Off-Label Use of Intravenous Immune Globulin (IVIG)

This policy approves off‑label IVIG for multiple specified autoimmune, inflammatory, and post‑transplant conditions when disease‑specific clinical criteria are met (e.g., sight‑threatening autoimmune retinopathy refractory to standard therapy; chronic GVHD with documented hypogammaglobulinemia and infection history; HSCT recipients age ≥20 within 100 days post‑transplant; IMNM; stiff‑person syndrome with anti‑GAD positivity). Coverage includes condition‑specific dosing regimens (examples: 1.5 g/kg induction for AIR; 500 mg/kg per HSCT dosing schedule; 2 g/kg monthly for scleromyxedema or SCLS) and requires documentation such as confirmed diagnosis, relevant lab tests (IgG, parvovirus B19 viremia, anti‑GAD), transplant timing, and prior treatment failures. Routine prophylactic use without documented hypogammaglobulinemia (in HSCT) and routine IVIG for SLE are not supported; SCLS coverage is allowed on a trial basis when associated with monoclonal gammopathy and may be re‑evaluated based on literature.