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Gene-Based Therapy for Duchenne Muscular Dystrophy (DMD) (CPB 0911, reviewed 2026-08-05)
Effective date
Not stated in the notice
Identified
Aug 15, 2026
Summary
Aetna's commercial policy requires precertification for casimersen (Amondys 45), delandistrogene moxeparvovec-rokl (Elevidys), eteplirsen (Exondys 51), golodirsen (Vyondys 53) and viltolarsen (Viltepso), and sets initial and continuation criteria for each. On November 14, 2025, the FDA approved new Elevidys labeling that adds a Boxed Warning for serious liver injury and acute liver failure, limits use to ambulatory patients aged four and older with a confirmed DMD gene mutation, and removes the indication for non-ambulatory patients.
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What to do
Action · 10 steps
01Billing team and providers: Before scheduling Amondys 45, Elevidys, Exondys 51, Vyondys 53 or Viltepso for a commercial member, obtain precertification by calling (866) 752-7021 or faxing (888) 267-3277, or use the Statement of Medical Necessity precertification forms.
02Include the genetic testing lab results in the clinical documentation sent for precertification review, since they are a required component of that documentation.
03Confirm the member meets the initial criteria for the specific drug: a DMD gene mutation amenable to that drug's exon skipping, treatment started before the age limit (before 14 for Amondys 45 and Exondys 51, before 16 for Vyondys 53, before 10 for Viltepso), and a dose not exceeding 30 mg/kg once weekly (80 mg/kg once weekly for Viltepso).
04Walking distance criteria are at least 300 meters over 6 minutes for Amondys 45, at least 180 meters for Exondys 51 and at least 250 meters for Vyondys 53, and Viltepso requires the member to walk independently without assistive devices.
05Golodirsen and viltolarsen may not be used concomitantly.
06For Elevidys, confirm the member is ambulatory, is 4 through 5 years old, has anti-AAVrh74 total binding antibody titers below 1:400, has no active infection, has no significant liver dysfunction, and does not have a deletion in exon 8 and/or exon 9 of the DMD gene.
07Elevidys must be administered at an Aetna Institutes GCIT Network unless the member's health plan has elected not to require this.
08Infusions of Amondys 45, Exondys 51, Vyondys 53 or Viltepso fall under the Site of Care Utilization Management Policy.
09For continuation requests, document a response to therapy showing the member remains ambulatory (able to walk with or without assistance, not wheelchair dependent) and that the dose does not exceed the limit.
10Members previously on Amondys 45, Exondys 51, Vyondys 53 or Viltepso who later received gene replacement therapy such as Elevidys must meet all initial criteria before restarting.
Codes mentioned
J1413J1426J1427J1428J1429G71.0181161
Original notice
Gene-Based Therapy for Duchenne Muscular Dystrophy (DMD) (CPB 0911, reviewed 2026-08-05)
aetna.com · Always check the source before changing claims.
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