CommercialPrior AuthMedium impact
Fosdenopterin (Nulibry) (CPB 0991, reviewed 2026-03-27)
Aetna·Genetics, Neurology, Pediatrics +1 more·Medical Policy
Effective date
Mar 27, 2026
We identified it
Aug 15, 2026
Summary
Aetna has established new coverage criteria for Fosdenopterin (Nulibry) for molybdenum cofactor deficiency Type A, requiring precertification for all commercial plans. Coverage requires either confirmed genetic testing (MOCS1 mutation) or presumed diagnosis with pending genetic results and clinical symptoms. Continuation requires either genetic confirmation with <12 months therapy or ≥12 months therapy with documented clinical benefit.
Action Required
By March 27, 2026: Billing and prior authorization teams must implement the following for all Aetna commercial plan claims involving Fosdenopterin (Nulibry, J1809): (1) Require mandatory precertification before claim submission by contacting Aetna at (866) 752-7021 or faxing (888) 267-3277 with Statement of Medical Necessity forms; (2) Verify prescriber is a specialist in enzyme or metabolic disorders before processing; (3) Update billing system to flag claims requiring either genetic testing documentation of MOCS1 pathogenic variants OR both presumed MoCD Type A diagnosis with pending genetic results AND clinical evidence of encephalopathy, seizures, developmental delay, or abnormal amino acid levels; (4) For continuation authorizations, require either genetic confirmation with <12 months cumulative therapy OR ≥12 months therapy with documented clinical benefit (improvement, stabilization, or disease progression slowing); (5) Configure system to associate J1809 with CPT chemotherapy administration codes (96413-96417) and ICD-10 E72.19; (6) Denote all other indications as experimental/investigational. Update encounter forms and specialty pharmacy templates accordingly. Claims submitted without required precertification and documentation will be denied.