CurrentBlue Cross Blue Shield - MassachusettsPolicy N/A

CAR T-Cell Therapy Services for Follicular Lymphoma (Axicabtagene ciloleucel) — Prior Authorization / Coverage Criteria

Prior authorization form and medical policy guidance for use of axicabtagene ciloleucel in relapsed or refractory follicular lymphoma for Blue Cross Blue Shield of Massachusetts members; applies to providers requesting CAR T services.|

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyCAR T-Cell Therapy Services for Follicular Lymphoma (Axicabtagene ciloleucel) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests and required clinical documentation via Authorization Manager (or fax for out-of-network) using the CAR T prior authorization form.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=2Lines of therapy required

>=18Minimum age

1Histologic diagnosis required

NonePrior CD19 CAR T

Outpatient/Inpatient

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Coverage Criteria for Axicabtagene Ciloleucel

Initial therapy eligibility

Covered when ALL of the following are met

Primary eligibility: Patient has histologically confirmed follicular lymphoma

Prior therapy: Relapsed or refractory disease defined as progression after 2 or more lines of systemic therapy>=2 lines

May or may not include therapy supported by autologous cell transplant

Age: At least 18 years of age at the time of infusion>=18 years

Organ function: Have adequate organ and bone marrow function as determined by the treating oncologist/hematologist

Clinical judgment required

Prior cell/gene therapy exclusion: Have not received prior CD19-directed CAR T-cell therapy, any other cell therapy, or any gene therapy

CNS involvement exclusion: Do not have primary central nervous system lymphoma

Coverage excludes patients with primary central nervous system lymphoma. Members who have previously received any CD19-directed CAR T-cell therapy, any other cell therapy, or any gene therapy are not eligible for coverage under this policy. These exclusions must be confirmed in the submitted clinical documentation.

Line of Therapy / Salvage Criteria

Salvage

Relapsed/refractory definition: Progression after 2 or more lines of systemic therapy>=2 lines

Definitions

Relapsed or refractory disease definition

DefinitionRelapsed or refractory disease is defined as progression after 2 or more lines of systemic therapy (which may or may not include therapy supported by autologous cell transplant).

ContextApplies to histologically confirmed follicular lymphoma being considered for axicabtagene ciloleucel

Minimum prior lines>= 2 lines of systemic therapy

Autologous transplant notePrior lines may or may not include therapy supported by autologous cell transplant

Age relevanceUsed together with other criteria, including minimum age of at least 18 years at time of infusion

Coding

HCPCS / Unclassified codes listedHCPCS

C9399	Unclassified drugs or biologicals
J3490	Unclassified biologics
J3590	Not otherwise classified, antineoplastic drugs
J9999	Not otherwise classified, antineoplastic drugs

HCPCS / Unclassified codes listed (alternate formatting)HCPCS

C9399	Unclassified drugs or biologicals
J3490	Unclassified biologics
J3590	Not otherwise classified, antineoplastic drugs
J9999	Not otherwise classified, antineoplastic drugs

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for CAR T-Cell Therapy services. Submit initial authorization requests via Authorization Manager (available 24/7). For out-of-network providers, requests may be faxed to 888-973-0726. Enter the servicing provider's NPI/provider ID (surgeon) and the facility's NPI/provider ID for the location where services will be performed. Requests for commercial members must meet medical policy guidelines.

Authorization Manager is the preferred submission method
Out-of-network fax: 888-973-0726
Enter servicing provider NPI/provider ID (not billing group)
Enter facility NPI/provider ID for service location

Documentation Required

Required Clinical Documentation and Clinical Exception

Submit clinical documentation that supports medical necessity for CAR T-Cell Therapy Services for Follicular Lymphoma (Axicabtagene Ciloleucel). If the patient does not meet all policy criteria, include a letter of medical necessity requesting a Clinical Exception (Individual Consideration) explaining why an exception is justified.

Background

Axicabtagene ciloleucel is a CD19-directed CAR T‑cell therapy indicated for patients with histologically confirmed follicular lymphoma that is relapsed or refractory. For coverage consideration, relapsed or refractory disease is defined as progression after 2 or more lines of systemic therapy. Patients must be at least 18 years of age at the time of infusion and have adequate organ and bone marrow function as determined by the treating oncologist/hematologist. The policy also requires documentation that the patient has not previously received CD19-directed CAR T-cell therapy, other cell therapy, or gene therapy.