Lisocabtagene Maraleucel (Breyanzi) (CPB 0986, reviewed 2026-03-11)
Summary
Aetna Clinical Policy Bulletin 0986 covers lisocabtagene maraleucel (Breyanzi) for commercial medical plans, and Medicare criteria are in a separate document. Aetna considers Breyanzi medically necessary as one dose for adult B-cell lymphomas after at least two lines of systemic therapy, or after first-line chemoimmunotherapy with relapsed or refractory disease in specified subtypes. It is also considered medically necessary for relapsed or refractory mantle cell lymphoma after a covalent Bruton tyrosine kinase inhibitor, relapsed or refractory ALK-positive large B-cell lymphoma if CD19-positive, relapsed or refractory CLL or SLL after a covalent Bruton tyrosine kinase inhibitor and BCL-2 inhibitor regimens, Richter transformation to DLBCL, and relapsed or refractory pediatric primary mediastinal large B-cell lymphoma under age 18. Members with primary central nervous system lymphoma, a previous treatment with Breyanzi or another CD19-directed CAR T-cell therapy, an ECOG performance status of 3 or greater, inadequate and unstable kidney, liver, pulmonary or cardiac function, active hepatitis B or C or other uncontrolled infection, active graft versus host disease, or an active inflammatory disorder are not eligible. Repeat administration and use for solid tumors are considered experimental, investigational, or unproven.
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