CurrentBlue Cross Blue Shield - MassachusettsPolicy 066

Chimeric Antigen Receptor Therapy for Hematologic Malignancies (Brexucabtagene Autoleucel)

Requirements and documentation needed for prior authorization of brexucabtagene autoleucel (CAR T‑cell) therapy for patients with relapsed or refractory mantle cell lymphoma; intended for providers requesting authorization through BCBSMA.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyChimeric Antigen Receptor Therapy for Hematologic Malignancies (Brexucabtagene Autoleucel)

Policy CodePolicy 066

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization through Authorization Manager (or fax if out-of-network) with required clinical documentation and completed CAR T‑Cell Therapy Services prior authorization form.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

age ≥ 18minimum age for infusion documented

BTK requiredprior BTK inhibitor required

no prior CD19 CAR Tno prior CD19 CAR T

Q2053listed HCPCS code

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Initial therapy criteria

Covered when ALL of the following are met

Eligibility criteria for brexucabtagene autoleucel in mantle cell lymphoma: (1) Histologically confirmed diagnosis of relapsed or refractory mantle cell lymphoma; AND (2) Received adequate prior therapy including anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 monoclonal antibody, AND a Bruton tyrosine kinase inhibitor (eg, acalabrutinib, ibrutinib, zanubrutinib); AND (3) At least 18 years of age at the time of infusion; AND (4) Adequate organ and bone marrow function as determined by the treating oncologist/hematologist; AND (5) No prior CD19-directed CAR T-cell therapy, any other cell therapy, or any gene therapy;

Relapsed or refractory disease is defined as disease progression after the last regimen or failure to achieve a partial or complete remission to the last regimen.

Patients who have received prior CD19‑directed chimeric antigen receptor (CAR) T‑cell therapy, any other cell therapy, or any gene therapy are excluded from coverage under this indication.

Coverage is granted only when a patient meets ALL listed eligibility criteria. Failure to meet ALL of the required criteria will result in the request being considered not medically necessary unless an approved exception is documented.

Coding and Product Details

HCPCS and related unclassified codesHCPCS

C9399	Unclassified drugs
J3490	Unclassified drugs or biologicals
J3590	Unclassified biologics
J9999	Not otherwise classified, antineoplastic drugs including leukapheresis and dose preparation procedures, per therapeutic dose
Q2053	Brexucabtagene autoleucel, up to 200 million autologous anti‑CD19 CAR positive viable T cells
XW23346	Transfusion of Brexucabtagene Autoleucel Immunotherapy into Peripheral Vein, Percutaneous Approach New Technology Group 6

Cell dose and coding

HCPCS product codeQ2053 — Brexucabtagene autoleucel, up to 200 million autologous anti‑CD19 CAR positive viable T cells

Related unclassified codesC9399, J3490, J3590, J9999 — unclassified drug/biologic codes as listed

Procedure code for administrationXW23346 — Transfusion of Brexucabtagene Autoleucel Immunotherapy into Peripheral Vein, percutaneous approach (New Technology Group 6)

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for CAR T-Cell Therapy Services for Mantle Cell Lymphoma (Brexucabtagene Autoleucel). Submit the initial authorization request through Authorization Manager (available 24/7) to request authorizations, submit required clinical documentation, check case status, and view/print the decision letter. Out-of-network providers may fax requests to 888-973-0726.

Authorization requests must include the servicing provider's NPI or provider ID and the facility's NPI or provider ID where services will be performed.
Authorization Manager resources (tips, guides, video demonstrations) and the Complete Prior Authorization Request Form for CAR T-Cell Therapy Services for Mantle Cell Lymphoma are available to assist submissions.

Documentation Required

Clinical Documentation Required

Providers must submit clinical documentation that supports the medical necessity criteria for CAR T-Cell Therapy Services for Mantle Cell Lymphoma. If the patient does not meet all listed criteria, submit a letter of medical necessity requesting Clinical Exception (Individual Consideration) that explains why an exception is justified.

Include a completed CAR T-Cell Therapy Services prior authorization form (patient and facility information, diagnosis, prior therapies, and clinical status).
For out-of-network requests, fax supporting clinical documentation to 888-973-0726.

Documentation Required

Prior Therapy and Eligibility Documentation

Prior therapy requirements must be documented. The patient should have relapsed or refractory mantle cell lymphoma and have received adequate prior therapy as specified below. Relapsed or refractory disease is defined as disease progression after the last regimen or failure to achieve a partial or complete remission to the last regimen.

Documentation of prior anthracycline- or bendamustine-containing chemotherapy.
Documentation of prior anti-CD20 monoclonal antibody therapy.
Documentation of prior Bruton tyrosine kinase (BTK) inhibitor therapy (eg, acalabrutinib, ibrutinib, zanubrutinib).
Confirmation that the patient has not received prior CD19-directed CAR T-cell therapy, other cell therapy, or gene therapy (or note if consideration for such therapies exists).
Patient age documented as at least 18 years at time of infusion and evidence of adequate organ and bone marrow function as determined by the treating oncologist/hematologist.

Denial Risk

Potential Denial or Delay

Failure to submit required documentation or to meet all listed criteria may result in denial or delay of the authorization. Ensure all form fields and supporting records are complete to avoid processing delays.

Incomplete forms or missing clinical evidence may prompt a request for additional information or lead to denial.
If requesting an exception, include a clear rationale and supporting evidence with the letter of medical necessity.

Background

Brexucabtagene autoleucel is a CD19‑directed CAR T‑cell therapy indicated for patients with histologically confirmed relapsed or refractory mantle cell lymphoma. Relapsed or refractory disease is defined as disease progression after the last regimen or failure to achieve a partial or complete remission to the last regimen. Eligible patients must meet additional requirements such as prior systemic therapies, minimum age, and adequate organ and bone marrow function as determined by the treating oncologist/hematologist.

Definitions

Relapsed or refractory — definition

DefinitionRelapsed or refractory disease is defined as disease progression after the last regimen or failure to achieve a partial remission or complete remission to the last regimen.

Clinical implicationApplies to determination of eligibility for brexucabtagene autoleucel for mantle cell lymphoma (must be relapsed or refractory per above).

Documentation noteProvider must document prior regimen and evidence of progression or lack of response to support relapsed/refractory status.

Line of Therapy / Salvage

salvage

line of therapy: Relapsed or refractory disease after prior systemic therapies including anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 monoclonal antibody, and a Bruton tyrosine kinase inhibitor.

Intended as salvage after those prior therapies.

Covered Regimens and Products

Regimen	HCPCS / Related Codes	Coverage status	Notes
Brexucabtagene autoleucel — up to 200 million autologous anti‑CD19 CAR positive viable T cells	Q2053; C9399; J3490; J3590; J9999; XW23346	Covered	CAR T‑cell therapy product; cell dose described as up to 200 million autologous anti‑CD19 CAR positive viable T cells