Blue Cross Blue Shield MA CAR T Coverage Update | OpenPayer
CurrentBlue Cross Blue Shield - MassachusettsPolicy 066
CAR T‑cell therapy (CD19-directed) for B‑cell malignancies — Medical necessity and prior authorization
Medical necessity and authorization criteria for specific commercially covered CAR T‑cell therapies for B‑cell acute lymphoblastic leukemia and various B‑cell non‑Hodgkin lymphomas for Blue Cross Blue Shield Massachusetts commercial products.
Policy Summary
PayerBlue Cross Blue Shield - Massachusetts
PolicyCAR T‑cell therapy (CD19-directed) for B‑cell malignancies — Medical necessity and prior authorization
Policy CodePolicy 066
Change TypeNo material changes
Effective Date
Next Review Date
Key ActionSubmit initial prior authorization requests via Authorization Manager using the product‑specific prior authorization form and include required clinical documentation.
No material clinical or coverage changes in this revision.
MultipleCAR T products referenced
YesPreauthorization required
≥2 lines (many)Prior therapy requirement
81%Response rate (Kymriah, pediatric ALL)
83%
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Response rate (Yescarta, aggressive NHL)
Coverage and Medical Necessity Criteria
Tisagenlecleucel (Kymriah) — B‑cell ALL
Covered when ALL of the following are met:
Kymriah for ALL: 1. Confirmed diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with morphologic bone marrow tumor involvement (≥5% lymphoblasts).
Kymriah for ALL - disease status: 2. Relapsed OR refractory disease as defined in policy (relapsed = reappearance of leukemia cells in marrow or peripheral blood after prior complete remission; refractory = failure to obtain complete response with induction therapy).
Kymriah for ALL - Ph+ requirement: 3. When Philadelphia chromosome–positive, documented failure of 2 tyrosine kinase inhibitors prior to CAR T consideration.
Kymriah for ALL - age: 4. Age up to 25 years at the time of infusion.
Kymriah for ALL - prior therapies: 5. No prior CD19-directed CAR T-cell therapy, other cell therapy, or gene therapy (or being considered for such therapies).
Kymriah for ALL - organ function: 6. Adequate organ function with no significant deterioration in organ function expected within 4 weeks after apheresis, as determined by the treating physician.
Kymriah for ALL - exclusions: 7. Absence of exclusionary conditions: Burkitt lymphoma; active hepatitis B or C or any uncontrolled infection; grade 2–4 graft-versus-host disease; concomitant genetic bone marrow failure syndromes (except Down syndrome); receipt of allogeneic cellular therapy (eg, donor lymphocyte infusion) within 6 weeks prior to infusion; or active CNS ALL (CSF WBC ≥5/μL with blasts).
Tisagenlecleucel (Kymriah) — Large B‑cell lymphoma
Covered when ALL of the following are met:
Kymriah for large B-cell lymphoma: 1. Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, or DLBCL arising from follicular lymphoma.
Kymriah for large B-cell lymphoma - prior therapy: 2. Relapsed or refractory disease defined as progression after ≥2 lines of systemic therapy including an anti‑CD20 monoclonal antibody for CD20-positive tumors and an anthracycline-containing chemotherapy regimen.
Kymriah for large B-cell lymphoma - transformed disease: 3. For histologic transformation from follicular or nodal marginal zone lymphoma: prior chemotherapy for the indolent lymphoma and ≥2 chemo‑immunotherapy regimens for the transformed disease.
Kymriah for large B-cell lymphoma - age: 4. At least 18 years of age at the time of infusion.
Tisagenlecleucel (Kymriah) — Follicular lymphoma
Covered when ALL of the following are met:
Kymriah for follicular lymphoma: 1. Histologically confirmed follicular lymphoma.
Kymriah for follicular lymphoma - prior therapy: 2. Relapsed or refractory disease defined as progression after ≥2 lines of systemic therapy for follicular lymphoma.
Kymriah for follicular lymphoma - age: 3. At least 18 years of age at the time of infusion.
Kymriah for follicular lymphoma - organ function: 4. Adequate organ and bone marrow function as determined by the treating oncologist/hematologist.
Axicabtagene ciloleucel (Yescarta) — Large B‑cell lymphoma
Covered when ALL of the following are met:
Yescarta for large B-cell lymphoma: 1. Meet any one of the following:
a. Large B‑cell lymphoma refractory to first‑line chemoimmunotherapy or relapsed within 12 months after first‑line chemoimmunotherapy that included an anti‑CD20 monoclonal antibody and an anthracycline-containing regimen; OR
b. Histologically confirmed DLBCL (and specified subtypes) with progression after ≥2 lines of systemic therapy including an anti‑CD20 monoclonal antibody and anthracycline-containing chemotherapy (with required prior chemo for transformed disease as applicable).
Yescarta for large B-cell lymphoma - age: 2. At least 18 years of age at the time of infusion.
Yescarta for large B-cell lymphoma - organ function: 3. Adequate organ and bone marrow function as determined by the treating oncologist/hematologist.
Yescarta for follicular lymphoma: 1. Histologically confirmed follicular lymphoma.
Yescarta for follicular lymphoma - prior therapy: 2. Relapsed or refractory disease defined as progression after ≥2 lines of systemic therapy for follicular lymphoma.
Yescarta for follicular lymphoma - age: 3. At least 18 years of age at the time of infusion.
Yescarta for follicular lymphoma - organ function: 4. Adequate organ and bone marrow function as determined by the treating oncologist/hematologist.
Brexucabtagene autoleucel (Tecartus) — B‑cell ALL
Covered when ALL of the following are met:
Tecartus for ALL: 1. Confirmed diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with morphologic bone marrow tumor involvement (≥5% lymphoblasts).
Tecartus for ALL - disease status: 2. Relapsed OR refractory disease as defined in policy (relapsed = reappearance of leukemia cells after prior remission; refractory = failure to obtain complete response with induction therapy).
Tecartus for ALL - Ph+ requirement: 3. When Philadelphia chromosome–positive: failure of tyrosine kinase inhibitors prior to CAR T consideration.
Tecartus for ALL - age: 4. At least 18 years of age at the time of infusion.
Tecartus for mantle cell lymphoma: 1. Histologically confirmed relapsed or refractory mantle cell lymphoma.
Tecartus for MCL - prior therapy: 2. Received adequate prior therapy including anthracycline- or bendamustine-containing chemotherapy, an anti‑CD20 monoclonal antibody, and a Bruton tyrosine kinase (BTK) inhibitor (eg, acalabrutinib, ibrutinib, zanubrutinib).
Tecartus for MCL - age: 3. At least 18 years of age at the time of infusion.
Tecartus for MCL - organ function: 4. Adequate organ and bone marrow function as determined by the treating oncologist/hematologist.
Lisocabtagene maraleucel (Breyanzi) — Large B‑cell lymphoma
Covered when ALL of the following are met:
Breyanzi for large B-cell lymphoma: 1. Histologically confirmed large B‑cell lymphoma including DLBCL not otherwise specified, DLBCL arising from indolent lymphoma, high‑grade B‑cell lymphoma, primary mediastinal large B‑cell lymphoma, and follicular lymphoma grade 3B.
Breyanzi for large B-cell lymphoma - disease scenarios: 2. Meets at least one of the following: (a) primary refractory or relapsed within 12 months of first‑line chemoimmunotherapy that included an anti‑CD20 and anthracycline; OR (b) same as (a) and ineligible for HSCT due to comorbidities/age; OR (c) relapsed or refractory disease after ≥2 lines of systemic therapy including anti‑CD20 and anthracycline-containing chemotherapy (with prior chemo for transformed disease as applicable).
Breyanzi for large B-cell lymphoma - age: 3. At least 18 years of age at the time of infusion.
Breyanzi for large B-cell lymphoma - organ function:
Obacabtegene for ALL: 1. At least 18 years of age at the time of infusion.
Obacabtegene for ALL - histology: 2. Histologically confirmed B‑cell lymphoma/ALL that is refractory or relapsed within 12 months following first‑line chemoimmunotherapy that included an anti‑CD20 monoclonal antibody and an anthracycline-containing regimen.
Obacabtegene for ALL - disease status: 3. Meet ONE of: (a) relapsed disease within 12 months as defined (reappearance of leukemia cells after prior remission); OR (b) refractory disease after first‑line chemoimmunotherapy as defined (failure to obtain complete response with induction therapy).
Obacabtegene for ALL - organ function: 4. Adequate organ and bone marrow function as determined by the treating oncologist/hematologist.
General medical necessity and authorization
Covered when ALL of the following are met:
General prerequisites: Medical necessity criteria in the policy must be met for the listed HCPCS/procedure codes to be covered, and prior authorization must be obtained via Authorization Manager using the product‑specific prior authorization form (or fax process for out‑of‑network requests).
Applies to Commercial Managed Care (HMO and POS), PPO, Indemnity, Medicare HMO Blue and Medicare PPO Blue as stated.
Product-specific efficacy summaries and implied coverage criteria
Coverage considerations tied to clinical trial evidence and FDA approvals; efficacy was established in single‑arm pivotal trials with notable response rates and substantial serious adverse events.
Tisagenlecleucel - pediatric/young adult ALL: For individuals up to 25 years with relapsed or refractory B‑cell ALL, pivotal trial reported an 81% response rate with MRD‑negativity among responders; high rates of grade ≥3 adverse events and CRS were observed.
Evidence sufficient to improve net health outcome.
Tisagenlecleucel - adult aggressive NHL: For adults with aggressive NHL (eg, DLBCL, high‑grade B‑cell lymphoma, transformed follicular lymphoma), pivotal single‑arm trial reported a 52% ORR with substantial CRS and grade ≥3 adverse events.
Evidence sufficient to improve net health outcome.
Axicabtagene ciloleucel - adult aggressive NHL: For adults with aggressive NHL, pivotal trial reported an 83% ORR and median duration of response 11.1 months; high frequency of CRS and grade ≥3 adverse events.
Evidence sufficient to improve net health outcome.
The policy addresses multiple commercially available CD19-directed chimeric antigen receptor (CAR) T‑cell products — including tisagenlecleucel (Kymriah), axicabtagene ciloleucel (Yescarta), brexucabtagene autoleucel (Tecartus), lisocabtagene maraleucel (Breyanzi), and obecabtagene autoleucel (Aucatzyl) — which are considered for coverage when the product‑specific medical necessity criteria in this policy are met (diagnosis, prior lines of therapy, age, organ function, absence of exclusionary conditions, and other prerequisites).
Inclusion of a HCPCS, CPT, or ICD code in this policy is provided for informational purposes only and does not guarantee coverage or payment for a given member; coverage is determined by the member's contract benefits in effect at the time of service and the member meeting the policy's medical necessity criteria.
Obecabtagene autoleucel (Aucatzyl) carries a Black Box warning for Cytokine Release Syndrome, Neurologic Toxicities, and Secondary Hematological Malignancies; providers must consider these serious risks when evaluating candidates and in documentation for authorization and treatment planning.
Within the reference and repeat‑infusion citation sections reviewed, there are no explicit coverage exclusions listed for the products beyond the investigational/medical necessity statements elsewhere in the policy.
The cited policy sections and reference windows do not contain any explicit statements designating services as "not medically necessary"; rather, products are described as medically necessary when specified criteria are met and investigational when criteria are not satisfied.
Procedure and Product Coding
HCPCS Codes (CAR T and related biologics)HCPCS
C9399
Unclassified drugs or biologicals.
J3490
Unclassified drugs.
J3590
Unclassified biologics.
J9999
Not otherwise classified, antineoplastic drugs.
Q2041
Axicabtagene ciloleucel, up to 200 million autologous anti‑CD19 CAR‑positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose.
Q2042
Tisagenlecleucel, up to 600 million CAR‑positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose.
Q2053
Brexucabtagene autoleucel, up to 200 million autologous anti‑CD19 CAR‑positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose.
Q2054
Lisocabtagene maraleucel, up to 110 million autologous anti‑CD19 CAR‑positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose.
Q2058
Obecabtagene autoleucel, up to 400 million CD19 CAR‑positive viable T cells, including leukapheresis and dose preparation procedures, per infusion (Aucatzyl).
ICD-10-PCS Procedure Codes (CAR T infusions)ICD-10
XW033H7
Introduction of Axicabtagene Ciloleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7.
XW043H7
Introduction of Axicabtagene Ciloleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7.
XW033J7
Introduction of Tisagenlecleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7.
XW043J7
Introduction of Tisagenlecleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7.
XW033M7
Introduction of Brexucabtagene Autoleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7.
XW043M7
Introduction of Brexucabtagene Autoleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7.
XW033N7
Introduction of Lisocabtagene Maraleucel Immunotherapy into Peripheral Vein, Percutaneous Approach, New Technology Group 7.
XW043N7
Introduction of Lisocabtagene Maraleucel Immunotherapy into Central Vein, Percutaneous Approach, New Technology Group 7.
MRD (ALL) threshold
MRD positivity threshold (ALL)>= 0.01% (presence of disease)
Clinical contextMRD refers to presence of disease in cases deemed in complete remission by conventional pathology
Prognostic significanceMRD positivity is the strongest prognostic factor for relapse and death when measured during/after induction
Prior Authorization, Documentation, and Submission Instructions
Prior Authorization
Prior Authorization Required
Prior authorization (precertification) is required for the services described in this policy when performed as inpatient or outpatient care. Failure to obtain required precertification may result in an adverse payment determination or denial. For inpatient services, precertification/preauthorization IS REQUIRED for all products. For outpatient services, prior authorization is required for Commercial Managed Care (HMO and POS), Commercial PPO and Indemnity.
Preauthorization must be submitted via Authorization Manager (see resources and forms).
Enter the facility's NPI or provider ID for where services are performed and the servicing provider's NPI/provider ID (not the billing group).
Out-of-network requests should be faxed to 888-973-0726 when applicable.
Prior Authorization
How to Submit Authorization
Use Authorization Manager to submit initial authorization requests and supporting clinical documentation. Authorization Manager is available 24/7 and is the primary method to: review authorization requirements, request authorizations, submit clinical documentation, check case status, and view/print decision letters. For commercial members, requests must meet the medical policy medical necessity criteria.
Covered CAR T Products and Treatment Pathways
Product
Indication (policy-supported / FDA‑labeled)
Coverage status
Tisagenlecleucel (Kymriah)
B‑cell acute lymphoblastic leukemia (pediatric/young adult) and selected large B‑cell and follicular lymphoma indications as specified in policy
Axicabtagene ciloleucel (Yescarta)
Relapsed or refractory large B‑cell lymphoma and relapsed/refractory follicular lymphoma meeting policy criteria
Brexucabtagene autoleucel (Tecartus)
CD19‑positive B‑cell acute lymphoblastic leukemia and relapsed/refractory mantle cell lymphoma when policy criteria are met
Lisocabtagene maraleucel (Breyanzi)
Relapsed or refractory large B‑cell lymphoma meeting policy criteria
Obacabtegene autoleucel (Aucatzyl)
B‑cell acute lymphoblastic leukemia / related B‑cell indications as described in policy (adult)
FDA‑approved CD19‑targeting CAR T products
Regulatory / Indication note
Coverage status
Tisagenlecleucel (Kymriah)
Approved for subsets of leukemia and lymphoma (FDA‑labeled indications summarized in policy)
Axicabtagene ciloleucel (Yescarta)
Approved for subsets of lymphoma (including large B‑cell lymphoma)
Brexucabtagene autoleucel (Tecartus)
Approved for subsets of leukemia and mantle cell lymphoma as specified by product labeling
Lisocabtagene maraleucel (Breyanzi)
Approved for subsets of large B‑cell lymphoma
Typical treatment pathway
Description
Notes / Coverage status
Leukapheresis
Harvest of patient peripheral blood mononuclear cells (leukapheresis) as the starting material for autologous CAR T manufacturing
Centralized manufacturing
Apheresis product is shipped to a centralized facility for genetic modification, expansion, quality control, and cryopreservation
Lymphodepleting chemotherapy
Short course lymphodepletion administered prior to CAR T infusion to create a favorable immune environment
Single intravenous infusion
Administration of one IV infusion of the manufactured autologous CAR T‑cell product per treatment episode
Additional products cited
Context / indications cited in document
Coverage status
Kymriah (tisagenlecleucel)
Cited for pediatric/young adult ALL and adult lymphoma indications in referenced trials and prescribing information
Yescarta (axicabtagene ciloleucel)
Cited for adult relapsed/refractory large B‑cell lymphoma and follicular lymphoma in trial reports and labels
Tecartus (brexucabtagene autoleucel)
Cited for relapsed/refractory mantle cell lymphoma and adult B‑cell ALL (prescribing label and trial reports)
Breyanzi (lisocabtagene maraleucel)
Cited for relapsed/refractory DLBCL and large B‑cell lymphomas in trials and labels
KTE‑X19
Referenced as another CAR T construct used in relapsed/refractory adult B‑cell malignancies (e.g., mantle cell lymphoma studies)
Aucatzyl (obacabtegene autoleucel)
Cited for adult relapsed/refractory B‑cell precursor ALL (FELIX trial) with prescribing label safety warnings noted
Indication by Line of Therapy
second-line_or_later
Prior lines for large B‑cell lymphoma: Progression after ≥2 lines of systemic therapy including an anti‑CD20 monoclonal antibody and anthracycline‑containing chemotherapy; some products allow use for relapse within 12 months of first‑line chemoimmunotherapy or primary refractory disease.
second-line
Indications referenced: CAR T therapies are used for subsets of relapsed or refractory leukemia and lymphoma patients after prior lines of therapy; specific line‑of‑therapy criteria and approvals are detailed elsewhere in the policy document.
second-line
Axicabtagene ciloleucel NHL line criteria:
Biomarkers and Diagnostic Criteria
CD19
MarkerCD19
RequirementCD19 positivity required for B-cell ALL and most listed lymphoma indications
MechanismCAR T therapies target CD19 antigen on B cells using engineered T cells
Philadelphia chromosome (Ph)
MarkerPhiladelphia chromosome (Ph)
Policy requirementIf Ph-positive ALL, failure of 2 tyrosine kinase inhibitors is required prior to CAR T
Context
Background and Context
CD19‑directed CAR T‑cell therapies are autologous immunotherapies in which a patient’s T cells are harvested, engineered to express an anti‑CD19 chimeric antigen receptor, expanded, and reinfused after lymphodepleting chemotherapy. These therapies are used primarily for relapsed or refractory B‑cell malignancies — including B‑cell acute lymphoblastic leukemia (ALL) and various large B‑cell and follicular lymphomas — when prior systemic therapies have failed or the disease is refractory. Individual products have differing age limits, prior‑therapy requirements, and exclusionary conditions; efficacy evidence is largely from single‑arm pivotal trials showing high response rates but with notable risks of severe adverse events such as cytokine release syndrome and immune‑effector neurologic toxicity.
Definitions and Key Terms
Relapsed disease
DefinitionReappearance of leukemia cells in bone marrow or peripheral blood after attainment of complete remission
SourceDefined in policy's ALL coverage sections (relapsed disease)
ImplicationMeets relapsed disease criterion for CAR T eligibility when present
Refractory disease
DefinitionFailure to obtain complete response with induction therapy (failure to eradicate detectable leukemia cells <5% blasts)
Bone marrow criteriaReconstitution with >25% marrow cellularity and normal peripheral blood counts required for remission
Policy Summary
PayerBlue Cross Blue Shield - Massachusetts
PolicyCAR T‑cell therapy (CD19-directed) for B‑cell malignancies — Medical necessity and prior authorization
Policy CodePolicy 066
Change TypeNo material changes
Effective Date
Next Review Date
Key ActionSubmit initial prior authorization requests via Authorization Manager using the product‑specific prior authorization form and include required clinical documentation.
Kymriah for large B-cell lymphoma - organ function: 5. Adequate organ and bone marrow function as determined by the treating oncologist/hematologist.
Kymriah for large B-cell lymphoma - prior CAR T: 6. No prior CD19-directed CAR T-cell therapy, other cell therapy, or gene therapy (or being considered for such therapies).
Kymriah for large B-cell lymphoma - CNS exclusion: 7. Do not have primary central nervous system lymphoma.
Kymriah for large B-cell lymphoma - investigational note: 8. Tisagenlecleucel is considered investigational for relapsed or refractory primary mediastinal large B‑cell lymphoma (if criteria not met).
Kymriah for follicular lymphoma - prior CAR T:
5. No prior CD19-directed CAR T-cell therapy, other cell therapy, or gene therapy (or being considered for such therapies).
Kymriah for follicular lymphoma - CNS exclusion: 6. Do not have primary central nervous system lymphoma.
4. No prior CD19-directed CAR T-cell therapy, other cell therapy, or gene therapy (or being considered for such therapies).
Yescarta for large B-cell lymphoma - CNS exclusion: 5. Do not have primary central nervous system lymphoma.
Yescarta for follicular lymphoma - prior CAR T:
5. No prior CD19-directed CAR T-cell therapy, other cell therapy, or gene therapy (or being considered for such therapies).
Yescarta for follicular lymphoma - CNS exclusion: 6. Do not have primary central nervous system lymphoma.
Tecartus for ALL - prior CAR T: 5. No prior CD19-directed CAR T-cell therapy, other cell therapy, or gene therapy (or being considered for such therapies).
Tecartus for ALL - organ function: 6. Adequate organ function with no significant deterioration in organ function expected within 4 weeks after apheresis, as determined by the treating physician.
Tecartus for ALL - exclusions: 7. Absence of exclusionary conditions: Burkitt lymphoma; active hepatitis B or C or any uncontrolled infection; grade 2–4 graft-versus-host disease; concomitant genetic bone marrow failure syndromes (except Down syndrome); receipt of allogeneic cellular therapy within 6 weeks; or active CNS ALL (CSF WBC ≥5/μL with blasts).
Tecartus for MCL - prior CAR T: 5. No prior CD19-directed CAR T-cell therapy, other cell therapy, or gene therapy (or being considered for such therapies).
4. Adequate organ and bone marrow function as determined by the treating oncologist/hematologist.
Breyanzi for large B-cell lymphoma - prior CAR T: 5. No prior CD19-directed CAR T-cell therapy, other cell therapy, or gene therapy (or being considered for such therapies).
Breyanzi for large B-cell lymphoma - CNS exclusion: 6. Do not have primary central nervous system lymphoma.
Obacabtegene for ALL - prior therapies: 5. No prior engineered T‑cell therapy, other cell therapy, or gene therapy (or being considered for such therapies).
Obacabtegene for ALL - CNS exclusion: 6. Do not have primary central nervous system lymphoma.
Axicabtagene ciloleucel - relapsed/refractory follicular lymphoma: In ZUMA‑5, after ≥2 prior systemic therapies including anti‑CD20 + alkylator, ORR 91% and CR 60% with median DOR not reached; 76% remained in remission at 12 months (interim data).
Evidence sufficient to improve net health outcome.
Brexucabtagene autoleucel - mantle cell lymphoma: In a phase II single‑arm study of relapsed/refractory MCL, ORR 87% and CR 62%; median DOR/PFS/OS not reached at data cutoff.
Evidence sufficient to improve net health outcome.
Brexucabtagene autoleucel - B-cell ALL: Pivotal single‑arm trial in adult relapsed/refractory B‑cell ALL reported a 52% response rate with many responders MRD‑negative; high frequency of CRS and neurotoxicity.
Evidence sufficient to improve net health outcome.
Lisocabtagene maraleucel - relapsed/refractory DLBCL: In trial, of 299 leukapheresis, 255 treated (85%), 192 evaluable; ORR 73% and CR 55%, median DOR 16.7 months; CRS in 46% (≥Grade 3 in 4%).
Evidence sufficient to improve net health outcome.
Obecabtagene autoleucel (Aucatzyl) - B-cell precursor ALL: FELIX trial Cohort 2A: overall complete remission within 3 months 77% (42% in efficacy‑evaluable subgroup) with median response duration 14.1 months; black box warnings include CRS, neurologic toxicities, and secondary hematologic malignancies.
Evidence from phase Ib/II FELIX trial.
Authorization Manager resources, tips, guides, and video demonstrations are available on the payer website.
Complete the applicable CAR T-Cell Therapy Prior Authorization Request Form in Authorization Manager (form numbers listed in policy).
Documentation Required
Medical Necessity Prerequisite and Codes Informational
The medical necessity criteria in this policy MUST be met for codes to be covered. Inclusion of procedure, CPT, HCPCS, and diagnosis codes in the policy is informational only and does not guarantee coverage or reimbursement. Providers should report services using current standard codes and verify member-specific benefits.
The above medical necessity criteria must be met for the listed codes to be covered for Commercial Members (Managed Care, PPO, Indemnity) and Medicare products where indicated.
Inclusion or exclusion of a code does not imply coverage — check the member's contract benefits.
Documentation Required
Clinical and Manufacturing Documentation
Clinical and manufacturing documentation should be provided with the authorization request. Documentation may include evidence of leukapheresis, transfer to manufacturing, manufacturing and quality control steps, final product receipt, and documentation of lymphodepleting chemotherapy given prior to the IV infusion.
Document leukapheresis procedure and date, chain-of-custody/transfer to manufacturing facility, and receipt of final cryopreserved product at treatment facility.
Document lymphodepleting chemotherapy administration and timing relative to planned infusion, and any manufacturing or product release documentation available.
Note
Documentation Sources (Informational)
Prescribing information, pivotal trial reports, and technology appraisals are cited as sources for clinical criteria and expected documentation. Providers should reference prescribing labels and trial reports as needed when preparing authorization requests.
Prescribing labels for products (e.g., Kymriah, Yescarta, Breyanzi, Aucatzyl) and published trial reports are primary documentation sources.
NICE technology appraisals and CMS guidance cited in References may inform clinical expectations.
Prior Authorization
Prior Therapy Requirements
Prior therapy requirements are specified in the medical necessity criteria for each product. Many large B‑cell lymphoma indications require progression after ≥2 lines of systemic therapy including an anti‑CD20 monoclonal antibody and anthracycline-containing chemotherapy, or relapse/refractory within 12 months of first-line chemoimmunotherapy as specified per product.
Examples: Diffuse large B-cell lymphoma indications commonly require progression after ≥2 systemic therapy lines including anti‑CD20 and anthracycline, or relapse within 12 months of first-line chemoimmunotherapy.
Policy history clarifies prior chemoimmunotherapy line specifications (see Policy History).
Step Therapy
No Step Therapy Requirements Described
No step therapy (also known as required step-wise trials) is described in this policy. Trials referenced compare CAR T therapies to standard salvage therapies but do not impose step-therapy requirements for authorization.
Step therapy is not required by this policy; authorization is based on meeting the specified medical necessity criteria.
Denial Risk
Investigational if Criteria Not Met
These therapies are considered investigational when the medical necessity criteria in this policy are not met, or when used for indications not described as medically necessary in this policy.
Tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, obacabtegene autoleucel, and lisocabtagene maraleucel are considered investigational if the above criteria are not met or for other indications.
Denial Risk
Denial Triggers from Policy Updates
Policy updates and clarifications in the policy history may change criteria and coding; failure to meet updated criteria or to follow updated submission instructions (including use of Authorization Manager) may trigger denials or adverse payment determinations.
Recent history entries note clarifications to clinical criteria and inclusion of Authorization Manager in 9/2023; review policy history for effective dates and changes.
Failure to follow updated preauthorization procedures or to supply required documentation may result in denial.
Note
No Explicit Authorization or Denial Risk Language in Some References
Some citation sections list references and codes for informational purposes without explicit language describing authorization or denial risk. Providers should rely on the policy medical necessity criteria and submission instructions (Authorization Manager) rather than assuming coverage from referenced materials alone.
References and code lists are informational; they do not by themselves authorize coverage.
Always confirm authorization requirements and member benefits prior to service.
Indicated for adults with large B‑cell lymphoma refractory to first‑line chemoimmunotherapy or relapse within 12 months of first‑line chemoimmunotherapy that included an anti‑CD20 and anthracycline‑containing regimen.
second-line
Lisocabtagene maraleucel line criteria: Considered medically necessary for adults with large B‑cell lymphoma refractory to first‑line chemoimmunotherapy or relapse within 12 months of first‑line chemoimmunotherapy, or relapsed/refractory after first‑line chemoimmunotherapy and not eligible for hematopoietic stem cell transplantation due to comorbidities or age.
Applied in ALL coverage criteria for tisagenlecleucel and brexucabtagene autoleucel
MRD (minimal residual disease)
MarkerMinimal residual disease (MRD)
DefinitionPresence of disease in cases deemed in complete remission by conventional pathologic analysis
Clinical useUsed for prognostic assessment in ALL responders; MRD-negativity associated with improved outcomes
MRD and related biomarker notes
MRD threshold>= 0.01% defines MRD-positivity in ALL
Product referencesMRD-negativity among responders reported with tisagenlecleucel and brexucabtagene autoleucel trials
Prognostic importanceMRD status is predictive of survival in ALL patients
Policy implicationMeets refractory disease criterion for CAR T eligibility when present
CAR T‑cell therapy
DefinitionAutologous CAR T-cell therapy: patient's T cells are harvested, genetically engineered to express a chimeric antigen receptor, expanded, cryopreserved, and infused back after lymphodepletion
Process stepsLeukapheresis → centralized manufacturing → lymphodepleting chemotherapy → single IV infusion
ManufacturingFinal products are manufactured at centralized facilities; apheresis product transfer and product shipment are part of the process
MRD positivity (ALL)
DefinitionMRD positivity in ALL is presence of ≥0.01% ALL cells during/after induction
Prognostic valueStrongest prognostic factor for relapse and death when measured during and after induction therapy
Clinical trial noteAll responders achieving CR with tisagenlecleucel were MRD-negative in pivotal trial
Autologous CAR T‑cell therapy
Process definitionAutologous CAR T-cell therapy includes leukapheresis, T-cell activation and genetic engineering (retroviral or lentiviral), expansion, quality control, cryopreservation, product shipment, lymphodepletion, and single infusion
Documentation relevanceLeukapheresis and manufacturing documentation are relevant for prior authorization
TimingLymphodepleting chemotherapy is required prior to single IV CAR T infusion
CD19-directed CAR T-cell
DefinitionCD19-directed CAR T-cells are engineered T cells that selectively bind CD19 antigen on B cells and B-cell-derived tumors
VariantsProducts may include different costimulatory domains (eg, 4-1BB or CD28) depending on product
Approved productsMultiple CD19-targeting CAR T therapies are FDA-approved for leukemia and lymphoma subsets
Cytokine Release Syndrome (CRS) grading
Reference standardASTCT consensus grading for Cytokine Release Syndrome (CRS) and neurologic toxicity
UseCited as the standard reference for assessing immune effector cell–associated toxicities