Aetna · Identified Aug 18, 2026Medium impact
Obinutuzumab (Gazyva) (CPB 0877, reviewed 2026-06-05)
Aetna considers obinutuzumab (Gazyva) medically necessary for commercial medical plans for these indications: chronic lymphocytic leukemia or small lymphocytic lymphoma, as a single agent or in combination with acalabrutinib, venetoclax, bendamustine, or chlorambucil, or with high-dose methylprednisolone for del(17p)/TP53 mutation disease; follicular lymphoma for up to 30 months total; extranodal, splenic and nodal marginal zone lymphoma; histologic transformation of indolent lymphomas and several high-grade B-cell lymphomas, Burkitt lymphoma, HIV-related B-cell lymphomas, post-transplant lymphoproliferative disorders and Castleman disease; mantle cell lymphoma with TP53 mutation; hairy cell leukemia in combination with vemurafenib for members who cannot tolerate purine analogs; and active lupus nephritis in members 18 years of age or older. For several lymphoma indications, use as a substitute for rituximab is covered when the member has intolerance or rare complications from rituximab, such as mucocutaneous reactions. Continuation of therapy is covered when there is no evidence of unacceptable toxicity or disease progression, and for lupus nephritis when the member achieves or maintains a positive clinical response. Re-challenge with the same anti-CD20 monoclonal antibody is not recommended. Aetna considers all other indications experimental, investigational or unproven, including acute lymphoblastic leukemia, B-cell prolymphocytic leukemia, anti-MAG demyelinating neuropathy, immune thrombotic thrombocytopenic purpura, lymphoma of the cervix, nephrotic syndrome, rheumatoid arthritis, systemic lupus erythematosus, Waldenstrom macroglobulinemia, and the combination with pixantrone for relapsed aggressive lymphoma. The available dose is a 1,000 mg/40 mL single-dose vial for intravenous infusion only, and the policy states that it is not to be given as an intravenous push or bolus.