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CAR-T Therapy

Policy
Version Date: January 2025

Restricted Product(s):

  • axicabtagene ciloleucel (Yescarta®) intravenous infusion for administration by a healthcare professional 
  • brexucabtagene autoleucel (Tecartus®) intravenous infusion for administration by a healthcare professional
  • ciltacabtagene autoleucel (Carvykti™) intravenous infusion for administration by a healthcare professional
  • idecabtagene vicleucel (Abecma®) intravenous infusion for administration by a healthcare professional
  • lisocabtagene maraleucel (Breyanzi®) intravenous infusion for administration by a healthcare professional
  • tisagenlecleucel (Kymriah®) intravenous infusion for administration by a healthcare professional 

FDA Approved Use:

  • Axicabtagene ciloleucel (Yescarta®) 
    • For treatment of adults with large B-cell lymphoma: 
      • That is relapsed or refractory 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; or
      • That is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy
      • Limitations of use: Not for treatment of primary central nervous system lymphoma
    • For treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy  • Brexucabtagene autoleucel (Tecartus®)
    • For treatment of adults with relapsed or refractory mantle cell lymphoma (MCL)
    • For treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
  • Idecabtagene vicleucel (Abecma®)
    • For treatment of adults with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody
  • Ciltacabtagene autoleucel (Carvykti™)
    • For the treatment of adults with relapsed or refractory multiple myeloma after at least one prior line of therapy, including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide.
  • • Lisocabtagene maraleucel (Breyanzi®)  
    • For treatment of adults with large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
      • Relapsed or refractory disease after two or more lines of systemic therapy; or
      • Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
      • Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age
      • Limitations of use: Not for treatment of primary central nervous system lymphoma
    • For the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor
  • Tisagenlecleucel (Kymriah®) 
    • For treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse 
    • For treatment of adults 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, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma
      • Limitations of use: Not for treatment of primary central nervous system lymphoma
    • For treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy 

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

  1. The request is for tisagenlecleucel (Kymriah); AND
    1. The patient has a diagnosis of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL); AND 
      1. The patient is 25 years of age or younger; AND
      2. The patient has a confirmed CD19 tumor expression [medical record documentation required]; AND
      3. The patient has not previously received genetically modified T cell therapy or tisagenlecleucel (Kymriah) [medical record documentation required]; AND
      4. For patients with Philadelphia Chromosome positive (Ph+) ALL, one of the following:
        1. The patient has tried and had an inadequate response to at least two tyrosine kinase inhibitors (TKI) [medical record documentation required]; OR
        2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL TKIs used in the treatment of ALL [medical record documentation required]; AND
      5. The patient has received or will receive a lymphodepleting chemotherapy regimen of fludarabine 30 mg/m2 intravenously daily for 4 days and cyclophosphamide 500 mg/m2 intravenously daily for 2 days starting with the first dose of fludarabine, within two weeks prior to infusion of tisagenlecleucel (Kymriah) [medical record documentation required]; AND
      6. The patient will not be treated with more than 2.5 x 108 CAR-positive viable T cells [documentation of planned dosage required]; AND
      7. If the patient weighs ≤ 50 kg, they will receive weight-based dosing of 0.2 to 5.0 x 106 CAR-positive viable T cells per kg of body weight [documentation of planned dosage required]; AND
      8. One of the following:
        1. The patient has been treated with two cycles of standard chemotherapy without a complete response [medical record documentation required]; OR
        2. The patient achieved a complete response and experienced multiple relapses following standard chemotherapy (at least 2 cycles) [medical record documentation required]; AND
      9. The patient does not have active central nervous system (CNS) 3 acute lymphoblastic leukemia [medical record documentation required]; OR
    2. The patient has a diagnosis of relapsed or refractory B-cell lymphoma including any of the following [medical record documentation required]: 
      1. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified
      2. High grade B-cell lymphoma
      3. Diffuse large B-cell lymphoma (DLBCL) arising from follicular lymphoma; AND
        1. The patient is 18 years of age or older; AND
        2. The patient has not previously received genetically modified T cell therapy or tisagenlecleucel (Kymriah) [medical record documentation required]; AND
        3. The patient has experienced disease progression following a trial of two or more lines of systemic therapy [medical record documentation required]; AND
        4. Previous therapy included an anthracycline chemotherapy agent and an anti-CD20 antibody [medical record documentation required]; AND
        5. One of the following: 
          1. The patient has received or will receive a lymphodepleting chemotherapy regimen of fludarabine 25 mg/m2 intravenously daily for 3 days and cyclophosphamide 250 mg/m2 intravenously daily for 3 days starting with the first dose of fludarabine, or alternate therapy with bendamustine 90 mg/m2 intravenously daily for 2 days for patients unable to receive cyclophosphamide, within two weeks prior to infusion of tisagenlecleucel (Kymriah) [medical record documentation required]; OR
          2. The patient is unable to receive lymphodepleting chemotherapy if WBC count is ≤ 1x109 /L within one week prior to tisagenlecleucel (Kymriah) infusion [medical record documentation required]; AND
        6. The patient will be treated within a dosage range of 0.6 to 6.0 x 108 CAR-positive viable T cells [documentation of planned dosage required]; AND 
        7. vii. The patient does not have primary central nervous system (CNS) lymphoma [medical record documentation required]; OR
    3. The patient has a diagnosis of relapsed or refractory follicular lymphoma [medical record documentation required]; AND
      1. i. The patient is 18 years of age or older; AND
      2. The patient has not previously received genetically modified T cell therapy or tisagenlecleucel (Kymriah) [medical record documentation required]; AND 
      3. The patient has experienced disease progression following a trial of two or more lines of systemic therapy [medical record documentation required]; AND
      4. Previous therapy included a combination of an anti-CD20 antibody and an alkylating agent [medical record documentation required]; AND
      5. One of the following:
        1. The patient has received or will receive a lymphodepleting chemotherapy regimen of fludarabine 25 mg/m2 intravenously daily for 3 days and cyclophosphamide 250 mg/m2 intravenously daily for 3 days starting with the first dose of fludarabine, or alternate therapy with bendamustine 90 mg/m2 intravenously daily for 2 days for patients unable to receive cyclophosphamide, within one week prior to infusion of tisagenlecleucel (Kymriah)  [medical record documentation required]; OR
        2. The patient is unable to receive lymphodepleting chemotherapy if WBC count is ≤ 1x109 /L within one week prior to tisagenlecleucel (Kymriah) infusion [medical record documentation required]; AND
      6. The patient will be treated within a dosage range of 0.6 to 6.0 x 108 CAR-positive viable T cells [documentation of planned dosage required]; OR
  2. The request is for axicabtagene ciloleucel (Yescarta); AND
    1. a. The patient has a diagnosis of relapsed or refractory B-cell lymphoma [medical record documentation required]; AND
      1. The patient is 18 years of age or older; AND 
      2. The patient has not previously received genetically modified T cell therapy or axicabtagene ciloleucel (Yescarta) [medical record documentation required]; AND
      3. ONE of the following:
        1. The patient has experienced disease progression following a trial of two or more lines of systemic therapy, including any of the following types [medical record documentation required]: 
          1. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified
          2. Primary mediastinal large B-cell lymphoma
          3. High grade B-cell lymphoma 
          4. Diffuse large B-cell lymphoma (DLBCL) arising from follicular lymphoma; OR
        2. The patient has experienced disease progression following first-line chemoimmunotherapy [medical record documentation required]; AND
      4. Previous therapy included an anthracycline chemotherapy agent and an anti-CD20 antibody [medical record documentation required]; AND
      5. The patient has received or will receive a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m2 intravenously and fludarabine 30 mg/m2 intravenously on the fifth, fourth, and third days before infusion of axicabtagene ciloleucel (Yescarta) [medical record documentation required]; AND
      6. The patient will not be treated with more than 2 x 108 CAR-positive viable T cells [documentation of planned dosage required]; AND
      7. The patient will receive a target dose of 2 x 106 CAR-positive viable T cells per kg body weight [documentation of planned dosage required]; AND
      8. The patient does not have primary central nervous system (CNS) lymphoma [medical record documentation required]; OR
    2. The patient has a diagnosis of relapsed or refractory follicular lymphoma [medical record documentation required]; AND
      1. The patient is 18 years of age or older; AND
      2. The patient has not previously received genetically modified T cell therapy or axicabtagene ciloleucel (Yescarta) [medical record documentation required]; AND
      3. The patient has experienced disease progression following a trial of two or more lines of systemic therapy [medical record documentation required]; AND
      4. Previous therapy included a combination of an anti-CD20 antibody and an alkylating agent [medical record documentation required]; AND
      5. The patient has received or will receive a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m2 intravenously and fludarabine 30 mg/m2 intravenously on the fifth, fourth, and third days before infusion of axicabtagene ciloleucel (Yescarta) [medical record documentation required]; AND 
      6. The patient will receive a target dose of 2 x 106 CAR-positive viable T cells per kg body weight [documentation of planned dosage required]; OR
  3. The request is for brexucabtagene autoleucel (Tecartus); AND
    1. The patient has a diagnosis of relapsed or refractory mantle cell lymphoma (MCL) [medical record documentation required]; AND
      1. The patient is 18 years of age and older; AND
      2. The patient has been treated with ALL of the following [medical record documentation required]:
        1. An anthracycline or bendamustine-containing chemotherapy; AND 
        2. Anti-CD20 monoclonal antibody therapy (e.g., rituximab); AND 
        3. A Bruton tyrosine kinase (BTK) inhibitor indicated for mantle cell lymphoma (e.g., acalabrutinib, ibrutinib); AND  The patient has disease progression after their last regimen or refractory disease to the most recent therapy [medical record documentation required]; AND 
      3. The patient has disease progression after their last regimen or refractory disease to the most recent therapy [medical record documentation required]; AND 
      4. The patient has not had a prior allogeneic hematopoietic stem cell transplant (HSCT) [medical record documentation required]; AND
      5. The patient has received or will receive a lymphodepleting chemotherapy regimen of cyclophosphamide 500 mg/m2 intravenously and fludarabine 30 mg/m2 intravenously on each of the fifth, fourth, and third days before infusion of brexucabtagene autoleucel (Tecartus) [medical record documentation required]; AND 
      6. The patient will not be treated with more than 2 x 108 CAR-positive viable T cells [documentation of planned dosage required]; AND 
      7. The patient has not previously received genetically modified T cell therapy or brexucabtagene autoleucel (Tecartus) [medical record documentation required]; AND 
      8. The patient does not have detectable malignant cells in the cerebrospinal fluid or brain metastases [medical record documentation required]; AND 
      9. The patient does not have any history of central nervous system (CNS) lymphoma [medical record documentation required]; OR
    2. The patient has a diagnosis of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL); AND
      1. The patient is 18 years of age or older; AND 
      2. The patient has not previously received genetically modified T cell therapy or brexucabtagene autoleucel (Tecartus) [medical record documentation required]; AND
      3. For patients with Philadelphia Chromosome positive (Ph+) ALL, one of the following:  
        1. The patient has tried and had an inadequate response to at least two tyrosine kinase inhibitors (TKI) [medical record documentation required]; OR
        2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL TKIs used in the treatment of ALL [medical record documentation required]; AND
      4. The patient has received or will receive a lymphodepleting chemotherapy regimen of fludarabine 30 mg/m2 intravenously daily for 4 days and cyclophosphamide 500 mg/m2 intravenously daily for 2 days starting with the first dose of fludarabine, within two weeks prior to infusion of brexucabtagene autoleucel (Tecartus) [medical record documentation required]; AND
      5. The patient will not be treated with more than 1 x 108 CAR-positive viable T cells [documentation of planned dosage required]; AND
      6. One of the following: 
        1. The patient has been treated with two cycles of standard chemotherapy without a complete response [medical record documentation required]; OR
        2. The patient achieved a complete response and experienced first relapse following a remission ≤ 12 months [medical record documentation required]; OR
        3. The patient has relapsed after their second line of therapy or higher [medical record documentation required]; OR
        4. The patient was refractory to or relapsed after at least 100 days post-allogeneic stem cell transplantation (HSCT)) [medical record documentation required]; AND
      7. The patient does not have any history of CNS disorders, including CNS-2 disease with neurologic changes and CNS-3 disease [medical record documentation required]; OR
  4. The requested agent is lisocabtagene maraleucel (Breyanzi); AND
    1. The patient has a diagnosis of relapsed or refractory B-cell lymphoma including any of the following [medical record documentation required]:
      1. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma)
      2. Primary mediastinal large B-cell lymphoma
      3. High grade B-cell lymphoma
      4. Follicular lymphoma grade 3B; AND
        1. The patient is 18 years of age or older; AND 
        2. The patient has not previously received genetically modified T cell therapy or lisocabtagene maraleucel (Breyanzi) [medical record documentation required]; AND
        3. ONE of the following: 
          1. The patient has experienced disease progression following a trial of two or more lines of systemic therapy [medical record documentation required]; OR
          2. The patient has refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy [medical record documentation required]; OR
          3. The patient has refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy, and the patient is not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age [medical record documentation required]; AND
        4. Previous therapy included an anthracycline chemotherapy agent and an anti-CD20 antibody [medical record documentation required]; AND 
        5. The patient has received or will receive a lymphodepleting chemotherapy regimen of cyclophosphamide 300 mg/m2/day intravenously and fludarabine 30 mg/m2/day intravenously daily for 3 days before infusion of lisocabtagene maraleucel (Breyanzi) [medical record documentation required]; AND 
        6. The patient will NOT be treated with more than 110 x 106 CAR-positive viable T cells (consisting of CD8 and CD4 components) [documentation of planned dosage required]; AND 
        7. The patient does not have primary central nervous system (CNS) lymphoma [medical record documentation required]; OR
    2. The patient has a diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)  [medical record documentation required]; AND
      1. The patient is 18 years of age or older; AND 
      2. The patient has not previously received genetically modified T cell therapy or lisocabtagene maraleucel (Breyanzi) [medical record documentation required]; AND
      3. The patient has received and failed at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a Bcell lymphoma 2 (BCL-2) inhibitor [medical record documentation required]; AND 
      4. The patient has received or will receive a lymphodepleting chemotherapy regimen of cyclophosphamide 300 mg/m2/day intravenously and fludarabine 30 mg/m2/day intravenously daily for 3 days before infusion of lisocabtagene maraleucel (Breyanzi) [medical record documentation required]; AND  
      5. The patient will be treated within a dosage range of 90 to 110 x 106 CAR-positive viable T cells (consisting of CD8 and CD4 components) [documentation of planned dosage required]; AND 
      6. The patient does not have primary central nervous system (CNS) lymphoma [medical record documentation required]; OR
  5. The requested agent is idecabtagene vicleucel (Abecma); AND 
    1. The patient has a diagnosis of relapsed or refractory multiple myeloma [medical record documentation required]; AND 
    2. The patient is 18 years of age or older; AND 
    3. The patient has not previously received genetically modified T cell therapy or idecabtagene vicleucel (Abecma) [medical record documentation required]; AND 
    4. The patient has experienced disease progression following a trial of two or more lines of systemic therapy [medical record documentation required]; AND 
    5. Previous therapy included an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody [medical record documentation required]; AND 
    6. The patient has received or will receive a lymphodepleting chemotherapy regimen of cyclophosphamide 300 mg/m2 intravenously and fludarabine 30 mg/m2 intravenously daily for 3 days before infusion of idecabtagene vicleucel (Abecma) [medical record documentation required]; AND 
    7. The patient will NOT be treated with more than 510 x 106 CAR-positive viable T cells [documentation of planned dosage required]; AND 
    8. The patient has NOT had a prior allogeneic hematopoietic stem cell transplant (HSCT) [medical record documentation required]; OR
  6. The requested agent is ciltacabtagene autoleucel (Carvykti); AND 
    1. The patient has a diagnosis of relapsed or refractory multiple myeloma [medical record documentation required]; AND 
    2. The patient is 18 years of age or older; AND 
    3. The patient has not previously received genetically modified T cell therapy or ciltacabtagene autoleucel (Carvykti); [medical record documentation required]; AND 
    4. The patient has experienced disease progression following a trial of at least 1prior line of systemic therapy [medical record documentation required]; AND 
    5. Previous therapy included an immunomodulatory agent, a proteasome inhibitor, and are refractory to lenalidomide [medical record documentation required]; AND 
    6. The patient has received or will receive a lymphodepleting chemotherapy regimen of cyclophosphamide 300 mg/m2 intravenously and fludarabine 30 mg/m2 intravenously daily for 3 days before infusion of ciltacabtagene autoleucel (Carvykti); [medical record documentation required]; AND 
    7. The patient will NOT be treated with more than 1 x 108 CAR-positive viable T cells [documentation of planned dosage required]; AND 
    8. The patient has NOT had a prior allogeneic hematopoietic stem cell transplant (HSCT) [medical record documentation required].

Duration of Approval: 180 days (one treatment course per lifetime) 

FDA Label Reference

MedicationIndicationDosingHCPCSMaximum Units*
axicabtagene ciloleucel (Yescarta®)  intravenous (IV) infusionRelapsed or refractory large B-cell lymphoma  Relapsed or refractory follicular lymphoma (FL)  Dosing is based on the number of chimeric antigen receptor (CAR)positive viable T cells. 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 via IV infusion Q2041 1 unit
brexucabtagene autoleucel (Tecartus®)  intravenous (IV) infusionRelapsed or refractory mantle cell lymphoma (MCL)     Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) 

Dosing is based on the number of chimeric antigen receptor (CAR)positive viable T cells.

Mantle Cell Lymphoma: Dose is 2 × 106 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 108 CAR-positive viable T cells via IV infusion

Adult B-cell ALL:  Dose is 1 x 106 CAR-positive viable T cells per kg body weight  with a maximum of 1 x 108 CAR-positive viable T cells via IV Infusion 

Q20531 unit
ciltacabtagene autoleucel (CarvyktiTM)Relapsed or refractory multiple myeloma Dosing is based on the number of chimeric antigen receptor (CAR)positive viable T cells. Dose is 0.51.0×106 CAR-positive viable T cells per kg of body weight, with a maximum dose of 1×108 CARpositive viable T cells via IV infusionQ20561 unit
idecabtagene vicleucel (Abecma®) intravenous (IV) infusionRelapsed or refractory multiple myeloma Dosing is based on the number of chimeric antigen receptor (CAR)positive viable T cells. Dose is 300 to 510 × 106 CAR-positive viable T cells via IV infusion Q20551 unit
lisocabtagene maraleucel (Breyanzi®)  intravenous (IV) infusionRelapsed or refractory large B-cell lymphoma (LBCL) 

Dosing is based on the number of chimeric antigen receptor (CAR)positive viable T cells.   

For LBCL after one line of therapy: Dose is 90 to 110 × 106 CAR-positive viable T cells (consisting of CD8 and CD4 components) via IV infusion 

For LBCL after two or more lines of therapy: Dose is 50 to 110 × 106 CAR-positive viable T cells (consisting of CD8 and CD4 components) via IV infusion 

Q20541 unit
tisagenlecleucel (Kymriah®) intravenous (IV) infusion  Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)    Patients up to 25 years of age with relapsed or refractory large B-cell lymphoma  Relapsed or refractory follicular lymphoma (FL) 

Pediatric and Young Adult B-cell ALL: 

Patients ≤50 kg administer 0.2 to 5.0 x 106 CAR-positive viable T cells per kg body weight via IV infusion

Patient >50 kg, administer 0.1 to 2.5 x 108 total CAR-positive viable T cells (non-weight based) via IV infusion

Relapsed or Refractory Diffuse Large B-cell Lymphoma: 0.6 to 6.0 x 108 CAR-positive viable T cells via IV infusion

Relapsed or Refractory Follicular: 0.6 to 6.0 x 108 CAR-positive viable T cells via IV infusion 

Q20421 unit

*Maximum units allowed for duration of approval

Other related CPT codes for CAR-T Therapy: 38225, 38226, 38227, 38228, 0870, 0871, 0872, 0873, 0874, 0875 For these codes, please assign the following revenue codes to the appropriate CPT codes:

  • 0871 to CPT 38225
  • 0872 to CPT 38226
  • 0873 to CPT 38227
  • 0874 to CPT 38228

Please note the following HCPCS code descriptions:

  • Q2041 – Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive T cells, including leukapheresis and dose preparation procedures, per therapeutic dose
  • Q2042 – Tisagenlecleucel, up to 600 million CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose
  • Q2053 – Brexucabtagene autoleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose
  • Q2054 – Lisocabtagene maraleucel, up to 110 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose
  • 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
  • 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

References:

all information referenced is from FDA package insert unless otherwise noted below.

  1. Maude SL, Laetsch TW, Buechner J, et al. Tisagenlecleucel in children and young adults with Bcell lymphoblastic leukemia. N Engl J Med. 2018;378(5):439-448.
  2. 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;382:1331-42. 

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

January 2025: Coding change: Added the following supporting CPT codes effective 1/1/2025: 38225 replacing 0537T, 38226 replacing 0538T, 38227 replacing 0539T, and 38228 replacing 0540T. Deleted CPT codes 0537T, 0538T, 0539T, and 0540T termed 12/31/2024

April 2024v2: Criteria change: Added new expanded indication for Abecma for relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, and added associated dosing within FDA label reference table. Added new expanded indication for Carvykti for relapsed or refractory multiple myeloma after at least one prior line of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and who are refractory to lenalidomide (Revlimid).

April 2024: Criteria change: Added new indication for Breyanzi for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor, and added associated dosing within FDA label reference table.

November 2022: Criteria update: Added indication for Breyanzi for relapsed/refractory large B-cell lymphoma after one line of therapy, and added associated dosing within FDA label reference table.

October 2022: Coding update: For Carvykti: Added HCPCS code Q2056 and description to dosing reference section effective 10/1/2022; deleted C9098, J3490, J3590, J9999 termed 9/30/2022.

August 2022: Criteria change: Added new indication for Kymriah for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy, with corresponding criteria and dosing table updates.

July 2022: Coding update: Added HCPCS code C9098 to dosing reference table for Carvykti effective 7/1/2022, deleted C9399 termed 6/30/2022.

June 2022: Coding update: Adjusted related CPT codes section for clarity to indicate specific revenue codes associated with specific CPT and/or HCPCS codes.

April 2022: Criteria change: Added new indication for Yescarta for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy with corresponding criteria and dosing table updates.

March 2022: Criteria change: Added new to market product Carvykti with corresponding criteria for indication of multiple myeloma.

February 2022: Criteria change: Added the following codes as other related CPT codes: 0870, 0871, 0872, 0873, 0874, and 0875. Added ALL indication for Tecartus.

January 2022: Coding update: For Abecma: Added HCPCS code Q2055 and description to dosing reference section effective 1/1/2022, deleted C9081, J3490, J3590, and J9999 termed 12/31/2021. 

October 2021: Coding update: For Breyanzi: Added HCPCS code Q2054 and description to dosing reference section effective 10/1/2021, deleted C9076, J3490, J3590, and J9999 termed 9/30/2021. For Abecma: Added HCPCS code C9081 to dosing reference table effective 10/1/2021, deleted C9399 termed 9/30/2021.

July 2021: Coding update: Added HCPCS code C9076 to dosing reference table effective 7/1/2021, deleted C9399 termed 6/30/2021.

June 2021: Criteria change: Removed criteria points regarding requirement of no active infection including hepatitis B, hepatitis C, and HIV.

June 2021: Criteria change: Removed specific weight dosing within Yescarta criteria based on updated FDA label; added requirement of documentation of planned dose; medical policy formatting change. Policy notification given 4/16/2021 for effective date 6/16/2021.

*Further historical criteria changes and updates available upon request from Medical Policy and/or Corporate Pharmacy. 

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