Vyvgart® (efgartigimod alfa-fcab) Vyvgart® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)

Covers Vyvgart IV for adults with anti‑AChR antibody–positive generalized myasthenia gravis and Vyvgart Hytrulo SC for adults with AChR‑positive gMG and for CIDP (AChR‑negative gMG is excluded). Key requirements: age ≥18, neurologist prescriber/consult, documented AChR seropositivity for gMG or electrodiagnostic confirmation for CIDP, prior/concomitant therapy (pyridostigmine for gMG unless failed/intolerant; prior IV/SCIG trial for CIDP unless contraindicated), MGFA II–IV and MG‑ADL ≥5 for gMG, specified dosing regimens (IV 10 mg/kg weekly ×4 with 1200 mg cap ≥120 kg; SC 1,008 mg + 11,200 U weekly ×4), minimum 50 days between cycle starts, initial approval 6 months (gMG) or 3 months (CIDP) with 12‑month renewals contingent on documented clinical benefit.

"Dosing / scheduling limitation: administer subsequent treatment cycles based on clinical evaluation; safety of initiating subsequent cycles sooner than 50 days from the start of the previous treatm..."