BlueCross BlueShield of Tennessee Medical Policy Manual
Lisocabtagene Maraleucel (Breyanzi®)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
Adult patients with large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS) (including DLBCL arising from indolent lymphoma), high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have:
Limitations of Use
BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.
Adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including, a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor
Adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy.
Adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
Compendial Uses
All other indications are considered experimental/investigational and not medically necessary.
DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: Chart notes or medical record documentation demonstrating failure of previous lines of therapy.
EXCLUSIONS
Coverage will not be provided for members with any of the following exclusions:
COVERAGE CRITERIA
Adult Large B-cell Lymphomas
Authorization of 3 months (one dose) may be granted for treatment of B-cell lymphomas in members 18 years of age or older when either of the following criteria are met:
Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Authorization of 3 months (one dose) may be granted for treatment of relapsed or refractory CLL/SLL in members 18 years of age or older when the member has received prior therapy with Bruton tyrosine kinase inhibitor (e.g., acalabrutinib [Calquence], ibrutinib [Imbruvica], zanubrutinib [Brukinsa])- and BCL-2 inhibitor (e.g., venetoclax)-containing regimens.
Histologic (Richter) Transformation to DLBCL
Authorization of 3 months (one dose) may be granted for treatment of histologic (Richter) transformation to DLBCL (clonally related or unknown clonal status) in members with del(17p)/TP53 mutation or who are chemotherapy refractory or unable to receive chemoimmunotherapy.
Pediatric Primary Mediastinal Large B-cell Lymphoma
Authorization of 3 months (one dose) may be granted for treatment of relapsed/ refractory primary mediastinal large B-cell lymphoma in members less than 18 years of age when the member has received prior therapy with at least two chemoimmunotherapy regimens and achieved partial response.
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
MOST RECENT REVIEW DATE: 1/30/2026
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.