Medicare AdvantagePrior AuthMedium impact
Vyondys 53 (golodirsen) (Revised)
Humana·KY, SC · Neurology, Pediatrics, Genetics·Medicaid
Effective date
Jan 1, 2025
We identified it
Jun 25, 2026
Summary
Humana has updated its Vyondys 53 (golodirsen) prior authorization policy effective January 1, 2025, with a revision date of May 27, 2026. This policy applies to Medicare and Medicaid (Kentucky and South Carolina) and requires prior authorization for this antisense oligonucleotide therapy used to treat Duchenne Muscular Dystrophy in patients with exon 53-amenable mutations. Billing teams must implement prior authorization requirements and ensure all seven initial approval criteria and renewal criteria are documented and submitted before claims can be processed.
Action Required
REQUIREMENTS:
Immediate (effective 1/1/2025): Billing team must configure prior authorization system to require approval BEFORE dispensing or infusing Vyondys 53 (golodirsen) for all Medicare and Medicaid (KY, SC) members.
Specific actions:
1. Update billing software to flag all Vyondys 53 claims as requiring prior authorization before submission
2. Create prior authorization checklist for providers to ensure ALL seven initial criteria are documented and submitted:
- DMD diagnosis confirmed
- DMD gene mutation amenable to exon 53 skipping confirmed
- Prescribed by/in consultation with DMD specialist (neurologist)
- Member stable on baseline corticosteroids or has contraindication/intolerance
- Member ambulatory at initiation
- Baseline ambulatory function tests (6MWT, 10MWT, or NSAA) documented
- Confirmation drug will NOT be used with other exon 53 skipping therapies (Viltepso)
3. For continuation/renewal requests, billing team must verify member shows improvement or maintenance of improvement from predicted disease progression
4. Update referral templates and prior auth submission forms to capture all required documentation
5. Train billing and clinical staff on the seven approval criteria
6. Contact Humana's PAL portal (www.humana.com/PAL) for specific medical and procedural coding
Consequences: Claims submitted without prior authorization will be denied. Claims missing required documentation will be rejected and require resubmission.