Efgartigimod Alfa-fcab (Vyvgart) and Efgartigimod Alfa and Hyaluronidase-qvfc (Vyvgart Hytrulo) (CPB 1002, reviewed 2026-08-11)

By 2026-08-11: Billing and precertification teams must implement the following: (1) Require precertification for ALL Vyvgart and Vyvgart Hytrulo claims before administration by calling (866) 752-7021 or faxing (888) 267-3277. (2) Update billing system to block claims without precertification approval. (3) Providers must verify patient meets gMG criteria: MGFA classification II-IV, MG-ADL score ≥5, AND failure of ≥2 immunosuppressive therapies OR ≥1 immunosuppressive plus IVIG OR documented clinical reason to avoid these therapies. (4) For CIDP: verify progressive/relapsing disease ≥2 months, electrodiagnostic confirmation, and failure of immunoglobulins/corticosteroids/plasma exchange. (5) Block claims if patient is concurrently on other neonatal Fc receptor blockers (Imaavy, Rystiggo), complement inhibitors (Soliris, Ultomiris, Zilbrysq), or Uplizna. (6) Ensure prescribing provider is neurologist or consulting with neurologist. (7) For continuation therapy, require documentation of positive response (improved MG-ADL, MMT, or Composite scores for gMG; improved I-RODS, INCAT, MRC, or grip strength for CIDP) with no unacceptable toxicity. (8) Update encounter forms to capture required clinical documentation. Claims submitted without precertification or missing required criteria will be denied.