Medicare AdvantagePrior AuthMedium impact
Elevidys (delandistrogene moxeparvovec-rokl) (Revised)
Humana·FL, KY, SC · Neurology, Genetics, Pediatrics·Medicaid
Effective date
Dec 17, 2025
We identified it
Jun 25, 2026
Summary
Humana revised its Elevidys (delandistrogene moxeparvovec-rokl) prior authorization policy effective December 17, 2025, for a gene therapy treatment of Duchenne Muscular Dystrophy. The policy requires comprehensive prior authorization with 11 strict clinical criteria including DMD diagnosis confirmation, ambulatory status verification via NSAA assessment, specific genetic testing, baseline lab work, antibody titers, and exclusions for prior gene therapy or antisense oligonucleotide use. Coverage is limited to a single lifetime dose with initial 6-month approval and one 6-month renewal.
Action Required
By December 17, 2025: Billing team must implement prior authorization workflow for Elevidys claims across Medicare, Medicaid-Florida, Medicaid-Kentucky, and Medicaid-South Carolina plans. Providers prescribing Elevidys must submit: (1) DMD gene mutation confirmation with exclusion of exon 8/9 deletions, (2) NSAA results within 6 months showing score ≥1, (3) baseline liver function tests (AST, ALT, bilirubin), (4) baseline troponin-I levels, (5) anti-AAVrh74 antibody titer results <1:400, and (6) documentation of corticosteroid tolerance and absence of cardiovascular impairment, liver impairment, active hepatic viral infection, and prior DMD-directed antisense oligonucleotide use within 7 days. Update billing system to flag Elevidys claims as requiring prior authorization and to enforce the single lifetime dose limit with tracking across renewal periods. Train billing and prior auth staff on the 11 clinical criteria requirements. Create internal checklist for front-line staff to ensure all required documentation is collected before submission. Failure to obtain prior authorization will result in claim denials.