Commercial

Chimeric Antigen Receptor (CAR) Therapy
08.01.43h

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.


MEDICALLY NECESSARY

TISAGENLECLEUCEL (KYMRIAH)

B-Cell Precursor Acute Lymphoblastic Leukemia (ALL)​​

Tisagenlecleucel (Kymriah) as a single-agent therapy is considered medically necessary and, therefore, covered for the autologous treatment of B-cell precursor acute lymphoblastic leukemia (ALL) when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) and all of the following criteria are met:

  • Confirmed diagnosis of CD19-positive B-cell precursor ALL with morphologic bone marrow tumor involvement (five percent or greater lymphoblasts) in individuals 25 years and younger at the time of infusion with refractory disease or two or more relapses and one of the following subtypes:
    • Philadelphia chromosome (Ph)--negative disease and failure of two tyrosine kinase inhibitors (e.g., dasatinib [Sprycel], imatinib [Gleevec], ponatinib [Iclusig]), National Comprehensive Cancer Network​ (NCCN)​ preferred regimen
    • Philadelphia chromosome (Ph)--positive disease and failure of two tyrosine kinase inhibitors (e.g., dasatinib [Sprycel], imatinib [Gleevec], ponatinib [Iclusig])
  • The individual does not have an active infection or inflammatory disorder
  • The individual has not received prior CAR treatment (i.e., tisagenlecleucel, axicabtagene ciloleucel)

Pediatric Acute Lymphoblastic Leukemia (ALL)

Tisagenlecleucel (Kymriah) as a single-agent therapy is considered medically necessary and, therefore, covered for the autologous treatment of  acute lymphoblastic leukemia (ALL) when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) and all of the following criteria are met:

  • Confirmed diagnosis of CD19-positive B-cell precursor ALL with morphologic bone marrow tumor involvement (five percent or greater lymphoblasts) in individuals 18 years and younger and one of the following subtypes:
    • Ph-negative disease with refractory disease or two or more relapses
    • Ph-positive disease and tyrosine kinase inhibitors (TKI) (e.g., dasatinib [Sprycel], imatinib [Gleevec]) intolerant or refractory
    • The individual has Ph-positive disease and relapse post-hematopoietic stem cell transplantation (HSCT)
  • The individual does not have an active infection or inflammatory disorder
  • The individual has not received prior CAR treatment (e.g., tisagenlecleucel​) 
B-Cell Lymphomas

Tisagenlecleucel (Kymriah) is considered medically necessary and, therefore, covered for the autologous treatment of B-cell lymphomas when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS), and all of the following criteria are met:
  • Diagnosis of one of the following types of relapsed or refractory large B-cell lymphomas, when the corresponding criteria are met:
    • The individual is diagnosed with any of the following:
      1. Diffuse large B-cell lymphoma (DLBCL) 
      2. Acquired immunodeficiency syndrome (AIDS)--related DLBCL
      3. Human herpesvirus (HHV) 8-positive DLBCL, not otherwise specified 
      4. Primary effusion lymphoma
      5. Monomorphic post-transplant lymphoproliferative disorders (PTLD), B-cell type
      6. Primary mediastinal large B-cell lymphoma
      7. High-grade B-cell lymphomas, not otherwise specified
      8. High grade B-cell lymphoma with translocations of MYC and BCL2 and/or BCL6 (double/triple hit lymphoma)
AND either of these additional criteria:
    • Additional therapy for the individual with intention to proceed to transplant with partial response following second-line therapy for relapsed or refractory disease
    • Treatment (if tisagenlecleucel or axicabtagene ciloleucel not previously given) of disease in second relapse or greater with partial response, no response, or progressive disease following therapy for relapsed or refractory disease
    • DLBCL arising from follicular lymphoma and either of the following criteria:
      • The individual has received minimal or no chemotherapy prior to histologic transformation to DLBCL and has partial response (NCCN preferred in individuals with partial response),​ no response, or progressive disease after treatment with two or more chemoimmunotherapy regimens which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated.
      • The individual has received multiple lines of prior therapies (not including axicabtagene ciloleucel or tisagenlecleucel) for indolent or transformed disease (only after treatment with two or more chemoimmunotherapy regimens which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated).
  • The individual is 18 years or older at the time of infusion.
  • The individual does not have clinically significant active systemic infection or inflammatory disorder.
  • The individual does not have primary central nervous system lymphoma.
Histologic Transformation of Nodal Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

Tisagenlecleucel (Kymriah) is considered medically necessary and, therefore, covered for the autologous treatment of B-cell lymphoma when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS), and all of the following criteria are met:
  • Diagnosis of the histologic transformation of nodal marginal zone lymphoma to diffuse large B-Cell lymphoma.
  • The individual has received multiple lines of prior therapies including two or more chemoimmunotherapy regimens for indolent or transformed disease which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated (NCCN preferred therapy if anti-CD19 CAR T-cell therapy [e.g., axicabtagene ciloleucel, tisagenlecleucel] was not previously given).
  • The individual is 18 years or older at the time of infusion.
  • The individual does not have clinically significant active systemic infection or inflammatory disorder.
  • The individual does not have primary central nervous system lymphoma​.
AXICABTAGENE CILOLEUCEL (YESCARTA)
B-Cell Lymphomas
Axicabtagene ciloleucel (Yescarta) is considered medically necessary and, therefore, covered for the autologous treatment of B-cell lymphomas when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS), and all of the following criteria are met:
  • Diagnosis of one of the following types of relapsed or refractory large B-cell lymphoma when the corresponding criteria are met:
    • The individual is diagnosed with any of the following:
      1. DLBCL 
      2. AIDS-related DLBCL
      3. HHV8-positive DLBCL, not otherwise specified
      4. Monomorphic post-transplant lymphoproliferative disorders (PTLD), B-cell type
      5. Primary mediastinal large B-cell lymphoma
      6. High-grade B-cell lymphomas, not otherwise specified
      7. High grade B-cell lymphoma with translocations of MYC and BCL2 and/or BCL6 (double/triple hit lymphoma)
      AND either of these additional criteria:
        • Additional therapy for the individual with intention to proceed to transplant who has partial response following second-line therapy for relapsed or refractory disease.
        • Treatment (if anti-CD19 CAR T-cell therapy was not previously given​ [e.g., axicabtagene ciloleucel, tisagenlecleucel] not previously given) of disease in second relapse or greater in the individual with partial response, no response, or progressive disease following therapy for relapsed or refractory disease.
    • DLBCL arising from follicular lymphoma and either of the following criteria:
      • The individual has received minimal or no chemotherapy prior to histologic transformation to DLBCL and has partial response, no response, or progressive disease after treatment with two or more chemoimmunotherapy regimens which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated.
      • The individual has received multiple lines of prior therapies (not including axicabtagene ciloleucel or tisagenlecleucel) for indolent or transformed disease only after treatment with two or more chemoimmunotherapy regimens which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated. 
  • ​The individual is 18 years or older at time of infusion.
  • The individual does not have clinically significant active systemic infection.
  • The individual does not have primary central nervous system lymphoma.
Histologic Transformation of Nodal Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma
Axicabtagene ciloleucel (Yescarta) is considered medically necessary and, therefore, covered for the autologous treatment of B-cell lymphomas when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS), and all of the following criteria are met:

  • The individual has diagnosis of the histologic transformation of nodal marginal zone lymphoma to diffuse large B-Cell lymphoma​ 
  • The individual has received multiple lines of prior therapies including two or more chemoimmunotherapy regimens for indolent or transformed disease which included at least one anthracycline or anthracenedione-based regimen, unless contraindicated (NCCN preferred therapy if anti-CD19 CAR T-cell therapy was not previously given [e.g., axicabtagene ciloleucel, or tisagenlecleucel or brexucabtagene autoleucel​]).
  • The individual is 18 years or older at time of infusion. 
  • The individual does not have clinically significant active systemic infection.
  • The individual does not have primary central nervous system lymphoma.
BREXUCABTAGENE AUTOLEUCEL (TECARTUS) 

Brexucabtagene autoleucel (Tecartus) is considered medically necessary and, therefore, covered for the autologous treatment for relapsed or refractory mantle cell lymphoma (MCL) when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS), and all of the following criteria are met:

  • The individual​ meets o​​ne of the following criteria:
    • The individual has diagnosis of the relapsed or refractory MCL.
    • As subsequent therapy for individuals who received prior chemoimmunotherapy and bruton tyrosine kinase inhibitor (e.g., polatuzumab vedotin-piiq, ibrutinib or acalabrutinib).
  • The individual does not have clinically significant active systemic infection.
  • The individual is 18 years or older at time of infusion.​
EXPERIMENTAL/INVESTIGATIONAL

All other uses for tisagenlecleucel (Kymriah), axicabtagene ciloleucel (Yescarta) or brexucabtagene autoleucel (Tecartus)​ 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 REIMBURSMENT​

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

RISK EVALUATION AND MITIGATION STRATEGY (REMS) PROGRAM

Due to the risk of cytokine release syndrome (CRS) and neurological toxicities, tisagenlecleucel (Kymriah), and axicabtagene ciloleucel (Yescarta), and brexucabtagene autoleucel (Tecartus) ​are only available through a Risk Evaluation and Mitigation Strategy (REMS) program. The requirements of the REMS include:
  • Healthcare facilities that dispense and administer tisagenlecleucel (Kymriah), or axicabtagene ciloleucel (Yescarta) or brexucabtagene autoleucel (Tecartus) ​must be enrolled in the program.
  • Certified healthcare facilities must have on-site, immediate access to tocilizumab (Actemra) and ensure that a minimum of two doses are available for each patient for administration within two hours after tisagenlecleucel (Kymriah), or axicabtagene ciloleucel (Yescarta) or brexucabtagene autoleucel (Tecartus)​ infusion if needed to treat CRS.
  • Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense or administer tisagenlecleucel (Kymriah), or axicabtagene ciloleucel (Yescarta) or brexucabtagene autoleucel (Tecartus)​ are trained about the management of CRS and neurological toxicities.
BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, tisagenlecleucel (Kymriah), or axicabtagene ciloleucel (Yescartaor brexucabtagene autoleucel (Tecartus)is 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 (FDA) STATUS

Tisagenlecleucel (Kymriah) was approved by the FDA on August 30, 2017 for the treatment of individuals up to age 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Supplemental approvals for tisagenlecleucel (Kymriah) have since been issued by the FDA. In the pediatric population, the safety and effectiveness of tisagenlecleucel (Kymriah) has been established for the treatment of relapsed or refractory B-cell ALL; the safety and effectiveness of tisagenlecleucel (Kymriah) has not been established for the treatment of relapsed or refractory diffuse large B-cell lymphoma.

Axicabtagene ciloleucel (Yescarta) was approved by the FDA on October 18, 2017 for the treatment of adult individuals with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. The safety and effectiveness of axicabtagene ciloleucel (Yescarta) in the pediatric population has not been established.

Brexucabtagene autoleucel (Tecartus) was approved by the FDA on July 24, 2020 for the treatment of adult individuals with relapsed refractory mantle cell lymphoma (MCL).​ The safety and effectivness of brexucabtagene autoleucel (Tecartus) has not been established in pediatric individuals MCL.

DOSING GUIDELINES 

TISAGENLECLEUCEL (KYMRIAH)
Adult Relapsed or Refractory  Diffuse Large B-cell lymphoma (DLBCL)

Pre-treatment:
  • Lymphodepleting chemotherapy: Fludarabine 25 mg/m2 intravenous​ (IV) daily for three days and cyclophosphamide 250 mg/m2 IV daily for three days starting with the first dose of fludarabine.
  • Alternate lymphodepleting chemotherapy: bendamustine 90 mg/m2 IV daily for two days if the individual experienced a previous Grade 4 hemorrhagic cystitis with cyclophosphamide or demonstrates resistance to a previous cyclophosphamide containing regimen.
  • Infuse tisagenlecleucel (Kymriah™) 2 to 11 days after completion of the lymphodepleting chemotherapy.
  • Lymphodepleting chemotherapy may be omitted if an individual’s white blood cell (WBC) count is less than or equal to 1 x 109/L within one week prior to tisagenlecleucel (Kymriah™) infusion.
Treatment:
Tisagenlecleucel (Kymriah) dose for adult individuals: 0.6 to 6.0 x 108 CAR-positive viable T cells.

Pediatric and Young Adult Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (ALL)

Pre-treatment:
Lymphodepleting chemotherapy: Fludarabine 30mg/m2 (IV) daily for 4 days and cyclophosphamide 500mg/m2 IV daily for 2 days starting with the first dose of fludarabine. Infuse tisagenlecleucel (Kymriah) 2 to 14 days after completion of lymphodepleting chemotherapy.
Treatment:
Tisagenlecleucel (Kymriah)​ dose is based on the individual's weight reported at the time of leukapheresis: 
 The individual is 50 kg or less: dose is 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight.
 The individual is above 50 kg: dose is 0.1 to 2.5 x 108 CAR-positive viable T cells.

AXICABTAGENE CILOLEUCEL (YESCARTA)
Large B-cell lymphoma​ 

Pre-treatment:
Lymphodepleting chemotherapy: Cyclophosphamide 500mg/m2 IV and fludarabine 30mg/m2 IV on the fifth, fourth, and third day before axicabtagene ciloleucel (Yescarta) infusion.
Treatment:
Axicabtagene ciloleucel (Yescarta) target dose is 2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells.​

​​BREXUCABTAGENE AUTOLEUCEL (TECARTUS)
Mantle cell lymphoma (MCL)

Pre-treatment: 
Lymphodepleting chemotherapy: cyclophosphamide 500 mg/m2 IV and fludarabine 30 mg/m2 IV on each of the fifth, fourth, and third days before infusion of brexucabtagene autoleucel (Tecartus).​
Treatment:
Brexucabtagene autoleucel (Tecartus™) dose is 2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells.

Description

Acute lymphoblastic leukemia (ALL) is a rapidly progressing cancer of immature forms of white blood cells (lymphocytes) in the bone marrow and blood. These cancerous cells grow quickly and crowd the bone marrow, preventing it from making normal red blood cells, white blood cells, and platelets. ALL is the most common form of cancer in children and the median age at diagnosis is 15 years old. There are approximately 5970 new cases per year, with 2500-3500 being children, in the United States. Lymphoblastic leukemias are classified in two categories: precursor B cell lymphoblastic leukemia, which accounts for approximately 70-80 percent of childhood ALL cases, and precursor T cell lymphoblastic leukemia.

Lymphoma is the most common blood cancer and is divided into two categories: Hodgkin lymphoma and non-Hodgkin lymphoma. Lymphoma occurs when lymphocytes grow abnormally. There are two main types of lymphocytes in the body: B-lymphocytes and T-lymphocytes. Non-Hodgkin lymphoma is the most common cancer of the lymphatic system, with over 74,000 cases diagnosed annually in the United States. Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of NHL, accounting for 32 percent of all cases.

TISAGENLECLEUCEL (KYMRIAH)

Tisagenlecleucel (Kymriah) is a genetically modified autologous T-cell immunotherapy. Each dose of tisagenlecleucel (Kymriah) is customized to the individual. The individual's T-cells are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a chimeric antigen receptor (CAR). The modified T-cells target and bind to CD19 expressing leukemia cells and eliminates them. Prior to initiating the Kymriah infusion, individuals must undergo lymphodepleting chemotherapy to reduce the level of white blood cells and help the body accept the reprogrammed CAR-T cells.

On August 30, 2017, the United States Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) for the treatment of individuals up to 25 years old with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later stage relapse. Efficacy and safety of tisagenlecleucel (Kymriah) in pediatric individuals with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL) were established in a single-arm, open-label, phase 2 study (ELIANA). The primary outcome of this trial is the overall remission rate within 3 months of infusion of tisagenlecleucel (Kymriah). Secondary outcomes included duration of remission, overall survival, and safety. Of the 63 individuals infused with tisagenlecleucel (Kymriah), 52 (83 percent) achieved complete response and were minimal residual disease (MRD) negative. Duration of remission was defined as the time since onset of complete remission to relapse or death due to underlying cancer, whichever is earlier. A median duration of remission was not reached by any of the 52 individuals.

On May 1, 2018, the FDA approved tisagenlecleucel (Kymriah) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Efficacy and safety of tisagenlecleucel (Kymriah) were established in a retrospective subgroup analysis of an open-label, single-arm trial (JULIET) of 68 individuals. The study included adults with relapsed or refractory DLBCL who had received 2 or more lines of chemotherapy, including rituximab and anthracycline, or relapsed following autologous hematopoietic stem cell transplantation. Tisagenlecleucel (Kymriah) was administered as a single infusion, following 2-11 days after completion of lymphodepleting chemotherapy. The complete response (CR) rate and partial response (PR) rate was 32 percent and 18 percent, respectively; median duration of response was longer in those with CR compared with PR (not reached vs 3.4 months). Median time to first response was 0.9 months (range, 0.7 to 3.3 months).

AXICABTAGENE CILOLEUCEL (YESCARTA)

On October 18, 2017, the United States Food and Drug Administration approved axicabtagene ciloleucel (Yescarta) for the treatment of adult individuals with relapsed or refractory large B-cell lymphoma after 2 or more lines of therapy. Axicabtagene ciloleucel (Yescarta) is the second CD 19-directed genetically modified autologous T cell immunotherapy available in the United States. Like tisagenlecleucel (Kymriah), axicabtagene ciloleucel (Yescarta) is customized to the individual after the T cells are harvested. The T cells are genetically modified to express a chimeric antigen receptor that targets CD19 expressing cells.

Safety and efficacy of axicabtagene ciloleucel (Yescarta) for the treatment of adult individuals with relapsed or refractory B-cell non-Hodgkin lymphoma were established in a single arm, open-label, multicenter trial (ZUMA-1). Individuals eligible for the trial had refractory disease to the most recent therapy or relapse within 1 year of autologous hematopoietic stem cell transplant. Of the 101 individuals who received the axicabtagene ciloleucel (Yescarta) infusion, 52 (51 percent) achieved complete remission and 21 (21 percent) achieved partial remission. At the median follow up of 7.9 months, individuals in complete remission had not reached the estimated duration of response.

BREXUCABTAGENE AUTOLEUCEL (TECARTUS)

On July 24, 2020, the United States Food and Drug Administration approved brexucabtagene autoleucel (Tecartus) for the treatment of adult individuals with relapsed or refractory mantle cell lymphoma (MCL)​ . Brexucabtagene autoleucel (Tecartus) is a CD19-directed genetically modified autologous T cell immunotherapy and is customized to the individual after the T cells are harvested. The T cells are genetically modified to express a chimeric antigen receptor that targets CD19 expressing cells.

Safety and efficacy of brexucabtagene autoleucel (Tecartusfor the treatment of adult individuals with relapsed or refractory mantle cell lymphoma, who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody, and a bruton tyrosine kinase inhibitor (BTKi) ibrutinib or acalabrutinib, were established in a single arm, open-label, multicenter trial (ZUMA-2).  Eligible individuals had disease progression after their last regimen or refractory disease to their most recent therapy. A total of 74 individuals were enrolled. Brexucabtagene autoleucel (​KTE-X19) was manufactured for 71 patients and administered to 68. The primary efficacy analysis showed that 67 percent (95 percent CI, 53 to 78) had a complete response. At a median follow-up of 12.3 months (range: 7.0 to 32.3), 57 percent​ of the 60 patients in the primary efficacy analysis were in remission.​ At 12 months, the estimated progression-free survival and overall survival were 61 percent and 83 percent, respectively. Common adverse events of grade 3 or higher were cytopenias (in 94 percent of the individuals) and infections (in 32percent). Grade 3 or higher cytokine release syndrome and neurologic events occurred in 15 percent and 31 percent​ of individuals, respectively; none were fatal
​​​
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. Key Statistics for Non-Hodgkin Lymphoma. [American Cancer Society Web site]. 01/08/2019. Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/key-statistics.html . Accessed August 24, 2020.

Axicabtagene ciloleucel (Yescarta™). Micromedex® Healthcare Series. DrugDex®. [Micromedex® Web site]. 08/20/2020. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed August 24, 2020.

Axicabtagene ciloleucel (Yescarta™) Elsevier’s Clinical Pharmacology Compendium. [Clinical Key Web site]. 07/27/2020. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed August 24, 2020.

Axicabtagene ciloleucel (Yescarta™). Lexi-Drugs Compendium. [Lexicomp Online Web site]. 08/28/2020​. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed August 31, 2020.

Brexucabtagene autoleucel (Tecartus). [prescribing information]. Santa Monica, CA​: Kite Pharma, Inc; 07/2020. Available at: https://www.gilead.com/-/media/files/pdfs/medicines/oncology/tecartus/tecartus-pi.pdf. Accessed August 31, 2020.

Brexucabtagene autoleucel (Tecartus). Elsevier’s Clinical Pharmacology Compendium.[Clinical Key Web site]. 07/28/2020. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed August 24, 2020.

Brexucabtagene autoleucel (Tecartus). Lexi-Drugs Compendium. [Lexicomp Online Web site]. 08/05/2020. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed August 24, 2020.

Brexucabtagene autoleucel (Tecartus). Micromedex® Healthcare Series. DrugDex®. [Micromedex® Web site]. 08/08/2020. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed August 24, 2020.

Grupp SA, Kalos M, Barrett D, et al. Chimeric antigen Receptor-Modified T Cells for Acute Lymphoid Leukemia. N Engl J Med 2013; 368(16):1509-1518.

Horton TM, Steuber CP. Overview of the presentation and diagnosis of acute lymphoblastic leukemia in children and adolescents. [UpToDate]. 08/28/2019. Available at: https://www.uptodate.com/contents/overview-of-the-presentation-and-diagnosis-of-acute-lymphoblastic-leukemia-in-children-and-adolescents?source=search_result&search=ALL&selectedTitle=1~150 [via subscription only]. Accessed August 24, 2020.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Acute Lymphoblastic Leukemia.V.1.2020. [NCCN Web site]. 01/15/2020. Available at: https://www.nccn.org/professionals/physician_gls/pdf/all.pdf [via free subscription]. Accessed August 24, 2020.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium.Brexucabtagene autoleucel (Tecartus)​. [NCCN Web site]. 2020. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed August 24, 2020.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Diffuse Large B-Cell Lymphoma.V.4.2020. [NCCN Web site]. 08/13/2020. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf [via free subscription]. Accessed August 24, 2020.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium.axicabtagene ciloleucel (Yescarta™). [NCCN Web site]. 2020. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed August 24, 2020.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium.tisagenlecleucel (Kymriah™). [NCCN Web site]. 2020. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed August 24, 2020.

Porter DL, Hwang WT, Frey NV, et al. Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphoytic leukemia. Sci Transl Med 7, 303ra139. 2015.

Schuster SJ, Bishop MR, Tam CS, et al. Primary Analysis of Juliet: A Global, Pivotal, Phase 2 Trial of CTL019 in Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma [abstract]. Blood 2017;130:Abstract 577.

Tisagenlecleucel (Kymriah™). Micromedex® Healthcare Series. DrugDex®. [Micromedex® Web site]. 11/05/2019. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed August 24, 2020.

Tisagenlecleucel (Kymriah™). Elsevier’s Clinical Pharmacology Compendium.[Clinical Key Web site]. 08/18/2019. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed August 24, 2020.

Tisagenlecleucel (Kymriah™). [prescribing information] East Hanover, NJ: Novartis Pharmaceuticals Corporation; 05/2018. Available at: https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/kymriah.pdf. Accessed August 24, 2020.

Tisagenlecleucel (Kymriah™). Lexi-Drugs Compendium. [Lexicomp Online Web site]. 08/28/2020. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed August 31, 2020.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. tisagenlecleucel (Kymriah™). Prescribing information, approval letter, REMS documents. [FDA Web site]. 03/28/2019. Available at: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/kymriah-tisagenlecleucel. Accessed August 24, 2020.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Brexucabtagene autoleucel (Tecartus)​. Prescribing information, approval letter, REMS documents. [FDA Web site]. 07/24/2020. Available at:
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/tecartus-brexucabtagene-autoleucel. Accessed August 31, 2020.​

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. axicabtagene ciloleucel (Yescarta™). Prescribing information, approval letter, REMS documents. [FDA Web site]. 05/28/2020. Available at: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/yescarta-axicabtagene-ciloleucel . Accessed August 24, 2020.

Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med 2020; 382:1331-1342.

Coding

CPT Procedure Code Number(s)
MEDICALLY NECESSARY

0540T 

NOT ELIGIBLE FOR SEPARATE REIMBURSEMENT

0537T, 0538T, 0539T

ICD - 10 Procedure Code Number(s)
N/A​

ICD - 10 Diagnosis Code Number(s)
See Attachment A.

HCPCS Level II Code Number(s)

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

USE THE FOLLOWING CODES FOR LISOCABTAGENE MARALEUCEL (BREYANZI)

J3590 Unclassified biologics

C9076 Lisocabtagene maraleucel, up to 110 million autologous anti-cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose​​

Revenue Code Number(s)
N/A




Coding and Billing Requirements


Policy History

7/1/2021
7/1/2021
08.01.43
Medical Policy Bulletin
Commercial
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No