Currentculinary health fundPolicy N/A

Tecartus (brexucabtagene autoleucel) CAR‑T therapy coverage

Defines prior authorization criteria, dosing limits, and coverage stance for Tecartus (brexucabtagene autoleucel) for adults with relapsed or refractory B‑cell precursor acute lymphoblastic leukemia and mantle cell lymphoma; intended for clinicians and billing/authorization staff.

Policy Summary

Payerculinary health fund

PolicyTecartus (brexucabtagene autoleucel) CAR‑T therapy coverage

Policy CodePolicy N/A

Change TypeClarified (no material criteria changes)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient meets the listed clinical criteria, including planned or received lymphodepleting chemotherapy, and that prescribing is by or in consultation with an oncologist.

SourceLink

POLICY UPDATE CHANGES

Policy revision history indicates no criteria changes for the most recent annual revision (08/20/2025).

2FDA‑approved indications covered

1 doseapproval duration per indication (single administration allowed)

6authorization duration to allow preparation/administration

Recommended Authorization Criteria

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FDA‑Approved Indication — Acute Lymphoblastic Leukemia (ALL)

Approve a single dose if the patient meets ALL of the following (A–F):

ALL of the following

Patient is ≥ 18 years of age≥ 18 years
Patient has B‑cell precursor disease
Patient has relapsed or refractory disease
Patient received or plans to receive lymphodepleting chemotherapy prior to Tecartus infusion
Patient has not been previously treated with CAR‑T therapy
Examples of CAR‑T therapy include Tecartus, Breyanzi (lisocabtagene maraleucel), Kymriah (tisagenlecleucel), Yescarta (axicabtagene), and Abecma (idecabtagene vicleucel).
Tecartus is prescribed by or in consultation with an oncologist

FDA‑Approved Indication — Mantle Cell Lymphoma (MCL)

Approve a single dose if the patient meets ALL of the following (A–E):

ALL of the following

Patient is ≥ 18 years of age≥ 18 years
Patient has relapsed or refractory disease
Patient received or plans to receive lymphodepleting chemotherapy prior to Tecartus infusion
Patient has not been previously treated with CAR‑T therapy
Examples of CAR‑T therapy include Tecartus, Breyanzi (lisocabtagene maraleucel), Kymriah (tisagenlecleucel), Yescarta (axicabtagene), and Abecma (idecabtagene vicleucel).

Authorization, Documentation, and Billing Actions

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for medical benefit coverage of Tecartus. Approval requires meeting the listed clinical criteria and dosing limits.

Documentation Required

Specialist prescribing/consult requirement

Tecartus must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist).

Documentation Required

Lymphodepleting chemotherapy documentation

Provider must document that the patient received or plans to receive lymphodepleting chemotherapy prior to Tecartus infusion.

Denial Risk

Not eligible outside criteria

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria; submissions that do not meet the criteria may be denied.

Documentation Required

Authorization duration

The approval duration is 6 months to allow for an adequate time frame to prepare and administer a single dose of therapy.

Clinical and Product Background

Tecartus (brexucabtagene autoleucel) is an autologous, CD19‑directed chimeric antigen receptor T‑cell (CAR‑T) immunotherapy indicated for adults with relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (ALL) and mantle cell lymphoma (MCL). The MCL indication is approved under accelerated approval based on overall response rate and durability of response; continued approval for MCL may be contingent on verification of clinical benefit in a confirmatory trial and ongoing verification of benefit is required.

Tecartus is supplied frozen in infusion bag(s) contained within a metal cassette stored in the vapor phase of liquid nitrogen and must be thawed prior to administration. The product handling and administration considerations reflect that it is a frozen cellular therapy requiring specialized preparation and one‑time intravenous infusion.

Tecartus carries a Boxed Warning for cytokine release syndrome and neurological (neurologic) toxicities; the prescribing information also notes risks of T‑cell malignancies. These serious toxicities require administration and monitoring by clinicians experienced with CAR‑T therapies and appropriate supportive care.

This policy requires specialist involvement and prior authorization to ensure appropriate patient selection and monitoring. Approval is for a single dose per indication with specific dosing limits (up to 1 x 10^8 CAR‑positive viable T‑cells for ALL; up to 2 x 10^8 CAR‑positive viable T‑cells for MCL) and an authorization duration of 6 months to allow for preparation and administration.

Policy Changes / History

2025-08-20annual_revisionLatest

Annual revision completed with no clinical criteria changes for the most recent review.

2024-08-21annual_revision

Mantle cell lymphoma criteria revised: removed requirement for prior chemotherapy plus a Bruton tyrosine kinase inhibitor and added requirement that the patient has relapsed or refractory disease.

2023-08-16annual_revision

Annual revision completed with no clinical criteria changes.

Policy Summary

Payerculinary health fund

PolicyTecartus (brexucabtagene autoleucel) CAR‑T therapy coverage

Policy CodePolicy N/A

Change TypeClarified (no material criteria changes)

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

dose_ALL	Up to 1 x 10^8 CAR‑positive viable T‑cells (single IV administration) for Acute Lymphoblastic Leukemia
dose_MCL	Up to 2 x 10^8 CAR‑positive viable T‑cells (single IV administration) for Mantle Cell Lymphoma

OpenPayer

Tecartus (brexucabtagene autoleucel) CAR‑T therapy coverage

Recommended Authorization Criteria

Dosing (clinical specification)

Authorization, Documentation, and Billing Actions

Clinical and Product Background

Defined Terms

Policy Changes / History

At-a-glance Authorization Metrics