CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Lenmeldy Treatment Policy

Coverage policy for Lenmeldy (atidarsagene autotemcel) for Medicaid, Commercial, and Medicare members governing initial authorization, dosing limits, clinical eligibility for metachromatic leukodystrophy (MLD) subtypes, and billing codes; applies when no applicable Medicare NCD/LCD supersedes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLenmeldy Treatment Policy

Policy CodePolicy N/A

Change TypeClarified review dates

Effective Date11/01/2024

Next Review Date

Key ActionSubmission of medical records (chart notes) related to the medical necessity criteria is REQUIRED on all requests for authorizations; documentation must include diagnosis, genetic/mutational testing, and relevant clinical markers.

SourceLink

POLICY UPDATE CHANGES

Review dates listed (08/28/2024, 06/25/2025) and effective date set to 11/01/2024; policy applies to Medicaid, Commercial, Medicare.

1Authorized treatment courses per member

E75.25Covered ICD-10 code

J3391HCPCS code for billing

83222-0200-xxProduct NDC

Coverage Summary

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Lenmeldy (atidarsagene autotemcel) is covered with criteria for treatment of pediatric metachromatic leukodystrophy (MLD) subtypes under this policy. The scope includes Medicaid, Commercial, and Medicare members. The policy effective date is 2024-11-01. Coverage is limited to one treatment course (1 dose) and may not be renewed.

Key thresholds and quick facts

Age< 18 years

GMFCMLD score≤1

IQ≥85

Authorized treatment courses per member1

Maximum dose (all subtypes)30 x 10^6 (CD34+ cells/kg)

Covered ICD-10E75.25

HCPCS codeJ3391

Product NDC83222-0200-xx

Length of Authorization

Length of Authorization: Coverage will be provided for one treatment course (1 dose) and may not be renewed

Billing Rule

Single-dose treatment only

Coverage is provided for one treatment course (one dose) only and may not be renewed. Bill using HCPCS code J3391 per treatment.

Provider Actions and Documentation Requirements

Prior Authorization

Authorization required with medical records

Submission of medical records (chart notes) related to the medical necessity criteria is REQUIRED on all requests for authorizations. Records will be reviewed at time of submission and should include documentation related to diagnosis, genetic/mutational testing, and relevant clinical markers.

Documentation Required

Infection and screening documentation

Provide documentation of negative screening for HBV, HCV, HTLV-1/2, HIV1/2, and mycoplasma infection prior to collection of cells for manufacturing. Document vaccination timing (no vaccinations during the 6 weeks before myeloablative conditioning and until hematologic recovery; where feasible give childhood vaccinations beforehand), an institutional infection prophylaxis plan, evaluation of thrombosis and veno-occlusive disease (VOD) risk prior to administration, and a monitoring plan for hematological malignancies after treatment.

Documentation Required

Site and prescriber requirements

Lenmeldy must be prescribed by or in consultation with a neurologist, geneticist, hematologist, or oncologist and must be administered at a manufacturer‑approved Qualified Treatment Center (QTC).

Documentation Required

Transplant history documentation

Document that the patient has not received a prior allogeneic stem cell transplant, or if they have, provide evidence that no residual donor cells are present. Also document the patient is a candidate for autologous stem cell transplantation with adequate renal and hepatic function.

Clinical Evidence

37Treated patients across trials and expanded access (N=37)

2Single-arm clinical trials (NCT01560182, NCT03392987) + EU expanded access

PSLIPrimary demonstrated benefit: motor and survival benefits in pre-symptomatic late-infantile (PSLI)

Clinical evidence derives from two single-arm, open-label trials (NCT01560182 and NCT03392987) and a European Union expanded access program that evaluated Lenmeldy-treated patients (N=37) against external natural history cohorts. These studies showed benefits in motor function and survival for the pre-symptomatic late-infantile (PSLI) population, retained normal gait in evaluable pre-symptomatic early-juvenile (PSEJ) patients, and reported mixed outcomes in the early symptomatic early-juvenile (ESEJ) group with some motor/cognitive decline and deaths.

Background and Definitions

Lenmeldy is an autologous hematopoietic stem cell–based lentiviral gene therapy indicated for treatment of children with pre-symptomatic late-infantile (PSLI), pre-symptomatic early-juvenile (PSEJ), or early symptomatic early-juvenile (ESEJ) metachromatic leukodystrophy (MLD).

Term	Definition
QTC
Qualified Treatment Center (manufacturer approved site for administration)
GMFCMLD
Gross Motor Function Classification for Metachromatic Leukodystrophy
Null (0) and Residual (R) ARSA alleles
Genetic allele classifications used to describe ARSA mutation severity

Revision History

08/28/2024review

Document header lists a review date; no material clinical policy statement changes indicated.

11/01/2024effective

Policy effective date set to 11/01/2024; applies to Medicaid, Commercial, and Medicare.

06/25/2025reviewLatest

Document header lists a review date; no material clinical policy statement changes indicated.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyLenmeldy Treatment Policy

Policy CodePolicy N/A

Change TypeClarified review dates

Effective Date11/01/2024

Next Review Date

SourceLink

On This Page

OpenPayer

Lenmeldy Treatment Policy

Coverage Summary

Initial Therapy Criteria

Length of Authorization

Renewal Criteria

Applicable Codes

Provider Actions and Documentation Requirements

Clinical Evidence

Background and Definitions

Revision History