CurrentCentenePolicy CP.PHAR.483

Lisocabtagene Maraleucel (Breyanzi) coverage policy

Policy Summary

PayerCentene

PolicyLisocabtagene Maraleucel (Breyanzi) coverage policy

Policy CodePolicy CP.PHAR.483

Change TypeMultiple indication additions & dosing corrections

Effective DateFeb 5, 2021

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria and route prior authorization requests to PDAC for review.

SourceLink

POLICY UPDATE CHANGES

Added new indication for CLL/SLL.

Added new indications for follicular lymphoma (FL) and mantle cell lymphoma (MCL).

Added new indication for marginal zone lymphoma (MZL).

Updated policy to redirect prior authorization reviews to PDAC Utilization Management Review.

Corrected maximum dose for FL and MCL from 100 to 110 x10^6 CAR-positive viable T cells.

Removed requirement for use as second line therapy for T-cell/histiocyte-rich LBCL.

Added bypass for age requirement for primary mediastinal LBCL per NCCN pediatric guidelines.

Updated boxed warnings to include secondary hematological malignancies.

Added ICHRA line of business.

Added new indications for follicular lymphoma (FL) and mantle cell lymphoma (MCL).

Corrected FL and MCL maximum dose from 100 to 110 x 10^6 CAR-positive viable T cells.

Added bypass for age requirement for primary mediastinal LBCL per NCCN Pediatric guidance.

Added NCCN Compendium supported use in HIV-related plasmablastic lymphoma.

Added marginal zone lymphoma (MZL) as an indication.

Removed reference to accelerated approval footnote for FL in FDA approved indications.

Updated language to redirect prior authorization reviews to PDAC Utilization Management Review.

Added ICHRA line of business to policy coverage applicability.

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6Covered Indications (example count)

1Dose per member allowed

110 x10^6Dose maximum (CAR-positive viable T cells)

Q2054Primary HCPCS code

PDACUtilization review committee

Coverage Summary

Defines medical necessity criteria, limitations, and administrative requirements for coverage of a single initial dose of lisocabtagene maraleucel (Breyanzi) across multiple lymphoma and CLL/SLL indications for Centene-affiliated health plans (Commercial, HIM/ICHRA, Medicaid); policy stance is covered with criteria and aligns coverage with FDA-labeled indications and NCCN guidance. Coverage is limited to a single initial therapeutic dose (1 dose only) with a per-dose maximum of 110 x 10^6 CAR-positive viable T cells, excludes primary CNS disease, requires oncology/hematology prescribing or consultation, submission of supporting documentation, and routing of prior authorization reviews to PDAC Utilization Management Review.

Quick thresholds & facts

Dose maximum110 x 10^6 CAR-positive viable T cells

Dose per member allowed1 (single initial therapeutic dose only; subsequent doses not covered)

Primary HCPCS codeQ2054

Utilization review committeePrecision Drug Action Committee (PDAC)

Covered indications count6

Covered indications (list)Large B‑cell lymphoma (LBCL) including DLBCL and listed subtypes; Chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL); Follicular lymphoma (FL); Mantle cell lymphoma (MCL); Marginal zone lymphoma (MZL); HIV‑related plasmablastic lymphoma

Initial Therapy Criteria (by indication)

A. Large B-Cell Lymphoma (LBCL)

I. Initial Approval Criteria - A. Large B-Cell Lymphoma (LBCL) (must meet ALL):

{

{"text":"Diagnosis of one of the following LBCL subtypes: DLBCL; DLBCL transformed from follicular lymphoma, nodal MZL, gastric MALT lymphoma, nongastric MALT lymphoma (noncutaneous), or splenic MZL; primary mediastinal LBCL; follicular lymphoma grade 3B; high-grade B-cell lymphomas; post-transplant lymphoproliferative disorders (B-cell type); HIV-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL, or HIV-related plasmablastic lymphoma; T cell/histiocyte-rich LBCL."},

{"text":"Prescribed by or in consultation with an oncologist or hematologist."},

{"text":"Age ≥ 18 years OR request is for primary mediastinal LBCL."},

Continuation Therapy

All Indications - Continued Therapy

General rule for continued therapy:

ALL of the following

Continued therapy will not be authorized as Breyanzi is indicated to be dosed one time only.
Approval duration: not applicable; single dose only
Denial rationale: Breyanzi is a single-dose therapy; subsequent doses are not covered.
Providers should submit only initial treatment dose requests

Provider Actions & Administrative Requirements

Prior Authorization

PDAC utilization management review required

All requests for Breyanzi require review by the Precision Drug Action Committee (PDAC) prior to utilization management decision. Redirect prior authorization reviews to PDAC per operational routing. See CC.PHAR.21 for PDAC review process details and submission instructions. Note: operational routing has been updated to send applicable prior auths to PDAC for review.

All prior authorization requests routed to PDAC for utilization management review
Operational routing updated to direct applicable requests to PDAC

Documentation Required

Submit supporting documentation

Submit supporting clinical documentation to demonstrate that the member meets all approval criteria. Required documentation includes office/clinic notes, laboratory results, and relevant imaging or pathology reports. Attach prior therapy records, lines of therapy, and documentation of HSCT eligibility if applicable. See provider documentation guidance items for additional acceptable documentation.

Applicable Codes

Primary HCPCS for productHCPCSCovered

Q2054

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

Clinical Evidence & Regulatory References

Key clinical evidence supporting lisocabtagene maraleucel includes the TRANSCEND program, most notably the TRANSCEND NHL 001 study and related TRANSCEND studies with publications in Lancet, Journal of Clinical Oncology, Blood, and TRANSCEND CLL and FL cohorts; ClinicalTrials.gov identifiers for TRANSCEND-NHL-001 and related trials are listed in the references. The policy cites the Breyanzi Prescribing Information (Feb 2026) as the authoritative prescribing reference. Boxed warnings listed in the policy (and updated per the PI) include cytokine release syndrome (CRS), neurologic toxicities, and secondary hematologic malignancies.

Evidence & PI access

Key trial evidenceTRANSCEND series (TRANSCEND NHL 001 and related TRANSCEND studies) cited as primary clinical evidence

Notable publications/trialsTRANSCEND NHL 001 (Lancet), TRANSCEND CLL 004 (Lancet), TRANSCEND FL and MCL cohorts (J Clin Oncol, Nat Med, Blood)

Prescribing information accessBreyanzi Prescribing Information (Feb 2026)

Regulatory / dosing concordancePI documents target and maximum dosing ranges (target 50–110 or 90–110 x10^6; maximum 110 x10^6 CAR-positive viable T cells)

Background & Definitions

Lisocabtagene maraleucel (Breyanzi) is a CD19-directed autologous CAR T-cell immunotherapy provided as a frozen single-dose vial and approved for multiple B‑cell malignancies; it is intended to be given as a single initial therapeutic dose (subsequent doses are not authorized) with dosing targets and maxima aligned to the FDA label (target ranges and a maximum of 110 x 10^6 CAR-positive viable T cells), and the policy includes the boxed warnings for cytokine release syndrome, neurologic toxicities, and secondary hematologic malignancies, consistent with the FDA prescribing information and NCCN guidance.

Term	Definition
CAR
Chimeric antigen receptor
HSCT
Hematopoietic stem cell transplantation
BTKi
Bruton tyrosine kinase inhibitor
BCL2i
B-cell lymphoma 2 inhibitor
CNS
Central nervous system
PDAC
Precision Drug Action Committee Utilization Management Review
FL
Follicular lymphoma
MCL
Mantle cell lymphoma
MZL
Marginal zone lymphoma
LBCL
Large B-cell lymphoma

Revision History

06.04.24indication_added

Added new FDA‑approved indications for follicular lymphoma (FL) and mantle cell lymphoma (MCL).

10.08.25dosing_correction

Corrected maximum dose for FL and MCL from 100 to 110 x 10^6 CAR‑positive viable T cells (dose limit enforced at 110 x 10^6 for all indications).

11.04.25operational_routing_update

Policy/criteria updated to redirect prior authorization reviews to the Precision Drug Action Committee (PDAC) Utilization Management Review (operational routing change).

Policy Summary

PayerCentene

PolicyLisocabtagene Maraleucel (Breyanzi) coverage policy

Policy CodePolicy CP.PHAR.483

Change TypeMultiple indication additions & dosing corrections

Effective DateFeb 5, 2021

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria and route prior authorization requests to PDAC for review.

SourceLink

On This Page

{"text":"Disease is refractory or relapsed after ≥ 2 lines of systemic therapy that included an anti-CD20 therapy (e.g., rituximab) and an anthracycline-containing regimen (e.g., doxorubicin)."},

{"text":"Disease is refractory to or relapsed no more than 12 months after first-line chemoimmunotherapy that included an anti-CD20 monoclonal antibody and an anthracycline-containing regimen."},

Member is not eligible for HSCT due to comorbidities or age and disease is refractory to or relapsed after first-line chemoimmunotherapy that included an anti-CD20 monoclonal antibody and an anthracycline-containing regimen.

{"text":"Member does not have primary CNS disease."},

{"text":"Member has not previously received treatment with CAR T-cell immunotherapy (e.g., Abecma, Carvykti, Kymriah, Tecartus, Yescarta)."},

{"text":"Breyanzi is not prescribed concurrently with other CAR T-cell immunotherapy (e.g., Abecma, Carvykti, Kymriah, Tecartus, Yescarta)."},

{"threshold":"<= 110 x 10^6","text":"Dose does not exceed 110 x 10^6 CAR-positive viable T cells."},

Only for initial treatment dose; subsequent doses will not be covered. Prior authorization may be required for prior anti-CD20 therapy (e.g., rituximab). Approval duration: 3 months (1 dose only, with up to 4 doses of tocilizumab if requested at up to 800 mg per dose).

B. Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL)

I. Initial Approval Criteria - B. Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) (must meet ALL):

{

{"text":"Diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)."},

{"text":"Prescribed by or in consultation with an oncologist or hematologist."},

{"text":"Age ≥ 18 years."},

{"text":"Measurable lymph nodes ≥ 1.5 cm in the greatest transverse diameter (assessed within the last 30 days)."},

{"text":"Hepatomegaly."},

{"text":"Splenomegaly."},

Demonstration of CLL cells in the peripheral blood by flow cytometry.

]},

{"text":"Member has received ≥ 2 prior lines of therapy that include BOTH: one BTK inhibitor (e.g., Brukinsa, Calquence, Imbruvica) AND one BCL-2 inhibitor (e.g., Venclexta)."},

{"text":"Member does not have active CNS involvement by malignancy or history/presence of clinically relevant CNS pathology (e.g., epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, cerebral edema, or psychosis)."},

{"text":"Member has not previously received treatment with CAR T-cell immunotherapy (e.g., Abecma, Carvykti, Kymriah, Tecartus, Yescarta)."},

{"text":"Breyanzi is not prescribed concurrently with other CAR T-cell immunotherapy (e.g., Abecma, Carvykti, Kymriah, Tecartus, Yescarta)."},

{"threshold":"<= 110 x 10^6","text":"Dose does not exceed 110 x 10^6 CAR-positive viable T cells."},

Only for initial treatment dose; subsequent doses will not be covered. Prior authorization may be required for prior therapies. Approval duration: 3 months (1 dose only, with up to 4 doses of tocilizumab if requested at up to 800 mg per dose).

]}

}

C. Follicular Lymphoma (FL)

I. Initial Approval Criteria - C. Follicular Lymphoma (FL) (must meet ALL):

{

{"text":"Diagnosis of follicular lymphoma (FL) grade 1, 2, or 3a."},

{"text":"Prescribed by or in consultation with an oncologist or hematologist."},

{"text":"Age ≥ 18 years."},

{"text":"Disease is relapsed or refractory after ≥ 2 lines of systemic therapy that included a combination of an anti-CD20 monoclonal antibody (e.g., rituximab or obinutuzumab) and an alkylating agent (e.g., bendamustine, cyclophosphamide, chlorambucil)."},

{"text":"Member does not have CNS-only involvement by malignancy (secondary CNS involvement is allowed)."},

{"text":"Member does not have history or presence of clinically relevant CNS pathology (e.g., epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, cerebral edema, or psychosis)."},

{"text":"Member has not previously received treatment with CAR T-cell immunotherapy (e.g., Abecma, Carvykti, Kymriah, Tecartus, Yescarta)."},

{"text":"Breyanzi is not prescribed concurrently with other CAR T-cell immunotherapy (e.g., Abecma, Carvykti, Kymriah, Tecartus, Yescarta)."},

{"threshold":"<= 110 x 10^6","text":"Dose does not exceed 110 x 10^6 CAR-positive viable T cells."},

Only for initial treatment dose; subsequent doses will not be covered. Prior authorization may be required. Approval duration: 3 months (1 dose only, with up to 4 doses of tocilizumab if requested at up to 800 mg per dose).

]}

}

D. Mantle Cell Lymphoma (MCL)

I. Initial Approval Criteria - D. Mantle Cell Lymphoma (MCL) (must meet ALL):

{

{"text":"Diagnosis of relapsed or refractory mantle cell lymphoma (MCL)."},

{"text":"Prescribed by or in consultation with an oncologist or hematologist."},

{"text":"Age ≥ 18 years."},

{"text":"Member has previously received ≥ 2 prior lines of systemic therapy that included ALL of the following: an anti-CD20 monoclonal antibody (e.g., rituximab); a BTK inhibitor (e.g., Imbruvica, Calquence, Brukinsa, Jaypirca); and an alkylating agent (e.g., bendamustine, cyclophosphamide, or platinum agent)."},

{"text":"Member does not have CNS-only involvement by malignancy (secondary CNS involvement is allowed)."},

{"text":"Member has not previously received treatment with CAR T-cell immunotherapy (e.g., Abecma, Carvykti, Kymriah, Tecartus, Yescarta)."},

{"text":"Breyanzi is not prescribed concurrently with other CAR T-cell immunotherapy (e.g., Abecma, Carvykti, Kymriah, Tecartus, Yescarta)."},

{"threshold":"<= 110 x 10^6","text":"Dose does not exceed 110 x 10^6 CAR-positive viable T cells."},

Only for initial treatment dose; subsequent doses will not be covered. Approval duration: 3 months (1 dose only, with up to 4 doses of tocilizumab if requested at up to 800 mg per dose).

]}

}

E. Marginal Zone Lymphoma (MZL)

I. Initial Approval Criteria - E. Marginal Zone Lymphoma (MZL) (must meet ALL):

{

{"text":"Diagnosis of marginal zone lymphoma (MZL), including nodal, extranodal, and splenic subtypes."},

{"text":"Prescribed by or in consultation with an oncologist or hematologist."},

{"text":"Age ≥ 18 years."},

{"text":"Disease is refractory or relapsed after ≥ 2 lines of systemic therapy that included an anti-CD20 therapy (e.g., rituximab) and one alkylating agent (e.g., bendamustine, chlorambucil, cyclophosphamide)."},

Member has relapsed after hematopoietic stem cell transplant (HSCT).

]},

{"text":"Member does not have primary CNS disease."},

{"text":"Member has not previously received treatment with CAR T-cell immunotherapy (e.g., Abecma, Carvykti, Kymriah, Tecartus, Yescarta)."},

{"text":"Breyanzi is not prescribed concurrently with other CAR T-cell immunotherapy (e.g., Abecma, Carvykti, Kymriah, Tecartus, Yescarta)."},

{"threshold":"<= 110 x 10^6","text":"Dose does not exceed 110 x 10^6 CAR-positive viable T cells."},

Only for initial treatment dose; subsequent doses will not be covered. Prior authorization may be required for prior therapies (e.g., rituximab). Approval duration: 3 months (1 dose only, with up to 4 doses of tocilizumab if requested at up to 800 mg per dose).

]}

}

F. Other diagnoses/indications

I. Initial Approval Criteria - F. Other diagnoses/indications (must meet 1 or 2):

{

{"text":"If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy (e.g., newly approved indication, age expansion, new dosing regimen), refer to the appropriate internal off-label/formulary policy: for drugs on the formulary or PDL use CP.CPA.190 (commercial), HIM.PA.33 (ICHRA/marketplace), or CP.PMN.255 (Medicaid)."},

If the drug is NOT on the formulary or PDL, refer to the non-formulary policies (e.g., HIM.PA.103 or CP.PMN.16) for coverage determination and routing.

Policy/Criteria change routing: All requests still require Precision Drug Action Committee (PDAC) Utilization Management Review per CC.PHAR.21. Dosing correction: Ensure dose does not exceed the single initial treatment limit of 110 x 10^6 CAR-positive viable T cells; subsequent doses are not covered. Regulatory status update: Document and route any recently approved label changes per the referenced internal policies and include supporting regulatory documentation with the request.

For off-label uses or indications not covered by the current label, follow the internal policies listed above for evaluation and potential prior authorization; provider must submit documentation supporting clinical rationale and necessity.

Only one initial treatment dose is covered; approvals are for initial dosing only unless policy is updated. Prior authorization and documentation requirements apply as described in the Policy/Criteria section.

]}

}

Office/clinic notes documenting diagnosis, disease status, and treating specialist
Recent laboratory results (e.g., CBC, chemistries) relevant to treatment
Imaging reports and pathology confirming diagnosis and disease burden
Prior therapy records documenting lines of systemic therapy and response
Documentation of HSCT ineligibility when claimed

Denial Risk

Single dose only; no continuation

Only a single (initial) dose will be considered for authorization. Continued or repeat therapy with Breyanzi will not be authorized under this policy.

Code Q2054 — single dose only; continued therapy will not be authorized

Billing Rule

Dose limit enforcement

Enforce dose limits at the time of billing and authorization. Ensure billed dose does not exceed the policy maximum for CAR-positive viable T cells.

Ensure billed dose does not exceed 110 x 10^6 CAR-positive viable T cells (Q2054)

Documentation Required

Specialty prescribing requirement

Breyanzi must be prescribed by or in consultation with an oncologist or hematologist. Include name and specialty of the prescribing or consulting clinician in the submission.

Prescriber must be an oncologist or hematologist, or documentation of consultation must be provided

Documentation Required

Clinical documentation for revised indications

For requests seeking authorization for newly added or revised indications, include supporting clinical documentation aligned with the NCCN guideline recommendation or the FDA Prescribing Information for that indication. Provide indication-specific evidence when requesting authorization for follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), HIV-related plasmablastic lymphoma, or pediatric primary mediastinal B-cell lymphoma (PMBCL bypass).

Include indication-specific supporting documentation per NCCN or FDA PI when requesting authorization for FL, MCL, MZL, HIV-related plasmablastic lymphoma, or pediatric PMBCL bypass

01.17.25age_bypass_added

Added age bypass for primary mediastinal large B‑cell lymphoma (LBCL) consistent with NCCN Pediatric guidance (permits requests for primary mediastinal LBCL without the standard age ≥18 requirement).

RT2 (date not listed)indication_added

Added new FDA‑approved indication for chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) per updated prescribing information.

01.13.26 (P&T 02.26)indication_added

Added new FDA‑approved indication for marginal zone lymphoma (MZL).

2Q2024 (04.09.24; P&T 05.24)policy_revision

Removed requirement that T‑cell/histiocyte‑rich LBCL use be limited to second‑line therapy.

2Q2025 (01.17.25; P&T 05.25)indication_added

Added NCCN Compendium–supported use in HIV‑related plasmablastic lymphoma (expanded coverage in LBCL subtypes).

RT2 (date not listed)boxed_warning_update

Updated boxed warnings in prescribing information to include secondary hematological malignancies.

03.26.26 (2Q2026 review 05.26)regulatory_clarificationLatest

Removed reference to accelerated approval footnote for FL in the FDA approved indications per updated prescribing information; also added ICHRA line of business to policy applicability.