CurrentBaylor Scott & White Health PlanPolicy N/A

Brexucabtagene autoleucel (Tecartus)

Defines medical necessity criteria, prior authorization requirement, indication-specific requirements, exclusions, lifetime limit, and applicable billing codes for brexucabtagene autoleucel (Tecartus) for mantle cell lymphoma (MCL) and B-cell precursor acute lymphoblastic leukemia (B-ALL). Applies to all lines of business unless superseded by plan documents or federal/state mandates.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyBrexucabtagene autoleucel (Tecartus)

Policy CodePolicy N/A

Change TypeReformatted; universal criteria updated (10/14/2024)

Effective DateJan 1, 2025

Next Review DateOct 14, 2025

Key ActionPrior authorization is required; provider must attest REMS requirements are met and document CD19 expression, ECOG 0-1, eligibility for apheresis, planned lymphodepletion, prior therapies, and indication-specific disease status.

POLICY UPDATE CHANGES

Reformatted with Universal and Specific criteria; updated universal criteria to align exclusion criteria when applicable across CAR-T therapies.

2Covered Indications (MCL, B-ALL)

1Lifetime doses allowed

Q2053Primary HCPCS code

Coverage Summary

This policy outlines coverage for brexucabtagene autoleucel (Tecartus) and the scope applies to mantle cell lymphoma (MCL) and B-cell precursor acute lymphoblastic leukemia (B-ALL). The plan stance is covered with criteria: Tecartus is considered medically necessary only when the specified universal criteria and the indication-specific criteria (MCL or B-ALL) are met. The policy effective date is 1/1/2025, last review 10/14/2024, and next review 10/14/2025. Prior authorization is required and only one dose per lifetime is considered medically necessary. Use of Tecartus is subject to the FDA REMS requirements because of the risk of cytokine release syndrome (CRS) and neurologic toxicities.

Policy metadata and quick facts

effective date2025-01-01

last_review2024-10-14

next_review2025-10-14

coverage_stancecovered_with_criteria

subjectBrexucabtagene autoleucel (Tecartus) CAR-T therapy coverage

scope_summaryDefines medical necessity criteria, prior authorization requirement, indication-specific requirements, exclusions, lifetime limit, and applicable billing codes for brexucabtagene autoleucel (Tecartus) for mantle cell lymphoma (MCL) and B-cell precursor acute lymphoblastic leukemia (B-ALL). Applies to all lines of business unless superseded by plan documents or federal/state mandates.

threshold: Allogeneic HSCT to leukapheresis interval (MCL exclusion)Allogeneic HSCT in the preceding 84 days before leukapheresis is exclusionary

threshold: Lifetime dose limitOnly ONE dose per lifetime is considered medically necessary

threshold: Primary HCPCS/drug codeQ2053 (brexucabtagene autoleucel, per therapeutic dose)

threshold: Relevant CPT code36511 (Therapeutic apheresis; white blood cells)

Medical Necessity Criteria

Universal criteria (applies to all indications)

Brexucabtagene autoleucel (Tecartus) is considered medically necessary when ALL of the following universal criteria are met:

ALL of the following

Member is ≥ 2 and ≤ 18 years old
As printed: 'Member is 2 18 years old' — likely intended as age criteria; source text ambiguous
Member diagnosed by a hematologist or oncologist
Brexucabtagene autoleucel will be used as monotherapy
Dose and frequency should be consistent with FDA labeling or NCCN
Member is eligible for apheresis
Member has or will receive lymphodepleting chemotherapy (e.g., fludarabine and cyclophosphamide) before infusion of brexucabtagene autoleucel
Provider attests all REMS program requirements are met
REMS required per boxed warning for CRS and neurologic toxicity
Member has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Member has documentation of CD19 tumor expression
Member has NOT received prior treatment with CD19-targeted CAR-T cell therapy
If the member has received prior treatment with anti-CD19 therapy the member's repeat biopsy indicated CD19 positive disease
Universal exclusions (member must NOT have any of the following)
- Active hepatitis B (HBsAg-positive), active hepatitis C, HIV infection, or uncontrolled infection
- History of central nervous system disorders (ex. seizure disorder, cerebrovascular ischemia)
- Primary immunodeficiency
- Pregnant

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for brexucabtagene autoleucel (Tecartus). All requests will be reviewed by a clinical pharmacist and a medical director.

Q2053
36511

Documentation Required

Attestation and documentation requirements

Provider must attest REMS program requirements are met and document CD19 tumor expression, ECOG performance status 0–1, eligibility for apheresis, planned lymphodepleting chemotherapy, prior therapies (including BTKi and TKIs where applicable), and indication-specific disease status.

REMS program requirements are met
Documentation of CD19 tumor expression
ECOG performance status 0-1
Eligibility for apheresis
Planned lymphodepleting chemotherapy (e.g., fludarabine and cyclophosphamide)
Documentation of prior therapies (including BTKi and TKIs where applicable)
Indication-specific disease status

Billing Rule

One dose lifetime limit

Only ONE dose per lifetime.

Q2053

Denial Risk

Exclusion conditions may lead to denial

Claims may be denied if the member has any exclusionary conditions listed in the policy.

Active hepatitis B (HBsAg-positive), active hepatitis C, HIV infection, or uncontrolled infection
Pregnancy
Primary immunodeficiency
History of central nervous system disorders (e.g., seizure disorder, cerebrovascular ischemia); for B-ALL includes CNS-2 with neurologic changes and CNS-3 disease
Allogeneic hematopoietic stem-cell transplantation within the preceding 84 days before leukapheresis
Active graft-versus-host disease (GVHD)
Active inflammatory disorder requiring systemic immunosuppression (depending on indication)

Background & Evidence

Brexucabtagene autoleucel (Tecartus) is an autologous anti-CD19 CAR-T cell therapy manufactured by collecting a patient’s lymphocytes via leukapheresis, genetically modifying them (viral vector transfer) to express a CD19-directed CAR, and then reinfusing the expanded CAR-T cells after the patient receives lymphodepleting chemotherapy (eg, fludarabine and cyclophosphamide). Tecartus received accelerated FDA approval for adult relapsed or refractory mantle cell lymphoma and was later approved for relapsed or refractory B-cell precursor ALL based on response rates in clinical trials. The product is available only through a restricted program under a REMS due to risks of cytokine release syndrome (CRS) and neurologic toxicities (boxed warning), and administration requires specialist management and facility capability to monitor and treat these toxicities. Relevant billing and procedure codes include CPT 36511 for therapeutic apheresis (white blood cells) and HCPCS Q2053 for brexucabtagene autoleucel (per therapeutic dose).

Evidence summaries

Number	Name	Type	Effective Date
110.24	Chimeric Antigen Receptor (CAR) T-cell Therapy	NCD