CurrentCareSource GeorgiaPolicy GA-MED-P-366579

Tecartus (brexucabtagene autoleucel) Coverage Criteria

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CareSource Georgia Medicaid coverage and medical prior authorization for Tecartus in adults with specified relapsed or refractory mantle cell lymphoma or B-cell acute lymphoblastic leukemia.

Policy Summary

PayerCareSource Georgia

PolicyTecartus (brexucabtagene autoleucel) Coverage Criteria

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial policy revision

Effective DateFebruary 1, 2026

Next Review DateN/A

Key ActionSubmit medical prior authorization with all indication-specific criteria and supporting documentation for Tecartus.

SourceLink

POLICY UPDATE CHANGES

The policy added coverage criteria for relapsed or refractory B-cell acute lymphoblastic leukemia.

The mantle cell lymphoma criteria were revised to require at least one measurable lesion and prior treatment with a covalent BTK inhibitor.

The policy changed infection screening language to require that members have been or will be screened for HBV, HCV, and HIV.

The ALL criteria distinguish relapsed or refractory Philadelphia chromosome-negative disease from Philadelphia chromosome-positive disease requiring prior tyrosine kinase inhibitor therapy.

2covered disease indications

3 monthsinitial authorization

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CurrentCareSource GeorgiaPolicy GA-MED-P-366579

Tecartus (brexucabtagene autoleucel) Coverage Criteria

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Sign up for caresourcegeorgia Policy GA-MED-P-366579 alerts

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CareSource Georgia Medicaid coverage and medical prior authorization for Tecartus in adults with specified relapsed or refractory mantle cell lymphoma or B-cell acute lymphoblastic leukemia.

Policy Summary

PayerCareSource Georgia

PolicyTecartus (brexucabtagene autoleucel) Coverage Criteria

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial policy revision

Effective DateFebruary 1, 2026

Next Review DateN/A

Key ActionSubmit medical prior authorization with all indication-specific criteria and supporting documentation for Tecartus.

SourceLink

POLICY UPDATE CHANGES

The policy added coverage criteria for relapsed or refractory B-cell acute lymphoblastic leukemia.

The mantle cell lymphoma criteria were revised to require at least one measurable lesion and prior treatment with a covalent BTK inhibitor.

The policy changed infection screening language to require that members have been or will be screened for HBV, HCV, and HIV.

The ALL criteria distinguish relapsed or refractory Philadelphia chromosome-negative disease from Philadelphia chromosome-positive disease requiring prior tyrosine kinase inhibitor therapy.

2covered disease indications

3 monthsinitial authorization

continued therapy reauthorization

2×10^6/kg MCL; 1×10^6/kg ALLmaximum dose

Covered Indications and Exclusions

Initial Therapy — Mantle Cell Lymphoma

Covered for initial authorization when ALL of the following are met:

ALL of the following

Member is at least 18 years of age.
Healthcare facility/provider has enrolled in the Yescarta and Tecartus REMS program.
Member has a documented diagnosis of relapsed or refractory mantle cell lymphoma (MCL), defined as disease progression after the last regimen or failure to achieve a partial response or complete response to the last regimen.
Member has had prior treatment with all of the following: anthracycline- or bendamustine-containing chemotherapy; an anti-CD20 monoclonal antibody (e.g., rituximab); and a covalent Bruton tyrosine kinase inhibitor (BTKi), specifically ibrutinib, acalabrutinib, or zanubrutinib.
Member has at least one measurable lesion.
Member has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Member does NOT have any of the following:
- Central nervous system (CNS) lymphoma.
- History of allogeneic stem cell transplantation.
- Prior chimeric antigen receptor (CAR) therapy or other genetically modified T-cell therapy.
Member has been or will be screened for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV).
Dosage allowed/quantity limit: 2 × 10^6 CAR-positive viable T cells per kg body weight, with a maximum of 2 × 10^8 CAR-positive viable T cells.
If all requirements are met, Tecartus will be approved for 3 months.

Reauthorization — Mantle Cell Lymphoma

Tecartus will not be reauthorized for continued therapy.

Initial Therapy — B-Cell Acute Lymphoblastic Leukemia

Covered for initial authorization when ALL of the following are met:

ALL of the following

Member is at least 18 years of age.
Healthcare facility/provider has enrolled in the Yescarta and Tecartus REMS program.
Member has a documented diagnosis of B-cell acute lymphoblastic leukemia (ALL).
Documentation of ONE of the following:
- Relapsed or refractory Philadelphia chromosome negative (Ph−) disease.
- Relapsed or refractory Philadelphia chromosome positive (Ph+) disease following therapy that has included tyrosine kinase inhibitors (TKIs).

Reauthorization — B-Cell Acute Lymphoblastic Leukemia

Tecartus will not be reauthorized for continued therapy.

For mantle cell lymphoma, coverage is subject to the initial-authorization criteria above. Tecartus is not covered when the member has central nervous system (CNS) lymphoma, a history of allogeneic stem cell transplantation, or prior chimeric antigen receptor (CAR) therapy or other genetically modified T-cell therapy.

The MCL dosage limit is 2 × 10^6 CAR-positive viable T cells per kg body weight, up to a maximum of 2 × 10^8 CAR-positive viable T cells. When all applicable criteria are met, authorization is limited to 3 months.

For B-cell acute lymphoblastic leukemia, Tecartus is not covered when the member has active graft-versus-host disease (GVHD) or prior CAR-T therapy.

The B-cell ALL dosage limit is 1 × 10^6 CAR-positive viable T cells per kg body weight, up to a maximum of 1 × 10^8 CAR-positive viable T cells. When all applicable criteria are met, authorization is limited to 3 months.

CareSource considers Tecartus (brexucabtagene autoleucel) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, refer to the Off-Label policy.

Initial Authorization Requirements

Initial MCL authorization

Initial MCL authorization requires ALL of the following.

Member is at least 18 years of age.Age ≥18
The healthcare facility or provider has enrolled in the Yescarta and Tecartus REMS program.
The member has a documented diagnosis of relapsed or refractory mantle cell lymphoma, defined as disease progression after the last regimen or failure to achieve a partial response or complete response to the last regimen.
Required prior MCL therapies
- Prior treatment includes anthracycline- or bendamustine-containing chemotherapy.

Reauthorization Policy

No continuation authorization

No continued therapy reauthorization is available for either covered indication.

Tecartus will not be reauthorized for continued therapy for mantle cell lymphoma or B-cell acute lymphoblastic leukemia.No reauthorization
Applies to both covered indications.

Clinical Thresholds and Coding Details

Bone marrow lymphoblasts

ThresholdAt least 5% lymphoblasts

Assessment methodBy morphologic assessment

Applicable indicationB-cell acute lymphoblastic leukemia

ECOG performance status

Qualifying ECOG status0 or 1

AssessmentEastern Cooperative Oncology Group performance status

Applies toInitial authorization criteria for mantle cell lymphoma and B-cell acute lymphoblastic leukemia

Authorization, Documentation, and Denial Risks

Prior Authorization

Medical Prior Authorization Required

Medical prior authorization is required for Tecartus (brexucabtagene autoleucel). When the applicable MCL or B-cell ALL criteria are met, initial authorization is limited to three months.

Benefit type: Medical Prior Authorization Required
MCL dose limit: 2 × 10⁶ CAR-positive viable T cells/kg, maximum 2 × 10⁸ cells
ALL dose limit: 1 × 10⁶ CAR-positive viable T cells/kg, maximum 1 × 10⁸ cells

Documentation Required

MCL Supporting Documentation

For MCL authorization, submit documentation supporting the diagnosis and all indication-specific clinical requirements.

Member is at least 18 years of age.
Relapsed or refractory MCL, defined as progression after the last regimen or failure to achieve a partial or complete response to the last regimen.

Indication-Specific Dose Limits

Tecartus for mantle cell lymphoma

Dose per kilogram2 x 10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg body weight

Maximum dose2 x 10^8 CAR-positive viable T cells

IndicationMantle cell lymphoma

Tecartus for B-cell acute lymphoblastic leukemia

Dose per kilogram1 x 10^6 CAR-positive viable T cells per kg body weight

Maximum dose1 x 10^8 CAR-positive viable T cells

IndicationB-cell acute lymphoblastic leukemia

Therapy Overview

Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T-cell immunotherapy. A patient’s T cells are harvested and genetically modified outside the body to express a chimeric antigen receptor, expanded, and then reinfused to recognize and eliminate CD19-expressing target cells. The policy addresses adults with relapsed or refractory mantle cell lymphoma and B-cell acute lymphoblastic leukemia.

Clinical Definitions

Relapsed or refractory mantle cell lymphoma

Disease progressionProgression after the last regimen

Partial responseFailure to achieve a partial response to the last regimen

Complete responseFailure to achieve a complete response to the last regimen

Covalent BTK inhibitor

DefinitionA covalent Bruton tyrosine kinase inhibitor

Listed exampleIbrutinib

Listed exampleAcalabrutinib

Policy Summary

PayerCareSource Georgia

PolicyTecartus (brexucabtagene autoleucel) Coverage Criteria

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial policy revision

Effective DateFebruary 1, 2026

Next Review DateN/A

Key ActionSubmit medical prior authorization with all indication-specific criteria and supporting documentation for Tecartus.

SourceLink

On This Page

Documentation of CD19 tumor expression.

Bone marrow with ≥ 5% lymphoblasts by morphologic assessment.

Member has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Member has been or will be screened for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV).

Member does NOT have any of the following:

Active graft-versus-host disease (GVHD).
Prior CAR-T therapy.

Dosage allowed/quantity limit: 1 × 10^6 CAR-positive viable T cells per kg body weight, with a maximum of 1 × 10^8 CAR-positive viable T cells.

If all requirements are met, Tecartus will be approved for 3 months.

Prior treatment includes an anti-CD20 monoclonal antibody, such as rituximab.

Prior treatment includes a covalent Bruton tyrosine kinase inhibitor, such as ibrutinib, acalabrutinib, or zanubrutinib.

The member has at least one measurable lesion.At least 1 measurable lesion

The member has an ECOG performance status of 0 or 1.ECOG 0 or 1

MCL exclusions absent

The member does not have CNS lymphoma.
The member has no history of allogeneic stem cell transplantation.
The member has not received prior CAR therapy or other genetically modified T-cell therapy.

The member has been or will be screened for HBV, HCV, and HIV.

Initial ALL authorization

Initial ALL authorization requires ALL of the following, including ONE of the two disease-status pathways.

Initial B-cell ALL authorization

Member is at least 18 years of age.Age ≥18
The healthcare facility or provider has enrolled in the Yescarta and Tecartus REMS program.
The member has a documented diagnosis of B-cell ALL.
ONE of 2 disease-status pathways
- Relapsed or refractory Philadelphia chromosome-negative (Ph-) disease.
- Relapsed or refractory Philadelphia chromosome-positive (Ph+) disease following therapy that included tyrosine kinase inhibitors (TKIs).
CD19 tumor expression is documented.
Bone marrow contains at least 5% lymphoblasts by morphologic assessment.≥ 5% lymphoblasts
The member has an ECOG performance status of 0 or 1.ECOG 0 or 1
The member has been or will be screened for HBV, HCV, and HIV.
ALL exclusions absent
- The member does not have active GVHD.
- The member has not received prior CAR-T therapy.

Prior treatment with an anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 monoclonal antibody such as rituximab, and a covalent BTK inhibitor such as ibrutinib, acalabrutinib, or zanubrutinib.

At least one measurable lesion and ECOG performance status of 0 or 1.

No CNS lymphoma, prior allogeneic stem cell transplantation, or prior CAR or other genetically modified T-cell therapy.

Member has been or will be screened for HBV, HCV, and HIV.

Documentation Required

ALL Supporting Documentation

For B-cell ALL authorization, submit documentation confirming the diagnosis, disease characteristics, prior therapy when applicable, and required clinical evidence.

Member is at least 18 years of age and has documented B-cell ALL.
Relapsed or refractory Philadelphia chromosome-negative disease, or relapsed or refractory Philadelphia chromosome-positive disease following therapy that included a TKI.
CD19 tumor expression and bone marrow with ≥ 5% lymphoblasts by morphologic assessment.
ECOG performance status of 0 or 1 and HBV, HCV, and HIV screening completed or planned.
No active graft-versus-host disease or prior CAR-T therapy.

Documentation Required

Yescarta and Tecartus REMS Enrollment

Before treatment, document that the healthcare facility or provider has enrolled in the Yescarta and Tecartus REMS program. REMS enrollment is required for both covered Tecartus indications.

MCL: REMS enrollment must be documented.
B-cell ALL: REMS enrollment must be documented.

Denial Risk

MCL Criteria Not Met

MCL authorization is at risk of denial when the member does not meet the required age, REMS, disease, treatment-history, disease-measurement, performance-status, exclusion, screening, or other clinical criteria.

Member is younger than 18 years of age.
Healthcare facility/provider is not enrolled in the Yescarta and Tecartus REMS program.
No documented relapsed or refractory MCL, or no qualifying prior treatment with anthracycline- or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody, and covalent BTK inhibitor.
No measurable lesion or ECOG performance status is not 0 or 1.
Presence of CNS lymphoma, history of allogeneic stem cell transplantation, or prior CAR or other genetically modified T-cell therapy.
Required HBV, HCV, or HIV screening is not completed or planned.

Denial Risk

ALL Criteria Not Met

B-cell ALL authorization is at risk of denial when the member does not meet the required age, REMS, diagnosis, Philadelphia chromosome, prior-therapy, CD19, marrow, performance-status, screening, or exclusion criteria.

Member is younger than 18 years of age or has no documented B-cell ALL diagnosis.
Healthcare facility/provider is not enrolled in the Yescarta and Tecartus REMS program.
Disease does not meet the relapsed or refractory Ph− requirement, or Ph+ disease was not treated with a TKI.
CD19 tumor expression is not documented or bone marrow has less than 5% lymphoblasts by morphologic assessment.
ECOG performance status is not 0 or 1, or required HBV, HCV, or HIV screening is not completed or planned.
Presence of active GVHD or prior CAR-T therapy.

Denial Risk

Unlisted Indication

Tecartus is not medically necessary for conditions that are not listed in this policy. For any other indication, evaluate coverage under the applicable Off-Label policy.

Covered indications described in this policy: relapsed or refractory MCL and relapsed or refractory B-cell precursor ALL meeting the applicable criteria.
Tecartus will not be reauthorized for continued therapy.

Listed exampleZanubrutinib

Relapsed or refractory B-cell acute lymphoblastic leukemia

Philadelphia chromosome-negative pathwayRelapsed or refractory Philadelphia chromosome-negative (Ph-) disease

Philadelphia chromosome-positive pathwayRelapsed or refractory Philadelphia chromosome-positive (Ph+) disease following therapy that included tyrosine kinase inhibitors (TKIs)

Pathways requiredDocumentation of one of the two disease-status pathways