ModifiedBaylor Scott & White Health PlanPolicy 281

Brexucabtagene autoleucel (Tecartus) Coverage

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This policy governs medical necessity and prior authorization for brexucabtagene autoleucel (Tecartus) in adults with relapsed or refractory mantle cell lymphoma or B-cell precursor acute lymphoblastic leukemia. Coverage requires universal and indication-specific criteria; applicable benefit-plan documents, federal requirements, and Medicaid guidance may further control coverage.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyBrexucabtagene autoleucel (Tecartus) Coverage

Policy CodePolicy 281

Change TypeModified

Effective DateOct 1, 2026

Last ReviewSep 24, 2026

Next Review DateSep 24, 2027

Key ActionSubmit prior authorization for brexucabtagene autoleucel; requests are reviewed by a clinical pharmacist and a medical director.

SourceLink

POLICY UPDATE CHANGES

Universal criteria were revised to align with standardized CAR-T therapy requirements.

Central nervous system involvement criteria were added or revised by indication.

Lifetime treatment limits and experimental-use language were revised.

Several prior universal exclusions were removed.

Two B-ALL exclusions were removed.

CAR T-cell and anti-CD19 therapy language was revised.

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ModifiedBaylor Scott & White Health PlanPolicy 281

Brexucabtagene autoleucel (Tecartus) Coverage

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Sign up for Baylor Scott & White Health Plan Policy 281 alerts

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Policy Summary

PayerBaylor Scott & White Health Plan

PolicyBrexucabtagene autoleucel (Tecartus) Coverage

Policy CodePolicy 281

Change TypeModified

Effective DateOct 1, 2026

Last ReviewSep 24, 2026

Next Review DateSep 24, 2027

Key ActionSubmit prior authorization for brexucabtagene autoleucel; requests are reviewed by a clinical pharmacist and a medical director.

SourceLink

POLICY UPDATE CHANGES

Universal criteria were revised to align with standardized CAR-T therapy requirements.

Central nervous system involvement criteria were added or revised by indication.

Lifetime treatment limits and experimental-use language were revised.

Several prior universal exclusions were removed.

Two B-ALL exclusions were removed.

CAR T-cell and anti-CD19 therapy language was revised.

2Covered adult cancer indications

ECOG 0-1Required performance status

1 lifetimeTreatment limit

18+Minimum member age

4CPT codes listed

Q2053HCPCS product code

Coverage Criteria

Universal criteria

Coverage is available when all universal criteria are met and the applicable indication-specific criteria are met.

Required exclusions absent: Member does not have active hepatitis B with HBsAg positivity, active hepatitis C, HIV infection, or an uncontrolled infection.

Mantle cell lymphoma

For mantle cell lymphoma, all criteria must be met, including the universal criteria.

MCL coverage criteria

Relapsed or refractory disease: Disease progression after the last regimen, or failure to achieve a partial response or complete response to the last regimen.
Required prior therapy: Anthracycline-, bendamustine-, or lenalidomide-containing chemotherapy; anti-CD20 monoclonal antibody therapy; and Bruton's tyrosine kinase inhibitor therapy.
Examples include rituximab, ibrutinib, acalabrutinib, and zanubrutinib.

B-cell precursor acute lymphoblastic leukemia

For B-cell precursor acute lymphoblastic leukemia, all criteria must be met, including the universal criteria.

B-ALL coverage criteria

Applicable disease pathway
- Ph-negative B-ALL: Member has disease refractory to first-line therapy; first relapse following a remission lasting 12 months or less; relapsed or refractory disease after second-line or higher therapy; or relapsed or refractory disease at least 100 days after allogeneic stem-cell transplantation.First remission ≤12 months; or at least 100 days after allogeneic HSCT
- Ph-positive B-ALL: Member has relapsed or refractory disease despite treatment with at least two different TKIs; is intolerant to TKI therapy; or has a contraindication to TKI therapy.At least 2 different TKIs when applicable

Experimental and investigational use

The following uses are not medically necessary under this policy.

Experimental and investigational use: Repeat administration of brexucabtagene after one treatment per lifetime, or treatment of indications other than relapsed or refractory mantle cell lymphoma and B-cell precursor acute lymphoblastic leukemia.One treatment per lifetime

Effectiveness of repeat administration and other indications has not been established.

Coverage requires absence of active hepatitis B with HBsAg positivity, active hepatitis C, HIV infection, and uncontrolled infection.

For mantle cell lymphoma, coverage is not available when the member has undergone allogeneic hematopoietic stem-cell transplantation within the preceding 84 days before leukapheresis or has central nervous system involvement.

For B-cell precursor acute lymphoblastic leukemia, coverage is not available for CNS-2 disease with neurologic changes or CNS-3 disease regardless of neurologic changes.

BSWHP considers only one treatment per lifetime medically necessary. Repeat administration of brexucabtagene autoleucel is considered experimental and investigational because its effectiveness has not been established.

Brexucabtagene autoleucel is considered experimental and investigational when used for indications other than covered relapsed or refractory mantle cell lymphoma and B-cell precursor acute lymphoblastic leukemia, because the effectiveness of treatment for other indications has not been established.

Coding and Operational Thresholds

CPT CodesCPT

38225	Chimeric antigen receptor T-cell (CAR-T) therapy; harvest of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day
38226	Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for transportation (e.g., cryopreservation, storage)
38227	Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preservation of CAR-T cells for administration
38228	Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous

HCPCS CodesHCPCS

Q2053

Brexucabtagene autoleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose

ICD-10 CodesICD-10

C83.10-C83.19	Mantle cell lymphoma
C91.00-C91.02	Acute lymphoblastic leukemia

ICD-10 Not coveredICD-10Not Covered

No codes listed

ECOG Performance Status

Required ECOG statusECOG performance status of 0 or 1

Applies toAll requests for brexucabtagene autoleucel

Not eligibleAn ECOG performance status above 1 does not meet the requirement

MCL HSCT Interval

Required intervalNo allogeneic hematopoietic stem-cell transplantation in the preceding 84 days before leukapheresis

Applicable indicationMantle cell lymphoma

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required before brexucabtagene autoleucel (Tecartus™) is administered. Submit clinical documentation for review; all requests are reviewed by both a clinical pharmacist and a medical director.

For Medicare plans, refer to Medicare NCD 110.24, Chimeric Antigen Receptor (CAR) T-cell Therapy.
For Medicaid plans, confirm coverage under the Texas Medicaid Provider Procedures Manual (TMPPM); Texas Mandate HB154 applies to Medicaid plans.

Documentation Required

Universal Eligibility Documentation

Submit documentation demonstrating that the member meets all universal eligibility criteria before indication-specific review.

Member is 18 years or older.
Tecartus™ is prescribed by or in consultation with a board-certified hematologist or oncologist.

Therapy Background

Brexucabtagene autoleucel is a CD19-directed, genetically modified autologous T-cell immunotherapy prepared from the member’s leukapheresis product. The engineered chimeric antigen receptor recognizes CD19 and activates T-cell antitumor activity against CD19-expressing cells. This policy addresses adults with relapsed or refractory mantle cell lymphoma or relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Relapsed or Refractory Disease Definitions

Relapsed or Refractory MCL

Relapsed diseaseDisease progression after the last regimen

Refractory diseaseFailure to achieve a partial response or complete response to the last regimen

Applicable conditionMantle cell lymphoma

Relapsed or Refractory Ph-Negative B-ALL

Primary refractory diseaseRefractory to first-line therapy

First relapseFirst relapse following a remission lasting 12 months or less

Later-line or post-transplant disease

Required Treatment Line

Salvage therapy — mantle cell lymphoma

For salvage therapy in mantle cell lymphoma, all of the following prior-treatment requirements must be met:

MCL salvage therapy: Relapsed or refractory mantle cell lymphoma after adequate prior therapy including anthracycline-, bendamustine-, or lenalidomide-containing chemotherapy, anti-CD20 monoclonal antibody therapy, and BTK inhibitor therapy.

Salvage therapy — B-cell precursor acute lymphoblastic leukemia

For salvage therapy in B-cell precursor acute lymphoblastic leukemia, the member must meet at least one applicable disease-course requirement:

B-ALL salvage therapy: Primary refractory disease; first relapse after a remission lasting 12 months or less; relapsed or refractory disease after second-line or higher therapy; relapsed or refractory disease at least 100 days after allogeneic HSCT; or Philadelphia chromosome-positive disease after treatment with at least two TKIs, TKI intolerance, or TKI contraindication.First remission ≤12 months; or at least 100 days after allogeneic HSCT; or at least 2 TKIs when applicable

Required Disease Biomarkers

CD19 Tumor Expression

Required biomarkerCD19 tumor expression must be documented

After prior anti-CD19 therapyA repeat biopsy must indicate CD19-positive disease

Examples of prior anti-CD19 therapyTafasitamab or loncastuximab

Philadelphia Chromosome

Applicable diseaseB-cell precursor acute lymphoblastic leukemia

Ph-negative pathwayPh-negative disease applies the criteria for primary refractory disease, first relapse after remission lasting 12 months or less, later-line relapse or refractory disease, or disease at least 100 days after allogeneic HSCT

Covered Treatment Regimens

Indication	Covered regimen	Coverage
Relapsed or refractory mantle cell lymphoma (MCL)	Brexucabtagene autoleucel as monotherapy after adequate prior therapy including anthracycline-, bendamustine-, or lenalidomide-containing chemotherapy; anti-CD20 monoclonal antibody therapy; and Bruton's tyrosine kinase inhibitor (BTKi) therapy. Member must have at least 1 measurable lesion.	Covered

Indication	Covered regimen	Coverage
Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL)	Brexucabtagene autoleucel as monotherapy for applicable Philadelphia chromosome (Ph)-negative or Ph-positive disease criteria. Ph-negative criteria include primary refractory disease, first relapse after remission lasting 12 months or less, relapse or refractory disease after second-line or higher therapy, or relapse or refractory disease at least 100 days after allogeneic HSCT. Ph-positive criteria include disease despite at least two different TKIs, TKI intolerance, or TKI contraindication.	Covered

Indication or treatment	Regimen	Coverage
Repeat administration or any indication other than relapsed or refractory MCL and B-cell precursor ALL	Repeat brexucabtagene autoleucel treatment beyond one treatment per lifetime, or treatment for another indication.	Experimental and investigational

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyBrexucabtagene autoleucel (Tecartus) Coverage

Policy CodePolicy 281

Change TypeModified

Effective DateOct 1, 2026

Last ReviewSep 24, 2026

Next Review DateSep 24, 2027

Key ActionSubmit prior authorization for brexucabtagene autoleucel; requests are reviewed by a clinical pharmacist and a medical director.

SourceLink

On This Page

Related exclusionAllogeneic HSCT within the preceding 84 days before leukapheresis excludes coverage for MCL

Ph-Negative B-ALL First Relapse

Applicable diseasePhiladelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia

First-relapse thresholdFirst relapse following a remission lasting 12 months or less

Other qualifying disease coursesPrimary refractory disease, relapsed or refractory disease after second-line or higher therapy, or relapsed or refractory disease at least 100 days after allogeneic HSCT

Ph-Negative B-ALL HSCT Interval

Required intervalAt least 100 days after allogeneic stem-cell transplantation

Applicable diseasePhiladelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia

Disease statusThe disease must be relapsed or refractory

Lifetime Treatment Limit

Lifetime limitOne treatment per lifetime

Repeat administrationRepeat administration beyond one treatment is experimental and investigational

RationaleThe effectiveness of repeat administration has not been established

Tecartus™ will be dosed and administered according to FDA-approved labeling and used as monotherapy.

Member has an ECOG performance status of 0 or 1.

A hematologist/oncologist has assessed the member as an appropriate candidate for apheresis.

Documentation confirms CD-19 tumor expression.

There has been no prior CAR T-cell immunotherapy (for example, lisocabtagene or obecabtagene).

If prior anti-CD19 therapy was given, a repeat biopsy confirms CD-19-positive disease.

Member does not have active hepatitis B (HBsAg-positive), active hepatitis C, HIV infection, or uncontrolled infection.

Documentation Required

MCL Clinical Documentation

For MCL requests, provide documentation that the member meets all universal criteria and the MCL-specific medical-necessity requirements.

At least one measurable lesion is present.
Disease is relapsed or refractory: progression after the last regimen, or failure to achieve a partial or complete response to the last regimen.
Adequate prior therapy includes an anthracycline-, bendamustine-, or lenalidomide-containing chemotherapy; an anti-CD20 monoclonal antibody such as rituximab; and a BTK inhibitor such as ibrutinib, acalabrutinib, or zanubrutinib.
Documentation confirms no allogeneic hematopoietic stem-cell transplantation within the 84 days preceding leukapheresis and no central nervous system involvement.

Documentation Required

B-ALL Clinical Documentation

For B-ALL requests, provide documentation that the member meets all universal criteria and the applicable B-ALL disease-status requirements.

For Philadelphia chromosome (Ph)-negative B-cell precursor ALL, document primary refractory disease, first relapse following remission lasting 12 months or less, relapsed or refractory disease after second-line or higher therapy, or relapsed or refractory disease at least 100 days after allogeneic HSCT.
For Ph-positive B-cell precursor ALL, document relapsed or refractory disease despite at least two different TKIs, or intolerance or contraindication to TKI therapy.
Document absence of CNS disorders, including CNS-2 disease with neurologic changes and CNS-3 disease regardless of neurologic changes.

Denial Risk

Failure to Meet Universal Treatment Requirements

Authorization may be denied when the requested treatment does not satisfy the universal treatment requirements. Tecartus™ must be used for an eligible adult, under hematology/oncology supervision, in accordance with FDA labeling, and as monotherapy.

Denial risk applies when the member is younger than 18, the prescriber requirement is not met, dosing or administration is outside FDA labeling, or the requested use is not monotherapy.

Denial Risk

Inadequate Clinical Status or Eligibility Documentation

Authorization may be denied when clinical status or eligibility cannot be established from the submitted records, including required performance status, apheresis candidacy, CD-19 expression, or disease-specific eligibility.

Submit adequate records to verify ECOG 0-1, hematologist/oncologist assessment for apheresis, CD-19 tumor expression, and the applicable MCL or B-ALL disease status.
For MCL, records must establish at least one measurable lesion; for B-ALL, records must establish a covered relapsed or refractory disease category.

Denial Risk

Prior Cellular or Anti-CD19 Therapy

Authorization may be denied when the member has received prior CAR T-cell immunotherapy or when prior anti-CD19 therapy is followed by CD-19-negative disease.

Prior CAR T-cell therapy includes agents such as lisocabtagene or obecabtagene.
After prior anti-CD19 therapy such as tafasitamab or loncastuximab, a repeat biopsy must demonstrate CD-19-positive disease.

Denial Risk

Active Infection or Viral Disease

Authorization may be denied when the member has active hepatitis B (HBsAg-positive), active hepatitis C, HIV infection, or an uncontrolled infection.

Document that none of these exclusionary infections or conditions is present at the time of review.

Denial Risk

MCL-Specific Denial Conditions

MCL requests may be denied when indication-specific clinical requirements are not met or an MCL exclusion applies.

No measurable lesion.
Disease is not relapsed or refractory as defined by progression after the last regimen or failure to achieve a partial or complete response.
Required prior therapy is incomplete: anthracycline-, bendamustine-, or lenalidomide-containing chemotherapy; anti-CD20 monoclonal antibody therapy; and BTKi therapy.
Allogeneic hematopoietic stem-cell transplantation occurred within the 84 days before leukapheresis.
Central nervous system involvement is present.

Denial Risk

B-ALL-Specific Denial Conditions

B-ALL requests may be denied when the disease status does not meet a covered relapsed or refractory pathway or when a CNS exclusion applies.

Ph-negative B-ALL does not meet the specified primary refractory, first-relapse with remission of 12 months or less, post-second-line-or-higher, or post-allogeneic-HSCT-at-least-100-days criteria.
Ph-positive B-ALL lacks relapsed or refractory disease after at least two TKIs and is not documented as TKI-intolerant or having a TKI contraindication.
CNS-2 disease with neurologic changes or CNS-3 disease, regardless of neurologic changes, is present.

Denial Risk

Repeat or Non-Covered Indication

BSWHP considers only one Tecartus™ treatment per lifetime medically necessary. Repeat administration and use for indications outside the covered MCL or B-ALL criteria are experimental and investigational because effectiveness has not been established.

Repeat administration is not medically necessary.
All other indications are considered experimental and investigational.

Relapsed or refractory disease after second-line or higher therapy, or at least 100 days after allogeneic HSCT

Relapsed or Refractory Ph-Positive B-ALL

Multiple TKI failureRelapsed or refractory disease despite treatment with at least two different tyrosine kinase inhibitors

TKI intoleranceThe member is intolerant to TKI therapy

TKI contraindicationThe member has a contraindication to TKI therapy

Ph-positive disease applies the criteria involving at least two different TKIs, TKI intolerance, or TKI contraindication