Single-dose injection of etuvetidigene autotemcel gene therapy per treatment course

Etuvetidigene autotemcel (Lenmeldy) is an autologous hematopoietic stem cell gene therapy indicated for the treatment of metachromatic leukodystrophy (MLD) in pediatric patients with pre-symptomatic late infantile, pre-symptomatic early juvenile, or early symptomatic early juvenile forms of the disease. This code captures a single administration of this one-time gene therapy, which involves infusion of the patient's own CD34+ hematopoietic stem cells transduced with a lentiviral vector encoding the ARSA gene. The therapy corrects the underlying arylsulfatase A (ARSA) enzyme deficiency responsible for MLD.

This code applies when a patient receives a complete infusion of etuvetidigene autotemcel as part of a single-course gene therapy treatment, typically administered in an inpatient hospital setting following myeloablative conditioning. Supporting documentation should include the confirmed MLD diagnosis (with ARSA enzyme activity and/or genetic testing results), patient age and disease stage classification, and the infusion administration record. Because this is a per-treatment code, it is reported once per course of therapy regardless of infusion duration.

• Payer prior authorization is virtually universal for this therapy given its status as one of the most expensive gene therapies available; confirm authorization before claim submission and retain all supporting clinical documentation.
• Do not confuse with other gene therapy or hematopoietic stem cell infusion codes; this code is product-specific to etuvetidigene autotemcel and should not be used for allogeneic stem cell transplants or other lysosomal storage disorder therapies.
• Separately report the administration/infusion service using the appropriate CPT infusion code, as this HCPCS code captures only the drug/product cost; verify whether the payer bundles or separately adjudicates the administration component in the inpatient versus outpatient setting.