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Brexucabtagene autoleucel (Tecartus) Form

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Brexucabtagene autoleucel (Tecartus)

Indications

(1) Member is 18 years or older; AND 2. Brexucabtagene is prescribed by or in consultation with a board-certified hematologist or oncologist; AND 3. Brexucabtagene will be dosed and administered according to FDA approved labeling; AND 4. Brexucabtagene will be used as monotherapy; AND 5. Member has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND 6. Member has been assessed by a hematologist/oncologist to be an appropriate candidate for apheresis; AND 7. Member has documentation of CD-19 tumor expression; AND 8. Member has no prior treatment with CAR T-cell immunotherapy (e.g., lisocabtagene, obecabtagene); AND 9. If the member has received prior treatment with anti-CD19 therapy (e.g., tafasitamab, loncastuximab) the member’s repeat biopsy indicated CD-19 positive disease; AND 10. Member does NOT have any of the following: a. Active hepatitis B (HBs AG-positive), active hepatitis C, HIV infection, or uncontrolled infection MEDICAL COVERAGE POLICY SERVICE: Brexucabtagene autoleucel (Tecartus™) Policy Number: 281 Effective Date: 11/1/2025 Last Review: 9/8/2025 Next Review: 9/8/2026 Page 2 of 7 Indication Specific Criteria Mantle Cell Lymphoma (MCL) specific criteria: 1. Member meets all universal criteria; AND 2. Member has at least 1 measurable lesion; AND 3. Member meets one of the following criteria: a. Member has relapsed or refractory MCL defined as disease progression after last regimen b. Member has refractory disease defined as failure to achieve a partial response or complete response to the last regimen; AND 4. Member must have received adequate prior therapy including ALL of the following: a. Anthracycline, bendamustine, or lenalidomide-containing chemotherapy b. Anti-CD20 monoclonal antibody therapy (e.g., rituximab) c. Bruton’s tyrosine kinase inhibitor (BTKi) therapy (e.g., ibrutinib, acalabrutinib, zanubrutinib); AND 5. Member does NOT have any of the following: a. Allogeneic hematopoietic stem-cell transplantation in the preceding 84 days before leukapheresis b. Central nervous system involvement B-cell precursor Acute Lymphoblastic Leukemia (B-ALL) specific criteria: 1. Member meets all universal criteria; AND 2. Member meets one of the following criteria: a. Member has Philadelphia chromosome (Ph)-negative B-cell precursor ALL that is relapsed or refractory defined as one of the following: i. Refractory to first-line therapy (i.e., primary refractory) ii. First relapse following a remission lasting ≤ 12 months iii. Relapsed or refractory ALL after second-line or higher therapy iv. Relapsed or refractory ALL at least 100 days after allogeneic stem cell transplantation (HSCT) b. Member has Philadelphia chromosome (Ph)-positive B-cell precursor ALL and meets one of the following: i. Member has relapsed or refractory disease despite treatment with at least two different tyrosine kinase inhibitors (TKIs) ii. Member is intolerant to TKI therapy iii. Member has a contraindication to TKI therapy AND 3. Member does NOT have any of the following: a. Presence of CNS disorders including CNS-2 disease with neurologic changes and CNS-3 disease irrespective of neurological changes MEDICAL COVERAGE POLICY SERVICE: Brexucabtagene autoleucel (Tecartus™) Policy Number: 281 Effective Date: 11/1/2025 Last Review: 9/8/2025 Next Review: 9/8/2026 Page 3 of 7 BSWHP considers only ONE treatment per lifetime is medically necessary as repeat administration of brexucabtagene autoleucel (Tecartus™) is experimental and investigational because the effectiveness of this strategy has not been established. BSWHP considers brexucabtagene autoleucel (Tecartus™) for the treatment of all other indications to be experimental and investigational because the effectiveness of this strategy has not been established. All requests will be reviewed by both a clinical pharmacist and a medical director. BACKGROUND: Brexucabtagene (Tecartus™) Brexucabtagene autoleucel (Tecartus™) is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of: • Adult patients with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (B- ALL). • Adult patients with relapsed/refractory mantle cell lymphoma (r/r MCL). Mechanism of Action Brexucabtagene is a CD19-directed genetically modified autologous T cell immunotherapy in which a patient's T cells are reprogrammed with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and normal cells. The CAR is comprised of a murine single-chain antibody fragment which recognizes CD19 and is fused to CD28 and CD3 zeta. CD3 zeta is a critical component for initiating T cell activation and antitumor activity. After binding to CD19- expressing cells, the CD28 and CD3-zeta costimulatory domains activate downstream signaling cascades, which results in T cell activation, proliferation, acquisition of effector functions, and secretion of inflammatory cytokines and chemokines, leading to destruction of CD19-expressing cells. Brexucabtagene is prepared from the patient's peripheral blood cells obtained via leukapheresis. Mantle Cell Lymphoma Mantle cell lymphoma (MCL) accounts for about 3% of non-Hodgkin lymphomas and combines features of both indolent and aggressive disease, with poor curability using standard chemoimmunotherapy. Most cases involve the t(11;14) translocation, leading to cyclin D1 overexpression, though rare cyclin D1-negative cases—often with CCND2 rearrangements—share similar biology and management. The 2022 WHO and ICC classifications recognize three subtypes: classical MCL (nodal and extranodal), leukemic/non-nodal MCL, and in situ mantle cell neoplasia (ISMCN). Accurate subtype distinction is essential, as ISMCN typically warrants close monitoring rather than immediate treatment when overt MCL is excluded. In a multicenter phase two trial, a total of 74 patients were enrolled to evaluate the safety and efficacy of brexucabtagene. To be eligible, patients had to have MCL that had relapsed or was refractory and MEDICAL COVERAGE POLICY SERVICE: Brexucabtagene autoleucel (Tecartus™) Policy Number: 281 Effective Date: 11/1/2025 Last Review: 9/8/2025 Next Review: 9/8/2026 Page 4 of 7 had previous therapy that included anthracycline- or bendamustine-containing chemotherapy, an anti- CD20 monoclonal antibody, and BTK inhibitor therapy with ibrutinib or acalabrutinib. It was found that 85% of patients had an objective response and 59% had a complete response. Regarding estimated progression-free survival and overall survival, the percentages of patients were 61% and 83% respectively. With respect to the safety of brexucabtagene, 99% of patients had an adverse event of grade 3 or higher with the most common types being cytopenias (94%) and infections (32%). For serious adverse events, it was found that 68% of patients experienced these types of adverse events. B-cell precursor Acute Lymphoblastic Leukemia Acute lymphoblastic leukemia is a malignant disorder of lymphoid progenitor cells characterized by uncontrolled proliferation and accumulation of immature lymphoblasts in the bone marrow and peripheral blood. B-cell precursor ALL is the most common subtype in children and adolescents, but it also occurs in adults. Relapsed or refractory disease following multiple lines of therapy is associated with poor outcomes and limited curative options. In October 2021 the FDA approved brexucabtagene for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) based on an open-label, single-arm, multicenter phase 1/2 trial. Eligible patients were adults with primary refractory ALL, first relapse following a remission lasting ≤ 12 months, relapsed or refractory ALL after second-line or higher therapy, or relapsed or refractory ALL at least 100 days after allogeneic stem cell transplantation (HSCT). Of 71 patients enrolled and leukapheresed, 54 were efficacy-evaluable. The primary end points were the percentage of participants experiencing dose-limiting toxicities (DLTs) and overall complete remission (CR) rate. 28 (51.9%) of the 54 evaluable patients achieved a complete remission (CR) with 3 months after the infusion. No DLTs occurred in the DLT-evaluable cohort. CODES: Important note: Due to the wide range of applicable diagnosis codes and potential changes to codes, an inclusive list may not be presented, but the following codes may apply. Inclusion of a code in this section does not guarantee that it will be reimbursed, and patient must meet the criteria set forth in the policy language. CPT Codes: 36511 Therapeutic apheresis; for white blood cells HCPCS Codes: Q2053 Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose ICD10 codes: C83.10-C83.19 Mantle cell lymphoma ICD10 Not covered: POLICY HISTORY: Status Date Action New 11/19/2021 New policy. Updated 01/28/2021 Minor updates to criteria and excluded sections. MEDICAL COVERAGE POLICY SERVICE: Brexucabtagene autoleucel (Tecartus™) Policy Number: 281 Effective Date: 11/1/2025 Last Review: 9/8/2025 Next Review: 9/8/2026 Page 5 of 7 Updated 04/22/2021 Medicaid instructions added. Updated 05/27/2021 Removed Oncology Analytics line, added apheresis criteria, reformatted criteria. Updated 07/22/2021 Added clinician reviewer criteria. Updated 06/23/2022 Added NCD information. Updated 12/01/2022 Removed language with CMS LCD since NCD applies. Removed Texas Mandate HB1584 language from main policy section as the policy is compliant. Added criteria for ALL. Reviewed 10/26/2023 Applied new layout and format. Updated 10/14/2024 Reformatted with Universal and Specific criteria, Updated universal criteria to align exclusion criteria when applicable across CAR-T therapies. Updated 09/08/2025 Updated beginning note to align with standard language, Updated age requirement to align with standard language, Updated prescriber requirement to align with standard language, Updated dosing and administration language to align with standard language, Updated monotherapy language to align with standard language, Updated apheresis language to align with standard language, Removed REMS program requirement, Updated formatting of no prior treatment with CAR T-cell immunotherapy requirement, Added examples of anti-CD19 therapy, Updated universal exclusion criteria language, Removed the following universal exclusion criteria to align with OncoHealth: History of CNS disorders, Primary immunodeficiency, Pregnant, Added "Central nervous system involvement" to MCL exclusion criteria, Updated B- ALL exclusion criteria from “History of CNS” to “Presence of CNS” Removed the following B-ALL exclusion criteria to align with OncoHealth: Active inflammatory disorder requiring systemic immunosuppression, Active GVHD Updated lifetime treatment and experimental and investigational language to align with standard language, Updated background section, Updated citation to AMA format. REFERENCES: The following scientific references were utilized in the formulation of this medical policy. BSWHP will continue to review clinical evidence related to this policy and may modify it at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available, MEDICAL COVERAGE POLICY SERVICE: Brexucabtagene autoleucel (Tecartus™) Policy Number: 281 Effective Date: 11/1/2025 Last Review: 9/8/2025 Next Review: 9/8/2026 Page 6 of 7 and they are not included in the list, please forward the reference(s) to BSWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order. 1. Almåsbak H, Aarvak T, Vemuri MC. CAR T cell therapy: a game changer in cancer treatment. J Immunol Res. 2016;2016:5474602. 2. Bijal DS, Bishop MR, Oluwole OO, et al. KTE-X19 anti-CD19 CAR T-cell therapy in adult relapsed/refractory acute lymphoblastic leukemia: ZUMA-3 phase 1 results. Blood. 2021;138(1):11-22. 3. Brentjens RJ. Are chimeric antigen receptor T cells ready for prime time? Clin Adv Hematol Oncol. 2016;14(1):17-19.? 
(2) Brudno JN, Somerville RP, Shi V, et al. Allogeneic T cells that express an anti-CD19 chimeric antigen receptor induce remissions of B-cell malignancies that progress after allogeneic hematopoietic stem-cell transplantation without causing graft-versus-host disease. J Clin Oncol. 2016;34(10):1112-1121. 5. Children’s Hospital of Philadelphia. What to expect: CAR T-cell therapy process. Published 2017. Accessed August 8, 2017. http://www.chop.edu/centers-programs/cancer-immunotherapy-program/your-experience 6. Fitzgerald JC, Weiss SL, Maude SL, et al. Cytokine release syndrome after chimeric antigen receptor T cell therapy for acute lymphoblastic leukemia. Crit Care Med. 2017;45(2):e124-e131. 7. Gisselbrecht C, Glass B, Mounier N, et al. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol. 2010;28(27):4184-4190. 8. Harris DT, Kranz DM. Adoptive T cell therapies: a comparison of T cell receptors and chimeric antigen receptors. Trends Pharmacol Sci. 2016;37(3):220-230. 9. Hettle R, Corbett M, Hinde S, et al. The assessment and appraisal of regenerative medicines and cell therapy products: an exploration of methods for review, economic evaluation and appraisal. Health Technol Assess. 2017;21(7):1-204. 10. Ikeda H. T-cell adoptive immunotherapy using tumor-infiltrating T cells and genetically engineered TCR-T cells. Int Immunol. 2016;28(7):349-353. 11. Kebriaei P, Singh H, Huls MH, et al. Phase I trials using Sleeping Beauty to generate CD19-specific CAR T cells. J Clin Invest. 2016;126(9):3363-3376. 12. Kochenderfer JN, Somerville RPT, Lu T, et al. Lymphoma remissions caused by anti-CD19 chimeric antigen receptor T cells are associated with high serum interleukin-15 levels. J Clin Oncol. 2017;35(16):1803-1813. 13. Leukemia and Lymphoma Society. Chimeric antigen receptor (CAR) T-cell therapy. Published 2017. Accessed August 8, 2017. https://www.lls.org/treatment/types-of-treatment/immunotherapy/chimeric-antigen-receptor-car-t-cell-therapy 14. Li T, Zhang Y, et al. A good response of refractory mantle cell lymphoma to haploidentical CAR T cell therapy after failure of autologous CAR T cell therapy. J Immunother Cancer. 2019;7(1):1-7. 15. Locke FL, Davila ML. Regulatory challenges and considerations for the clinical application of CAR-T cell anti-cancer therapy. Expert Opin Biol Ther. 2017;17(6):659-661. 16. Lymphoma Research Foundation. Diffuse large B-cell lymphoma (DLBCL). Published 2016. Accessed August 8, 2017. http://www.lymphoma.org/site/pp.asp?c=bkLTKaOQLmK8E&b=6300153? 

Effective Date

NA

Last Reviewed

NA

Original Document

  Reference



MEDICAL COVERAGE POLICY SERVICE: Brexucabtagene autoleucel (Tecartus™) Policy Number: 281 Effective Date: 11/1/2025 Last Review: 9/8/2025 Next Review: 9/8/2026

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Important note: Unless otherwise indicated, medical policies will apply to all lines of business. Medical necessity as defined by this policy does not ensure the benefit is covered. This medical policy does not replace existing federal or state rules and regulations for the applicable service or supply. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan documents. See the member plan specific benefit plan document for a complete description of plan benefits, exclusions, limitations, and conditions of coverage. In the event of a discrepancy, the plan document always supersedes the information in this policy.

SERVICE: Brexucabtagene autoleucel (Tecartus™) PRIOR AUTHORIZATION: Required POLICY: Please review the plan’s EOC (Evidence of Coverage) or Summary Plan Description (SPD) for details. For Medicare plans, please refer to Medicare NCD 110.24 Chimeric Antigen Receptor (CAR) T-cell Therapy For Medicaid plans, please confirm coverage as outlined in the Texas Medicaid Provider Procedures Manual | TMHP (TMPPM). Texas Mandate HB154 is applicable for Medicaid plans.
Baylor Scott & White Health Plan (BSWHP) may consider brexucabtagene autoleucel (Tecartus™) medically necessary when documentation is submitted showing ALL of the following criteria are met:
Universal Criteria Applied to All Requests

  1. Member is 18 years or older; AND
  2. Brexucabtagene is prescribed by or in consultation with a board-certified hematologist or oncologist; AND
  3. Brexucabtagene will be dosed and administered according to FDA approved labeling; AND
  4. Brexucabtagene will be used as monotherapy; AND
  5. Member has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
  6. Member has been assessed by a hematologist/oncologist to be an appropriate candidate for apheresis; AND
  7. Member has documentation of CD-19 tumor expression; AND
  8. Member has no prior treatment with CAR T-cell immunotherapy (e.g., lisocabtagene, obecabtagene); AND
  9. If the member has received prior treatment with anti-CD19 therapy (e.g., tafasitamab, loncastuximab) the member’s repeat biopsy indicated CD-19 positive disease; AND
  10. Member does NOT have any of the following:
    a. Active hepatitis B (HBs AG-positive), active hepatitis C, HIV infection, or uncontrolled infection

MEDICAL COVERAGE POLICY SERVICE: Brexucabtagene autoleucel (Tecartus™) Policy Number: 281 Effective Date: 11/1/2025 Last Review: 9/8/2025 Next Review: 9/8/2026

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Indication Specific Criteria
Mantle Cell Lymphoma (MCL) specific criteria:

  1. Member meets all universal criteria; AND
  2. Member has at least 1 measurable lesion; AND
  3. Member meets one of the following criteria: a. Member has relapsed or refractory MCL defined as disease progression after last regimen b. Member has refractory disease defined as failure to achieve a partial response or complete response to the last regimen; AND
  4. Member must have received adequate prior therapy including ALL of the following: a. Anthracycline, bendamustine, or lenalidomide-containing chemotherapy
    b. Anti-CD20 monoclonal antibody therapy (e.g., rituximab) c. Bruton’s tyrosine kinase inhibitor (BTKi) therapy (e.g., ibrutinib, acalabrutinib, zanubrutinib); AND

  5. Member does NOT have any of the following: a. Allogeneic hematopoietic stem-cell transplantation in the preceding 84 days before leukapheresis b. Central nervous system involvement B-cell precursor Acute Lymphoblastic Leukemia (B-ALL) specific criteria:

  6. Member meets all universal criteria; AND

  7. Member meets one of the following criteria: a. Member has Philadelphia chromosome (Ph)-negative B-cell precursor ALL that is relapsed or refractory defined as one of the following:
    i. Refractory to first-line therapy (i.e., primary refractory) ii. First relapse following a remission lasting ≤ 12 months iii. Relapsed or refractory ALL after second-line or higher therapy iv. Relapsed or refractory ALL at least 100 days after allogeneic stem cell transplantation (HSCT) b. Member has Philadelphia chromosome (Ph)-positive B-cell precursor ALL and meets one of the following: i. Member has relapsed or refractory disease despite treatment with at least two different tyrosine kinase inhibitors (TKIs) ii. Member is intolerant to TKI therapy iii. Member has a contraindication to TKI therapy

    AND

  8. Member does NOT have any of the following: a. Presence of CNS disorders including CNS-2 disease with neurologic changes and CNS-3 disease irrespective of neurological changes

MEDICAL COVERAGE POLICY SERVICE: Brexucabtagene autoleucel (Tecartus™) Policy Number: 281 Effective Date: 11/1/2025 Last Review: 9/8/2025 Next Review: 9/8/2026

Page 3 of 7

BSWHP considers only ONE treatment per lifetime is medically necessary as repeat administration of brexucabtagene autoleucel (Tecartus™) is experimental and investigational because the effectiveness of this strategy has not been established. BSWHP considers brexucabtagene autoleucel (Tecartus™) for the treatment of all other indications to be experimental and investigational because the effectiveness of this strategy has not been established. All requests will be reviewed by both a clinical pharmacist and a medical director. BACKGROUND:
Brexucabtagene (Tecartus™) Brexucabtagene autoleucel (Tecartus™) is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of: • Adult patients with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (B- ALL). • Adult patients with relapsed/refractory mantle cell lymphoma (r/r MCL). Mechanism of Action Brexucabtagene is a CD19-directed genetically modified autologous T cell immunotherapy in which a patient's T cells are reprogrammed with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and normal cells. The CAR is comprised of a murine single-chain antibody fragment which recognizes CD19 and is fused to CD28 and CD3 zeta. CD3 zeta is a critical component for initiating T cell activation and antitumor activity. After binding to CD19- expressing cells, the CD28 and CD3-zeta costimulatory domains activate downstream signaling cascades, which results in T cell activation, proliferation, acquisition of effector functions, and secretion of inflammatory cytokines and chemokines, leading to destruction of CD19-expressing cells. Brexucabtagene is prepared from the patient's peripheral blood cells obtained via leukapheresis. Mantle Cell Lymphoma Mantle cell lymphoma (MCL) accounts for about 3% of non-Hodgkin lymphomas and combines features of both indolent and aggressive disease, with poor curability using standard chemoimmunotherapy. Most cases involve the t(11;14) translocation, leading to cyclin D1 overexpression, though rare cyclin D1-negative cases—often with CCND2 rearrangements—share similar biology and management. The 2022 WHO and ICC classifications recognize three subtypes: classical MCL (nodal and extranodal), leukemic/non-nodal MCL, and in situ mantle cell neoplasia (ISMCN). Accurate subtype distinction is essential, as ISMCN typically warrants close monitoring rather than immediate treatment when overt MCL is excluded. In a multicenter phase two trial, a total of 74 patients were enrolled to evaluate the safety and efficacy of brexucabtagene. To be eligible, patients had to have MCL that had relapsed or was refractory and

MEDICAL COVERAGE POLICY SERVICE: Brexucabtagene autoleucel (Tecartus™) Policy Number: 281 Effective Date: 11/1/2025 Last Review: 9/8/2025 Next Review: 9/8/2026

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had previous therapy that included anthracycline- or bendamustine-containing chemotherapy, an anti- CD20 monoclonal antibody, and BTK inhibitor therapy with ibrutinib or acalabrutinib. It was found that 85% of patients had an objective response and 59% had a complete response. Regarding estimated progression-free survival and overall survival, the percentages of patients were 61% and 83% respectively. With respect to the safety of brexucabtagene, 99% of patients had an adverse event of grade 3 or higher with the most common types being cytopenias (94%) and infections (32%). For serious adverse events, it was found that 68% of patients experienced these types of adverse events. B-cell precursor Acute Lymphoblastic Leukemia Acute lymphoblastic leukemia is a malignant disorder of lymphoid progenitor cells characterized by uncontrolled proliferation and accumulation of immature lymphoblasts in the bone marrow and peripheral blood. B-cell precursor ALL is the most common subtype in children and adolescents, but it also occurs in adults. Relapsed or refractory disease following multiple lines of therapy is associated with poor outcomes and limited curative options. In October 2021 the FDA approved brexucabtagene for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) based on an open-label, single-arm, multicenter phase 1/2 trial. Eligible patients were adults with primary refractory ALL, first relapse following a remission lasting ≤ 12 months, relapsed or refractory ALL after second-line or higher therapy, or relapsed or refractory ALL at least 100 days after allogeneic stem cell transplantation (HSCT). Of 71 patients enrolled and leukapheresed, 54 were efficacy-evaluable. The primary end points were the percentage of participants experiencing dose-limiting toxicities (DLTs) and overall complete remission (CR) rate. 28 (51.9%) of the 54 evaluable patients achieved a complete remission (CR) with 3 months after the infusion. No DLTs occurred in the DLT-evaluable cohort.
CODES: Important note: Due to the wide range of applicable diagnosis codes and potential changes to codes, an inclusive list may not be presented, but the following codes may apply. Inclusion of a code in this section does not guarantee that it will be reimbursed, and patient must meet the criteria set forth in the policy language.

CPT Codes: 36511 Therapeutic apheresis; for white blood cells HCPCS Codes: Q2053 Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose ICD10 codes: C83.10-C83.19 Mantle cell lymphoma ICD10 Not covered:

POLICY HISTORY: Status Date Action New 11/19/2021 New policy. Updated 01/28/2021 Minor updates to criteria and excluded sections.

MEDICAL COVERAGE POLICY SERVICE: Brexucabtagene autoleucel (Tecartus™) Policy Number: 281 Effective Date: 11/1/2025 Last Review: 9/8/2025 Next Review: 9/8/2026

Page 5 of 7

Updated 04/22/2021 Medicaid instructions added. Updated 05/27/2021 Removed Oncology Analytics line, added apheresis criteria, reformatted criteria. Updated 07/22/2021 Added clinician reviewer criteria. Updated 06/23/2022 Added NCD information. Updated 12/01/2022 Removed language with CMS LCD since NCD applies. Removed Texas Mandate HB1584 language from main policy section as the policy is compliant. Added criteria for ALL. Reviewed 10/26/2023 Applied new layout and format. Updated 10/14/2024 Reformatted with Universal and Specific criteria, Updated universal criteria to align exclusion criteria when applicable across CAR-T therapies. Updated 09/08/2025 Updated beginning note to align with standard language,
Updated age requirement to align with standard language,
Updated prescriber requirement to align with standard language,
Updated dosing and administration language to align with standard language,
Updated monotherapy language to align with standard language,
Updated apheresis language to align with standard language, Removed REMS program requirement,
Updated formatting of no prior treatment with CAR T-cell immunotherapy requirement,
Added examples of anti-CD19 therapy, Updated universal exclusion criteria language, Removed the following universal exclusion criteria to align with OncoHealth: History of CNS disorders, Primary immunodeficiency, Pregnant, Added "Central nervous system involvement" to MCL exclusion criteria, Updated B- ALL exclusion criteria from “History of CNS” to “Presence of CNS” Removed the following B-ALL exclusion criteria to align with OncoHealth: Active inflammatory disorder requiring systemic immunosuppression, Active GVHD Updated lifetime treatment and experimental and investigational language to align with standard language, Updated background section, Updated citation to AMA format.

REFERENCES:

The following scientific references were utilized in the formulation of this medical policy. BSWHP will continue to review clinical evidence related to this policy and may modify it at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available,

MEDICAL COVERAGE POLICY SERVICE: Brexucabtagene autoleucel (Tecartus™) Policy Number: 281 Effective Date: 11/1/2025 Last Review: 9/8/2025 Next Review: 9/8/2026

Page 6 of 7

and they are not included in the list, please forward the reference(s) to BSWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order.

  1. Almåsbak H, Aarvak T, Vemuri MC. CAR T cell therapy: a game changer in cancer treatment. J Immunol Res. 2016;2016:5474602.
  2. Bijal DS, Bishop MR, Oluwole OO, et al. KTE-X19 anti-CD19 CAR T-cell therapy in adult relapsed/refractory acute lymphoblastic leukemia: ZUMA-3 phase 1 results. Blood. 2021;138(1):11-22.
  3. Brentjens RJ. Are chimeric antigen receptor T cells ready for prime time? Clin Adv Hematol Oncol. 2016;14(1):17-19.
  4. Brudno JN, Somerville RP, Shi V, et al. Allogeneic T cells that express an anti-CD19 chimeric antigen receptor induce remissions of B-cell malignancies that progress after allogeneic hematopoietic stem-cell transplantation without causing graft-versus-host disease. J Clin Oncol. 2016;34(10):1112-1121.
  5. Children’s Hospital of Philadelphia. What to expect: CAR T-cell therapy process. Published 2017. Accessed August 8,
  6. http://www.chop.edu/centers-programs/cancer-immunotherapy-program/your-experience
  7. Fitzgerald JC, Weiss SL, Maude SL, et al. Cytokine release syndrome after chimeric antigen receptor T cell therapy for acute lymphoblastic leukemia. Crit Care Med. 2017;45(2):e124-e131.
  8. Gisselbrecht C, Glass B, Mounier N, et al. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol. 2010;28(27):4184-4190.
  9. Harris DT, Kranz DM. Adoptive T cell therapies: a comparison of T cell receptors and chimeric antigen receptors. Trends Pharmacol Sci. 2016;37(3):220-230.
  10. Hettle R, Corbett M, Hinde S, et al. The assessment and appraisal of regenerative medicines and cell therapy products: an exploration of methods for review, economic evaluation and appraisal. Health Technol Assess. 2017;21(7):1-204.
  11. Ikeda H. T-cell adoptive immunotherapy using tumor-infiltrating T cells and genetically engineered TCR-T cells. Int Immunol. 2016;28(7):349-353.
  12. Kebriaei P, Singh H, Huls MH, et al. Phase I trials using Sleeping Beauty to generate CD19-specific CAR T cells. J Clin Invest. 2016;126(9):3363-3376.
  13. Kochenderfer JN, Somerville RPT, Lu T, et al. Lymphoma remissions caused by anti-CD19 chimeric antigen receptor T cells are associated with high serum interleukin-15 levels. J Clin Oncol. 2017;35(16):1803-1813.
  14. Leukemia and Lymphoma Society. Chimeric antigen receptor (CAR) T-cell therapy. Published 2017. Accessed August 8,
  15. https://www.lls.org/treatment/types-of-treatment/immunotherapy/chimeric-antigen-receptor-car-t-cell-therapy
  16. Li T, Zhang Y, et al. A good response of refractory mantle cell lymphoma to haploidentical CAR T cell therapy after failure of autologous CAR T cell therapy. J Immunother Cancer. 2019;7(1):1-7.
  17. Locke FL, Davila ML. Regulatory challenges and considerations for the clinical application of CAR-T cell anti-cancer therapy. Expert Opin Biol Ther. 2017;17(6):659-661.
  18. Lymphoma Research Foundation. Diffuse large B-cell lymphoma (DLBCL). Published 2016. Accessed August 8, 2017. http://www.lymphoma.org/site/pp.asp?c=bkLTKaOQLmK8E&b=6300153
  19. Martin A, Morgan E, Hijiya N. Relapsed or refractory pediatric acute lymphoblastic leukemia: current and emerging treatments. Paediatr Drugs. 2012;14(6):377-387.
  20. Maude SL, Frey N, Shaw PA, et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014;371(16):1507-1517.
  21. Maus MV, Nikiforow S. The why, what, and how of the new fact standards for immune effector cells. J Immunother Cancer. 2017;5:36.
  22. Pan J, Yang JF, Deng BP, et al. High efficacy and safety of low-dose CD19-directed CAR-T cell therapy in 51 refractory or relapsed B acute lymphoblastic leukemia patients. Leukemia. Published online May 15, 2017. doi:10.1038/leu.2017.145

MEDICAL COVERAGE POLICY SERVICE: Brexucabtagene autoleucel (Tecartus™) Policy Number: 281 Effective Date: 11/1/2025 Last Review: 9/8/2025 Next Review: 9/8/2026

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  1. Kite Pharma, Inc. TECARTUS (brexucabtagene autoleucel) suspension for intravenous infusion injection, for intravenous use [prescribing information]. US Food and Drug Administration. Accessed October 2020. http://www.accessdata.fda.gov
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    Note: Health Maintenance Organization (HMO) products are offered through Scott and White Health Plan dba Baylor Scott & White Health Plan, and Scott & White Care Plans dba Baylor Scott & White Care Plan. Insured PPO and EPO products are offered through Baylor Scott & White Insurance Company. Scott and White Health Plan dba Baylor Scott & White Health Plan serves as a third-party administrator for self-funded employer-sponsored plans. Baylor Scott & White Care Plan and Baylor Scott & White Insurance Company are wholly owned subsidiaries of Scott and White Health Plan. These companies are referred to collectively in this document as Baylor Scott & White Health Plan. RightCare STAR Medicaid is offered through Scott and White Health Plan in the Central Texas Medicaid Rural Service Area (MRSA); FirstCare STAR is offered through SHA LLC dba FirstCare Health Plans (FirstCare) in the Lubbock and West MRSAs; and FirstCare CHIP is offered through FirstCare in the Lubbock Service Area.

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