CurrentNeighborhood Health Plan of Rhode IslandPolicy Evolent Clinical Guideline 3022

Evolent Clinical Guideline 3022 for Tecartus TM (brexucabtagene autoleucel)

Defines approved and acceptable uses, exclusions, and coding for Tecartus (brexucabtagene autoleucel) for treatment of relapsed/refractory B-cell acute lymphoblastic leukemia and mantle cell lymphoma; governs authorization decisions processed by Evolent on behalf of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEvolent Clinical Guideline 3022 for Tecartus TM (brexucabtagene autoleucel)

Policy CodePolicy Evolent Clinical Guideline 3022

Change TypeTemplate conversionrevised indications/exclusions

Effective DateFeb 1, 2025

Next Review Date

Key ActionProviders must supply confirmed documentation of CD-19 positivity in tumor cells for approval.

SourceLink

POLICY UPDATE CHANGES

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

Updated indication section to follow FDA labeling and updated exclusion criteria and verbiage.

2Covered Indications

1HCPCS Code Listed

4Key Exclusion Categories

Coverage Summary & Indications

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Tecartus (brexucabtagene autoleucel) is covered with criteria for adults with relapsed or refractory B‑Cell Acute Lymphoblastic Leukemia (B‑Cell ALL) and relapsed or refractory Mantle Cell Lymphoma when tumor cells are confirmed CD19‑positive. Authorization requires evidence and use that align with FDA approved product labeling, CMS‑recognized compendia, NCCN/ASCO clinical guidelines, or acceptable peer‑reviewed literature meeting CMS standards.

Covered Indications / Initial Use

Tecartus may be authorized when ALL of the following are met:

ALL of the following

Indication is one of the following: relapsed or refractory B-Cell Acute Lymphoblastic Leukemia (B-Cell ALL) in adults with confirmed CD-19 positivity; OR relapsed or refractory Mantle Cell Lymphoma in adults with confirmed CD-19 positivity.
Both indications require confirmed CD-19 positive tumor cells.
Supportive evidence: Use must be supported by one of the following: FDA approved product labeling, CMS-approved compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements.
Dosage limits: treatment does not exceed the maximum limit of 2 × 10^8 CAR-positive viable T cells for Mantle Cell Lymphoma, and 1 × 10^8 CAR-positive viable T cells for B-Cell ALL; and is a one-time administration.Maximum cell dose for Mantle Cell Lymphoma = 2 × 10^8; Maximum cell dose for B-Cell ALL = 1 × 10^8; One-time administration
Requests exceeding these maximums are excluded.

Continuation Therapy Criteria

Continuation Therapy Exemption

Continuation requests for a previously authorized medication may be approved when ALL of the following are met:

No progression: The member has not experienced disease progression on the requested medication.
Recency of use: The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.used within last 1 year with no lapse > 30 days of active authorization
No additional meds: No additional medication(s) are being added to the continuation request.

Exclusion Criteria / Not Medically Necessary

Tecartus is not approvable when ANY of the following exclusion criteria are met:

Prior CD19 CAR-T/progression: Tecartus is being used after disease progression on or after the same regimen or another CAR-T cell therapy directed towards CD19 (e.g., Kymriah, Yescarta).
Concurrent immunosuppression: Concurrent use of other systemic immunosuppressive therapy or live virus vaccines.
Lack of CD19 documentation: Lack of confirmed documentation of CD-19 positivity in tumor cells.
Dose limits exceeded: Treatment exceeds maximum cell dose limits (2 × 10^8 for Mantle Cell Lymphoma; 1 × 10^8 for B-Cell ALL).Maximum cell dose for Mantle Cell Lymphoma = 2 × 10^8; Maximum cell dose for B-Cell ALL = 1 × 10^8
One-time administration: Treatment exceeds maximum duration limit as one-time administration.One-time administration
Investigational/off-label lacking evidence
- Examples of insufficient evidence elements: Clinical characteristics of the patient and cancer are not adequately represented in published evidence; Administered therapy regimen is not adequately represented in published evidence; Reported study outcomes do not represent clinically meaningful outcomes (ASCO guidance: HR <0.80 and OS/PFS benefit >= 3 months as examples); Experimental design is inappropriate to address the investigative question; Case reports and abstracts without full peer-reviewed articles are considered inadequate supportive evidence.Clinically meaningful outcomes example: Hazard Ratio <0.80 and OS/PFS benefit >= 3 months

Provider Actions & Authorization Requirements

Prior Authorization

Authorization required

Evolent must process and authorize all medication requests for Tecartus. Medications that are not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Q2053

Documentation Required

Document CD19 positivity

Approval requires confirmed documentation that the member’s tumor cells are CD19 positive.

Denial Risk

Excluded when prior CD19-directed CAR-T or progression after such therapy

Claims may be denied if Tecartus is used after disease progression on or after the same regimen or another CD19-directed CAR‑T therapy (for example, Kymriah or Yescarta).

Documentation Required

Supportive evidence requirement for off-label use

Off-label (investigational) uses require sufficient supporting evidence from FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. Absence of adequate evidence (for example, lack of representation of the patient/cancer characteristics, inadequate regimen representation, outcomes not clinically meaningful, inappropriate experimental design, reliance on case reports or abstracts without full peer‑reviewed articles) can result in denial.

Clinical Evidence & References

Key evidence includes pivotal/ZUMA studies: ZUMA‑2 (KTE‑X19 in mantle cell lymphoma) and ZUMA‑3 (KTE‑X19) for adult relapsed/refractory B‑Cell ALL, as well as the Tecartus prescribing information (Kite Pharma, 2024). ASCO illustrative thresholds for clinically meaningful outcomes (e.g., HR < 0.80 and OS/PFS benefit of at least 3 months) are provided in the guideline definitions.

Thresholds

Maximum cell dose for Mantle Cell Lymphoma2 × 10^8 CAR-positive viable T cells

Maximum cell dose for B-Cell ALL1 × 10^8 CAR-positive viable T cells

Continuation request recencyUsed within last 1 year with no lapse > 30 days of active authorization

Background & Definitions

Tecartus is a CD19‑directed CAR T‑cell therapy indicated for certain adult patients with relapsed or refractory B‑Cell ALL and mantle cell lymphoma (confirmed CD19 positivity). Authorization and continued use must be supported by alignment with FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Definitions

Clinically meaningful outcomes (ASCO guidance)Hazard Ratio < 0.80 and OS/PFS benefit of at least 3 months (illustrative guidance)