat administration. Although limited retreatment was reported for a single patient in the pivotal study, requests for retreatment will be reviewed case‑by‑case, with decisions based on the totality of clinical circumstances and supporting documentation.

Coding, Dosing, and Quantity Limits

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 NDC

Covered Diagnosis CodesICD-10Covered

D71.1

Leukocyte adhesion deficiency

inv-08: Dose and maximum units

Recommended minimum doseSingle intravenous infusion of 2.8 x 10^6 CD34+ cells/kg (autologous use only; one-time single-dose)

Dose administration notesConfirm autologous HSCT appropriateness before mobilization, apheresis, and conditioning; consider administering ustekinumab prior to mobilization/apheresis or infusion

Vaccination guidanceAvoid vaccination during the 6 weeks prior to myeloablative conditioning and until hematologic recovery after treatment

Biosafety/handlingKresladi contains LVV-modified human blood cells; follow universal precautions and institutional biosafety guidelines for handling and disposal

inv-18: Kresladi (marnetegragene autotemcel)

Provider Actions, Authorization and Documentation Requirements

Prior Authorization

Prior authorization required — single-dose initial authorization

Prior authorization is required for Kresladi; initial authorization will be provided for ONE dose total and prior authorization validity may NOT be renewed. Requests for retreatment are considered investigational and will be reviewed on a case-by-case basis.

Step Therapy

Pre-treatment and HSCT candidacy requirements

Member must be a candidate for autologous HSCT, have not had prior HSCT, have no known and available suitable 10/10 HLA-matched related donor willing to participate in allogeneic HSCT, and must undergo mobilization with G-CSF and plerixafor prior to apheresis. Members must have no active or clinically significant systemic infection and will require monitoring for infection, VOD, LVV-mediated insertional oncogenesis, and DMSO hypersensitivity per institutional practice.

Autologous HSCT candidacy and no prior HSCT
No suitable 10/10 HLA-matched related donor available/willing for allogeneic HSCT

Definitions

inv-14: Severe Leukocyte Adhesion Deficiency‑I

DefinitionSevere Leukocyte Adhesion Deficiency‑I (LAD‑I): confirmed diagnosis defined by neutrophil CD18 expression <2% or CD11a and/or CD11b expression <2% (if neutrophil CD18 ≥2%), documented biallelic ITGB2 mutations, and clinical history consistent with severe LAD‑I or known family history

Treatment contextIndication for Kresladi when member is a candidate for autologous HSCT, has not had prior HSCT, and lacks a known suitable 10/10 HLA‑matched related donor willing to proceed with allogeneic HSCT

Screening and monitoringMembers must be screened negative for HIV prior to mobilization and apheresis; monitor for infection, veno-occlusive disease, LVV-mediated insertional oncogenesis, and DMSO hypersensitivity

Initial Therapy Criteria (detailed)

Initial Therapy — detailed initial therapy criteria

Initial therapy criteria

Indication and diagnostics: Confirmed severe LAD‑I with required genetic and flow cytometry markers: neutrophil CD18 expression <2% or CD11a and/or CD11b expression <2% (if neutrophil CD18 expression >=2%); documented biallelic ITGB2 mutations; and clinical history consistent with severe LAD‑I or known family history.

Treatment logistics: Autologous use only, single-dose intravenous infusion; member must undergo mobilization with G-CSF and plerixafor prior to apheresis and conditioning per HSCT protocols. Consider administering ustekinumab prior to mobilization and/or infusion as per product information.

Consider administering ustekinumab prior to mobilization and/or infusion as per product information.

Safety monitoring: Monitor for infection before and after infusion with prophylactic antimicrobials per institutional guidelines; monitor for veno-occlusive disease with liver function tests during the first month post-infusion; monitor for LVV-mediated insertional oncogenic hematologic malignancies as clinically indicated; follow institutional biosafety guidelines for handling genetically modified cells; avoid vaccination during the 6 weeks prior to the start of myeloablative conditioning and until hematologic recovery.

Continuation / Retreatment Criteria

Continuation/Retransplant — continuation or retreatment rules

Continuation or retreatment

Continuation: Authorization is single-dose only; renewals are not permitted and retreatment is considered investigational and will be evaluated on a case-by-case basis.

Step Therapy and Preconditions

Step	Requirement
1
Member must be a candidate for autologous hematopoietic stem cell transplant (HSCT) and have not had prior HSCT; member must not have a known and available suitable 10/10 HLA‑matched related donor willing to participate in an allogeneic HSCT.

Site of Care Considerations

Billing Rule

Hospital outpatient site of care and HCPCS billing

Kresladi is intended for hospital outpatient delivery given the HCPCS hospital outpatient code listing and requirements for HSCT-related procedures and monitoring.

HCPCS codes: J3590, C9399
HSCT-related procedures and monitoring required (mobilization, apheresis, conditioning, infusion, post‑infusion monitoring)

Background

Kresladi (marnetegragene autotemcel) is an autologous, ex vivo gene‑modified hematopoietic stem cell product intended as a one‑time intravenous treatment for severe Leukocyte Adhesion Deficiency‑I (LAD‑I). Treatment requires that the member be a candidate for autologous HSCT and involves mobilization with granulocyte‑colony‑stimulating factor (G‑CSF) and plerixafor followed by apheresis, conditioning, and single‑dose infusion with post‑procedure monitoring for infection, veno‑occlusive disease, lentiviral vector‑mediated insertional oncogenesis, and DMSO hypersensitivity.