Off-label Use of Rituximab and Rituximab Biosimilars

This policy addresses off‑label (non‑oncologic) use of rituximab and biosimilars, permitting use primarily as second‑line or for refractory disease across a range of autoimmune and immune‑mediated conditions (e.g., acquired hemophilia, acquired TTP, AIHA, certain myopathies, membranous nephropathy with defined proteinuria/CrCl thresholds, MG subsets, AMR in transplants, and cGVHD). Use is contingent on documented failure of standard first‑line therapies (or contraindication to them), adherence to condition‑specific dosing (e.g., MN: two 1000 mg IV doses 14 days apart), and required screening/monitoring for HBV per FDA boxed‑warning guidance; several conditions (Behçet’s, cerebral ataxia, Sjögren’s, PAN) are considered investigational and not covered.

"Acquired hemophilia: Rituximab may be used in acquired or refractory hemophilia as first‑line combination therapy with corticosteroids or as a second‑line/refractory option."