CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tecartus (brexucabtagene autoleucel) coverage

Defines accepted indications, exclusions, coding, and authorization expectations for Tecartus (brexucabtagene autoleucel) for adult members; applies to Neighborhood Health Plan of Rhode Island lines of business managed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTecartus (brexucabtagene autoleucel) coverage

Policy CodePolicy N/A

Change TypeUpdated indications & exclusions

Effective DateN/A

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization for Tecartus for adult relapsed/refractory CD19-positive B‑Cell ALL or Mantle Cell Lymphoma and document CD19 positivity.

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.

2FDA-approved adult indications listed

Q2053Primary billing code included

2e8;1e8CAR-positive T cell limits

Commercial,Exchange,MedicaidLines of business

Coverage Criteria for Tecartus (brexucabtagene autoleucel)

Initial FDA‑aligned Indications

Covered when ALL of the following are met for the respective diagnosis:

B-Cell ALL (adult): Adult member with relapsed or refractory B-Cell Acute Lymphoblastic Leukemia and confirmed CD19 positivity; therapy consistent with FDA labeling or accepted compendia/guidelines.

Mantle Cell Lymphoma (adult): Adult member with relapsed or refractory Mantle Cell Lymphoma and confirmed CD19 positivity; therapy consistent with FDA labeling or accepted compendia/guidelines.

Initial therapy indications

Initial authorization for FDA‑aligned indications:

Adult B-Cell ALL: Relapsed or refractory disease with confirmed CD19 positivity and documentation supporting FDA label or accepted compendia/guideline use.

Adult Mantle Cell Lymphoma: Relapsed or refractory disease with confirmed CD19 positivity and documentation supporting FDA label or accepted compendia/guideline use.

Coverage excludes uses that do not meet the policy's evidence and safety expectations. Specifically, Tecartus (brexucabtagene autoleucel) is excluded when administered after disease progression on or after the same regimen or another CD19-directed CAR‑T therapy, when given concurrently with other systemic immunosuppressive therapy or live virus vaccines, or when there is no confirmed documentation of tumor CD19 positivity.

Requests are also excluded if the requested treatment would exceed established product limits: a maximum of 2 × 10^8 CAR‑positive viable T cells for Mantle Cell Lymphoma or 1 × 10^8 CAR‑positive viable T cells for B‑Cell ALL, or if administration would exceed the one-time administration duration.

Investigational or off‑label uses lacking sufficient supporting evidence are excluded. Sufficient evidence must be consistent with CMS‑recognized compendia or acceptable peer‑reviewed literature; case reports, meeting abstracts without full peer‑reviewed articles, or other anecdotal uncontrolled reports are not considered adequate supportive clinical evidence.

Use of Tecartus after disease progression on the same regimen or following another CD19‑directed CAR‑T therapy is explicitly excluded and therefore considered not medically necessary.

Such requests will be excluded from coverage consideration and are likely to be denied under this policy when progression on a prior CD19 CAR‑T or the same therapeutic regimen is documented.

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for Tecartus when requested for adult relapsed or refractory CD19-positive B‑cell malignancies (e.g., B‑Cell ALL, Mantle Cell Lymphoma).

Applies to requests for adults with relapsed/refractory disease and confirmed CD19 positivity.
Authorization must be obtained prior to administration.

Prior Authorization

Continuation/Reauthorization Conditions

Continuation (reauthorization) may be allowed without full re-evaluation when all of the following are met: the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of >30 days of active authorization; and no additional medications are being added to the continuation request.

Continuation exemption applies only when prior authorization was previously active and continuous (≤30-day lapse).
If disease progression has occurred or additional agents are added, a full review is required.

Documentation Required

Required Supporting Documentation

Documentation must support use of Tecartus via FDA-approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

Provide documentation of confirmed CD19 positivity in tumor cells.
Include relevant FDA labeling, compendia citations, guideline excerpts, or peer‑reviewed literature that demonstrates adequate evidence for the requested indication.
For off‑label requests, submit supporting literature showing that the clinical characteristics, regimen, and outcomes are applicable to the patient and meet standards for clinically meaningful benefit (e.g., ASCO recommendations).

Denial Risk

Exclusion-Based Denial Triggers

Requests will be excluded/denied when any of the following apply: use after disease progression on the same regimen or another CD19-directed CAR‑T therapy; lack of confirmed CD19 positivity; concurrent use of other systemic immunosuppressive therapy or live virus vaccines; exceeding labeled maximum cell dose or administration limits; investigational or insufficient‑evidence off‑label use.

Use after progression on or after the same regimen or another CD19-targeted CAR‑T (e.g., Kymriah, Yescarta) — exclusion trigger.
No confirmed documentation of CD19 positivity in tumor cells — exclusion trigger.
Concurrent systemic immunosuppression or recent live virus vaccination — exclusion trigger.
Exceeds maximum cell dose limits: >2 × 10^8 CAR‑positive viable T cells (Mantle Cell Lymphoma) or >1 × 10^8 CAR‑positive viable T cells (B‑Cell ALL) — exclusion trigger.
Use that exceeds single‑administration maximum or duration limits — exclusion trigger.
Investigational/off‑label uses lacking sufficient evidence or not supported by CMS compendia or acceptable peer‑reviewed literature — exclusion trigger.

Coding and Code Definitions

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

Maximum CAR-positive viable T cells

Mantle Cell Lymphoma (maximum)2 × 10^8 CAR-positive viable T cells

B‑Cell ALL (maximum)1 × 10^8 CAR-positive viable T cells

ContextLimits apply to treatment with Tecartus (brexucabtagene autoleucel); exceeding these limits is an exclusion trigger.

HCPCS code for brexucabtagene autoleucel

HCPCS codeQ2053

DescriptionBrexucabtagene autoleucel, up to 200 million autologous anti‑CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose

UseBilling code to submit for Tecartus per therapeutic dose

Step	Requirement	Notes
1	Not eligible if disease progression occurred on or after prior CD19-directed CAR‑T therapy or the same regimen	Requests for Tecartus after progression on a prior CD19 CAR‑T (or same regimen) are excluded per policy and considered not medically necessary

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTecartus (brexucabtagene autoleucel) coverage

Policy CodePolicy N/A

Change TypeUpdated indications & exclusions

Effective DateN/A

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization for Tecartus for adult relapsed/refractory CD19-positive B‑Cell ALL or Mantle Cell Lymphoma and document CD19 positivity.

SourceLink

On This Page

OpenPayer

Tecartus (brexucabtagene autoleucel) coverage

Coverage Criteria for Tecartus (brexucabtagene autoleucel)

Provider Actions, Documentation, and Authorization

Coding and Code Definitions

Initial Therapy Authorization Logic

Continuation / Reauthorization Criteria

Step Therapy Constraints

Quantity Limits

Definitions

Background