CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Yescarta (axicabtagene ciloleucel) coverage criteria

Defines accepted indications, exclusions, coding, and prior authorization expectations for Yescarta (axicabtagene ciloleucel) for network providers; applies to members covered under Neighborhood Health Plan of Rhode Island lines of business noted in the guideline.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyYescarta (axicabtagene ciloleucel) coverage criteria

Policy CodePolicy N/A

Change TypeAdded indicationtemplate conversion

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization referencing HCPCS code Q2041 and submit documentation confirming CD19 positivity and supporting evidence per FDA labeling or recognized compendia.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1329 guideline.

Added 'Follicular Lymphoma' to indication section.

2Minimum prior lines for several indications

Q2041HCPCS code

2×10^6/kgMax CAR-positive dosing

Commercial/Exchange/MedicaidApplicable lines of business

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Yescarta (axicabtagene ciloleucel)

Large B-cell lymphoma

Covered when any of the following adult large B-cell lymphoma criteria are met:

Large B-cell lymphoma indications: Member is an adult with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy OR relapses within 12 months of first-line chemoimmunotherapy

Includes DLBCL NOS, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Relapsed/ refractory after >=2 lines (also acceptable here): Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy>=2 prior systemic therapies

Applies to diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Relapsed/refractory after >=2 lines

Covered when ALL of the following for relapsed/refractory large B-cell lymphoma are met:

Relapsed/refractory after two or more lines: Member has relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy>=2 prior systemic therapies

Applies to specified histologies: DLBCL NOS, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Adult member: Member is an adult (age as defined by plan) with the above diagnosis

Policy applies to adult members only.

CD19 confirmation: Documentation confirming CD19 positivity in lymphoma cells is provided

Required supporting documentation per policy.

Follicular lymphoma

Covered when ALL of the following are met for follicular lymphoma:

Follicular lymphoma after >=2 lines: Member is an adult with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy>=2 prior systemic therapies

This indication was added to the guideline; coverage aligns with relevant evidence and compendia.

CD19 confirmation: Documentation confirming CD19 positivity in lymphoma cells is provided

Required supporting documentation per policy.

Requests will be excluded when Yescarta (axicabtagene ciloleucel) is being used on or after documented disease progression while the patient remains on the same regimen or when the member has previously received a CD19-directed CAR‑T therapy (for example, Kymriah, Breyanzi, or Tecartus).

Concurrent administration with other systemic immunosuppressive therapies or recent receipt of live virus vaccines is not allowed. Lack of confirmed CD19 positivity in the lymphoma cells is a contraindication to coverage.

Coverage is also excluded when treatment would exceed established limits: more than a single administration per the policy or a cellular dose over the maximum of 2 × 10^6 CAR-positive viable T cells per kg body weight (cumulative maximum 2 × 10^8 CAR-positive viable T cells).

Use of Yescarta for off‑label or investigational indications that lack sufficient supporting evidence is considered not approvable. The policy requires support from FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed literature; reliance on uncontrolled case reports, meeting abstracts without full peer‑reviewed articles, or evidence that does not adequately represent the patient or regimen in question is insufficient.

When published evidence is limited to nonrandomized studies, abstracts only, or anecdotal case reports that do not demonstrate clinically meaningful outcomes by accepted standards (for example, ASCO‑recommended effect sizes and survival benefits), the indication may be determined to be investigational and not medically necessary.

Regimen	Indication / Evidence
Axicabtagene ciloleucel (Yescarta) per FDA labeling and recognized compendia	Second‑line therapy for large B‑cell lymphoma — supported by ZUMA‑7 (Locke et al., N Engl J Med 2022) — and relapsed/refractory large B‑cell lymphoma evidence from ZUMA‑1 and longer‑term follow‑up; also supported for relapsed/refractory indolent non‑Hodgkin lymphoma (including follicular lymphoma) by ZUMA‑5 (Jacobson et al., Lancet Oncol 2022). See prescribing information and cited trials for full indications and eligibility criteria.

Regimen

Indication / Evidence

Axicabtagene ciloleucel (Yescarta) per FDA labeling and recognized compendia

Second‑line therapy for large B‑cell lymphoma — supported by ZUMA‑7 (Locke et al., N Engl J Med 2022) — and relapsed/refractory large B‑cell lymphoma evidence from ZUMA‑1 and longer‑term follow‑up; also supported for relapsed/refractory indolent non‑Hodgkin lymphoma (including follicular lymphoma) by ZUMA‑5 (Jacobson et al., Lancet Oncol 2022). See prescribing information and cited trials for full indications and eligibility criteria.

Billing and Coding

Covered HCPCS CodesHCPCSCovered

Q2041

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

inv-07: Maximum CAR-positive viable T cells — dosing limit

Maximum per-kg dose2 × 10^6 CAR-positive viable T cells per kg body weight

Maximum total doseUp to a maximum total dose of 2 × 10^8 CAR-positive viable T cells

Dose specification contextApplies to a single therapeutic administration of Yescarta (axicabtagene ciloleucel)

inv-13: Maximum dose — treatment must not exceed dosing limits

Mandatory dosing capTreatment must not exceed 2 × 10^6 CAR-positive viable T cells per kg body weight

Absolute total capMaximum total dose of 2 × 10^8 CAR-positive viable T cells per therapeutic dose

Consequence of exceedingRequests exceeding specified cellular dose limits may be excluded per policy

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required — use HCPCS Q2041

Prior authorization is required for Yescarta (axicabtagene ciloleucel) requests; billing should reference HCPCS code Q2041 for dosing up to 200 million autologous anti‑CD19 CAR‑positive viable T cells per therapeutic dose.

Use HCPCS Q2041 for axicabtagene ciloleucel (includes leukapheresis and dose preparation per therapeutic dose).

Step Therapy

Continuation (renewal) request exemption

Continuation (renewal) requests may be exempt from standard policy review when the member has not experienced disease progression on the requested medication, the prior authorization has not lapsed for more than 30 days, and no additional medications are being added to the request.

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 active authorization.
No additional medications are being added to the continuation request.

Documentation Required

Provide supporting clinical evidence and CD19 confirmation

Support for Yescarta use must be provided by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature; documentation confirming CD19 positivity in lymphoma cells is required.

Provide citation(s) to FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature that meet CMS criteria.
Include confirmed documentation of CD19 positivity in the member's lymphoma cells.

Denial Risk

Common denial triggers for Yescarta requests

Common denial triggers include prior CD19‑directed CAR‑T therapy for the same regimen or use on or after disease progression with the same regimen; lack of documented CD19 positivity; concurrent systemic immunosuppression or live virus vaccines; exceeding single‑administration or cellular dose limits; and investigational/off‑label indications lacking sufficient evidence or CMS compendia support.

Prior CAR‑T directed to CD19 (e.g., tisagenlecleucel, lisocabtagene maraleucel, brexucabtagene autoleucel).
Use on or after disease progression with the same regimen.
No confirmed documentation of CD19 positivity.
Concurrent systemic immunosuppressive therapy or live virus vaccines.
Treatment exceeding one‑time administration or the maximum of 2 × 10^6 CAR‑positive viable T cells/kg (max 2 × 10^8 total).
Off‑label or investigational uses not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature.

Line of Therapy Requirements

second-line | salvage

Second-line refractory/early relapse: Refractory to first-line chemoimmunotherapy OR relapse within 12 months of first-line chemoimmunotherapyfirst-line failure or relapse <=12 months

Supported by ZUMA-7 evidence for second-line large B-cell lymphoma.

Salvage / third-line or later: Relapsed or refractory after two or more lines of systemic therapy>=2 prior lines

Applies to large B-cell lymphoma and follicular lymphoma where specified.

Biomarker Requirements

inv-15: CD19 — documented CD19 positivity required

Required biomarkerDocumented CD19 positivity in lymphoma cells is required

PurposeConfirmation of target antigen expression prior to CD19-directed CAR-T therapy

Supporting documentationProvider must supply documentation confirming CD19 positivity as part of prior authorization

Covered Regimens and Evidence Basis

Regimen	Indication / Mapping to Evidence
Axicabtagene ciloleucel (Yescarta) — autologous anti‑CD19 CAR T‑cell therapy	Mapped to: second‑line large B‑cell lymphoma (ZUMA‑7, Locke et al. NEJM 2022); relapsed/refractory large B‑cell lymphoma (ZUMA‑1, Neelapu et al., NEJM 2017 and 5‑year follow‑up); relapsed/refractory indolent NHL/follicular lymphoma (ZUMA‑5, Jacobson et al., Lancet Oncol 2022). Refer to Yescarta prescribing information for full labeled indications and eligibility criteria.

Background

Axicabtagene ciloleucel (Yescarta) is an autologous anti‑CD19 CAR T‑cell therapy indicated for certain relapsed or refractory B‑cell lymphomas, including specified large B‑cell histologies and, per this guideline, relapsed or refractory follicular lymphoma after prior lines of systemic therapy.

Use must align with FDA labeling and accepted compendia or peer‑reviewed evidence; dosing is constrained by cellular dose limits and other exclusions described in the policy (see dosing and exclusion sections for details).

Definitions and Dosing Limits

inv-13: Maximum dose — Treatment must not exceed 2 × 10^6 CAR-positive viable T cells per kg up to a maximum total dose of 2 × 10^8 CAR-positive viable T cells.

Per-kg limitDo not exceed 2 × 10^6 CAR-positive viable T cells per kg body weight

Total dose capDo not exceed a maximum total dose of 2 × 10^8 CAR-positive viable T cells per therapeutic dose

ApplicabilityLimits apply to administration of Yescarta (axicabtagene ciloleucel) and are enforced under exclusion criteria