Etranacogene dezaparvovec-drlb

This policy covers etranacogene dezaparvovec‑drlb (Hemgenix), an FDA‑approved AAV gene therapy for treatment of severe or moderately severe congenital hemophilia B (factor IX deficiency) in adults. Coverage is limited to individuals ≥18 years assigned male at birth who require factor IX prophylaxis or have a history of life‑threatening or recurrent serious bleeding, have no detectable factor IX inhibitor, and undergo baseline liver assessment with recommended periodic post‑treatment monitoring. Major exclusions/requirements include significant liver disease, active hepatitis B/C or uncontrolled HIV, prior gene therapy, a single lifetime dose (minimum recommended 2×10^13 gc/kg), and applicability based on the member’s benefit plan and state rules.

"Coverage of FDA‑approved drugs when prescribed for a use recognized as safe and effective in one or more standard medical reference compendia adopted by the U."