MED.00148 Gene Therapy for Metachromatic Leukodystrophy

This policy addresses atidarsagene autotemcel, an ex vivo autologous gene therapy for metachromatic leukodystrophy (MLD). Coverage is medically necessary as a one-time infusion for individuals with confirmed MLD and biallelic ARSA pathogenic variants who are either pre-symptomatic late infantile (expected onset ≤30 months), pre-symptomatic early juvenile (expected onset >30 months and <7 years), or early symptomatic early juvenile (onset >30 months and <7 years). Gene therapy for MLD is investigational and not medically necessary when these criteria are not met or in any other situation.

"A one-time infusion of atidarsagene autotemcel is consideredmedically necessaryin individuals who meetallof the following criteria:"

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