ModifiedBaylor Scott & White Health PlanPolicy 291
Lisocabtagene Maraleucel (Breyanzi®) Coverage
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This policy governs medical necessity and prior authorization for lisocabtagene maraleucel (Breyanzi) for eligible hematologic malignancies. It applies across lines of business unless otherwise indicated and requires documentation of universal and indication-specific criteria.
The 2026 update added policy content for marginal zone lymphoma, histologic Richter transformation to diffuse large B-cell lymphoma, and pediatric primary mediastinal large B-cell lymphoma.
The 2026 update revised the CPT code list, added an ICD-10 code for marginal zone lymphoma, updated the background and references, and made minor formatting changes.
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18+Minimum member age
ECOG 0–1Required performance status
CD19+Required tumor expression
1Lifetime treatment limit
6Disease categories addressed
Medical Necessity and Coverage Criteria
Universal criteria
Covered when all universal criteria are met.
Universal criteria: Member is 18 years or older; lisocabtagene is prescribed by or in consultation with a board-certified hematologist or oncologist; treatment follows FDA-approved labeling and is used as monotherapy; ECOG performance status is 0 or 1; bone marrow, renal, hepatic, pulmonary, and cardiac function are adequate; the member is an appropriate candidate for apheresis; CD19 tumor expression is documented; the member has not received prior CAR T-cell immunotherapy; if prior anti-CD19 therapy was given, repeat biopsy demonstrates CD19-positive disease; and none of the listed exclusion conditions are present.Age >=18; ECOG 0-1; no allogeneic hematopoietic stem-cell transplantation within 84 days before leukapheresis
Exclusion conditions include primary CNS malignancy, active hepatitis B or C, HIV, uncontrolled infection, CNS disorders, active inflammatory disease requiring systemic immunosuppression, active GVHD, unmanaged venous thrombosis or embolism, and pregnancy.
Large B-cell lymphoma
Covered for large B-cell lymphoma when all universal and disease-specific criteria are met.
ONE qualifying treatment-history pathway
Multiple prior lines: Relapsed or refractory disease after two or more prior lines of systemic therapy.>=2 prior systemic lines
Early relapse or refractory disease: Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy.Relapse within 12 months
Transplant-ineligible pathway: Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and not eligible for HSCT because of comorbidities or age.
Covered for chronic lymphocytic leukemia/small lymphocytic lymphoma when all universal and disease-specific criteria are met.
CLL/SLL: Member has relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma and has received at least two prior lines of systemic therapy, including a BTK inhibitor and a BCL-2 inhibitor.>=2 prior systemic lines; must include BTK inhibitor and BCL-2 inhibitor
Examples of BTK inhibitors include ibrutinib, acalabrutinib, zanubrutinib, and pirtobrutinib. An example of a BCL-2 inhibitor is venetoclax. The member must also meet all universal criteria.
Mantle cell lymphoma
Covered for mantle cell lymphoma when all universal and disease-specific criteria are met.
Mantle cell lymphoma: Member has relapsed or refractory mantle cell lymphoma confirmed by cyclin D1 expression or evidence of t(11;14) by cytogenetics, FISH, or PCR, and has received at least two prior lines of systemic therapy including a BTK inhibitor.>=2 prior systemic lines; must include BTK inhibitor
Examples of BTK inhibitors include ibrutinib, acalabrutinib, zanubrutinib, and pirtobrutinib. The member must also meet all universal criteria.
Follicular lymphoma
Covered for follicular lymphoma when all universal and disease-specific criteria are met.
Follicular lymphoma: Member has histologically confirmed relapsed or refractory follicular lymphoma grade 1, 2, or 3a and has received at least two prior lines of systemic therapy including a CD20 antibody and an alkylator.>=2 prior systemic lines; must include CD20 antibody and alkylator
Examples of CD20 antibodies include obinutuzumab and rituximab. Examples of alkylators include bendamustine and cyclophosphamide. The member must also meet all universal criteria.
Marginal zone lymphoma
Covered for marginal zone lymphoma when all universal and disease-specific criteria are met.
Marginal zone lymphoma: Member has relapsed or refractory marginal zone lymphoma and has received at least two prior lines of systemic therapy including a CD20 antibody and an alkylator.>=2 prior systemic lines; must include CD20 antibody and alkylator
Examples of CD20 antibodies include obinutuzumab and rituximab. Examples of alkylators include bendamustine and cyclophosphamide. The member must also meet all universal criteria.
Histologic Richter transformation to DLBCL
Covered for histologic Richter transformation to DLBCL when all universal and disease-specific criteria are met.
Richter transformation to DLBCL: Member has histologic Richter transformation to DLBCL and has partial response, refractory disease, or progression following at least one prior systemic therapy regimen for Richter transformation.>=1 prior systemic regimen for Richter transformation
The member must also meet all universal criteria.
Pediatric primary mediastinal large B-cell lymphoma
Covered for pediatric primary mediastinal large B-cell lymphoma when the modified universal criteria and all disease-specific criteria are met.
Pediatric primary mediastinal large B-cell lymphoma: Member meets all universal criteria apart from the standard age requirement; is 18 years or younger, or is younger than 39 years and treated under the pediatric NCCN PMBCL pathway; has relapsed or refractory PMBCL; has received at least two prior chemoimmunotherapy regimens; and lisocabtagene is used as consolidation or additional therapy following partial response to chemoimmunotherapy.Age <=18, or age <39 under pediatric NCCN PMBCL pathway; >=2 prior chemoimmunotherapy regimens
The pediatric pathway modifies the standard universal age criterion.
Experimental repeat administration
Repeat treatment is not covered.
Repeat administration of lisocabtagene maraleucel after one prior lifetime treatment is experimental and investigational because effectiveness has not been established.One treatment per lifetime
Experimental or investigational indications
Other indications are not covered.
Other indications: Lisocabtagene maraleucel for indications other than those specified in this policy is experimental and investigational because effectiveness has not been established.
Coverage requires that the member does not have a primary central nervous system malignancy; active hepatitis B, active hepatitis C, HIV infection, or uncontrolled infection; a history of CNS disorders such as seizure disorder or cerebrovascular ischemia; an active inflammatory disorder requiring systemic immunosuppression; active graft-versus-host disease; allogeneic hematopoietic stem-cell transplantation within the preceding 84 days before leukapheresis; unmanaged venous thrombosis or embolism; or pregnancy.
Only one lisocabtagene maraleucel treatment per lifetime is medically necessary. Repeat administration after one prior lifetime treatment is considered experimental and investigational because the effectiveness of repeat treatment has not been established.
Chimeric antigen receptor T-cell (CAR-T) therapy; harvest of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day
Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose
ICD-10 Diagnosis CodesICD-10
C82.00-C82.69
Follicular lymphoma
C82.80-C82.99
Follicular lymphoma
C83.10-C83.19
Mantle cell lymphoma
C83.30-C83.39
Diffuse large B-cell lymphoma
C83.90-C83.99
Non-follicular (diffuse) lymphoma
C85.20-C85.29
Mediastinal (thymic) large B-cell lymphoma
C88.4
Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue
C91.10
Chronic lymphocytic leukemia of B-cell type not having achieved remission
Authorization and Documentation Requirements
Prior Authorization
Prior Authorization Required
Prior authorization is required for lisocabtagene maraleucel (Breyanzi®). Submit the request and supporting clinical documentation for review by a clinical pharmacist and medical director before treatment.
Confirm coverage under the applicable Evidence of Coverage/Summary Plan Description; Medicare and Medicaid requests may be subject to additional program-specific requirements.
Documentation Required
Universal Clinical Documentation Required
Document that every universal requirement is satisfied, including the member’s age, specialist involvement, FDA-labeled dosing, monotherapy, performance status, organ function, apheresis candidacy, CD19 status, and prior-treatment history.
Member is 18 years or older, except as allowed under the pediatric PMBCL criteria.
Therapy Background
Lisocabtagene maraleucel is a CD19-directed, genetically modified autologous CAR T-cell immunotherapy manufactured from the patient's leukapheresed T cells. The product contains defined CD8- and CD4-positive CAR T cells designed to recognize CD19-expressing cells and is used in the treatment of relapsed or refractory B-cell malignancies.
Cell compositionContains defined CD8- and CD4-positive CAR T cells.
MechanismThe CAR T cells recognize CD19-expressing cells.
GVHD
AbbreviationGVHD.
Full termGraft-versus-host disease.
Coverage relevanceActive graft-versus-host disease is an exclusion condition.
Therapy-Line Requirements
Salvage therapy: large B-cell lymphoma
For large B-cell lymphoma, the applicable salvage-therapy pathway must be met in addition to the disease-specific coverage criteria.
ONE qualifying salvage-therapy pathway
Multiple prior lines: Relapsed or refractory disease after two or more prior lines of systemic therapy.>=2 prior systemic lines
Early relapse or refractory disease: Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy.Relapse within 12 months
Transplant-ineligible pathway:
Required Biomarker Evidence
CD19
Required biomarkerCD19 tumor expression must be documented for covered requests.
Standard evidenceDocumentation of CD-19 tumor expression is required under the universal criteria.
After prior anti-CD19 therapyIf prior anti-CD19 therapy was given, a repeat biopsy must indicate CD-19-positive disease.
Cyclin D1 or t(11;14)
Disease applicationRequired to confirm a diagnosis of relapsed or refractory mantle cell lymphoma.
Cyclin D1 evidenceCyclin D1 expression may confirm the diagnosis.
t(11;14) evidence
Covered Treatment Pathways
Disease setting
Prior treatment or response
Lisocabtagene maraleucel use
Coverage
Large B-cell lymphoma, including DLBCL not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, or follicular lymphoma grade 3B
Relapsed or refractory after at least 2 prior systemic therapy lines; or refractory to first-line chemoimmunotherapy or relapse within 12 months; or refractory/relapsed after first-line chemoimmunotherapy when HSCT is not appropriate because of comorbidities or age
Monotherapy
Covered
Disease setting
Prior treatment or response
Lisocabtagene maraleucel use
Coverage
Relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma
At least 2 prior systemic therapy lines, including a BTK inhibitor and a BCL-2 inhibitor
Monotherapy
Covered
Disease setting
Prior treatment or response
Lisocabtagene maraleucel use
Coverage
Relapsed or refractory mantle cell lymphoma confirmed by cyclin D1 expression or t(11;14) evidence by cytogenetics, FISH, or PCR
At least 2 prior systemic therapy lines, including a BTK inhibitor
Monotherapy
Covered
Disease setting
Prior treatment or response
Lisocabtagene maraleucel use
Coverage
Relapsed or refractory follicular lymphoma grade 1, 2, or 3a, or marginal zone lymphoma
At least 2 prior systemic therapy lines, including a CD20 antibody and an alkylator
Monotherapy
Covered
Disease setting
Prior treatment or response
Lisocabtagene maraleucel use
Coverage
Relapsed or refractory pediatric primary mediastinal large B-cell lymphoma; age 18 years or younger, or younger than 39 years treated under the pediatric NCCN PMBCL pathway
At least 2 prior chemoimmunotherapy regimens with partial response to chemoimmunotherapy
Consolidation or additional therapy
Covered
Disease setting
Prior treatment or response
Lisocabtagene maraleucel use
Coverage
Histologic Richter transformation to diffuse large B-cell lymphoma
Partial response, refractory disease, or progression following at least 1 prior systemic therapy regimen for Richter transformation
CAR T-cell therapy option for eligible patients; liso-cel may be used as monotherapy
Eligible option
Disease setting
Prior treatment or response
Lisocabtagene maraleucel use
Coverage
Relapsed or refractory pediatric primary mediastinal large B-cell lymphoma
Partial response to second-line therapy
CAR T-cell therapy option; clinical trial or best supportive care is recommended for less than a partial response
Prescribed by or administered in consultation with a board-certified hematologist or oncologist.
Dosed and administered according to FDA-approved labeling and used as monotherapy.
ECOG performance status is 0 or 1.
Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function is documented.
Hematologist/oncologist assessment confirms the member is an appropriate candidate for apheresis.
CD19 tumor expression is documented.
No prior CAR T-cell immunotherapy, including axicabtagene, tisagenlecleucel, or brexucabtagene.
If prior anti-CD19 therapy was given, such as tafasitamab or loncastuximab, submit a repeat biopsy confirming CD19-positive disease.
Documentation Required
Indication-Specific Documentation Required
Submit diagnosis-specific records establishing the eligible disease, pathology or molecular confirmation when required, and the qualifying prior treatment history and disease response, relapse, or refractory status.
Large B-cell lymphoma: Document eligible LBCL subtype and either relapse/refractory disease after at least two systemic regimens; refractory disease or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease/relapse after first-line chemoimmunotherapy with HSCT ineligibility due to comorbidities or age.
CLL/SLL: Document relapsed or refractory disease and at least two prior systemic regimens, including a BTK inhibitor and a BCL-2 inhibitor.
MCL: Document relapsed or refractory mantle cell lymphoma confirmed by cyclin D1 expression or t(11;14) evidence by cytogenetics, FISH, or PCR, plus at least two prior systemic regimens including a BTK inhibitor.
FL: Submit histologic confirmation of relapsed or refractory follicular lymphoma grade 1, 2, or 3a and evidence of at least two prior systemic regimens including a CD20 antibody and an alkylator.
MZL: Document relapsed or refractory marginal zone lymphoma and at least two prior systemic regimens including a CD20 antibody and an alkylator.
Richter transformation to DLBCL: Document histologic transformation and partial response, refractory disease, or progression after at least one prior systemic regimen for Richter transformation.
Pediatric PMBCL: Document relapsed or refractory PMBCL, age 18 years or younger or age under 39 while treated under the pediatric NCCN PMBCL pathway, at least two prior chemoimmunotherapy regimens, and use as consolidation/additional therapy after partial response to chemoimmunotherapy.
Denial Risk
Failure to Meet Universal Criteria
Requests may be denied when any universal coverage requirement is not met or cannot be substantiated in the submitted records. All universal criteria apply unless the policy expressly permits the pediatric PMBCL age exception.
Member is younger than 18 and does not qualify under the pediatric PMBCL pathway.
No board-certified hematologist/oncologist prescriber or consultant is documented.
Dosing is inconsistent with FDA-approved labeling or treatment is planned with combination therapy rather than monotherapy.
ECOG performance status is above 1 or is undocumented.
Adequate marrow, renal, hepatic, pulmonary, or cardiac function is not established.
Member is not documented as an appropriate apheresis candidate.
CD19 tumor expression is absent, undocumented, or not reconfirmed after prior anti-CD19 therapy.
Member has received prior CAR T-cell immunotherapy.
Denial Risk
Excluded Clinical Conditions
Do not request coverage when an excluded clinical condition is present. These conditions must be specifically assessed and addressed in the clinical documentation.
Primary CNS malignancy.
Active hepatitis B (HBsAg-positive), active hepatitis C, HIV infection, or uncontrolled infection.
History of a CNS disorder, such as seizure disorder or cerebrovascular ischemia.
Active inflammatory disorder requiring systemic immunosuppression.
Active graft-versus-host disease.
Allogeneic hematopoietic stem-cell transplantation within the 84 days before leukapheresis.
Unmanaged venous thrombosis or embolism.
Pregnancy.
Denial Risk
Repeat Treatment or Other Indications
BSWHP considers only one lisocabtagene maraleucel treatment per lifetime medically necessary. Repeat administration and treatment for indications not addressed by the policy are experimental and investigational because effectiveness has not been established.
Repeat administration after a prior lisocabtagene maraleucel treatment is not medically necessary.
Requests for all other indications are experimental and investigational and are not covered under this policy.
ICANS
AbbreviationICANS.
Full termImmune effector cell-associated neurotoxicity syndrome.
Clinical contextICANS is a neurologic toxicity associated with lisocabtagene maraleucel treatment.
Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and not eligible for HSCT because of comorbidities or age.
Salvage therapy: CLL/SLL, mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma
For CLL/SLL, mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma, all applicable salvage-therapy requirements must be met.
Relapsed or refractory disease after prior therapy: Member has relapsed or refractory disease after at least two prior lines of systemic therapy; required prior drug classes vary by disease.>=2 prior systemic lines
CLL/SLL requires a BTK inhibitor and a BCL-2 inhibitor; mantle cell lymphoma requires a BTK inhibitor; follicular lymphoma and marginal zone lymphoma require a CD20 antibody and an alkylator.
Salvage therapy: Richter transformation to DLBCL
For histologic Richter transformation to DLBCL, the applicable salvage-therapy requirement must be met.
Richter transformation treatment setting: Member has partial response, refractory disease, or progression following at least one prior systemic regimen for Richter transformation.>=1 prior systemic regimen
Salvage therapy: pediatric primary mediastinal large B-cell lymphoma
For pediatric PMBCL, the applicable salvage-therapy requirements must be met.
Pediatric PMBCL treatment setting: Member has relapsed or refractory PMBCL after at least two prior chemoimmunotherapy regimens, with lisocabtagene used as consolidation or additional therapy following partial response to chemoimmunotherapy.>=2 prior chemoimmunotherapy regimens; partial response
Salvage therapy: CLL/SLL
The CLL/SLL salvage indication requires all of the following.
CLL/SLL salvage indication: Adult patient has relapsed or refractory CLL or SLL after two or more prior lines of systemic therapy, including a BTK inhibitor and a BCL-2 inhibitor.At least 2 prior systemic therapy lines
FDA-approved disease setting.
Salvage therapy: follicular lymphoma
The follicular lymphoma salvage indication requires all of the following.
Follicular lymphoma salvage indication: Adult patient has relapsed or refractory follicular lymphoma after two or more prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent.At least 2 prior systemic therapy lines
FDA-approved disease setting.
Salvage therapy: mantle cell lymphoma
The mantle cell lymphoma salvage indication requires all of the following.
Mantle cell lymphoma salvage indication: Adult patient has relapsed or refractory mantle cell lymphoma after two or more prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.At least 2 prior systemic therapy lines
FDA-approved disease setting.
Salvage therapy: marginal zone lymphoma
The marginal zone lymphoma salvage indication requires all of the following.
Marginal zone lymphoma salvage indication: Adult patient has relapsed or refractory marginal zone lymphoma and has received at least two prior lines of systemic therapy.At least 2 prior systemic therapy lines
FDA-approved disease setting; the supporting trial also included patients relapsing after hematopoietic stem-cell transplant.
Salvage therapy: Richter transformation to DLBCL
The Richter transformation salvage indication requires all of the following.
Richter transformation setting: Patient has histologic Richter transformation to DLBCL and has received at least one prior systemic therapy regimen.At least 1 prior systemic therapy regimen
CAR T-cell therapy is an option for eligible patients; clinical-trial enrollment is recommended for all patients.
Second-line therapy: pediatric primary mediastinal large B-cell lymphoma
For pediatric PMBCL, the second-line treatment requirement must be met.
Pediatric PMBCL second-line setting: Patient has relapsed or refractory pediatric PMBCL with a partial response to second-line therapy.Partial response to second-line therapy
Clinical trial or best supportive care is recommended for patients achieving less than a partial response to second-line therapy.
Evidence of t(11;14) may be established by cytogenetics, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR).