MED.00146 Gene Therapy for Sickle Cell Disease

This policy addresses exagamglogene autotemcel, a one-time autologous gene therapy infusion for sickle cell disease. It is covered as medically necessary only when all criteria are met: confirmed SCD, age 12 or older, at least 4 severe vaso-occlusive crises in the prior 2 years, and failure or intolerance to hydroxyurea; gene therapy for SCD is investigational and not medically necessary when these criteria are not met. Key limitation: coverage is limited to a single infusion of exagamglogene autotemcel under the specified conditions.

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

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