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Chimeric Antigen Receptor Therapy (CART): Carvykti® & Abecma®​
08.02.50

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

INDEX OF MEDICALLY NECESSARY INDICATIONS
 
This policy addresses numerous medically necessary indications for the use of ciltacabtagene autoleucel (Carvykti®) and idecabtagene vicleucel (Abecma®), listed in order of appearance within the Policy section. Please see below for the specific medical necessity criteria. (NOTE: Experimental/Investigational section below must also be reviewed.)​

Product name​Brand nameIndication



Ciltacabtagene autoleucelCarvykti®
  • ​Multiple myeloma (MM)
Idecabtagene vicleucelAbecma® 
  • Multiple myeloma (MM)

MEDICALLY NECESSARY


The following general criteria must be met for all chimeric antigen receptor T-cell (CAR-T) therapy products for the treatment of relapsed/refractory (RR) MM:

  • The individual does not have clinically significant active systemic infection or inflammatory disorder including, but not limited to, hepatitis B; hepatitis C; HIV infection; presence of fungal, bacterial, viral, or other infection that is uncontrolled ​​​
  • The individual does not have known active or prior history of significant central nervous system (CNS) disease 
  • The individual does not have a history of prior CAR-T therapy or prior gene therapy 
  • The individual is 18 years or older at time of infusion​

CILTACABTAGENE AUTOLEUCEL (CARVYKTI)*

Ciltacabtagene autoleucel (Carvykti) is considered medically necessary and, therefore, covered for the autologous treatment for R/R MM when all the general criteria above AND the following are met:

  • Diagnosis of late relapse or progressive MM  
  • The individual has been treated with one of the following regimens:
    • One prior line of therapy including all of the following (National Comprehensive Cancer Network [NCCN] preferred): 
      • A proteasome inhibitor (e.g., carfilzomib, ixazomib, bortezomib) 
      • An immunomodulatory agent (e.g., thalidomide, lenalidomide, pomalidomide, cyclophosphamide)
      • Are refractory to lenalidomide
    •  Three prior lines of therapy (NCCN preferred) ​
  • The individual does not have a history of prior therapy that is targeted to B-cell maturation antigen (BCMA) (e.g., belantamab mafodotin, teclistamab, idecabtagene vicleucel [Abecma]) 
  • The individual has not undergone allogeneic hematopoietic stem cell transplantation (HSCT) within the past 6 months or an autologous HSCT 12 weeks or less before apheresis​ 

IDECABTAGENE VICLEUCEL (ABECMA)*​ 

Idecabtagene vicleucel (Abecma) is considered medically necessary and, therefore, covered for the autologous treatment for R/R MM when all the general criteria above AND of the following are met: 

  • Diagnosis of late relapse or progressive MM  
  • The individual has been treated with one of the following regimens:
    • Two prior lines of therapy including all of the following (NCCN preferred): 
      • A proteasome inhibitor (e.g., carfilzomib, ixazomib, bortezomib) 
      • An immunomodulatory agent (e.g., thalidomide, lenalidomide, pomalidomide, cyclophosphamide)
      • An anti-CD38 monoclonal antibody (e.g., isatuximab, daratumumab)​
    • ​At least three prior lines of therapy (NCCN preferred) ​
*May also be used for the treatment of POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes), monoclonal immunoglobulin deposition disease (MIDD), and plasma cell–​related monoclonal gammopathy of renal significance (MGRS).
​​​
​​EXPERIMENTAL/INVESTIGATIONAL

All other uses for ​ciltacabtagene autoleucel (Carvykti) and idecabtagene vicleucel (Abecma) are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT​

The harvesting and preparation of blood-derived T lymphocytes and the receipt and preparation of CAR-T cells are not eligible for separate reimbursement from the CAR-T cell administration. ​

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.​

Guidelines

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box warnings.​​

ADEQUATE ORGAN AND BONE MARROW FUNCTION

Prior to being considered for chimeric antigen receptor T-cell (CAR-T) therapy, the individual should be assessed for adequate organ and bone marrow function. The following parameters from published peer-reviewed literature may be used for guidance:
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Left ventricular ejection fraction of 45% or greater
  • Serum creatinine of 1.5 times the upper limit of normal (ULN) or less
  • Estimated glomerular filtration rate (eGFR) 60 mL/min/1.73 m2 or greater
  • Alanine aminotransferase (ALT) five times the ULN or less for age
  • Bilirubin 2.0 mg/dL or less (except for individuals with Gilbert syndrome whose total bilirubin should be three times the ULN or less and direct bilirubin 1.5 times the ULN or less)
  • Pulmonary reserve of grade 1 or less dyspnea and pulse oximetry of greater than 91% on room air
  • Absolute neutrophil count (ANC) greater than 1.000/mm3
  • Absolute lymphocyte count (ALC) 300/mm3 or greater
  • Platelets 50.000/mm3 or greater
  • Hemoglobin (Hgb) greater than 8.0 g/dL
BENEFIT APPLICATION​

Subject to the terms and conditions of the applicable benefit contract, ciltacabtagene autoleucel (Carvykti) and idecabtagene vicleucel (Abecma) are covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION STATUS
Ciltacabtagene autoleucel (Carvykti) was approved by the US Food and Drug Administration (FDA) on February 28, 2022, for the treatment of adult individuals with relapsed/refractory (R/R) multiple myeloma (MM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti–cluster of differentiation (CD)38 monoclonal antibody. Supplemental approvals for ciltacabtagene autoleucel (Carvykti) have since been issued by the FDA. The safety and effectiveness of ciltacabtagene autoleucel (Carvykti) in the pediatric population have not been established. 

Idecabtagene vicleucel (Abecma) was approved by the FDA on March 26, 2021, for the treatment of adult individuals with R/R MM after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Supplemental approvals for idecabtagene vicleucel (Abecma) have since been issued by the FDA. The safety and effectiveness of idecabtagene vicleucel (Abecma) in the pediatric population have not been established. 

DOSING GUIDELINES 
*There is a dosing limit of 1 treatment course​ per lifetime.*

CILTACABTAGENE AUTOLEUCEL (CARVYKTI)
Pre-treatment:
Lymphodepleting chemotherapy: fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 IV daily for 3 days. Infuse ciltacabtagene autoleucel (Carvykti) 2 to 4 days after completion of lymphodepleting chemotherapy.

Treatment:
Ciltacabtagene autoleucel (Carvykti) dose is 0.5 to 1.0 × 106 CAR-positive viable T cells per kilogram body weight with a maximum of 1 × 108 CAR-positive viable T cells.

IDECABTAGENE VICLEUCEL (ABECMA)
Pre-treatment:
Lymphodepleting chemotherapy: fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 IV daily for 3 days. Infuse idecabtagene vicleucel (Abecma) 2 days after completion of lymphodepleting chemotherapy.

Treatment:
Idecabtagene vicleucel (Abecma) target dose is 300 to 510 × 106 CAR-positive T cells.

Description

MULTIPLE MYELOMA

Multiple myeloma (MM) is a type of blood cancer, particularly of the plasma cells within the bone marrow. Like leukemia and lymphoma, the cancer affects the immune system of the individual with the malignancy. Treatment includes a combination of chemotherapy, biologicals, radiation therapy, and hematopoietic stem cell transplantation (HSCT). 

CHIMERIC ANTIGEN RECEPTOR T-CELL (CAR-T) THERAPY

Ciltacabtagene Misspelled Wordautoleucel (Misspelled WordCarvykti) and Misspelled Wordidecabtagene Misspelled Wordvicleucel (Misspelled WordAbecma) are both B-cell maturation antigen (BCMA)–directed chimeric antigen receptor T-cell (CAR-T) therapies. ​Chimeric antibody receptor (CAR) T-cell therapy is a method whereby the T cells (a type of white blood cell) are altered in a laboratory in order to have them find and destroy cancer cells or other disease-producing cells. Each dose of CAR-T is customized to the individual and their cancer or disease. The individual's T cells are collected during a process called Misspelled Wordleukaph​eresis and sent to a manufacturing center where they are genetically modified to include a new CAR gene. The modified T cells target and bind to the specific protein on the surface of the antigen causing the cancer or disease and trigger the individual’s own immune system to help destroy the target. Prior to initiating the CAR-T infusion, individuals undergo Misspelled Wordlymphodepleting chemotherapy to reduce the level of white blood cells and help the body accept the reprogrammed CAR-T cells. 

CILTACABTAGENE AUTOLEUCEL (CARVYKTI) 

On February 28, 2022, the FDA approved Misspelled Wordciltacabtagene Misspelled Wordautoleucel (Misspelled WordCarvykti) for the treatment of adult individuals with relapsed/refractory (R/R) multiple myeloma (MM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Misspelled WordCiltacabtagene Misspelled Wordautoleucel (Misspelled WordCarvykti) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T-cell immunotherapy.

The safety and efficacy of Misspelled Wordciltacabtagene Misspelled Wordautoleucel (Misspelled WordCarvykti) for the treatment of adult individuals with MM were evaluated in a single-arm, open-label, multicenter, phase 1b/2 trial (CARTITUDE-1; NCT03548207). Individuals were eligible for treatment if they had a diagnosis of R/R MM and had received three or more previous lines of therapy or were double-refractory to a proteasome inhibitor and an immunomodulatory drug, and had received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. One of the primary endpoints was overall response rates along with safety data. Key secondary endpoints included duration of response (DOR) and progression-free survival (PFS). A total of 113 individuals were enrolled in the study and 97 individuals received the Misspelled Wordciltacabtagene Misspelled Wordautoleucel (Misspelled WordCarvykti) infusion. The overall response rate was 97% (95% confidence interval [CI], 91.2–99.4 in 94 of 97 individuals). A stringent complete response was achieved by 65 individuals (67%). Neither median DOR (95% CI, 15.9 to not estimable) nor median PFS (95% CI, 16.8 to not estimable) was reached as of the data cut-off (median follow-up, 12.4 months). At 1 year, the PFS was 77% (95% CI, 66.0–84.3) and overall survival rate was 89% (95% CI, 80.2–93.5). All of the transfused individuals experienced an adverse event, with hematological adverse events being the most common. CRS occurred in 95% (92 of 97) of individuals, but only 4% were grade 3 or 4. Fourteen individuals died during the study, with six of these believed to be treatment related.

The safety and efficacy of Misspelled Wordciltac​Misspelled Wordabtagene Misspelled Wordautoleucel (Misspelled WordCarvykti) for the treatment of adult individuals with MM refractory to Misspelled Wordlenalidomide were evaluated in a phase 3, randomized, open-label study (CARTITUDE-4; NCT04181827) versus the provider’s choice of effective standard therapy (Misspelled Wordpomalidomide, Misspelled Wordbortezomib, dexamethasone [Misspelled WordPVd] or Misspelled Worddaratumumab, Misspelled Wordpomalidomide, dexamethasone [Misspelled WordDPd]) in individuals who had received one to three lines of prior therapy that included a proteasome inhibitor and an immunomodulatory drug. The primary endpoint was PFS up to 6 years or death due to any cause, whichever occurred first. Key secondary endpoints included objective response rate (ORR) and percentage of individuals with CR or better (stringent CR). A total of 419 individuals were randomly assigned in a 1:1 ratio to treatment with Misspelled Wordciltacabtagene Misspelled Wordautoleucel (Misspelled WordCarvykti) or standard therapy. At a median follow-up of 15.9 months, the medium PFS was not reached for the Misspelled Wordciltacabtagene Misspelled Wordautoleucel (Misspelled WordCarvykti) cohort versus 11.8 months for the standard therapy cohort (P<0.0001). The ORR was 84.6% for the Misspelled Wordciltacabtagene Misspelled Wordautoleucel (Misspelled WordCarvykti) cohort versus 67.8% for the standard therapy cohort (P<0.0001). The percentage of individuals who experienced a complete response or better in the Misspelled Wordciltacabtagene Misspelled Wordautoleucel (Misspelled WordCarvykti) cohort was 74.1% versus 22.3% for the standard therapy cohort (P<0.0001). Of the individuals in the Misspelled Wordciltacabtagene Misspelled Wordautoleucel (Misspelled WordCarvykti) cohort, 76.1% experienced CRS; 1.1% grade 3 or 4, none grade 5. The percentage of adverse events was similar between the two cohorts. ​
​
IDECABTAGENE VICLEUCEL (ABECMA) 

On February 28, 2022, the FDA approved Misspelled Wordidecabtagene Misspelled Wordvicleucel (Misspelled WordAbecma) for the treatment of adult individuals with R/R MM after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Misspelled WordIdecabtagene Misspelled Wordvicleucel (Misspelled WordAbecma) is a BCMA-directed genetically modified autologous T-cell immunotherapy.

The safety and efficacy of Misspelled Wordidecabtagene Misspelled Wordvicleucel (Misspelled WordAbecma) for the treatment of adult individuals with MM were evaluated in a single-arm, open-label, multicenter, phase 2 trial (Misspelled WordKarMMa; NCT03361748). Individuals were eligible for treatment if they had a diagnosis of R/R MM and had received three or more previous lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The primary endpoint was an overall response of partial response or better. A key secondary endpoint was the rate of complete response or better. A total of 140 individuals were enrolled with 128 individuals being transfused with target doses of 150 × 106 CAR T cells, 300 × 106 CAR T cells, or 450 × 106 CAR T cells. Ninety-two percent of the individuals had received a prior autologous HSCT. At a median follow-up of 13.3 months (range, 0.2–21.2), 94 individuals (73%; 95% CI, 66–81) had a response to the infusion (P<0.001), and 42 individuals (33%) had a complete or stringent complete response. The median DOR for any dose was 10.7 months (95% CI, 9.0–11.3) with a median DOR of 11.3 months (95% CI, 10.3–11.4) for the 450 × 106 cohort. The median PFS for any dose was 8.8 months (95% CI, 5.6–11.6), with a PFS of 12.1 months (95% CI, 8.8–12.3) for the 450 × 106 cohort. All of the individuals who were transfused reported adverse events, with 99% (127 of 128) experiencing grade 3 or 4 events that were mostly hematological. Infections occurred in 88 individuals (69%). CRS occurred in 107 individuals (84%) with most being grade 1 or 2. Forty-four individuals (34%) died during the study period, with four of these believed to be treatment related.

The safety and efficacy of Misspelled Wordidecabtagene Misspelled Wordvicleucel (Misspelled WordAbecma) for the treatment of adult individuals with R/R MM who had received two to four prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and Misspelled Worddaratumumab, and were refractory to the most recent regimen were evaluated in a phase 3, randomized, open-label study (KarMMa-3; NCT03651128) versus the provider’s choice of effective standard therapy (Misspelled Worddaratumumab, Misspelled Wordpomalidomide, dexamethasone [Misspelled WordDPd], Misspelled Worddaratumumab, Misspelled Wordbortezomib, dexamethasone [Misspelled WordDVd], Misspelled Wordixazomib, Misspelled Wordlenalidomide, dexamethasone [Misspelled WordIrd], Misspelled Wordcarfilzomib, dexamethasone [Misspelled WordKd], Misspelled Wordelotuzumab, Misspelled Wordpomalidomide, dexamethasone [Misspelled WordEPd]) depending on what treatment the individual had previously received. The primary endpoint was PFS. Key secondary endpoints included ORR and the percentage of individuals who achieved a CR or better (stringent CR). A total of 386 individuals were randomly assigned in a 2:1 ratio to treatment with Misspelled Wordidecabtagene Misspelled Wordvicleucel (Misspelled WordAbecma) or standard therapy. At a median follow-up of 18.6 months, the median PFS was 13.3 months in the Misspelled Wordidecabtagene Misspelled Wordvicleucel (Misspelled WordAbecma) cohort versus 4.4 months in the standard treatment cohort (P<0.0001). The ORR was 71% for the Misspelled Wordidecabtagene Misspelled Wordvicleucel (Misspelled WordAbecma) cohort versus 42% for the standard therapy cohort (P<0.0001). The percentage of individuals in the Misspelled Wordidecabtagene Misspelled Wordvicleucel (Misspelled WordAbecma) cohort who achieved CR or better was 98% versus 7% in the standard therapy cohort. In the Misspelled Wordidecabtagene Misspelled Wordvicleucel (Misspelled WordAbecma) cohort, 88% experienced CRS, with 5% being grade 3 or higher. The percentage of adverse events were higher in the Misspelled Wordidecabtagene Misspelled Wordvicleucel (Misspelled WordAbecma) cohort than in the standard therapy cohort, but were consistent with previous studies. No new safety signals were identified. 

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.​

References

American Cancer Society. What is multiple myeloma. [American Cancer Society Web site]. 08/27/2024. Available at:  https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed November 25, 2025.

American Cancer Society. CAR T-cell therapy and its side effects. [American Cancer Society Web site]. 11/11/2024. Available at: https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/car-t-cell1.html. Accessed November 25, 2025.

American Cancer Society. Multiple myeloma. [American Cancer Society Web site]. Available at:  https://www.cancer.org/cancer/types/multiple-myeloma.html.  Accessed November 25, 2025.

American Hospital Formulary Service (AHFS). Ciltacabtagene autoleucel (Carvykti®). AHFS Drug Information 2024. [UpToDate Lexidrug Web site]. 11/13/25​. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed November 25, 2025.

American Hospital Formulary Service (AHFS). Idecabtagene vicleucel (Abecma®​). AHFS Drug Information 2024. [UpToDate Lexidrug Web site]. 11/13/25​​. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed November 25, 2025.

American Society of Hematology. Myeloma. [American Society of Hematology Web site]. Available at:  https://www.hematology.org/education/patients/blood-cancers/myeloma. Accessed November 25, 2025.  

Berdeja JG, Madduri D, Usmani SZ, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021;398(10297):314-324.

Ciltacabtagene autoleucel (Carvykti®). [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; 10/2025. Available at:  https://www.carvykti.com/. Accessed November 25, 2025.

ClinicalTrial.gov. A study comparing JNJ-68284528, a CAR-T therapy directed against B-cell maturation antigen (BCMA), versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in participants with relapsed and lenalidomide-refractory multiple myeloma (CARTITUDE-4). ClinicalTrials.gov Identifier: NCT 04181827. First Posted: December 2, 2019. Last Update Posted: October 9, 2024. Available at: https://clinicaltrials.gov/. Accessed November 25, 2025.​

ClinicalTrial.gov. A study of JNJ-68284528, a chimeric antigen receptor T Cell (CAR-T) therapy directed against B-Cell maturation antigen (BCMA) in participants with relapsed or refractory multiple myeloma (CARTITUDE-1). ClinicalTrials.gov Identifier: NCT03548207. First Posted: June 7, 2018. Last Update Posted: April 2, 2024. Available at: https://clinicaltrials.gov/. Accessed November 25, 2025.

ClinicalTrial.gov. Efficacy and safety study of bb2121 in subjects with relapsed and refractory multiple myeloma (KarMMa). ClinicalTrials.gov Identifier: NCT03361748. First Posted: December 5, 2017. Last Update Posted: February 1, 2024. Available at: https://clinicaltrials.gov/. Accessed November 25, 2025.

ClinicalTrial.gov. Efficacy and safety study of bb2121 versus standard regimens in subjects with relapsed and refractory multiple myeloma (RRMM) (KarMMa-3). ClinicalTrials.gov Identifier: NCT03651128. First Posted: August 29, 2018. Last Update Posted: December 15, 2022. Available at: https://clinicaltrials.gov/. Accessed November 25, 2025.

Elsevier's Clinical Pharmacology Compendium. Ciltacabtagene autoleucel (Carvykti®). [Clinical Key Web site]. 09/25/2025. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed November 25, 2025.

Elsevier's Clinical Pharmacology Compendium. Idecabtagene vicleucel (Abecma®​). [Clinical Key Web site]. 09/25/2025. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed November 25, 2025.

Idecabtagene vicleucel (Abecma®). [prescribing information]. Summit, NJ: Bristol-Myers Squibb; 09/2025​. Available at:  https://www.abecma.com/. Accessed November 25, 2025.

Merative Micromedex® DRUGDEX® (electronic version). Ciltacabtagene autoleucel (Carvykti®). [Micromedex Web site]. Merative L.P., Ann Arbor, Michigan, USA. 08/20/2025. Available at:  https://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed November 25, 2025.

Merative Micromedex® DRUGDEX® (electronic version). Idecabtagene vicleucel (Abecma®). [Micromedex Web site]. Merative L.P., Ann Arbor, Michigan, USA. 08/20/2025​. Available at:  https://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed November 25, 2025.

Munshi NC, Anderson LD, Shah N, et al. Idecabtagene vicleucel in relapsed and refractory multiple myeloma. N Engl J Med. 2021;384(8):705-716.

​National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology® - Multiple Myeloma V3.2026.  [NCCN Web site]. 11/03/2025. Available at:  https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. [via subscription only]. Accessed November 25, 2025.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium®. [NCCN Web site]. Ciltacabtagene autoleucel (Carvykti®). Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed November 25, 2025.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium®. [NCCN Web site]. Idecabtagene vicleucel (Abecma®​). Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed November 25, 2025.

San-Miguel J, Dhakal B, Yong K, et al. Cilta-cel or standard care in lenalidomide-refractory multiple myeloma. N Engl J Med. 2023;389(4):335-347.

UpToDate® LexidrugTM. Ciltacabtagene autoleucel (Carvykti®). [UpToDate Lexidrug Web site]. 11/06/2025. Available at:  https://online.lexi.com/lco/action/home [via subscription only]. Accessed November 25, 2025.

UpToDate® LexidrugTM. Idecabtagene vicleucel (Abecma®). [UpToDate Lexidrug Web site]. 11/06/2025. Available at:  https://online.lexi.com/lco/action/home [via subscription only]. Accessed November 25, 2025.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Ciltacabtagene autoleucel (Carvykti®). Prescribing information, approval letter, REMS documents. [FDA Web site]. 10/2025. Available at:  https://www.fda.gov/vaccines-blood-biologics/carvykti. Accessed November 25, 2025.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Idecabtagene vicleucel (Abecma®). Prescribing information, approval letter, REMS documents. [FDA Web site]. 09/2025. Available at:  https://www.fda.gov/vaccines-blood-biologics/abecma-idecabtagene-vicleucel. Accessed November 25, 2025​.​

Coding

CPT Procedure Code Number(s)

MEDICALLY NECESSARY

38228

NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT

38225, 38226, 38227

ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.​
HCPCS Level II Code Number(s)

Q2055 Idecabtagene vicleucel, up to 510 million autologous B-cell maturation antigen (BCMA) directed CAR-positive T cells, including leukapheresis and dose preparation procedures, per therapeutic dose

Q2056 Ciltacabtagene autoleucel, up to 100 million autologous B-cell maturation antigen (BCMA) directed CAR-positive T cells, including leukapheresis and dose preparation procedures, per therapeutic dose

Revenue Code Number(s)
N/A

Coding and Billing Requirements

Policy History

Revisions From 08.02.50:

02/09/​2026

This version of the policy will become effective 02/09/2026. This new policy number, 08.02.50, supersedes 08.01.43q for Chimeric Antigen Receptor Therapy (CART): Yescarta, Tecartus, Breyanzi, Kymriah, and Aucatzyl. Information for the these products resides in ​a separate CAR-T drug policy.  

 
The following indication has been included in accordance with National Comprehensive Cancer Network (NCCN):​

  • Ciltacabtagene autoleucel (Carvykti) and idecabtagene vicleucel (Abecma) may also be used for the treatment of POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes), monoclonal immunoglobulin deposition disease (MIDD), and plasma cell–​related monoclonal gammopathy of renal significance (MGRS).​

2/9/2026
2/9/2026
08.02.50
Medical Policy Bulletin
Commercial
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