CommercialPrior AuthMedium impact
Atidarsagene Autotemcel (LENMELDY™)
BCBS Tennessee·TN · Pediatrics, Genetics, Neurology·Medical Policy
Effective date
Dec 1, 2026
We identified it
Sep 10, 2026
Summary
BlueCross BlueShield of Tennessee is introducing a new medical policy for Atidarsagene Autotemcel (LENMELDY™), a gene therapy for metachromatic leukodystrophy in pediatric patients. The policy establishes coverage criteria requiring prior authorization for one-time administration, specific diagnostic confirmation (ARSA gene variants, biochemical testing, MLD classification), infectious disease screening, and long-term monitoring protocols.
Action Required
By November 15, 2026 (before effective date): Billing and clinical teams must prepare to implement this policy. (1) Providers: Identify and document all pediatric MLD patients who may be candidates; ensure geneticists/metabolic specialists perform ARSA gene testing, arylsulfatase A activity testing, and urine sulfatide analysis per documentation requirements. (2) Prior Authorization team: Create prior auth workflows requiring submission of genetic testing results, biochemical confirmation, MLD classification documentation (PSLI/PSEJ/ESEJ), baseline liver/renal function tests, infectious disease serology (HIV-1/HIV-2, HBV, HCV, HTLV-1/HTLV-2, mycoplasma), and thrombotic risk assessment. (3) Billing team: Add LENMELDY authorization requests to the system with 3-month approval window for one-time administration; flag claims for patients with prior gene therapy or allo-HSCT within past 6 months for denial. (4) All staff: Note the prescriber specialty requirement—this drug must be prescribed by or in consultation with an MLD specialist. Failure to obtain prior authorization before administration will result in claim denials; claims without complete documentation of MLD type, ARSA variants, and biochemical confirmation will be rejected.