CurrentHealth NetPolicy CP PHAR483

Lisocabtagene Maraleucel (Breyanzi)

Policy governing medical necessity and prior authorization requirements for lisocabtagene maraleucel (Breyanzi) for specified hematologic malignancies across Commercial, HIM, and Medicaid lines of business for Health Net.

Policy Summary

PayerHealth Net

PolicyLisocabtagene Maraleucel (Breyanzi)

Policy CodePolicy CP PHAR483

Change TypeNo material changes noted in this revision

Effective DateFeb 5, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of indication, intended cell dose within specified target ranges, and supporting clinical records for medical director review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

110 x10^6Max CAR+ viable T cell dose

Commercial/HIM/MedicaidApplies to

1 doseDose course

FL, MCL addedNew indications

CRS / neurotoxicityBoxed warnings

Related Billing Codes

HCPCS-Q2054-LISOCABTAGENE-MARALEUCEL-CAR-T-THERAPY

HCPCS Q2054: Lisocabtagene Maraleucel CAR-T Therapy

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Initial Therapy - LBCL

Covered when ALL of the following are met for initial (one-time) treatment:

LBCL_general: 1) Diagnosis of one of the specified large B-cell lymphoma (LBCL) subtypes as listed in policy (e.g., DLBCL, DLBCL transformed from specified indolent lymphomas, primary mediastinal LBCL, high-grade B-cell lymphoma, follicular lymphoma grade 3B, splenic or nodal marginal zone, post-transplant lymphoproliferative disorders B-cell type, HIV-related DLBCL/plasmablastic lymphoma, T cell/histiocyte-rich LBCL); 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Age > 18 years; 4) One of the following disease statuses: (a) disease refractory to or relapsed ≤ 12 months after first-line chemoimmunotherapy that included an anti-CD20 monoclonal antibody and an anthracycline-containing regimen, OR (b) relapsed/refractory after ≥ 2 lines of systemic therapy that included an anti-CD20 agent and an anthracycline-containing regimen; 5) Member is not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age when using the pathway for relapse after first-line therapy (see Appendix D examples); 6) No primary central nervous system (CNS) disease; 7) Member has not previously received CAR T-cell therapy and Breyanzi is not prescribed concurrently with another CAR T-cell therapy; 8) Dose does not exceed 110 x 10^6 CAR-positive viable T cells;

Only for initial treatment dose; subsequent doses will not be covered.

Initial Therapy - CLL/SLL

Covered when ALL of the following are met for initial (one-time) treatment:

CLL_SLL_initial: 1) Diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL); 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Age ≥ 18 years; 4) Measurable disease within the last 30 days (e.g., measurable lymph nodes ≥ 1.5 cm in greatest transverse diameter, hepatomegaly, or splenomegaly); 5) Member has received ≥ 2 prior lines of therapy that include both: (a) at least one Bruton tyrosine kinase inhibitor (BTKi) and (b) one BCL2 inhibitor; 6) No active CNS involvement by malignancy or history/presence of clinically relevant CNS pathology (e.g., seizure disorder, stroke with sequelae, dementia, Parkinson's disease, cerebellar disease, cerebral edema, psychosis); 7) Member has not previously received CAR T-cell therapy and Breyanzi is not prescribed concurrently with another CAR T-cell therapy; 8) Dose does not exceed 110 x 10^6 CAR-positive viable T cells;

Only for initial treatment dose; subsequent doses will not be covered.

Initial Therapy - Follicular Lymphoma

Covered when ALL of the following are met for initial (one-time) treatment:

FL_initial: 1) Diagnosis of follicular lymphoma (FL) grade 1, 2, or 3a; 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Age ≥ 18 years; 4) Disease relapsed or refractory after ≥ 2 lines of systemic therapy that include an anti-CD20 agent and an alkylating agent (e.g., bendamustine, cyclophosphamide, chlorambucil); 5) No CNS-only involvement by malignancy (secondary CNS involvement is allowed); 6) No history or presence of clinically relevant CNS pathology (e.g., epilepsy, generalized seizure disorder, aphasia, stroke with sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, cerebral edema, psychosis); 7) Member has not previously received CAR T-cell therapy and Breyanzi is not prescribed concurrently with another CAR T-cell therapy; 8) Dose does not exceed 110 x 10^6 CAR-positive viable T cells;

Only for initial treatment dose; subsequent doses will not be covered.

Initial Therapy - MCL

Covered when ALL of the following are met for initial (one-time) treatment:

MCL_initial: 1) Diagnosis of relapsed or refractory mantle cell lymphoma (MCL); 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Age > 18 years; 4) Member has received ≥ 2 prior lines of systemic therapy that included an anti-CD20 monoclonal antibody, an alkylating agent (e.g., bendamustine, cyclophosphamide, platinum agents), and a Bruton tyrosine kinase inhibitor (BTKi); 5) No CNS-only involvement by malignancy (secondary CNS involvement is allowed); 6) No history or presence of clinically relevant CNS pathology (e.g., epilepsy, generalized seizure disorder, aphasia, stroke with sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, cerebral edema, psychosis); 7) Member has not previously received CAR T-cell therapy and Breyanzi is not prescribed concurrently with another CAR T-cell therapy; 8) Dose does not exceed 110 x 10^6 CAR-positive viable T cells;

Only for initial treatment dose; subsequent doses will not be covered.

Dosage by indication

Dose parameters by indication

LBCL after two or more lines: Target dose: 50 to 110 x 10^6 CAR-positive viable T cells; Maximum Dose: 110 x 10^6 CAR-positive viable T cells50-110 x10^6 / max 110 x10^6

single-dose product

LBCL after one line; CLL/SLL; FL; MCL: Target dose: 90 to 110 x 10^6 CAR-positive viable T cells; Maximum Dose: 110 x 10^6 CAR-positive viable T cells90-110 x10^6 / max 110 x10^6

single-dose product

Coverage is not authorized for members with primary CNS disease. This policy specifically lists primary CNS disease as a diagnosis/indication for which coverage is not authorized and therefore requests for Breyanzi for primary CNS disease should be denied unless covered under a separate documented exception or other applicable policy.

This policy does not address non‑FDA approved indications. Requests for indications not covered here must be supported by applicable off‑label use policies (e.g., CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) or evidence of coverage documents before coverage will be considered.

Patients with primary CNS lymphoma were excluded from the TRANSCEND NHL‑001 trial. The document also notes that NCCN recommendations for primary CNS lymphoma favor high‑dose methotrexate‑based induction or whole brain radiation and consolidation regimens, which differ from the CAR T trial populations and may affect coverage decisions.

No additional explicit exclusions are detailed beyond those listed in the exclusions section. Policy history documents that the minimum absolute lymphocyte count requirement was removed (trial enrollment did not require a prespecified blood count threshold), and the policy was updated accordingly.

Continued therapy is not authorized. Breyanzi is indicated to be dosed one time only, and follow‑on or repeat dosing requests will not be approved under this policy.

Initial (One-Time) Therapy Criteria

Initial Therapy

Initial (one-time) therapy criteria per diagnosis group

initial_overview: Initial approval is limited to one dose; subsequent doses are not covered. Dose must not exceed 110 x 10^6 CAR-positive viable T cells. Prescriber must be or consult with oncology/hematology and meet diagnosis-specific prior therapy and clinical-status requirements as detailed in the diagnosis-specific criteria groups.

Approval duration noted for administrative purposes only.

Therapeutic alternatives

Therapeutic alternatives table

Preferred alternatives: Multiple first- and second-line systemic regimens and targeted agents (for example: R-CHOP, RCEPP, DA-EPOCH + rituximab, bendamustine-containing regimens, gemcitabine-based regimens, platinum-based salvage regimens, lenalidomide + rituximab, and targeted agents such as BTK inhibitors and BCL2 inhibitors) are listed as therapeutic alternatives and may be considered prior to CAR T therapy as appropriate to the indication.

Continuation Therapy

Continuation therapy

continuation_none: Continued therapy is not authorized; product is dosed one time only.

Coding

Referenced HCPCS CodeHCPCS

Q2054

Lisocabtagene maraleucel, up to 110 million autologous anti-CD19 CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose

Maximum CAR-positive viable T cell dose — 110 x 10^6

Maximum dose (CAR-positive viable T cells)110 x 10^6 CAR-positive viable T cells

ContextDose limit applies to initial (one-time) treatment across indications; subsequent doses are not covered.

Related administration noteSingle-dose frozen 5 mL vial; approval duration recorded as 3 months for administrative purposes.

Maximum CAR-positive viable T cells per dose — up to 110 million

Plain language maximumUp to 110 million CAR-positive viable T cells per therapeutic dose

HCPCS descriptor linkQ2054 describes lisocabtagene maraleucel as up to 110 million autologous anti-CD19 CAR-positive viable T cells, per therapeutic dose.

Policy applicationMaximum applies across covered indications for the single-dose product; claims should reference appropriate coding and documentation.

Provider Actions & Requirements

Prior Authorization

Prior Authorization & Documentation Requirements

Prior authorization is required. Authorization requests must document the indication and supporting clinical information, including relevant office chart notes, laboratory results, treatment history, and staging/pathology reports as applicable.

Prior authorization should document the specific diagnosis, prior lines of therapy, dates and outcomes of prior therapies, and reason for HSCT ineligibility when applicable.
All requests reviewed under this policy require medical director review and may be denied if documentation is insufficient.

Denial Risk

Medical Director Review Required

All requests for Breyanzi (lisocabtagene maraleucel) require medical director review per policy history. Medical director review is required for initial and single-dose requests; lack of adequate supporting documentation may result in denial.

Medical director review will consider whether criteria for the requested indication are met (see Diagnoses/Indications and criteria for LBCL, CLL/SLL, etc.).
Requests lacking documentation of prior therapies, HSCT eligibility status, or prior CAR T-cell therapy will be routed for denial or peer-to-peer review.

Note

Requests Reviewed Under This Policy / Off-Label and Formulary Referencing

Requests will be reviewed under this policy and must meet the documented clinical criteria for the specific indication. For uses not specifically listed in this policy, refer to applicable off-label or formulary/non-formulary policies for step or alternative requirements.

If the requested use is on-formulary, follow the no-coverage criteria policy for the relevant line of business (e.g., CP.CPA.190 for commercial).
If the requested use is not on-formulary, follow the non-formulary policy for the relevant line of business (e.g., HIM.PA.103).
If the requested use is not specifically listed and criterion 1 does not apply, refer to the off-label use policy (e.g., CP.CPA.09 for commercial).

Documentation Required

Provider Documentation Requirement

Provider must submit documentation supporting that the member meets all approval criteria. Examples include office chart notes, pathology reports, flow cytometry, imaging reports demonstrating measurable disease, prior therapy regimens and responses, and documentation of HSCT ineligibility when claimed.

Include dates and agents for prior chemoimmunotherapy (e.g., rituximab plus anthracycline-containing regimen) and outcomes (refractory vs relapsed).
Document absence of prior CAR T-cell therapy and that Breyanzi is not being prescribed concurrently with another CAR T product.
Provide measurable disease evidence (e.g., lymph node measurements, hepatomegaly, splenomegaly) when applicable.

Documentation Required

Product Dose and Formulation

Product dose and formulation must be documented in the request. Use the dosing and administration guidance when specifying target and maximum CAR-positive viable T-cell counts and vial information.

LBCL after two or more lines of therapy: target dose 50 to 110 x 10^6 CAR-positive viable T cells; maximum 110 x 10^6.
LBCL after one line of therapy and CLL/SLL/FL/MCL: target dose 90 to 110 x 10^6; maximum 110 x 10^6.
Product form: single-dose 5 mL frozen vial (autologous T-cell suspension).

Billing Rule

Coding and Documentation

Coding and billing guidance should be included with the authorization and claim submission. Providers should reference current coding resources when submitting claims for reimbursement.

HCPCS Q2054: Lisocabtagene maraleucel, up to 110 million autologous anti‑CD19 CAR‑positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose.
Provide supporting documentation for leukapheresis and dose preparation when submitting requests and claims.
Inclusion or exclusion of codes in this policy does not guarantee coverage; reference up-to-date professional coding guidance.

Step Therapy

Therapeutic Alternatives Listed

Therapeutic alternatives and preferred regimens are listed in the clinical policy and should be considered when applicable. Prior authorization for alternative systemic regimens may be required.

Preferred first-line regimens: e.g., R-CHOP, DA-EPOCH + rituximab and other NCCN-recommended regimens.
Preferred second-line regimens and targeted agents are enumerated in the clinical policy (see policy treatment regimen tables).
For indications not specifically listed, consult off-label/formulary policies for step or alternative requirements.

Step Therapy / Prior Treatments

When requested use is not listed
Refer to the applicable off‑label or formulary/non‑formulary policy for the member's line of business (e.g., CP.CPA.190 for commercial, HIM.PA.33/HIM.PA.154 for health insurance marketplace, CP.PMN.255/CP.PMN.53 for Medicaid) to determine required prior therapies or alternative step therapy requirements.

Requirement
Document prior systemic therapies and, when applicable, transplant‑eligibility status (e.g., PILOT criteria such as age ≥70, DLCO <60%, LVEF <50%, CrCl <60 mL/min, AST/ALT >2× ULN, or ECOG 2) to justify use of second‑line or transplant‑ineligible study data as the basis for authorization.

Policy history note
Policy history documents line‑of‑therapy changes over time (for example, addition of a pre‑emptive second‑line LBCL indication that was subsequently converted to an FDA‑approved second‑line indication and addition of new indications such as CLL/SLL, FL, and MCL).

Quantity Limits

lisocabtagene maraleucel (Breyanzi) — 1 dose

Quantity limit1 dose (single administration only)

Policy noteContinued therapy will not be authorized; product is dosed one time only.

Approval durationAdministrative approval duration documented as 3 months for the single dose.

tocilizumab (Actemra) supportive — up to 4 doses

Supportive therapy quantityTocilizumab (Actemra): up to 4 doses per course (up to 800 mg per dose)

Indication for useProvided as supportive management for cytokine release syndrome per clinical need.

Approval contextQuantity limit applies to the single CAR T-cell treatment episode.

Lisocabtagene maraleucel — up to 110 million CAR-positive viable T cells

Maximum cell doseUp to 110 million CAR-positive viable T cells per course (maximum dose)

Target dose ranges by indicationTarget dose varies by indication (e.g., 50–110 x10^6 or 90–110 x10^6); maximum remains 110 x10^6.

Product formSingle-dose frozen 5 mL vial of genetically modified autologous T-cells.

Site of Care / Administration

Note

One‑time CAR T therapy — coordinate hospital outpatient care

Administration is a one‑time CAR T‑cell therapy delivered as a single therapeutic dose with supportive care (e.g., tocilizumab) as needed; coordinate with inpatient or specialized clinical teams to confirm appropriateness of hospital outpatient administration.

Note

Administer in a facility equipped for CAR T monitoring and management

Breyanzi is administered as a single infusion of an autologous frozen vial and requires appropriate monitoring and facility capabilities (infusion center or specialized center) to manage boxed toxicities and provide necessary supportive care.

Background

Lisocabtagene maraleucel (Breyanzi) is a CD19‑directed, autologous, genetically modified CAR T‑cell immunotherapy administered as a single frozen vial infusion. It is indicated for specified relapsed or refractory B‑cell malignancies under the dosing and indication‑specific target ranges documented in this policy, with a maximum dose of up to 110 million CAR‑positive viable T cells. The therapy carries boxed warnings for cytokine release syndrome, neurologic toxicities, and risk of secondary hematologic malignancies; administration requires appropriate specialized care and documentation including use of HCPCS code Q2054 when billing.

Definitions

chimeric antigen receptor — CAR

DefinitionChimeric antigen receptor (CAR)

Usage contextAbbreviation used throughout policy and appendices to describe genetically engineered T-cell receptors.

Appendix referenceListed in Appendix A: Abbreviation/Acronym Key.

Bruton tyrosine kinase inhibitor — BTKi

DefinitionBruton tyrosine kinase inhibitor (BTKi)

Example agentsExamples appear in policy appendices and therapy requirement lists (e.g., ibrutinib, acalabrutinib).

Role in criteriaRequired prior therapy class for certain indications (e.g., CLL/SLL, MCL).

B-cell lymphoma 2 inhibitor — BCL2i

DefinitionB-cell lymphoma 2 inhibitor (BCL2i)

Example agentVenetoclax is listed as a BCL2 inhibitor in the policy appendices and prior therapy requirements.

Role in criteriaRequired as part of prior-line therapy for CLL/SLL coverage (one BTKi and one BCL2i).

Target dose — planned CAR-positive viable T cells

DefinitionTarget dose: the planned number of CAR-positive viable T cells to be administered (e.g., 50 to 110 x 10^6 or 90 to 110 x 10^6 depending on indication).

Examples by indicationLBCL after ≥2 lines: target 50–110 x10^6; LBCL after 1 line, CLL/SLL, FL, MCL: target 90–110 x10^6.

Maximum constraintTarget dose must not exceed the documented maximum of 110 x10^6 CAR-positive viable T cells.

Boxed warning — Serious, potentially fatal adverse events

DefinitionBoxed warning: Serious, potentially fatal adverse events specifically highlighted for this therapy (cytokine release syndrome, neurologic toxicities, secondary hematologic malignancies).

ImplicationBoxed warnings may influence coverage decisions and require documented risk acknowledgement per policy notes.

Reference locationAppendix C: Contraindications/Boxed Warnings; updated in policy history per prescribing information.

Q2054 — HCPCS code description for lisocabtagene maraleucel

HCPCS codeQ2054 — Lisocabtagene maraleucel, up to 110 million autologous anti-CD19 CAR-positive viable T cells (includes leukapheresis and dose preparation), per therapeutic dose.

Coding noteCodes referenced for informational purposes only; inclusion or exclusion does not guarantee coverage—providers should reference up-to-date coding guidance.

Claims guidanceClaims should reference Q2054 with supporting documentation for leukapheresis and dose preparation as described.

Policy Summary

PayerHealth Net

PolicyLisocabtagene Maraleucel (Breyanzi)

Policy CodePolicy CP PHAR483

Change TypeNo material changes noted in this revision

Effective DateFeb 5, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of indication, intended cell dose within specified target ranges, and supporting clinical records for medical director review.

SourceLink

On This Page

OpenPayer

Lisocabtagene Maraleucel (Breyanzi)

Related Billing Codes

Coverage Criteria

Initial (One-Time) Therapy Criteria

Continuation Therapy

Coding

Provider Actions & Requirements

Step Therapy / Prior Treatments

Quantity Limits

Site of Care / Administration

Background

Definitions