Vyvgart (efgartigimod alfa-fcab injection)

Vyvgart is covered only for adults (≥18) with FDA‑approved anti‑acetylcholine receptor (AChR) antibody–positive generalized myasthenia gravis (MGFA class II–IV) with unresolved symptoms and MG‑ADL ≥5, and is not covered for seronegative/non‑AChR gMG or patients outside these criteria. Key requirements: initial authorization 6 months (renewal 12 months), neurologist prescription/consultation, documented positive anti‑AChR test, baseline MGFA/MG‑ADL and prior or failed/contraindicated pyridostigmine, evidence of clinical benefit for renewals, dosing 10 mg/kg IV weekly ×4 per cycle (max 1200 mg), and subsequent cycles should not be started sooner than 50 days without justification.

"Treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive (FDA-approved indication)."

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