Uplizna® (inebilizumab-cdon) Injection

Uplizna (inebilizumab‑cdon) is covered for adults (≥18) only for the FDA‑approved indications—AQP4‑antibody–positive NMOSD and IgG4‑related disease—and is not covered for patients <18 or off‑label uses. Approval is for 12 months and requires documented diagnostic criteria (positive anti‑AQP4 serum test for NMOSD; organ involvement plus prior/current systemic corticosteroid use or steroid intolerance for IgG4‑RD), prescription by or consultation with the specified specialists (neurologist for NMOSD; endocrinologist, gastroenterologist, immunologist, nephrologist, neurologist, pulmonologist, rheumatologist, or immune‑disorder specialist for IgG4‑RD), adherence to the IV dosing schedule (300 mg ×2 doses 2 weeks apart then 300 mg every 6 months), and documented clinical benefit for re‑authorization.

"The treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive."