MED.00140 Gene Therapy for Beta Thalassemia

This policy addresses gene therapy for beta thalassemia, specifically a one-time infusion of betibeglogene autotemcel. It is covered as medically necessary only when all criteria are met: confirmed beta thalassemia; transfusion-dependent disease (≥8 transfusions or ≥100 mL/kg/year over the prior 2 years); the individual is a candidate for allogeneic hematopoietic cell transplantation but lacks an available donor; and no evidence of severe iron overload (e.g., per cardiac MRI/T2*). Gene therapy for beta thalassemia is investigational and not medically necessary when these criteria are not met.

"A one-time infusion of betibeglogene autotemcel is consideredmedically necessaryin individuals whenallof the following criteria are met:"

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