Off-label Use of Rituximab and Rituximab Biosimilars
L39297
This policy addresses off-label, non-compendia use of rituximab and biosimilars: it covers specific non-oncologic indications when criteria are met (e.g., AAV induction/maintenance, transplant AMR as second-line/combination therapy, refractory CIDP, acquired hemophilia, select myopathies with lung involvement, refractory ITP, IgG4-RD refractory cases, pediatric steroid-dependent MCD, refractory adult MCD, refractory MS, severe Susac syndrome, and refractory/relapsed acquired TTP). Coverage generally requires documented failure of first-line therapies (where specified), documentation of indication-specific risk factors (eg, bleeding risk for ITP), and HBV screening/monitoring per FDA boxed warning; multiple other uses are listed as investigational (e.g., Behçet’s, cerebral ataxia, polyarteritis nodosa).
"Rituximab is recommended for induction of remission in patients with severe or relapsing ANCA-associated vasculitis (particularly granulomatosis with polyangiitis and microscopic polyangiitis) and ..."