Modifiedculinary health fundPolicy N/A

Breyanzi (lisocabtagene maraleucel) coverage for B-cell malignancies

Defines prior authorization and medical necessity criteria for a single-dose medical-benefit administration of Breyanzi (CAR-T) for multiple B-cell lymphomas and CLL/SLL in adults, including required prior therapies, lymphodepleting chemotherapy, prescriber specialty, dosing, and exclusions.

Policy Summary

Payerculinary health fund

PolicyBreyanzi (lisocabtagene maraleucel) coverage for B-cell malignancies

Policy CodePolicy N/A

Change TypeSelected and annual revisions (material changes to indications and criteria)

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of prior lines of systemic therapy, prior BTK and BCL-2 inhibitor use (where required), absence of prior CAR-T exposure, and planned lymphodepleting chemotherapy; approval is for a single dose with a 6-month duration.

POLICY UPDATE CHANGES

Selected Revision 01/07/2026: Added 'Marginal zone lymphoma' as one of the conditions for approval after at least two lines of prior systemic therapy.

Annual Revision 11/19/2025: Various CLL/SLL and lymphoma criteria wording changes (e.g., added relapsed/refractory requirement; modified prior therapy wording to 'tried').

Selected Revision 06/12/2024: Added Mantle cell lymphoma and Classic follicular lymphoma as new conditions of approval; added new CLL/SLL condition of approval.

6FDA-listed indications

6Approval duration (months)

Coverage Summary

This policy defines prior authorization and medical necessity criteria for a single-dose medical-benefit administration of Breyanzi (lisocabtagene maraleucel), a CD19-directed autologous CAR‑T cell therapy for adults. Approval is contingent on meeting the listed diagnosis- and prior-therapy–specific criteria, documentation of planned or received lymphodepleting chemotherapy, and that the product is prescribed by or in consultation with an oncologist. The approval is issued for a single dose with an approval duration of 6 months to allow preparation and administration.

Key thresholds

Age≥ 18 years

Dose — LBCL (≥2 prior lines)50 to 110 x 10^6 CAR-positive viable T cells (single IV dose, 1:1 CD8:CD4)

Dose — other indications (CLL/SLL, mantle cell, marginal zone, follicular, LBCL after 1 line)90 to 110 x 10^6 CAR-positive viable T cells (single IV dose, 1:1 CD8:CD4)

Approval duration6 months

Single-dose1 (single IV administration)

FDA-listed indications count6

Recommended Authorization Criteria (Medical Necessity)

CLL/SLL Dosing

Dosing for CLL/SLL

Dose is 90 to 110 x 10^6 CAR-positive viable T-cells administered intravenously as a single dose90 to 110 x 10^6

Conditions Not Recommended for Approval

Coverage not recommended when criteria are not met

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria

Coding

Drug J-code / HCPCS (not specified in document)HCPCS

No codes listed

Provider Actions / Authorization Requirements

Prior Authorization

Prior authorization required

Prior Authorization is recommended for medical benefit coverage of Breyanzi. Approval requires that the patient meets the policy criteria and dosing for the listed indications. Approval is for a single dose of Breyanzi and the approval duration is 6 months to allow preparation and administration.

Single-dose administration per approval
Approval duration: 6 months

Documentation Required

Prescriber specialty requirement

Breyanzi must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist). Documentation should reflect when the medication is prescribed in consultation with an oncologist.

Background and Safety

Breyanzi (lisocabtagene maraleucel) is a CD19-directed, autologous, genetically modified CAR‑T cell therapy indicated for multiple relapsed or refractory B‑cell malignancies (including CLL/SLL, follicular lymphoma, large B‑cell lymphomas, mantle cell lymphoma, and marginal zone lymphoma). The prescribing information includes a Boxed Warning for cytokine release syndrome (CRS), neurologic toxicities, and T‑cell malignancies. The product is supplied as separate frozen CD8 and CD4 component vials, stored in the vapor phase of liquid nitrogen at ≤ -130°C.

Definitions

CAR-T therapy (definition)Chimeric antigen receptor T-cell therapies; examples include Breyanzi, Kymriah (tisagenlecleucel), Tecartus (brexucabtagene), and Yescarta (axicabtagene)

Lymphodepleting chemotherapy (definition)Chemotherapy given prior to CAR-T infusion to prepare patient; must be received or planned before Breyanzi infusion per criteria

Evidence and References

Source	Reference
Prescribing Information	Breyanzi intravenous infusion; Juno Therapeutics; December 2025
Guideline	NCCN B-Cell Lymphoma and CLL/SLL guidelines (versions 2025/2026) - B-Cell Lymphomas (v1.2026 - Dec 22, 2025); CLL/SLL (v1.2026 - Oct 10, 2025)

Revision History

06/12/2024revised

Selected Revision 06/12/2024: Added Mantle cell lymphoma and Classic follicular lymphoma as new conditions of approval; added new CLL/SLL condition of approval.

11/19/2025revised

Annual Revision 11/19/2025: Various CLL/SLL and lymphoma criteria wording changes (e.g., added relapsed/refractory requirement; modified prior therapy wording to 'tried'; updated histologic transformation criteria and examples).

01/07/2026revisedLatest

Selected Revision 01/07/2026: Added 'Marginal zone lymphoma' as one of the conditions for approval after at least two lines of prior systemic therapy.