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Etranacogene Dezaparvovec-drlb (Hemgenix) (CPB 1023, reviewed 2026-04-17)
Effective date
Not stated in the notice
Identified
Aug 13, 2026
Summary
Aetna's Clinical Policy Bulletin 1023 covers Hemgenix (etranacogene dezaparvovec-drlb) for commercial plans as one dose total for hemophilia B in members 18 or older who meet the listed criteria. Precertification is required for all Aetna participating providers and members in applicable plan designs, and gene therapies must be given at an Aetna Institutes GCIT Network unless the member's health plan has elected not to require it. The medication must be prescribed by or in consultation with a hematologist, and it is given as a single intravenous infusion at 2 x 10^13 genome copies per kg of body weight.
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What to do
Action · 7 steps
01Before scheduling the infusion: Get precertification by calling (866) 752-7021 or faxing (888) 267-3277, and use the Statement of Medical Necessity forms under Specialty Pharmacy Precertification where applicable.
02Providers: Confirm the infusion will be given at an Aetna Institutes GCIT Network site, unless the member's health plan has elected not to require it, and confirm the prescriber is a hematologist or is consulting with one.
03Before treatment, document that the member is 18 or older, has a negative Factor IX inhibitor test within the past 30 days, has no history of Factor IX inhibitors of 0.6 Bethesda units or more, has severe or moderately severe Factor IX deficiency (2% or less of normal), has at least 150 exposure days of prophylactic Factor IX use, and has platelets of at least 50,000 cells/microL.
04Document a hepatic ultrasound and/or elastography, and document that ALT, AST, ALP, total bilirubin and creatinine are not above 2 times the upper limit of normal, that there is no current unstable liver or biliary disease, that there is no active hepatitis B or C infection and no antiviral therapy for prior exposure, and that the member has no uncontrolled HIV (CD4 of 200 or less or viral load above 20 copies/mL).
05Document that the member has not received Hemgenix or any other gene therapy before.
06Billing team: Bill J1411 per therapeutic dose when the criteria are met.
07Providers: Attest that liver enzymes and Factor IX activity will be followed per the prescribing information after the infusion, and do not give routine Factor IX prophylaxis after Hemgenix once adequate Factor IX levels are reached.
Codes mentioned
J1411D677670076705769818007685250853358636187536912009636596368
Original notice
Etranacogene Dezaparvovec-drlb (Hemgenix) (CPB 1023, reviewed 2026-04-17)
aetna.com · Always check the source before changing claims.
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