Off-label Use of Rituximab and Rituximab Biosimilars

This policy governs off-label, non-compendia use of rituximab and biosimilars: coverage is allowed for a defined set of non-neoplastic conditions when specific criteria are met (e.g., severe or relapsing ANCA-associated vasculitis; second-line AMR in selected transplant patients; refractory CIDP, immune-mediated myopathies, ITP with documented criteria; severe TTP; selected MCD, IgG4‑RD, MS, Sjögren’s/systemic sclerosis, Susac syndrome and acquired hemophilia scenarios). Many other off-label uses are considered investigational and not covered. Per FDA guidance, HBV screening and ongoing monitoring and documentation of prior therapy failure, disease severity, and procedure/transplant details (where applicable) are required.

"Rituximab is recommended for induction of remission in patients with severe or relapsing ANCA-associated vasculitis (including granulomatosis with polyangiitis and microscopic polyangiitis) and is ..."