Baylor Scott & White Health PlanCommercial Clinical Policy

Idacabtagene vicleucel (Abecma) Form

Chat with GenHealth to automate any policy or prior auth task.


Idacabtagene vicleucel (Abecma)

Indications

(1) Member has a diagnosis of relapsed or refractory multiple myeloma (RRMM); AND 2. Member is ≥ 18 years old; AND 3. Idecabtagene is prescribed by or in consultation with a board-certified hematologist or oncologist; AND 4. Idecabtagene will be dosed and administered according to FDA approved labeling; AND 5. Idecabtagene will be used as monotherapy; AND 6. Provider attests member will receive idecabtagene at a REMS-certified healthcare facility; AND 7. Member has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND 8. Member has adequate bone marrow, renal, hepatic, and cardiac function; AND 9. Member has been assessed by a hematologist/oncologist to be an appropriate candidate for apheresis; AND 10. Member has relapsed or refractory disease and received two or more prior lines of systemic therapy including: a. Immunomodulatory agent b. Proteasome inhibitor c. Anti-CD38 monoclonal antibody AND 11. Member has Not previously been treated with CAR-T cell therapy; AND 12. Member has Not received prior B-cell maturation antigen (BCMA) targeted therapy (ex., teclistamab, elranatamab); AND MEDICAL COVERAGE POLICY SERVICE: Idecabtagene Vicleucel (Abecma®) Policy Number: 290 Effective Date: 09/01/2025 Last Review: 06/09/2025 Next Review: 06/09/2026 Page 2 of 5 13. Member does Not have any of the following: a. Active infection (including hepatitis B, hepatitis C, or HIV infection) b. Inflammatory disorder c. History of allogeneic stem cell transplant d. History of autologous stem cell transplant less than or equal to 12 weeks before apheresis e. Known active, or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma BSWHP considers only ONE treatment per lifetime is medically necessary as repeat administration of idecabtagene vicleucel (Abecma®) is experimental and investigational because the effectiveness of this strategy has not been established. BSWHP considers idecabtagene vicleucel (Abecma®) 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 a clinical pharmacist and medical director. BACKGROUND: Chimeric antigen receptor (CAR) T cells and genetically engineered T-cell receptor (TCR T) cells are manufactured by collecting lymphocytes from a patient or donor and modifying them using gene transfer techniques. Viral vectors are introduced that express cell receptors that are highly specific for tumor antigens. CAR T and TCR T cells are then infused back into the patient where they direct a targeted immune response to cancerous tissue. CAR T cells express a hybrid receptor with an extracellular single-chain antibody fragment, a transmembrane domain, and at least 1 intracellular signaling domain. CAR T cells are most often used to treat hematological malignancies, and a common target is B-cell cluster of differentiation antigen 19 (CD19). Multiple myeloma (MM) is a rare hematologic cancer arising from plasma cells in the bone marrow. Malignant plasma cells produce abnormal monoclonal paraproteins that cause organ damage. According to the American Cancer Society (ACS), an estimated 34,920 new cases of MM will be diagnosed, and 12,410 people will die from the disease in the U.S. in 2021. The median age at diagnosis is 69 years, and almost all cases of MM (95%) are diagnosed after the cancer has metastasized. The treatment landscape for MM has evolved over the past 15 years, delivering many new options for improved management of the disease. Despite these advances, MM remains incurable. Almost all patients eventually relapse and develop relapsed/refractory MM (RRMM). The overall 5-year survival rate for MM is 53.9%. The U. S. Food and Drug Administration (FDA) granted approval for idecabtagene vicleucel (Abecma®) on March 26, 2021 which is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Idecabtagene is available only through a MEDICAL COVERAGE POLICY SERVICE: Idecabtagene Vicleucel (Abecma®) Policy Number: 290 Effective Date: 09/01/2025 Last Review: 06/09/2025 Next Review: 06/09/2026 Page 3 of 5 restricted program under a Risk Evaluation and Mitigation Strategy (REMS) and has a boxed warning for cytokine release syndrome (CRS), neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), prolonged cytopenia, and T-cell malignancies. The FDA approval of idecabtagene is based on data from the KarMMA (NCT03361748) open-label, single-arm, multicenter study in adult patients after 3 or more lines of prior therapy showing an overall response rate (ORR) of 72%, stringent complete response rate (sCR) of 28%, median progression-free survival (PFS) of 8.8 months overall, a PFS of 20.2 months among patients with a complete response (CR) or better, and a median overall survival (OS) of 19.4 months out of 100 evaluable patients. In KarMMa-3 (NCT03651128), an open-label, multicenter, randomized control trial, adult patients with relapsed and refractory multiple myeloma who had received two to four prior lines of therapy showed an ORR of 71%, sCR 39%, and median PFS was 13.3 months overall which was significantly higher than 4.4 months for standard-regimen group. With respect to safety, a higher proportion of the idecabtagene arm died within the first 9 months of randomization in the KarMMA-3 trial compared to standard regimen. However, the OS curves in the Kaplan-Meier Plot cross at month 15 of the study rendering the overall hazard ratio unreliable to estimate the treatment effect on OS. The most common grade 3 or higher adverse effects were febrile neutropenia and infections. Serious adverse reactions occurred in 67% of patients in the KarMMA study and 43% of patients in the KarMMA-3 trial. 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: 0540T - Chimeric antigen receptor T cell (CAR-T) therapy; CAR-T cell administration, autologous 96409 - Chemotherapy administration; intravenous, push technique, single or initial substance/drug 96413 - Chemotherapy administration; intravenous infusion technique; up to 1 hour, single or initial substance/drug HCPCS Codes: Q2055: Idecabtagene vicleucel, up to 460 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose ICD10 codes: C90.00 Multiple myeloma not having achieved remission C90.01 Multiple myeloma in relapse Z51.12 Encounter for antineoplastic immunotherapy ICD10 Not covered: POLICY HISTORY: MEDICAL COVERAGE POLICY SERVICE: Idecabtagene Vicleucel (Abecma®) Policy Number: 290 Effective Date: 09/01/2025 Last Review: 06/09/2025 Next Review: 06/09/2026 Page 4 of 5 Status Date Action New 04/22/2021 New policy Updated 05/27/2021 Removed Oncology Analytics line, added apheresis criteria Updated 07/22/2021 Added clinician reviewer criteria Updated 06/23/2022 Added NCD information Updated 10/27/2022 Removed language with CMS LCD since NCD applies. Updated HCPCS code. Removed Texas Mandate HB1584 language from main policy section as the policy is compliant. Minor formatting update. Reviewed 10/09/2023 Applied new layout and format. Updated 06/10/2024 Updated criteria for 3rd line therapy, max dose, and background Updated 06/09/2025 Corrected spelling error, Updated beginning note to align with standard language, Updated criteria #1-4 language to align with standard language, Added “Idecabtagene will be used as monotherapy”, Updated treatment center criteria to attestation only, Updated criteria to include examples of BCMA targeted therapy, Added allogeneic/autologous HSCT exclusion criteria, Added CNS exclusion criteria, Updated ending note section to algin with business entity changes, Updated drug name in background. 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, 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. Abecma (idecabtagene vicleucel) [prescribing information]. Summit, NJ: Celgene Corporation; April 2024. 2. Almåsbak H, Aarvak T, Vemuri MC. CAR T cell therapy: a game changer in cancer treatment. J Immunol Res. 2016;2016:5474602. 3. American Cancer Society. Key Statistics About Multiple Myeloma. Available at: https://www.cancer.org/cancer/multiple- myeloma/about/key-statistics.html. Accessed April 16, 2021. 4. Brentjens RJ. Are chimeric antigen receptor T cells ready for prime time? Clin Adv Hematol Oncol. 2016;14(1):17-19.? 

Effective Date

NA

Last Reviewed

NA

Original Document

  Reference



MEDICAL COVERAGE POLICY SERVICE: Idecabtagene Vicleucel (Abecma®) Policy Number: 290 Effective Date: 09/01/2025 Last Review: 06/09/2025 Next Review: 06/09/2026

Page 1 of 5

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: Idecabtagene Vicleucel (Abecma®) 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 idecabtagene vicleucel (Abecma®) medically necessary when documentation is submitted showing ALL of the following criteria are met:

  1. Member has a diagnosis of relapsed or refractory multiple myeloma (RRMM); AND
  2. Member is ≥ 18 years old; AND
  3. Idecabtagene is prescribed by or in consultation with a board-certified hematologist or oncologist; AND
  4. Idecabtagene will be dosed and administered according to FDA approved labeling; AND
  5. Idecabtagene will be used as monotherapy; AND
  6. Provider attests member will receive idecabtagene at a REMS-certified healthcare facility; AND
  7. Member has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
  8. Member has adequate bone marrow, renal, hepatic, and cardiac function; AND
  9. Member has been assessed by a hematologist/oncologist to be an appropriate candidate for apheresis; AND
  10. Member has relapsed or refractory disease and received two or more prior lines of systemic therapy including: a. Immunomodulatory agent b. Proteasome inhibitor c. Anti-CD38 monoclonal antibody AND
  11. Member has Not previously been treated with CAR-T cell therapy; AND
  12. Member has Not received prior B-cell maturation antigen (BCMA) targeted therapy (ex., teclistamab, elranatamab); AND

MEDICAL COVERAGE POLICY SERVICE: Idecabtagene Vicleucel (Abecma®) Policy Number: 290 Effective Date: 09/01/2025 Last Review: 06/09/2025 Next Review: 06/09/2026

Page 2 of 5

  1. Member does Not have any of the following: a. Active infection (including hepatitis B, hepatitis C, or HIV infection) b. Inflammatory disorder c. History of allogeneic stem cell transplant d. History of autologous stem cell transplant less than or equal to 12 weeks before apheresis e. Known active, or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

    BSWHP considers only ONE treatment per lifetime is medically necessary as repeat administration of idecabtagene vicleucel (Abecma®) is experimental and investigational because the effectiveness of this strategy has not been established.

    BSWHP considers idecabtagene vicleucel (Abecma®) 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 a clinical pharmacist and medical director. BACKGROUND:
    Chimeric antigen receptor (CAR) T cells and genetically engineered T-cell receptor (TCR T) cells are manufactured by collecting lymphocytes from a patient or donor and modifying them using gene transfer techniques. Viral vectors are introduced that express cell receptors that are highly specific for tumor antigens. CAR T and TCR T cells are then infused back into the patient where they direct a targeted immune response to cancerous tissue. CAR T cells express a hybrid receptor with an extracellular single-chain antibody fragment, a transmembrane domain, and at least 1 intracellular signaling domain. CAR T cells are most often used to treat hematological malignancies, and a common target is B-cell cluster of differentiation antigen 19 (CD19). Multiple myeloma (MM) is a rare hematologic cancer arising from plasma cells in the bone marrow. Malignant plasma cells produce abnormal monoclonal paraproteins that cause organ damage. According to the American Cancer Society (ACS), an estimated 34,920 new cases of MM will be diagnosed, and 12,410 people will die from the disease in the U.S. in 2021. The median age at diagnosis is 69 years, and almost all cases of MM (95%) are diagnosed after the cancer has metastasized. The treatment landscape for MM has evolved over the past 15 years, delivering many new options for improved management of the disease. Despite these advances, MM remains incurable. Almost all patients eventually relapse and develop relapsed/refractory MM (RRMM). The overall 5-year survival rate for MM is 53.9%.
    The U. S. Food and Drug Administration (FDA) granted approval for idecabtagene vicleucel (Abecma®) on March 26, 2021 which is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Idecabtagene is available only through a

MEDICAL COVERAGE POLICY SERVICE: Idecabtagene Vicleucel (Abecma®) Policy Number: 290 Effective Date: 09/01/2025 Last Review: 06/09/2025 Next Review: 06/09/2026

Page 3 of 5

restricted program under a Risk Evaluation and Mitigation Strategy (REMS) and has a boxed warning for cytokine release syndrome (CRS), neurologic toxicities, hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), prolonged cytopenia, and T-cell malignancies. The FDA approval of idecabtagene is based on data from the KarMMA (NCT03361748) open-label, single-arm, multicenter study in adult patients after 3 or more lines of prior therapy showing an overall response rate (ORR) of 72%, stringent complete response rate (sCR) of 28%, median progression-free survival (PFS) of 8.8 months overall, a PFS of 20.2 months among patients with a complete response (CR) or better, and a median overall survival (OS) of 19.4 months out of 100 evaluable patients. In KarMMa-3 (NCT03651128), an open-label, multicenter, randomized control trial, adult patients with relapsed and refractory multiple myeloma who had received two to four prior lines of therapy showed an ORR of 71%, sCR 39%, and median PFS was 13.3 months overall which was significantly higher than 4.4 months for standard-regimen group.
With respect to safety, a higher proportion of the idecabtagene arm died within the first 9 months of randomization in the KarMMA-3 trial compared to standard regimen. However, the OS curves in the Kaplan-Meier Plot cross at month 15 of the study rendering the overall hazard ratio unreliable to estimate the treatment effect on OS. The most common grade 3 or higher adverse effects were febrile neutropenia and infections. Serious adverse reactions occurred in 67% of patients in the KarMMA study and 43% of patients in the KarMMA-3 trial. 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: 0540T - Chimeric antigen receptor T cell (CAR-T) therapy; CAR-T cell administration, autologous 96409 - Chemotherapy administration; intravenous, push technique, single or initial substance/drug 96413 - Chemotherapy administration; intravenous infusion technique; up to 1 hour, single or initial substance/drug HCPCS Codes: Q2055: Idecabtagene vicleucel, up to 460 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose ICD10 codes: C90.00 Multiple myeloma not having achieved remission C90.01 Multiple myeloma in relapse Z51.12 Encounter for antineoplastic immunotherapy ICD10 Not covered:

POLICY HISTORY:

MEDICAL COVERAGE POLICY SERVICE: Idecabtagene Vicleucel (Abecma®) Policy Number: 290 Effective Date: 09/01/2025 Last Review: 06/09/2025 Next Review: 06/09/2026

Page 4 of 5

Status Date Action New 04/22/2021 New policy Updated 05/27/2021 Removed Oncology Analytics line, added apheresis criteria Updated 07/22/2021 Added clinician reviewer criteria Updated 06/23/2022 Added NCD information Updated 10/27/2022 Removed language with CMS LCD since NCD applies. Updated HCPCS code. Removed Texas Mandate HB1584 language from main policy section as the policy is compliant. Minor formatting update. Reviewed 10/09/2023 Applied new layout and format. Updated 06/10/2024 Updated criteria for 3rd line therapy, max dose, and background
Updated 06/09/2025 Corrected spelling error, Updated beginning note to align with standard language, Updated criteria #1-4 language to align with standard language, Added “Idecabtagene will be used as monotherapy”, Updated treatment center criteria to attestation only, Updated criteria to include examples of BCMA targeted therapy, Added allogeneic/autologous HSCT exclusion criteria, Added CNS exclusion criteria, Updated ending note section to algin with business entity changes, Updated drug name in background.

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, 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. Abecma (idecabtagene vicleucel) [prescribing information]. Summit, NJ: Celgene Corporation; April 2024.
  2. Almåsbak H, Aarvak T, Vemuri MC. CAR T cell therapy: a game changer in cancer treatment. J Immunol Res. 2016;2016:5474602.
  3. American Cancer Society. Key Statistics About Multiple Myeloma. Available at: https://www.cancer.org/cancer/multiple- myeloma/about/key-statistics.html. Accessed April 16, 2021.
  4. Brentjens RJ. Are chimeric antigen receptor T cells ready for prime time? Clin Adv Hematol Oncol. 2016;14(1):17-19.
  5. Children’s Hospital of Philadelphia (CHOP). What to Expect: CAR T-cell Therapy Process. 2017. Available at: http://www.chop.edu/centers-programs/cancer-immunotherapy-program/your-experience. Accessed August 8, 2017.
  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. 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.

MEDICAL COVERAGE POLICY SERVICE: Idecabtagene Vicleucel (Abecma®) Policy Number: 290 Effective Date: 09/01/2025 Last Review: 06/09/2025 Next Review: 06/09/2026

Page 5 of 5

  1. 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.
  2. Ikeda H. T-cell adoptive immunotherapy using tumor-infiltrating T cells and genetically engineered TCR-T cells. Int Immunol. 2016;28(7):349-353.
  3. 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.
  4. Leukemia and Lymphoma Society (LLS). Chimeric Antigen Receptor (CAR) T-Cell Therapy. 2017. Available at: https://www.lls.org/treatment/types-of-treatment/immunotherapy/chimeric-antigen-receptor-car-t-cell-therapy. Accessed April 16, 2021.
  5. 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.
  6. Maus MV, Nikiforow S. The why, what, and how of the new fact standards for immune effector cells. J Immunother Cancer. 2017;5:36.
  7. NIH National Cancer Institute. Cancer Stat Facts: Myeloma. Available at: https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed April 16, 2021.
  8. Rodriguez-Otero, Paula et al. “Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma.” The New England journal of medicine vol. 388,11 (2023): 1002-1014. doi:10.1056/NEJMoa2213614

  9. Ye B, Stary CM, Gao Q, et al. Genetically modified T-cell-based adoptive immunotherapy in hematological malignancies. J Immunol Res. 2017;2017:5210459.

    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.

Book a walkthrough

Walk through this policy with us

Review how this policy can be converted into cited criteria, prior authorization checks, and operational automation.