Chimeric Antigen Receptor Therapy for Leukemia and Lymphoma (ARCHIVED)

Policy ID: Y-5063-009

Section: Therapy

Effective Date: June 01, 2020

Revised Date: October 28, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.

Policy ID: Y-5063-009

Section: Therapy

Effective Date: June 01, 2020

Revised Date: October 28, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Chimeric antigen receptor (CAR) T-cells are genetically engineered cells that represent a novel class of cancer immunotherapy. In general, the process of autologous CAR T-cell therapy begins with harvesting white blood cells from the individual via leukapheresis followed by T-cell receptor activation and genetic engineering via retroviral or lentiviral transduction. After the CAR T-cells are generated, they are expanded to clinically relevant numbers, undergo quality control testing, and are cryopreserved. Commercial CAR T-cell products are manufactured at a centralized facility, necessitating transfer of the apheresis product to the manufacturing site, and the final cryopreserved CAR T-cell product back to the treatment facility. Typically, the individual undergoes lymphodepleting chemotherapy to create a favorable immune environment for CAR T-cell activity prior to receiving a single intravenous infusion of the product. Four commercial CAR T-cell products have been approved by the U.S. Food and Drug Administration for the treatment of lymphoma and leukemia. Tisagenlecleucel and brexucabtagene autoleucel are approved for treatment of subsets of individuals with leukemia and lymphoma and axicabtagene ciloleucel and lisocabtagene maraleucel are approved to treat subsets of individuals with lymphoma.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Tisagenlecleucel for B-cell Acute Lymphoblastic Leukemia

Tisagenlecleucel is considered medically necessary for individuals with B-cell acute lymphoblastic leukemia (ALL) if individuals meet all of the following criteria:

Confirmed diagnosis of CD19-positive B-cell ALL with morphologic bone marrow tumor involvement (greater than or equal to 5% lymphoblasts); and
Meet any one of the following:
- Relapsed disease defined as the reappearance of leukemia cells in the bone marrow or peripheral blood after the attainment of a complete remission with chemotherapy and/or allogeneic cell transplant; or
- Refractory disease defined as failure to obtain complete response with induction therapy (ie, failure to eradicate all detectable leukemia cells [< 5% blasts] from the bone cellularity and normal peripheral blood counts); and
When Philadelphia chromosome-positive: failure of 2 tyrosine kinase inhibitors; and
Are up to 25 years old at the time of infusion; and
Have not received prior treatment CD19-directed chimeric antigen receptor T-cell treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy; and
Have adequate organ function with no significant deterioration in organ function expected within four (4) weeks after apheresis; and
Do not have any of the following
- Burkitt lymphoma; or
- Active hepatitis B, C, or any uncontrolled infection; or
- Grade 2 to 4 graft-versus-host disease; or
- Concomitant genetic syndrome associated with bone marrow failure with the exception of Down syndrome; or
- Received allogeneic cellular therapy, such as donor lymphocyte infusion, within six (6) weeks prior to tisagenlecleucel infusion; or
- Active central nervous system ALL (i.e., white blood cell count greater than or equal to 5 cells/μL in cerebrospinal fluid with presence of lymphoblasts).

Tisagenlecleucel for Non-Hodgkin Lymphoma

Tisagenlecleucel is considered medically necessary individuals with with large B-cell lymphoma if individuals meet all of the following criteria:

Are an individual with an age greater than or equal to 18 at the time of infusion; and
Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), not otherwise specified; high-grade B-cell lymphoma or DLBCL arising from follicular lymphoma; and
Relapsed or refractory disease defined as progression after ≥2 lines of systemic therapy including anti-CD20 monoclonal antibody for CD20-positive tumor and anthracycline-containing chemotherapy; and
When the individual has histological transformation of follicular lymphoma or nodal marginal zone lymphoma to diffuse large B-cell lymphoma: prior chemotherapy for follicular lymphoma and ≥2 chemo-immunotherapy regimens for the transformed disease; and
Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; and
Have not received prior CD19-directed chimeric antigen receptor T-cell therapy treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy; and
Do not have primary central nervous system lymphoma.

Tisagenlecleucel is considered investigational for the treatment of relapsed or refractory primary mediastinal large B-cell lymphoma.

Tisagenlecleucel for Follicular Lymphoma

Tisagenlecleucel is considered medically necessary for individuals with follicular lymphoma if individuals meet all of the following criteria:

Are an individual with an age greater than or equal to 18 at the time of infusion; and
Histologically confirmed diagnosis of follicular lymphoma; and
Relapsed or refractory disease as defined as progression after ≥2 lines of systemic therapy for follicular lymphoma; and
Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; and
Have not received prior CD19-directed chimeric antigen receptor T-cell therapy treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy; and
Do not have primary central nervous system lymphoma.

Axicabtagene Ciloleucelfor Non-Hodgkin Lymphoma

Axicabtagene ciloleucel is considered medically necessary for individuals large B-cell lymphoma if individuals meet all of the following criteria:

Meet any one of the following:
- Histologically confirmed diagnosis of large B-cell lymphoma that is considered relapsed or primary refractory within 12 months following completion of first-line chemo-immunotherapy that included an anti-CD20 monoclonal antibody and anthracycline-containing regimen; or
- Histologically confirmed diagnosis of diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, or diffuse B-cell lymphoma arising from follicular lymphoma, and all of the following:
  - Relapsed or refractory disease defined as progression after ≥2 lines of systemic therapy including anti-CD20 monoclonal antibody for CD20-positive tumor and anthracycline-containing chemotherapy; and
  - When the individual has histological transformation of follicular lymphoma or nodal marginal zone lymphoma to diffuse large B-cell lymphoma: prior chemotherapy for follicular lymphoma and ≥2 chemo-immunotherapy regimens for the transformed disease; and
Are an individual with an age greater than or equal to 18 at the time of infusion; and
Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; and
Have not received prior CD19-directed chimeric antigen receptor T-cell therapy treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy; and
Do not have primary central nervous system lymphoma.

Axicabtagene Ciloleucel for Follicular Lymphoma

Axicabtagene ciloleucel is considered medically necessary for individuals with follicular lymphoma if individuals meet all of the following criteria:

Are an individual with an age greater than or equal to 18 at the time of infusion; and
Histologically confirmed diagnosis of follicular lymphoma; and
Relapsed or refractory disease defined as progression after ≥2 lines of systemic therapy for follicular lymphoma; and
Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; and
Have not received prior CD19-directed chimeric antigen receptor T-cell therapy treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy; and
Do not have primary central nervous system lymphoma.

Brexucabtagene Autoleucel for Mantle Cell Lymphoma

Brexucabtagene autoleucel is considered medically necessary for individuals with mantle cell lymphoma if individuals meet all of the following criteria:

Are an individual with an age greater than or equal to 18 at the time of infusion; and
Histologically confirmed diagnosis of relapsed or refractory mantle cell lymphoma; and
Received adequate prior therapy including anthracycline- or bendamustine-containing chemotherapy, anti-CD20 antibody, and a Bruton tyrosine kinase inhibitor (i.e. acalabrutinib, ibrutinib, zanubrutinib); and
Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; and
Have not received prior CD19-directed chimeric antigen receptor T-cell therapy treatment, any other cell therapy, or any other gene therapy or are being considered for treatment with any other cell therapy or any gene therapy.

Brexucabtagene Autoleucel for B-cell Acute Lymphoblastic Leukemia

Brexucabtagene autoleucel is considered medically necessary for individuals with B-cell ALL if individuals meet all of the following criteria:

Confirmed diagnosis of CD19-positive B-cell ALL with morphologic bone marrow tumor involvement (greater than or equal to 5% lymphoblasts); and
Meet any one of the following:
- Relapsed disease defined as the reappearance of leukemia cells in the bone marrow or peripheral blood after the attainment of a complete remission with chemotherapy and/or allogeneic cell transplant; or
- Refractory disease defined as failure to obtain complete response with induction therapy (i.e., failure to eradicate all detectable leukemia cells [less than 5% blasts] from the bone marrow and blood with subsequent restoration of normal hematopoiesis [greater than 25% marrow cellularity and normal peripheral blood counts]); and
When Philadelphia chromosome-positive: failure of tyrosine kinase inhibitors; and
Are an individual 18 years or older at the time of infusion; and
Have not received prior CD19-directed chimeric antigen receptor T-cell treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy; and
Have adequate organ function with no significant deterioration in organ function expected within four (4) weeks after apheresis; and
Do not have any of the following:
- Burkitt lymphoma; or
- Active hepatitis B, C, or any uncontrolled infection; or
- Grade 2 to 4 graft-versus-host disease; or
- Concomitant genetic syndrome associated with bone marrow failure with the exception of Down syndrome; or
- Received allogeneic cellular therapy, such as donor lymphocyte infusion, within six (6) weeks prior to brexucabtagene autoleucel infusion; or
- Active central nervous system ALL (i.e., white blood cell count greater than or equal to 5 cells/μL in cerebrospinal fluid with presence of lymphoblasts).

Lisocabtagene Maraleucel for Non-Hodgkin Lymphoma

Lisocabtagene maraleucel is considered medically necessary for individuals with large B-cell lymphoma if individuals meet all of the following criteria:

Are an individual with an age greater than or equal to 18 at the time of infusion; and
Histologically confirmed diagnosis of large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified (including diffuse large B-cell lymphoma arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B; and
Meets at least ONE of the following:
- Primary refractory or relapsed disease within 12 months of first-line chemo-immunotherapy that included an anti-CD20 monoclonal antibody and anthracycline-containing regimen; or
- Primary refractory or relapsed disease within 12 months of first-line chemo-immunotherapy that included an anti-CD20 monoclonal antibody and anthracycline-containing regimen and are not eligible for hematopoietic stem cell transplantation due to comorbidities or age; or
- Relapsed or refractory disease as defined as progression after greater than or equal to two (2) lines of systemic therapy including anti-CD20 monoclonal antibody for CD20-positive tumor and anthracycline-containing chemotherapy; and
  - When the individual has histological transformation of follicular lymphoma or marginal zone lymphoma to diffuse large B-cell lymphoma: prior chemotherapy for follicular lymphoma or marginal zone lymphoma and ≥2 chemo-immunotherapy regimens for the transformed disease; and
Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist; and
Have not received prior CD19-directed chimeric antigen receptor T-cell therapy treatment, any other cell therapy, or any gene therapy or are being considered for treatment with any other cell therapy or any gene therapy; and
Do not have primary central nervous system lymphoma.

Tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, and lisocabtagene maraleucel are considered investigational when the above criteria are not met.

Tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, and lisocabtagene maraleucel are considered investigational for all other indications.

Procedure Codes

0537T

0538T

0539T

0540T

Q2041

Q2042

Q2053

Q2054

Policy Guidelines

Central nervous system (CNS) disease for B-cell Acute Lymphoblastic Leukemia

Disease is defined by the following groups:

CNS 1: Absence of blasts on cerebrospinal fluid cytospin preparation, regardless of the white blood cell (WBC) count
CNS 2: WBC count of less than 5/mL and blasts on cytospin findings
CNS 3: WBC count of 5/mL or more and blasts on cytospin findings and/or clinical signs of CNS leukemia (e.g., facial nerve palsy, brain/eye involvement, hypothalamic syndrome)

Boxed Warning and Associated Restricted Program under a Risk Evaluation and Mitigation Strategy (REMS)

Tisagenlecleucel (Kymriah ^® ), axicabtagene ciloleucel (Yescarta ^® ), brexucabtagene autoleucel (Tecartus ^® ), and lisocabtagene maraleucel (Breyanzi ^® ) have boxed warnings regarding the risks of cytokine release syndrome (CRS) and neurologic toxicities (NT) that include fatal or life-threatening reactions. These agents should not be administered to individuals with active infection or inflammatory disorders. It is recommended that severe or life-threatening CRS be treated with tocilizumab. Individuals should be monitored for NTs after treatment.

Tisagenlecleucel (Kymriah), axicabtagene ciloleucel (Yescarta), brexucabtagene autoleucel (Tecartus), and lisocabtagene maraleucel (Breyanzi) are available only through a restricted program under a risk evaluation and mitigation strategy (REMS) called the Kymriah REMS, Yescarta REMS, Tecartus REMS, and Breyanzi REMS, respectively. The requirement for the REMS components are as follows:

Health care facilities that dispense and administer these chimeric antigen receptor (CAR) T therapies must be enrolled and comply with the REMS requirements.
Certified health care facilities must have onsite, immediate access to tocilizumab, and ensure that a minimum of 2 doses are available for each patient for administration within 2 hours after infusion of these chimeric antigen receptor (CAR) T-cell therapies, if needed for treatment of CRS.
Certified health care facilities must ensure that health care providers who prescribe, dispense, or administer these CAR T-cell therapies are trained to manage CRS and NT.

Procedure Codes

0537T

0538T

0539T

0540T

Q2041

Q2042

Q2053

Q2054

Diagnosis Codes

C82.00

C82.01

C82.02

C82.03

C82.04

C82.05

C82.06

C82.07

C82.08

C82.09

C82.10

C82.11

C82.12

C82.13

C82.14

C82.15

C82.16

C82.17

C82.18

C82.19

C82.20

C82.21

C82.22

C82.23

C82.24

C82.25

C82.26

C82.27

C82.28

C82.29

C82.30

C82.31

C82.32

C82.33

C82.34

C82.35

C82.36

C82.37

C82.38

C82.39

C82.40

C82.41

C82.42

C82.43

C82.44

C82.45

C82.46

C82.47

C82.48

C82.49

C82.50

C82.51

C82.52

C82.53

C82.54

C82.55

C82.56

C82.57

C82.58

C82.59

C82.60

C82.61

C82.62

C82.63

C82.64

C82.65

C82.66

C82.67

C82.68

C82.69

C82.80

C82.81

C82.82

C82.83

C82.84

C82.85

C82.86

C82.87

C82.88

C82.89

C82.90

C82.91

C82.92

C82.93

C82.94

C82.95

C82.96

C82.97

C82.98

C82.99

C83.00

C83.01

C83.02

C83.03

C83.04

C83.05

C83.06

C83.07

C83.08

C83.09

C83.10

C83.11

C83.12

C83.13

C83.14

C83.15

C83.16

C83.17

C83.18

C83.19

C83.30

C83.31

C83.32

C83.33

C83.34

C83.35

C83.36

C83.37

C83.38

C83.39

C83.50

C83.51

C83.52

C83.53

C83.54

C83.55

C83.56

C83.57

C83.58

C83.59

C83.70

C83.71

C83.72

C83.73

C83.74

C83.75

C83.76

C83.77

C83.78

C83.79

C83.80

C83.81

C83.82

C83.83

C83.84

C83.85

C83.86

C83.87

C83.88

C83.89

C83.90

C83.91

C83.92

C83.93

C83.94

C83.95

C83.96

C83.97

C83.98

C83.99

C84.00

C84.01

C84.02

C84.03

C84.04

C84.05

C84.06

C84.07

C84.08

C84.09

C84.10

C84.11

C84.12

C84.13

C84.14

C84.15

C84.16

C84.17

C84.18

C84.19

C84.40

C84.41

C84.42

C84.43

C84.44

C84.45

C84.46

C84.47

C84.48

C84.49

C84.60

C84.61

C84.62

C84.63

C84.64

C84.65

C84.66

C84.67

C84.68

C84.69

C84.70

C84.71

C84.72

C84.73

C84.74

C84.75

C84.76

C84.77

C84.78

C84.79

C84.A0

C84.A1

C84.A2

C84.A3

C84.A4

C84.A5

C84.A6

C84.A7

C84.A8

C84.A9

C84.Z0

C84.Z1

C84.Z2

C84.Z3

C84.Z4

C84.Z5

C84.Z6

C84.Z7

C84.Z8

C84.Z9

C84.90

C84.91

C84.92

C84.93

C84.94

C84.95

C84.96

C84.97

C84.98

C84.99

C85.10

C85.11

C85.12

C85.13

C85.14

C85.15

C85.16

C85.17

C85.18

C85.19

C85.20

C85.21

C85.22

C85.23

C85.24

C85.25

C85.26

C85.27

C85.28

C85.29

C85.80

C85.81

C85.82

C85.83

C85.84

C85.85

C85.86

C85.87

C85.88

C85.89

C85.90

C85.91

C85.92

C85.93

C85.94

C85.95

C85.96

C85.97

C85.98

C85.99

C91.00

C91.01

C91.02

Z80.6

Z80.7

Z85.72

Z92.850

Z92.858

Z92.859

Z92.86

Professional Statements and Societal Positions Guidelines

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in 'Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

National Comprehensive Cancer Network

Current National Comprehensive Cancer Network (NCCN) guidelines ^i.ii for ALL ( v. 2.2023) ^41, recommend (category 2A) tisagenlecleucel as a treatment option for relapsed or refractory

Philadelphia chromosome-positive patients 26 years or less in age with refractory disease OR ≥2 relapses and failure of 2 tyrosine kinase inhibitors.
Philadelphia chromosome-negative patients 26 years or less in age with refractory disease OR ≥2 relapses.

Current National Comprehensive Cancer Network (NCCN) guidelines ^i.ii for ALL ( v. 2.2023) ^41, recommend (category 2A) brexucabtagene autoleucel as a treatment option for relapsed or refractory

Philadelphia chromosome-positive adolescent and young adult patients with refractory disease OR ≥2 relapses and failure of tyrosine kinase inhibitors.
Philadelphia chromosome-negative adolescent and young adult patients with refractory disease OR ≥2 relapses.

Current NCCN guidelines for B-cell lymphoma (v.5.202 3) ^40, recommend axicabtagene ciloleucel (category 1) and lisocabtagene maraleucel (category 2A) with appropriate bridging therapy as a treatment option for relapsed DLBCL <12 months or primary refractory DLBCL.

Current NCCN guidelines for B-cell lymphoma (v.5.20 3) ^40, recommend (category 2A) axicabtagene ciloleucel, tisagenlecleucel, or lisocabtagene maraleucel as a third-line and subsequent therapy for DLBCL.

Current NCCN guidelines for B-cell lymphoma (v.5.20 3) ^40, recommend (category 2A) axicabtagene ciloleucel and tisagenlecleucel as a treatment option for histological transformation of follicular lymphoma or marginal zone lymphoma (all subtypes) to DLBCL after multiple lines of prior therapies which include ≥2 chemo-immunotherapy regimens for the indolent or transformed disease.

Current NCCN guidelines for B-cell lymphoma (v.5.20 3) ^40, recommend (category 2A) lisocabtagene maraleucel as a treatment option for histological transformation of follicular lymphoma or nodal marginal zone lymphoma to DLBCL after multiple lines of prior therapies which include ≥2 chemo-immunotherapy regimens for the indolent or transformed disease.

Current NCCN guidelines for B-cell lymphoma (v.5.20 3) ^40, recommend (category 2A) brexucabtagene autoleucel as a treatment option for adult patients with relapsed or refractory MCL only after chemoimmunotherapy and BTK inhibitor therapy.

Current NCCN guidelines for B-cell lymphoma (v.5.20 3) ^40, recommend (category 2A) axicabtagene ciloleucel or tisagenlecleucel as a third-line treatment option for adult patients with follicular lymphoma (grade 1-2) only after 2 or more lines of systemic therapy.

ⁱ Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia (v. 2.2023) and B-Cell Lymphomas (v 5.2023) .
© National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed Sep 10, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org.

ⁱⁱ NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this review are listed in Table 21.

Table 21. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

Tisagenlecleucel

NCT02445222 ^a

CAR-T Long Term Follow Up (LTFU) Study (PAVO)

1400

Feb 2036

NCT03876769 ^a

Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients (CASSIOPEIA)

120

Oct 2027

NCT05888493 ^a

A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma (LEDA)

108

Jan 2029

Axicabtagene ciloleucel

NCT03761056 ^a (ZUMA-12)

Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma

Nov 2023

NCT05605899 ^a (ZUMA-23)

Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma (ZUMA-23)

300

Mar 2031

Brexucabtagene autoleucel

NCT02625480 ^a (ZUMA-4)

Study evaluating brexucabtagene autoleucel in pediatric and adolescent participants with r/r ALL or r/r B-cell NHL

116

August 2027

NCT05537766 ^a (ZUMA-25)

Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies

170

Nov 2029

Lisocabtagene maraleucel

NCT03484702 (TRANSCEND WORLD)

Trial to determine the efficacy and safety of lisocabtagene maraleucel in aggressive B-Cell NHL

11 2

Dec 2023

NCT03575351 (TRANSFORM)

A study to compare the efficacy and safety of lisocabtagene maraleucel to standard of care in high-risk, transplant-eligible r/r aggressive B-cell NHL

18 4

Oct 2023

NCT04245839 (TRANSCEND FL)

A study to evaluate the efficacy and safety of lisocabtagene maraleucel in r/r indolent B-cell NHL

213

Sep 2028

NCT03331198

Study evaluating safety and efficacy of lisocabtagene maraleucel in subjects with r/r CLL or SLL

20 9

Jul 2026

NCT03743246

A study to evaluate the safety and efficacy of lisocabtagene maraleucel r/r B-cell ALL and B-cell NHL

121

Dec 2024

NCT03744676 (OUTREACH-007)

A safety trial of lisocabtagene maraleucel for r/r B-cell NHL in the outpatient setting

Sep 2023

Unpublished

Axicabtagene ciloleucel

NCT02926833 ^a (ZUMA-6)

Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Adults With Refractory Diffuse Large B-Cell Lymphoma

Jan 2023

NCT04002401 ^a (ZUMA-14)

Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma

Jan 2023

Lisocabtagene maraleucel

NCT03310619 (PLATFORM)

A safety and efficacy Trial of lisocabtagene maraleucel combinations in r/r B-cell malignancies

Feb 2023

NCT: national clinical trial.
^a Denotes industry-sponsored or cosponsored trial.

ND Committee Review

Internal Medical Policy Committee 5-19-2020 Adopt policy to replace Adoptive Immunotherapy policy

Internal Medical Policy Committee 9-21-2020 Added new therapy, brexucabtagene autoleucel (Tecartus), to policy

Internal Medical Policy Committee 1-19-2021 Policy updated with literature review through August 20, 2020; Policy statements for tisagenlecleucel and axicabtagene ciloleucel therapies were edited for formatting and editorial purposes but remained unchanged. Multiple sections of the policy were edited for brevity. Policy statements and Rationale for brexucabtagene autoleucel were added. New code for brexucabtagene autoleucel, C9073 was added and is effective 1-1-2021

Internal Medical Policy Committee 3-17-2021 Added new code Q2053 and removed code C9073 from policy effective 4-1-2021

Internal Medical Policy Committee 7-22-2021 Policy updated with literature review through February 6, 2021. Policy statements and Rationale for lisocabtagene maraleucel were added. Lisocabtagene maraleucel is considered medically necessary for adult individuals with specific types of aggressive non-Hodgkin lymphoma. The title of the policy was changed from 'Chimeric Antigen Receptor Therapy for Hematologic Malignancies ' to 'Chimeric Antigen Receptor Therapy for Leukemia and Lymphoma, added new code C9076 for lisocabtagene maraleucel which is effective 7/1/2021

Internal Medical Policy Committee 9-21-2021 Policy updated with literature review through May 18, 2021. Policy statements and Rationale for additional indication for axicabtagene ciloleucel were added. Axicabtagene ciloleucel is considered medically necessary for adult individuals with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy. Added new code Q2054 to the policy and removed C9076 effective 10-1-2021

Internal Medical Policy Committee 1-20-2022 Policy updated with literature review through October 1, 2021; relevant information on brexucabtagene autoleucel for B-cell acute lymphoblastic leukemia was added. Brexucabtagene autoleucel is considered medically necessary for adult individuals with relapsed/refractory B-cell acute lymphoblastic leukemia. Added Z92.850, Z92.858, Z92.859, Z92.86

Internal Medical Policy Committee 1-26-2023 - Effective March 1, 2023

Updated with literature review through July 22, 2022.
Added criteria for tisagenlecleucel for relapsed or refractory individuals with follicular lymphoma, axicabtagene ciloleucel for adults with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, lisocabtagene maraleucel for adults with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy or is refractory to first-line chemoimmunotherapy or relapse after first line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation due to comorbidities or age.

Internal Medical Policy Committee 1-16-2024 - Effective March 1, 2024

Updated with literature review through September 8, 2023; multiple references were added. Policy statements for tisagenlecleucel and brexucabtagene autoleucel were updated to address Philadelphia-chromosome positive individuals. Editorial refinements were also made without changing the original intent.

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

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Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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Chimeric Antigen Receptor Therapy for Leukemia and Lymphoma (ARCHIVED)

This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.

Description

Criteria

Tisagenlecleucel for B-cell Acute Lymphoblastic Leukemia

Tisagenlecleucel for Non-Hodgkin Lymphoma

Tisagenlecleucel for Follicular Lymphoma

Axicabtagene Ciloleucelfor Non-Hodgkin Lymphoma

Axicabtagene Ciloleucel for Follicular Lymphoma

Brexucabtagene Autoleucel for Mantle Cell Lymphoma

Brexucabtagene Autoleucel for B-cell Acute Lymphoblastic Leukemia

Lisocabtagene Maraleucel for Non-Hodgkin Lymphoma

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Policy Guidelines

Boxed Warning and Associated Restricted Program under a Risk Evaluation and Mitigation Strategy (REMS)

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National Comprehensive Cancer Network

Ongoing and Unpublished Clinical Trials

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