CurrentMass General Brigham Health PlanPolicy 054

Tecartus (brexucabtagene autoleucel) — Coverage Criteria

Medical necessity and authorization criteria for Tecartus (brexucabtagene autoleucel) for treatment of relapsed or refractory mantle cell lymphoma (MCL) and B-cell precursor acute lymphoblastic leukemia (B-ALL) for Mass General Brigham Health Plan members, including commercial, MassHealth, and Medicare Advantage variations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTecartus (brexucabtagene autoleucel) — Coverage Criteria

Policy CodePolicy 054

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prior therapies (including BTKI exposure for MCL), CD19 positivity, and facility REMS enrollment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved indications

singleAuthorized treatment courses

Q2053,38225-28Listed procedure codes

REMSREMS required

requiredTocilizumab onsite

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Coverage and Medical Necessity Criteria

Facility and Prescriber Criteria

Facility and Prescriber Criteria — Covered when ALL of the following are met:

ALL of the following

The healthcare facility that dispenses and administers brexucabtagene autoleucel (Tecartus) must be enrolled in and comply with the FDA Risk Evaluation and Mitigation Strategy (REMS) program for Tecartus.
REMS enrollment and documentation must be available in the medical record.
The healthcare facility must have tocilizumab available on site for management of Cytokine Release Syndrome (CRS).
Immediate access to tocilizumab for CRS management is required at the time of CAR-T infusion.
Tecartus must be prescribed by a hematologist or oncologist with demonstrated expertise in CAR-T therapy.
Provider qualifications, including experience with CAR-T therapy and management of associated toxicities, should be documented in the record.
The treating facility must have protocols and capability for inpatient monitoring and management of CAR-T–related adverse events, including CRS and neurotoxicity (ICANS).
Facility should document availability of critical care support and established pathways for management of severe toxicities.

Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tecartus (brexucabtagene autoleucel) across Commercial, Qualified Health Plans, MassHealth, and Medicare Advantage. For MassHealth ACO members, submit requests to the MassHealth Drug Utilization Review Program and follow MassHealth Table 75: T-Cell Immunotherapies.

Authorization required for Commercial, Qualified Health Plans, MassHealth, and Medicare Advantage
MassHealth requests: submit to MassHealth Drug Utilization Review Program; follow Table 75: T-Cell Immunotherapies

Step Therapy

Pre-requisite Therapies for MCL

For mantle cell lymphoma (MCL), all of the following prior therapies must be documented before approval will be granted: the disease is in second or later relapse after a Bruton's tyrosine kinase inhibitor (BTKI) and chemoimmunotherapy; the member has previously received a BTKI (ibrutinib, acalabrutinib, or zanubrutinib) with inadequate response, intolerance, or contraindication; and the member has previously received an anti-CD20 monoclonal antibody (e.g., rituximab, obinutuzumab) plus either anthracycline- or bendamustine-containing chemotherapy. The member must not have received any prior FDA‑approved CD19‑directed therapy (e.g., Tecartus, Kymriah, Yescarta). Exceptions for non‑FDA approved CD19 therapies will be reviewed case‑by‑case with detailed medical review.

Procedure and Billing Codes

Informational procedure and HCPCS/CPT codesmixed

38225	Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting 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 (eg, cryopreservation, storage).
38227	Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for administration.
38228	Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous.
Q2053	Brexucabtagene autoleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose.

Biomarkers, Definitions, and Related Requirements

CD19 — biomarker requirement entry

BiomarkerCD19-positive B cells required in the latest relapse, confirmed by immunohistochemistry or flow cytometry

Required forEligibility for MCL initial approval (member >=18 years, second or later relapse after BTKI and chemoimmunotherapy)

Testing methodConfirmation by immunohistochemistry or flow cytometry as stated in policy

Impact of prior CD19 therapyMember must NOT have received any prior FDA‑approved CD19‑directed therapy (e.g., Tecartus, Kymriah, Yescarta)

Philadelphia chromosome (BCR-ABL) — biomarker requirement entry

BiomarkerPhiladelphia chromosome (BCR-ABL) positive status is recognized in B‑cell precursor ALL

Regimen and Dosing

Item	Detail	Coverage status
Dose and route
Single intravenous infusion (single treatment course)
covered
Administration standards
Administer per FDA-approved dosing and institutional ZUMA protocols at a facility enrolled in Tecartus REMS; tocilizumab must be available onsite for CRS management
covered
Limitations
Only one authorized treatment course per member; additional courses considered experimental/investigational
covered

Clinical Background

Tecartus (brexucabtagene autoleucel) is described in this policy as an autologous CD19‑directed chimeric antigen receptor T‑cell (CAR‑T) therapy. Authorization is limited to adult members (age ≥18) with relapsed or refractory mantle cell lymphoma meeting specified eligibility criteria, including confirmation that the tumor B‑cells are CD19‑positive at the latest relapse and that the member has not received prior FDA‑approved CD19‑directed therapy. The policy supports a single treatment course given per the FDA‑approved regimen and requires facility and prescriber program compliance.

Documentation Required

Required Documentation

Clinical documentation must be provided with the authorization request. Required items include confirmation of CD19‑positive B‑cells in the most recent relapse (immunohistochemistry or flow cytometry), documentation of refractory disease or prior lines of therapy for MCL, detailed records showing receipt and response/adverse reaction/contraindication to prior BTKI(s) and chemoimmunotherapy, documentation of prior anti‑CD20 therapy and the specific chemotherapy regimens used, and demonstration of adequate organ and bone marrow function as determined by the treating oncologist/hematologist. Facility documentation must show CAR‑T expertise, enrollment in and compliance with the Tecartus REMS program, and on‑site availability of tocilizumab for CRS management.

Confirmation of CD19 positivity (IHC or flow cytometry) in latest relapse
Detailed prior therapy history: BTKI(s), chemoimmunotherapy, anti‑CD20 therapy, dates, responses, and reasons for discontinuation
Documentation of inadequate response, adverse reaction, or contraindication to listed BTKIs
Evidence of adequate organ and bone marrow function per treating physician
Facility requirements: prescriber expertise in CAR‑T, enrollment/compliance with Tecartus REMS, on‑site tocilizumab availability

Denial Risk

Denial Triggers

Requests may be denied if the clinical eligibility criteria or facility requirements are not met. Denial triggers include: absence of documented CD19 positivity, lack of required prior therapies (BTKI plus chemoimmunotherapy and prior anti‑CD20 therapy), prior receipt of an FDA‑approved CD19‑directed therapy, incomplete or missing documentation of prior lines of therapy or organ function, failure to demonstrate facility REMS enrollment or on‑site tocilizumab, or requests for additional courses beyond the single authorized treatment (additional courses considered experimental/investigational).

Denial if CD19 positivity not documented
Denial if required prior therapies (BTKI + chemoimmunotherapy and anti‑CD20) are not documented
Denial if prior FDA‑approved CD19‑directed therapy has been administered
Denial for incomplete/missing documentation of prior lines of therapy or organ/bone marrow function
Denial if facility REMS enrollment, CAR‑T expertise, or on‑site tocilizumab not demonstrated
Denial for requests for additional courses beyond the single authorized treatment