Rozanolixizumab-noli (Rystiggo) (CPB 1035, reviewed 2026-08-11)

By 2026-08-11, implement the following: (1) Billing team must configure system to require precertification for all Rystiggo claims using J9333 prior to claim submission; (2) Update authorization protocols to require neurologist prescription verification and documented AChR/MuSK antibody positivity, MGFA classification II-IV, and MG-ADL score ≥5 per policy criteria; (3) Configure system to deny claims if member has not failed at least two immunosuppressive therapies over 12 months OR one immunosuppressive plus IVIG, unless documented clinical contraindication exists; (4) Establish precertification submission process to contact (866) 752-7021 or fax (888) 267-3277 with completed Statement of Medical Necessity form; (5) Update billing system to block claims combining J9333 with competing neonatal Fc receptor blockers (Imaavy, Vyvgart, Vyvgart Hytrulo), complement inhibitors (Soliris, Ultomiris, Zilbrysq), or Uplizna; (6) Train front desk and clinical staff that this medication requires neurologist consultation; (7) Configure reauthorization protocols to verify no unacceptable toxicity, disease progression, and documented positive response (MG-ADL, MMT, or MG Composite improvement) for continuation requests. Claims submitted without valid precertification will be denied.