CurrentEmblemHealthPolicy N/A

Lenmeldy (atidarsagene autotemcel) intravenous infusion — Coverage Criteria

Covers medical necessity and authorization criteria for a one-time autologous HSC-based gene therapy (Lenmeldy) for pediatric patients with specific forms of metachromatic leukodystrophy (MLD); applies to EmblemHealth members and providers submitting requests to EmblemHealth/ConnectiCare.

Policy Summary

PayerEmblemHealth

PolicyLenmeldy (atidarsagene autotemcel) IV infusion — Coverage Criteria

Policy CodePolicy N/A

Change TypeAnnual review — no criteria changes

Effective DateN/A

Next Review DateMar 21, 2025

Key ActionSubmit prior authorization with clinical evidence documenting eligibility, diagnostic confirmation, infection screening, and absence of a matched related donor.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

one-timedose frequency

age <18age requirement

E75.25ICD-10

J3590procedure code

NDC 83222-0200-01product NDC

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Coverage Criteria for Lenmeldy (atidarsagene autotemcel)

Initial Therapy Criteria

Covered when ALL of the following are met:

Age and dosing

Dosing limits: Presymptomatic late infantile: minimum 4.2 x10^6 CD34+ cells/kg, maximum 30 x10^6 CD34+ cells/kg; Presymptomatic early juvenile: minimum 9 x10^6 CD34+ cells/kg, maximum 30 x10^6 CD34+ cells/kg; Early symptomatic early juvenile: minimum 6.6 x10^6 CD34+ cells/kg, maximum 30 x10^6 CD34+ cells/kg.see text
Single dose (once per lifetime)

Infection screening and vaccination timing: Patient is screened and found negative for HBV, HCV, HTLV-1/2, HIV-1/2, and mycoplasma prior to collection of cells for manufacturing; patient will not receive vaccinations during the 6 weeks preceding myeloablative conditioning and until hematologic recovery (where feasible give childhood vaccinations prior to conditioning); prophylaxis for infection will follow institutional guidelines; patients will not receive prophylactic HIV antiretroviral therapy for at least one month prior to mobilization.laboratory confirmation of negatives

Vaccination timing and ARV withholding per policy

Thrombosis, VOD evaluation and monitoring: Patient risk factors for thrombosis and veno-occlusive disease are evaluated prior to administration; patient will be monitored periodically for hematological malignancies after treatment.pre-administration risk assessment and monitoring plan

Mobilization and transplant history: Patient will undergo stem cell mobilization using G-CSF with or without plerixafor; patient has not received a prior allogeneic stem cell transplant (or, if received, has no evidence of residual donor cells) and is a candidate for autologous stem cell transplantation with adequate renal and hepatic function; patient does not have a known 10/10 HLA matched related donor willing to participate in allogeneic HSCT.documented mobilization and organ function; documentation that no willing 10/10 matched related donor exists

Prior treatments and therapy use: Lenmeldy is used as single-agent therapy (excluding busulfan conditioning regimen); patient has not received other therapy for MLD.no prior MLD therapies

Diagnostic confirmation of MLD: Either ARSA enzyme activity below the normal range in peripheral blood mononuclear cells–leukocytes or fibroblasts OR confirmed diagnosis of MLD evidenced by increased urinary sulfatides AND presence of biallelic ARSA pathogenic mutations (patients with novel mutations require elevated 24‑hour urinary sulfatide levels); AND patient phenotype is presymptomatic late infantile (PSLI), presymptomatic early juvenile (PSEJ), or early symptomatic early juvenile (ESEJ).biochemical and molecular confirmation per policy

Nested OR between enzyme assay and combined urinary/molecular testing

Coverage excludes patients who have a known 10/10 HLA matched related donor willing to participate in allogeneic HSCT. The initial criteria explicitly require documentation that the patient does not have such a donor prior to authorization for Lenmeldy treatment.

This policy does not contain explicit statements labeling any uses as “not medically necessary.” The policy was last reviewed in an annual review dated 03/21/2025 with the documented outcome: No criteria changes.

Relevant Billing and Diagnosis Codes

Applicable Procedure CodesHCPCSCovered

J3590

Unclassified biologics

Applicable NDCsNDCCovered

83222-0200-01

Lenmeldy Intravenous Suspension

ICD-10 DiagnosesICD-10

E75.25

Metachromatic Leukodystrophy

Authorization, Documentation, and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests for Lenmeldy (IV, one-time dose) must include documentation demonstrating the member meets all eligibility and safety criteria listed in the policy (including diagnostic confirmation, infection screening, thrombosis and VOD risk evaluation, vaccination and antiviral management, mobilization approach, transplant history, donor availability, and that no prior MLD therapy was received).

One-time IV administration (lifetime limit)
Documentation must show patient is < 18 years and meets all Initial Criteria in policy
Include pre-manufacturing infection screening and mobilization plan

Documentation Required

Exclusion / Therapy Sequencing

Patient must not have received any other therapy for MLD and must not have a willing 10/10 HLA-matched related donor available for allogeneic hematopoietic stem cell transplantation (HSCT). Lenmeldy is an autologous hematopoietic stem cell (HSC)-based gene therapy and is intended as single-agent therapy with the specified conditioning regimen.

Key Definitions

Lenmeldy — definition and indication summary for pediatric MLD

ProductLenmeldy (atidarsagene autotemcel)

Therapy typeAutologous hematopoietic stem cell (HSC)-based gene therapy

Indication (age and diseases)Treatment of children with pre-symptomatic late‑infantile (PSLI), pre‑symptomatic early‑juvenile (PSEJ), or early symptomatic early‑juvenile (ESEJ) metachromatic leukodystrophy (MLD)

AdministrationSingle IV infusion (one-time, administered as autologous HSC product)

Key diagnostic requirementDiagnosis of MLD with phenotype consistent with PSLI, PSEJ, or ESEJ (biochemical and/or molecular confirmation required per coverage criteria)

Background

Lenmeldy (atidarsagene autotemcel) is an autologous hematopoietic stem cell (HSC)-based gene therapyone-time IV infusion with dosing determined by CD34+ cells per kg within phenotype-specific ranges. Patients must meet diagnostic confirmation and safety screening requirements, including negative testing for HBV, HCV, HTLV-1/2, HIV-1/2, and mycoplasma prior to cell collection, and must be candidates for autologous stem cell transplantation.