MED.00135 Gene Therapy for Hemophilia

This policy addresses gene therapy for hemophilia, specifically etranacogene dezaparvovec-drlb for individuals with hemophilia B. It is medically necessary only when all are met: confirmed hemophilia B, age 18 or older, baseline factor IX <1 IU/dL, and no infusion contraindications (including active infection, immunosuppressive disorder, liver cirrhosis, active hepatitis B/C, ALT/bilirubin/alkaline phosphatase >3× ULN, INR >1.4, or prior hemophilia B gene therapy). Gene therapy for hemophilia that does not meet these criteria, and all other uses, is considered investigational and not medically necessary.

"Etranacogene dezaparvovec-drlb is consideredmedically necessaryin individuals who meetallof the following criteria:"

Sign up to see full coverage criteria, indications, and limitations.