Atidarsagene autotemcel (Lenmeldy) — Medical Coverage Policy
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Defines coverage and prior authorization requirements for atidarsagene autotemcel (Lenmeldy) for treatment of metachromatic leukodystrophy (MLD) in pediatric patients; applies when member benefits include the drug per plan documents.
No material clinical or coverage changes in this revision.
Coverage Criteria for Atidarsagene Autotemcel (Lenmeldy)
Initial Treatment Criteria
Covered when ALL of the following are met
Only one lifetime treatment is considered medically necessary; repeat administration is experimental/investigational.
Diagnosis of early symptomatic late infantile, late juvenile, or adult MLD is an explicit exclusion for coverage under these criteria. Members with these diagnoses do not meet the policy’s initial treatment criteria and are not eligible for atidarsagene autotemcel under this coverage guidance.
Repeat administration of atidarsagene autotemcel is considered experimental and investigational and therefore not medically necessary. Baylor Scott & White Health Plan authorizes only one treatment per lifetime; effectiveness of repeat dosing has not been established.
Relevant Procedure and Diagnosis Codes
| 96365 | Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour |
| 96366 | Intravenous infusion; each additional hour |
| 96413 | Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug |
| 96415 | Chemotherapy administration, intravenous infusion technique; each additional hour |
| J3391 | Injection, atidarsagene autotemcel, per treatment |
| E75.25 | Metachromatic leukodystrophy |
Provider Requirements, Prior Authorization, and Denial Risks
Provider prescribing and treatment logistics
Medication must be prescribed by or in consultation with a pediatric neurologist or MLD specialist; provider must attest the member will receive treatment at a qualified treatment center and that the member is an appropriate candidate for apheresis.
- Prescribing physician: pediatric neurologist or specialist in MLD
- Attestation: treatment at a qualified treatment center
- Assessment: documented apheresis candidacy
Required clinical documentation to support medical necessity
Documentation submitted with prior authorization must demonstrate diagnostic confirmation of MLD and relevant clinical assessments.
- ARSA enzyme activity below the normal range in peripheral blood mononuclear cells or fibroblasts
- Presence of sulfatides in a 24-hour urine collection
- ARSA genotype consistent with the required MLD subtype (two null alleles for PSLI; one null and one residual allele for early juvenile)
- Neurologic status and, when applicable, IQ (≥85) and ambulatory ability (independent walking ≥10 steps)
- Documentation of apheresis candidacy and treatment center attestation
- Absence of excluded infections/conditions per policy
Repeat treatment denial risk — only one lifetime treatment allowed
Only one atidarsagene autotemcel treatment per member is considered medically necessary; requests for repeat administration will be denied as experimental/investigational.
- BSWHP considers only one treatment per lifetime medically necessary
- Repeat administration is labeled experimental and investigational and not covered
Non-MLD indications will be denied
Requests for use of atidarsagene autotemcel for indications other than metachromatic leukodystrophy (MLD) will be considered experimental and investigational and denied.
- Treatment for all other indications is considered experimental and investigational by BSWHP
Background on Metachromatic Leukodystrophy (MLD)
Metachromatic leukodystrophy (MLD) is an autosomal recessive lysosomal storage disease caused by defects in the ARSA gene leading to deficient arylsulfatase A activity and accumulation of sulfatides, which produce progressive central and peripheral demyelination with cognitive and motor decline. MLD is classified by age of onset (late infantile, juvenile, adult) and clinical course; atidarsagene autotemcel is an autologous hematopoietic stem/progenitor cell (HSPC) gene therapy intended to restore ARSA activity. Policy coverage is limited to specific early forms of MLD and requires specialist involvement, apheresis candidacy, treatment at a qualified center, and absence of listed infectious, hematologic, neoplastic, prior-treatment, or rapid-decline exclusionary conditions.
Definitions and Phenotype Categories
Policy Dates and Revision History
Policy became effective with coverage criteria defining prior authorization requirements and clinical eligibility for atidarsagene autotemcel (Lenmeldy).
Policy last reviewed; clarified one treatment per lifetime authorized and simplified the background section.
Updated HCPCS code and removed Medicare NCD/LCD InterQual statement for clarity.
Updated treatment center criteria to attestation only, made minor formatting changes, and updated ending note sections to align with CMS requirements and business entity changes.
Policy created as a new medical coverage policy for atidarsagene autotemcel (Lenmeldy).
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