CurrentBlue Cross Blue Shield - MassachusettsPolicy Medical Policy #066

Chimeric Antigen Receptor Therapy for Hematologic Malignancies (axicabtagene ciloleucel)

Prior authorization and medical necessity criteria for CAR T-cell therapy (axicabtagene ciloleucel) for adults with relapsed or refractory diffuse large B‑cell and related high‑grade B‑cell lymphomas; defines documentation and facility requirements for providers requesting coverage from BCBSMA.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyChimeric Antigen Receptor Therapy for Hematologic Malignancies (axicabtagene ciloleucel)

Policy CodePolicy Medical Policy #066

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization via Authorization Manager (or fax for OON providers) with required clinical documentation demonstrating medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum age for infusion

>=2Prior therapy lines (general)

12 monthsRelapse window after 1st‑line

Q2041HCPCS code (axi CAR T)

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Initial therapy coverage criteria

Covered when ALL of the following are met

Main eligibility: Patient has a histologically confirmed diagnosis of one of: diffuse large B-cell lymphoma (including transformation from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, or follicular lymphoma grade 3B; AND disease is relapsed or refractory per the definitions below; AND patient is at least 18 years of age at the time of infusion; AND patient has adequate organ and bone marrow function as determined by the treating oncologist/hematologist; AND patient has not previously received CD19-directed CAR T-cell therapy, any other cell therapy, or gene therapy; AND the treating facility is REMS-certified by Kite Pharma to manage cytokine release syndrome and neurotoxicity.

Definition of relapsed/refractory (path A): Refractory to first-line chemoimmunotherapy OR relapsed within 12 months following first-line chemoimmunotherapy that included an anti‑CD20 monoclonal antibody and an anthracycline-containing regimen.12 months

Definition of relapsed/refractory (path B): Relapsed or refractory disease defined as progression after 2 or more lines of systemic therapy (which may or may not include therapy supported by autologous cell transplant).>=2 lines

For histologic transformation from follicular lymphoma or nodal marginal zone lymphoma, prior chemotherapy for the indolent disease plus 2 chemo‑immunotherapy regimens for the transformed disease are required.

Coverage does not apply to patients with primary central nervous system lymphoma. The policy explicitly excludes individuals who have primary CNS lymphoma from eligibility for axicabtagene ciloleucel under these criteria.

The policy notes that tisagenlecleucel IV infusion is considered investigational for relapsed or refractory primary mediastinal large B‑cell lymphoma; this is documented in the exclusions and related authorization form guidance.

Other adoptive immunotherapies — including tumor‑infiltrating lymphocytes, antigen‑loaded autologous dendritic cells, cytokine‑induced killer cells, and other genetically engineered T‑cell approaches not specified in this policy — are considered investigational and are not covered as standard therapy under this policy.

Billing and Coding

Relevant HCPCS/CPT/other codes listedmixed

C9399	Unclassified drugs or biologicals.
J3490	Unclassified drugs.
J3590	Unclassified biologics.
J9999	Not otherwise classified antineoplastic drugs.
Q2041	Axicabtagene Ciloleucel, up to 200 Million Autologous Anti-CD19 CAR T Cells, Including Leukapheresis And Dose Preparation Procedures Per Infusion.
S2107	Adoptive immunotherapy, i.e. development of specific anti-tumor reactivity (e.g., tumor infiltrating lymphocyte therapy) per course of treatment.

Minimum age for infusion

Minimum age for infusionAt least 18 years of age at the time of infusion.

Age documentationAge must be verified and documented in the clinical record at time of authorization request.

Pediatric exclusionPolicy applies to adults; patients under 18 do not meet this criterion.

Provider Requirements and Submission

Prior Authorization

Prior Authorization Required

Prior authorization required for axicabtagene ciloleucel and related CAR T services. Use Authorization Manager to submit initial authorization requests and clinical documentation. Out-of-network providers may fax requests to 888-973-0726.

Authorization Manager is available 24/7 to request authorizations, submit clinical documentation, check case status, and view/print decision letters.
For out-of-network providers, fax prior authorization requests to 888-973-0726.

Denial Risk

Prior Therapy Requirements

The patient must have relapsed or refractory disease and meet the policy’s prior therapy requirements before CAR T is authorized. Submit documentation that the patient’s lymphoma is histologically confirmed and that disease is refractory to first-line chemoimmunotherapy or relapsed within 12 months of completing first-line chemoimmunotherapy that included an anti‑CD20 monoclonal antibody and an anthracycline-containing regimen, or meets the alternative prior-therapy pathways described in the policy.

Relapsed or refractory disease is typically defined as progression after ≥2 lines of systemic therapy (may include autologous transplant–supported therapy) or as specified for transformed/other histologies in the policy.
When transformation from follicular or nodal marginal zone lymphoma has occurred, document prior chemotherapy for the indolent disease and the required chemoimmunotherapy regimens for the transformed disease.

Documentation Required

Clinical Documentation and Submission Pathway

Submit complete clinical documentation demonstrating medical necessity with the Authorization Manager request. Documentation must include histologic diagnosis, prior therapy history (agents, dates, and responses), organ and bone marrow function assessments, prior exposure to CD19‑directed or other cell/gene therapies, and REMS-certified facility confirmation when applicable.

If the patient does not meet all criteria, submit a Letter of Medical Necessity requesting a Clinical Exception with supporting rationale.
Include patient age, clinical trial enrollment status (if applicable), and documentation that the facility is certified by Kite Pharma for REMS if required.

Documentation Required

Documentation and Criteria Adherence

Failure to meet the stated criteria may result in denial. If criteria are unmet, a Letter of Medical Necessity with justification may be required for individual consideration (Clinical Exception). Ensure correct provider and facility NPIs are entered in Authorization Manager to avoid processing delays.

Enter the servicing provider’s NPI/provider ID (surgeon or treating clinician) and the facility’s NPI/provider ID where services will occur.
Clinical Exception (Individual Consideration) requests must clearly explain why standard criteria are not met and provide supporting evidence.

Background and Clinical Context

Axicabtagene ciloleucel is an autologous anti‑CD19 chimeric antigen receptor (CAR) T‑cell therapy indicated under this policy for certain relapsed or refractory large B‑cell lymphomas. The policy requires a histologically confirmed diagnosis of an eligible large B‑cell lymphoma, documentation of relapsed or refractory disease per the defined criteria, that the patient be at least 18 years of age at infusion, and that the treating facility be REMS‑certified by Kite Pharma. Patients must not have previously received CD19‑directed CAR T, other cell therapy, or gene therapy.

Definitions and Eligibility

Relapsed or refractory disease definition

Primary definitionRelapsed or refractory disease is defined as progression after 2 or more lines of systemic therapy.

First‑line chemoimmunotherapy pathRefractory to first‑line chemoimmunotherapy OR relapsed within 12 months after first‑line chemoimmunotherapy that included an anti‑CD20 monoclonal antibody and an anthracycline-containing regimen.

Transformed disease requirementFor transformation from follicular or nodal marginal zone lymphoma, prior chemo for the indolent disease plus 2 chemo‑immunotherapy regimens for the transformed disease are required.

Scope noteDefinition may include therapies supported by autologous cell transplant as part of the count of systemic therapy lines.

Covered Regimens and Alternatives

Regimen	Indication	Coverage status
Axicabtagene ciloleucel (CAR T-cell therapy)	Relapsed or refractory diffuse large B‑cell and related large B‑cell lymphomas meeting prior therapy criteria: histologically confirmed diffuse large B‑cell lymphoma (including transformation from indolent lymphoma), high‑grade B‑cell lymphoma, primary mediastinal large B‑cell lymphoma, or follicular lymphoma grade 3B that is refractory to first‑line chemoimmunotherapy or relapsed within 12 months after first‑line chemoimmunotherapy including an anti‑CD20 monoclonal antibody and an anthracycline regimen, or progression after ≥2 lines of systemic therapy; patient ≥18 years of age; adequate organ and marrow function; no prior CD19‑directed CAR T or other cell/gene therapy; treating facility REMS‑certified by Kite Pharma.	Covered

Regimen	Indication	Coverage status
Adoptive immunotherapy (non‑axi CAR T approaches) — e.g., tumor‑infiltrating lymphocytes (TILs), antigen‑loaded dendritic cell vaccines, cytokine‑induced killer cells, alternative genetically engineered T‑cells.	Other adoptive cellular therapies used for treatment of malignancy (not specified CAR T from Kite) — considered investigational per policy.	Experimental

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