CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tecartus (brexucabtagene autoleucel) — Coverage Criteria

Defines indications, exclusions, coding, and authorization context for Tecartus (brexucabtagene autoleucel) use for adult members with specific CD19-positive hematologic malignancies and describes payer processing responsibilities.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTecartus (brexucabtagene autoleucel) — Coverage Criteria

Policy CodePolicy N/A

Change TypeIndication and exclusion updatestemplate conversion

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of FDA indication, confirmed CD19 positivity, and dosing within product-specific CAR-positive viable T cell limits using HCPCS Q2053.

SourceLink

POLICY UPDATE CHANGES

Updated indication section to follow FDA labeling.

Updated exclusion criteria.

Converted to new Evolent guideline template and replaced prior UM ONC_1413 Tecartus policy.

2FDA-recognized primary indications covered

Q2053HCPCS code

1Max administrations

200MMax CAR+ viable T cells

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Coverage Criteria for Tecartus (brexucabtagene autoleucel)

Initial Therapy

Covered when ALL of the following are met:

Initial therapy for indicated adult malignancies

Diagnosis: Relapsed or refractory B-Cell Acute Lymphoblastic Leukemia (adult) OR relapsed or refractory Mantle Cell Lymphoma (adult)
See FDA‑labeled indications in source
Biomarker requirement: Documentation of confirmed CD19 positivity in tumor cells
Required for authorization
Evidence basis: Use is supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO clinical guidelines, or acceptable peer‑reviewed literature
Per policy purpose and evidence standards

Authorization and coding: Prior authorization is required and claims should use the specified HCPCS code for Tecartus (Q2053)

See provider actions and coding requirements

Initial Therapy Coverage

Initial coverage limited to the following FDA‑recognized, CD19‑positive indications:

Covered indications (initial coverage): Relapsed or refractory B-Cell Acute Lymphoblastic Leukemia (adult) with confirmed CD19 positivity; Relapsed or refractory Mantle Cell Lymphoma (adult) with confirmed CD19 positivity

Initial coverage is limited to these FDA‑labeled indications

Exclusions

Exclusions and limits — any of the following excludes coverage:

Exclusion conditions: Use after disease progression on or after the same regimen or another CD19‑directed CAR‑T therapy; concurrent use of systemic immunosuppressive therapy or live virus vaccines; lack of confirmed documentation of CD19 positivity in tumor cells; treatment exceeding product‑specific maximum CAR‑positive viable T cell limits for the indication (Mantle Cell Lymphoma: 2 × 10^8; B‑Cell ALL: 1 × 10^8); treatment exceeding the single‑administration limit (one time administration); investigational or off‑label use without sufficient supportive evidence (case reports or abstracts without full peer‑reviewed support are inadequate)

See exclusion criteria details in source

Coverage is excluded when Tecartus is used after disease progression on or after the same regimen or another CD19‑directed CAR‑T therapy. Requests will also be excluded when there is concurrent systemic immunosuppressive therapy or live virus vaccination documented, when there is no confirmed documentation of CD19 positivity in tumor cells, when dosing would exceed product‑specific CAR‑positive viable T cell limits for the indication (up to 2 × 10^8 for Mantle Cell Lymphoma; up to 1 × 10^8 for B‑Cell ALL), or when treatment would exceed the single‑administration limit specified by the product.

These exclusion conditions are used to determine authorization eligibility and potential denial risk; providers should include documentation demonstrating absence of these exclusion triggers when submitting an authorization request.

Use of Tecartus for off‑label or investigational indications is considered not medically necessary unless there is sufficient supportive evidence from CMS‑recognized compendia or acceptable peer‑reviewed literature. The policy requires evidence that the patient population and treatment regimen are adequately represented, that reported outcomes are clinically meaningful (for example, ASCO‑recommended effect sizes such as a hazard ratio < 0.80 or survival benefit thresholds), and that the study design is appropriate to the question being addressed.

Single case reports and meeting abstracts without a full peer‑reviewed publication are specifically noted as inadequate to support coverage for investigational/off‑label uses.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Tecartus (brexucabtagene autoleucel) for covered indications. Authorization must be obtained prior to administration.

Applies to Tecartus (brexucabtagene autoleucel)
See coding: Q2053

Prior Authorization

Continuation Request Conditions

Continuation requests will be considered when all conditions below are met. Continuation requests for a medication that would otherwise be not-approvable are exempt from denial when these conditions are satisfied.

Member has not experienced disease progression on the requested medication
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
No additional medication(s) are being added to the continuation request

Documentation Required

Required Documentation

Documentation must be provided to support the request and demonstrate that the use aligns with FDA labeling, recognized compendia, or accepted clinical guidelines. Submit clinical records that clearly confirm diagnosis, CD19 positivity where required, prior therapies, dosing limits, and site-of-care details.

Diagnosis and indication (e.g., relapsed/refractory B‑Cell ALL or Mantle Cell Lymphoma)
Pathology report or other documentation confirming CD19 positivity in tumor cells
Documentation of prior lines of therapy and response (including prior CAR‑T therapies and outcomes)
Planned dose and manufacturing specification (to demonstrate compliance with dosing limits)
Documentation that treatment will not exceed single‑administration limits (1 × 10^8 CAR‑positive viable T cells for B‑Cell ALL; 2 × 10^8 CAR‑positive viable T cells for Mantle Cell Lymphoma)
Site of care documentation (infusion center or authorized facility) and treatment plan
Supporting literature or compendia if used for an off‑label indication (NCCN, ASCO, CMS‑recognized compendia, or peer‑reviewed literature meeting Medicare standards)

Denial Risk

Exclusion Triggers for Authorization

Authorization may be denied for uses that meet any of the exclusion triggers below. Requests that are investigational or lack adequate supporting evidence will also be denied.

Use of Tecartus after disease progression on or after the same regimen or another CD19‑directed CAR‑T cell therapy
Prior treatment with another CD19 CAR‑T product (e.g., tisagenlecleucel/Kymriah, axicabtagene ciloleucel/Yescarta) with subsequent progression
Concurrent use of other systemic immunosuppressive therapy or administration of live virus vaccines
Lack of confirmed documentation of CD19 positivity in tumor cells
Requested treatment exceeds maximum per‑dose CAR‑positive viable T cell limits (exceeds 1 × 10^8 for B‑Cell ALL; exceeds 2 × 10^8 for Mantle Cell Lymphoma)
Requests that exceed the single‑administration duration limit (Tecartus is administered as a one‑time therapy)
Investigational or off‑label indications lacking sufficient evidence or not supported by CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature (insufficient evidence includes inadequate representation of patient/clinical characteristics, inadequate regimen representation, lack of clinically meaningful outcomes, or inappropriate experimental design)

Documentation Required

Infusion Center / Site of Care Documentation

Site‑of‑care information should be provided to confirm appropriate administration setting and capabilities (e.g., inpatient/authorized outpatient infusion center experienced with CAR‑T therapy and management of cytokine release syndrome and neurotoxicity).

Name and address of treating facility and contact provider
Confirmation that the facility has CAR‑T experience and protocols for managing expected toxicities
Planned admission status (inpatient vs outpatient) and monitoring plan

Coding and Quantity Limits

Covered HCPCS CodesHCPCSCovered

Q2053

Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose

inv-06: Maximum CAR-positive viable T cells per dose — product-specific per-indication limits

Mantle Cell Lymphoma maximum per doseUp to 2 × 10^8 CAR-positive viable T cells per administration (product-specific limit)

B-Cell ALL maximum per doseUp to 1 × 10^8 CAR-positive viable T cells per administration (product-specific limit)

Billing code and aggregated capReported per therapeutic dose using HCPCS Q2053 (Brexucabtagene autoleucel) which is billed for up to 200 million CAR-positive viable T cells per dose

inv-15: Brexucabtagene autoleucel (Tecartus) — Maximum per administration product-specific CAR-positive viable T cell limit

ProductBrexucabtagene autoleucel (Tecartus)

HCPCS code (per therapeutic dose)Q2053 — Brexucabtagene autoleucel, up to 200 million autologous anti-CD19 CAR-positive viable T cells (includes leukapheresis and dose preparation)

Administration limitSingle administration per treatment course as specified; dosing must not exceed product-specific CAR-positive viable T cell limits for the indicated diagnosis

Background on Tecartus

Tecartus (brexucabtagene autoleucel) is an autologous anti‑CD19 chimeric antigen receptor T‑cell (CAR‑T) therapy indicated for certain relapsed or refractory adult B‑cell malignancies. The policy covers FDA‑labeled indications for adults with relapsed or refractory B‑Cell Acute Lymphoblastic Leukemia and relapsed or refractory Mantle Cell Lymphoma when tumor cells are confirmed CD19‑positive and documentation supports use per accepted guidance.

Clinical evidence supporting Tecartus includes pivotal CAR‑T trials in these indications (for example, ZUMA‑2 for mantle cell lymphoma and ZUMA‑3 for B‑cell ALL); authorization requires documentation consistent with FDA labeling, compendia, or accepted peer‑reviewed literature, and site‑of‑care and dosing must conform to product‑specific limits.

OpenPayer

Tecartus (brexucabtagene autoleucel) — Coverage Criteria

Coverage Criteria for Tecartus (brexucabtagene autoleucel)

Continuation / Re-authorization Criteria

Provider Actions and Authorization Requirements

Coding and Quantity Limits

Background on Tecartus

Definitions and Key Terms

Site of Care Requirements