Medicare AdvantagePrior AuthMedium impact
Exondys 51 (eteplirsen) (Revised)
Humana·KY, SC · Neurology, Pediatrics·Medicaid
Effective date
Jan 1, 2022
We identified it
Jun 25, 2026
Summary
Humana revised its Exondys 51 (eteplirsen) prior authorization policy effective January 1, 2022, with the most recent revision dated December 17, 2025. This policy establishes strict prior authorization requirements for this rare disease therapy used to treat Duchenne Muscular Dystrophy (DMD), requiring confirmation of exon 51-amenable mutations, specialist prescription, baseline ambulatory function testing, and corticosteroid stability before initial approval. Renewal requires documented improvement or maintenance of ambulatory function compared to predicted disease progression.
Action Required
By January 15, 2026: Billing and prior authorization teams must implement the revised Exondys 51 policy across all affected plans (Medicare, Medicaid-Kentucky, Medicaid-South Carolina). Update authorization systems to enforce all six initial approval criteria (DMD diagnosis, exon 51-amenable mutation confirmation, neurologist/DMD specialist prescription requirement, baseline corticosteroid stability or documented contraindication/intolerance, ambulatory status at initiation, and baseline functional assessment documentation including 6MWT, 10MWT, or NSAA). For renewal requests, configure systems to verify improvement or maintenance of ambulatory function versus predicted natural disease progression. Train authorization staff to request baseline functional assessment documentation from providers during initial authorization requests. Ensure claims are denied if initial criteria are not met or renewal criteria cannot be verified. Coordinate with providers and specialty pharmacies dispensing Exondys 51 to ensure they understand new documentation requirements before submitting authorization requests.