ModifiedArkansas Blue Cross and Blue ShieldPolicy 2024038

Axicabtagene Ciloleucel

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This policy governs coverage of axicabtagene ciloleucel, including FDA-labeled and specified off-label uses for large B-cell lymphoma, follicular lymphoma, and other NCCN-supported lymphoma indications. Coverage is subject to diagnosis, age, prior-treatment, organ-function, CAR T-cell therapy history, and lifetime administration criteria.

Policy Summary

PayerArkansas Blue Cross and Blue Shield

PolicyAxicabtagene Ciloleucel

Policy CodePolicy N/A

Change TypeModified

Effective DateOctober 7, 2026

Next Review DateN/A

Key ActionVerify the applicable diagnosis, age, prior-treatment, organ and bone marrow function, therapy history, and one-administration-per-lifetime requirements before requesting coverage.

SourceLink

POLICY UPDATE CHANGES

FDA-labeled and off-label indications for axicabtagene ciloleucel were updated.

1Administrations per individual per lifetime

2+ linesRequired prior systemic therapy for relapsed or refractory follicular lymphoma

12 monthsMaximum relapse interval under one large B-cell lymphoma pathway

1 or 2ARequired NCCN recommendation category for specified off-label use

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ModifiedArkansas Blue Cross and Blue ShieldPolicy 2024038

Axicabtagene Ciloleucel

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Sign up for arkansas_blue_cross_blue_shield Policy 2024038 alerts

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Policy Summary

PayerArkansas Blue Cross and Blue Shield

PolicyAxicabtagene Ciloleucel

Policy CodePolicy N/A

Change TypeModified

Effective DateOctober 7, 2026

Next Review DateN/A

Key ActionVerify the applicable diagnosis, age, prior-treatment, organ and bone marrow function, therapy history, and one-administration-per-lifetime requirements before requesting coverage.

SourceLink

POLICY UPDATE CHANGES

FDA-labeled and off-label indications for axicabtagene ciloleucel were updated.

1Administrations per individual per lifetime

2+ linesRequired prior systemic therapy for relapsed or refractory follicular lymphoma

12 monthsMaximum relapse interval under one large B-cell lymphoma pathway

1 or 2ARequired NCCN recommendation category for specified off-label use

Covered Indications and Requirements

FDA-labeled large B-cell lymphoma

Covered when all applicable requirements are met.

Large B-cell lymphoma requirements

Adult and qualifying diagnosis
- Individual is an adult at the time of infusion.
- Qualifying large B-cell lymphoma pathway
  - Individual has a histologically confirmed diagnosis of large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.Relapse within 12 months of first-line chemoimmunotherapy
  - Individual has a histologically confirmed diagnosis of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, or diffuse large B-cell lymphoma arising from follicular lymphoma.Two or more lines of systemic therapy
Adequate prior therapy
- For a CD20-positive tumor, individual has received an anti-CD20 monoclonal antibody.
- Individual has received an anthracycline-containing chemotherapy regimen.
- For transformed follicular lymphoma, individual has received prior chemotherapy for follicular lymphoma and subsequently has chemotherapy-refractory disease after transformation to diffuse large B-cell lymphoma.
  Applies when relevant.
Individual has adequate organ and bone marrow function as determined by the treating oncologist/hematologist.
Individual has not received prior treatment with CAR T-cell therapy or other genetically modified T-cell therapy and is not or has not been a subject of a clinical trial for such therapy.
There is only one administration of axicabtagene ciloleucel per individual per lifetime.One administration per lifetime

FDA-labeled follicular lymphoma

Covered when all of the following requirements are met.

Follicular lymphoma requirements

Individual is an adult at the time of infusion.
Individual has a histologically confirmed diagnosis of relapsed or refractory follicular lymphoma.
Individual has received two or more lines of systemic therapy for treatment of follicular lymphoma.Two or more lines of systemic therapy
Individual has adequate organ and bone marrow function as determined by the treating oncologist/hematologist.
Individual has not received prior treatment with CAR T-cell therapy or other genetically modified T-cell therapy and is not or has not been a subject of a clinical trial for CAR T-cell therapy or other genetically modified T-cell therapy.

Specified off-label indications

Covered for specified off-label indications when one age-and-diagnosis option and all additional requirements are met.

Specified off-label requirements

One age-and-diagnosis option
- Option A and B
  - Individual is 18 years of age or younger.18 years of age or younger
  - Individual is diagnosed with pediatric aggressive mature B-cell lymphoma—primary mediastinal large B-cell lymphoma.
    NCCN 2A.
- Option C and D
  - Individual is 18 years of age or older.

Coverage is not available for individuals who have received prior CAR T-cell therapy or other genetically modified T-cell therapy, or who are or were subjects of a clinical trial involving such therapy.

Coverage excludes more than one administration of axicabtagene ciloleucel per individual per lifetime. The policy permits only one lifetime administration.

Authorization and Denial Considerations

Denial Risk

Failure to meet coverage criteria

Coverage may be denied when the individual does not meet the applicable diagnosis and age requirements, prior-treatment requirements, adequate organ and bone marrow function requirements, prior CAR T-cell or other genetically modified T-cell therapy restrictions, clinical-trial restrictions, or the one-administration-per-lifetime requirement.

For large B-cell lymphoma, applicable pathways require refractory disease or relapse within 12 months of first-line chemoimmunotherapy, or relapsed/refractory disease after two or more lines of systemic therapy.
Adequate prior therapy must include an anti-CD20 monoclonal antibody for CD20-positive tumor and an anthracycline-containing chemotherapy regimen; additional therapy is required for transformed follicular lymphoma.
The individual must be an adult at the time of infusion for the FDA-labeled large B-cell and follicular lymphoma indications.

Denial Risk

Unsupported off-label indication

Specified off-label coverage may be denied when the indication is not among the listed lymphoma diagnoses, the individual does not meet the applicable age-and-diagnosis option, or axicabtagene ciloleucel is not used in accordance with NCCN recommended use with category 1 or 2A.

Therapy Overview

Axicabtagene ciloleucel is a CAR T-cell therapy used for selected relapsed, refractory, or transformed B-cell lymphomas. This policy addresses FDA-labeled large B-cell and follicular lymphoma indications, as well as specified off-label lymphoma uses supported by NCCN category 1 or 2A recommendations.

Initial Treatment Requirements

Initial therapy

Initial treatment is covered when the applicable indication-specific criteria are met.

General initial-treatment requirements

Individual meets the applicable FDA-labeled or specified off-label diagnosis and age criteria.
Individual has adequate organ and bone marrow function as determined by the treating oncologist/hematologist.
Individual has not received prior CAR T-cell therapy or other genetically modified T-cell therapy and has no applicable clinical-trial history for such therapy.
Individual receives only one administration of axicabtagene ciloleucel per lifetime.One administration per individual per lifetime

Administration Limit

Quantity Limits

MedicationAxicabtagene ciloleucel

Administration limitOne administration

Applies toPer individual per lifetime

Confirmed diagnosis of one listed lymphoma condition

Post-transplant lymphoproliferative disorder (B-cell type).
NCCN 2A.
HIV-related B-cell lymphoma.
NCCN 2A.
Primary CNS lymphoma.
NCCN 2A.
High-grade B-cell lymphoma.
NCCN 2A.
Diffuse large B-cell lymphoma.
NCCN 1 or 2A.
Classic follicular lymphoma.
NCCN 2A.
Primary mediastinal large B-cell lymphoma.
NCCN 2A.
Chronic lymphocytic leukemia/small lymphocytic lymphoma with histologic transformation (Richter transformation).
NCCN 2A.
Nodal marginal zone lymphoma.
NCCN 2A.
Extranodal marginal zone lymphoma of the stomach.
NCCN 2A.
Extranodal marginal zone lymphoma of nongastric, noncutaneous sites.
NCCN 2A.
Histologic transformation of indolent lymphoma to diffuse large B-cell lymphoma.
NCCN 2A.
Splenic marginal zone lymphoma.
NCCN 2A.