CommercialPrior AuthHigh impact
Atidarsagene Autotemcel (Lenmeldy) (CPB 1058, reviewed 2026-07-13)
Aetna·Genetics, Pediatrics, Neurology +2 more·Medical Policy
Effective date
Jul 13, 2026
We identified it
Aug 12, 2026
Summary
Aetna has established a new clinical policy (CPB 1058) for Lenmeldy (atidarsagene autotemcel), a gene therapy for metachromatic leukodystrophy. The policy requires precertification for all commercial plans, mandates treatment at Aetna GCIT Network facilities, and establishes strict medical necessity criteria including diagnosis confirmation, genetic testing, infectious disease screening, and 15-year post-treatment monitoring. Billing teams must implement prior authorization processes and ensure claims are routed through designated network providers.
Action Required
IMMEDIATE: Billing team must implement mandatory precertification process for all Lenmeldy (atidarsagene autotemcel) claims. Contact National Medical Excellence (NME) at 877-212-8811 for all prior authorization requests before any Lenmeldy-related services are rendered. Update billing software to flag CPT code 38204, 38205, 38206 (stem cell harvesting), 81405 (ARSA genetic testing), 84392 (urine sulfatide testing), 95860-95913 (electroneurography/nerve conduction studies), and HCPCS J3391 (Lenmeldy infusion) as requiring precertification for Aetna commercial plans. Implement network validation: ensure all Lenmeldy administrations occur at Aetna Institutes GCIT Designated Network facilities (verify on Aetna Institutes GCIT Network list before scheduling). Educate providers that prescribing physicians must specialize in metachromatic leukodystrophy treatment. Configure system to deny or flag claims for ICD-10 E75.25 (MLD) if provider is not network-designated GCIT facility. Document that patients must meet ALL criteria: diagnosis confirmation via ARSA genetic testing, biochemical ARSA activity below normal range, two disease-causing ARSA alleles identified, negative HIV/HBV/HCV/HTLV/mycoplasma serology, no prior gene therapy or Lenmeldy, and baseline assessment of thrombotic risk, liver/renal function. Establish post-treatment monitoring requirement tracking: patients require annual hematologic malignancy monitoring (CBC with differential), integration site analysis as warranted, and monitoring for at least 15 years post-infusion. Failure to obtain precertification will result in claim denials. Verify network status before authorization approval.