CurrentCareSourcePolicy N/A

Breyanzi (lisocabtagene maraleucel) — Medical Necessity and Prior Authorization Criteria

Medicare Advantage utilization management policy governing prior authorization and medical benefit coverage criteria for Breyanzi (lisocabtagene maraleucel) for adults with specified B‑cell malignancies; applies to CareSource Medicare Advantage members.

Policy Summary

PayerCareSource

PolicyBreyanzi (lisocabtagene maraleucel) — Medical Necessity and Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJun 3, 2025

Key ActionObtain prior authorization with documentation that the patient meets indication-specific criteria, required prior systemic therapies, planned or received lymphodepleting chemotherapy, is ≥18 years old, and has not previously received CAR‑T therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsapproval duration

90-110 x10^6common dosing range

NCD 110.24NCD cited

All Statesapplicability

Coverage Criteria for Breyanzi (lisocabtagene maraleucel)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

FDA‑Approved Indications (General criteria)

Approve a single dose if the patient meets ALL of the following (A, B, C, and D) unless otherwise specified

Overall

A - Diagnosis: Patient has one of the listed diagnoses
Includes large B-cell lymphoma, diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, follicular lymphoma Grade 3B, HIV-related DLBCL, HHV8-positive DLBCL, primary effusion lymphoma, post-transplant lymphoproliferative disorder, mantle cell lymphoma, classic follicular lymphoma, transformed indolent lymphoma to DLBCL
B - Prior therapy: Patient has received required prior systemic therapy per diagnosis
Examples: patient has received at least one line of systemic therapy for many indications; received at least two lines for transformed or certain follicular presentations
C - Lymphodepletion: Patient has received or plans to receive lymphodepleting chemotherapy prior to infusion of Breyanzi
Per policy requirement
D - Age and prior CAR‑T: Patient is ≥18 years of age AND has not been previously treated with CAR‑T therapy
Examples of CAR‑T therapies include Breyanzi, Kymriah (tisagenlecleucel), Tecartus (brexucabtagene), and Yescarta (axicabtagene)

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

CLL/SLL specific criteria: Approve a single dose if the patient meets ALL of the following (A, B, C, and D)

CLL/SLL criteria

B - Prior therapy options
- i: Patient meets BOTH of the following: (a) Received a Bruton tyrosine kinase (BTK) inhibitor AND (b) Received venetoclax (Venclexta)
  Examples of BTK inhibitors include ibrutinib, acalabrutinib, zanubrutinib
- ii: Patient meets BOTH of the following: (a) Histologic transformation to diffuse large B-cell lymphoma AND (b) One of: del(17p)/TP53 mutation positive disease, chemotherapy refractory, or unable to receive chemoimmunotherapy
  del(17p)/TP53 testing required when using transformation pathway

Breyanzi (lisocabtagene maraleucel) is not indicated for treatment of primary central nervous system lymphoma. The product carries a boxed warning for cytokine release syndrome (CRS), neurologic toxicities, and reported T‑cell malignancies, and is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

Coverage is not recommended for uses or clinical circumstances that are not specifically listed in the Recommended Authorization Criteria. Criteria will be updated as new published data become available; requests outside the listed criteria should be denied consistent with this policy.

Indication	Dose (CAR‑positive viable T cells)	Administration
Relapsed or refractory large B‑cell lymphoma (LBCL) after ≥2 prior lines of therapy
50–110 x10^6
Single intravenous infusion (single dose)
Relapsed or refractory LBCL after 1 prior line of therapy; chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); follicular lymphoma; mantle cell lymphoma
90–110 x10^6
Single intravenous infusion (single dose)

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for medical benefit coverage of Breyanzi. Approval is recommended for patients who meet the policy's specific Criteria and Dosing for the listed indications. Approvals are for a single dose with an approval duration of 6 months to allow adequate time to prepare and administer therapy.

Approval duration: 6 months (single dose)
Prior authorization recommended for medical benefit coverage of Breyanzi

Step Therapy

Prior Lines of Therapy Required

Policy requires prior lines of systemic therapy as a prerequisite for certain indications. For most large B‑cell lymphoma indications, at least one prior line of systemic therapy is required; specific diagnoses (e.g., chronic lymphocytic leukemia/small lymphocytic lymphoma) have defined prior therapy requirements such as prior Bruton tyrosine kinase inhibitor and/or venetoclax in accordance with the indication criteria. Patients must not have received prior CAR‑T therapy.

Most LBCL indications: at least one prior line of systemic therapy (per indication criteria)
CLL/SLL: prior BTK inhibitor and/or venetoclax as specified in criteria
Patient must be CAR‑T naïve

Documentation Required

Required Documentation for Prior Authorization

Prior authorization request should include documentation demonstrating that the patient meets all applicable indication-specific criteria (age, diagnosis, prior therapies, histologic features or mutations when required, inability to receive or refractory to chemoimmunotherapy when applicable, and that the patient has not previously received CAR‑T therapy). Approval is recommended for a single dose only when documentation confirms the patient meets the specified criteria.

Include documentation of diagnosis and any required mutations or histologic transformation (when applicable)
Document prior systemic therapies received (e.g., chemoimmunotherapy, BTK inhibitors, venetoclax)
Document prior CAR‑T exposure (must be none)

Denial Risk

Out‑of‑Criteria Denials

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Requests that do not meet the policy’s specified criteria (including prior therapy requirements and exclusion of prior CAR‑T therapy) should be denied.

Deny coverage for indications or clinical scenarios not meeting the Recommended Authorization Criteria

Definitions and Background

Risk Evaluation and Mitigation Strategy (REMS)

REMS requirementBreyanzi is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (Breyanzi REMS)

Reason for REMSRequired due to boxed warnings for cytokine release syndrome (CRS), neurologic toxicities, and T‑cell malignancies

Access implicationUse and administration are limited to providers and settings that comply with REMS program requirements

Breyanzi is an autologous CD19‑directed CAR T‑cell therapy approved for multiple relapsed or refractory B‑cell malignancies, including specified forms of large B‑cell lymphoma, follicular lymphoma grade 3B, mantle cell lymphoma, and relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after required prior therapies. The product has important safety considerations with a boxed warning for cytokine release syndrome and neurologic toxicities and is distributed only through a REMS program because of these risks.

Policy Summary

PayerCareSource

PolicyBreyanzi (lisocabtagene maraleucel) — Medical Necessity and Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJun 3, 2025

SourceLink

On This Page

OpenPayer

Breyanzi (lisocabtagene maraleucel) — Medical Necessity and Prior Authorization Criteria

Coverage Criteria for Breyanzi (lisocabtagene maraleucel)

Dosing and Regimens

Coding and National Coverage Determination

Provider Actions and Authorization Requirements

Line of Therapy Requirements

Biomarker and Test Requirements

Definitions and Background