CurrentCareSourcePolicy N/A

Yescarta (axicabtagene ciloleucel) — CAR‑T therapy coverage criteria

Medicare Advantage medical necessity and prior authorization guidance for use of Yescarta (axicabtagene ciloleucel) in adults with various relapsed/refractory B‑cell lymphomas; applies to CareSource Medicare Advantage members and providers administering therapy.

Policy Summary

PayerCareSource

PolicyYescarta (axicabtagene ciloleucel) — CAR‑T therapy coverage criteria

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical changes

Effective DateN/A

Next Review DateJun 3, 2025

Key ActionSubmit prior authorization with documentation of diagnosis, prior systemic therapies, intent/receipt of lymphodepleting chemotherapy, age, and prior CAR‑T exposure status.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsapproval duration for a single dose

≤2 x10^8maximum CAR‑positive viable T‑cell dose

NCD 110.24referenced NCD

All Statesapplicability

Coverage Criteria for Yescarta (axicabtagene ciloleucel)

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.

Initial therapy / single‑dose approval

Covered when ALL of the following are met (A–D) for B‑cell lymphoma:

Main criteria: A) Patient meets ONE of the diagnosis pathways (i or ii); B) Disease status and prior therapy requirements as specified; C) Patient is >=18 years of age; D) Patient has not been previously treated with CAR-T therapy; and patient received or plans to receive lymphodepleting chemotherapy prior to Yescarta infusion.

Approve single dose up to maximum dose listed (up to 2 x 10^8 CAR-positive viable T-cells).

A(i) Diagnoses (examples): Follicular lymphoma; extranodal marginal zone lymphoma of the stomach; extranodal marginal zone lymphoma of nongastric sites (noncutaneous); nodal marginal zone lymphoma; splenic marginal zone lymphoma; and other listed indolent/transforming B-cell lymphomas (IC-COMP).

These diagnoses are denoted IC-COMP and require disease relapsed/refractory after two or more lines of systemic therapy.

A(i) Disease state requirement: Yescarta is used for disease that is relapsed or refractory after two or more lines of systemic therapy.two or more prior systemic therapy lines

Examples of systemic therapy include CHOP, CVP, lenalidomide + rituximab, and rituximab-containing regimens.

A(ii) Alternative diagnosis group: Diffuse large B-cell lymphoma (DLBCL) and variants (including transformed DLBCL), high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, primary effusion lymphoma, HHV8-positive DLBCL, HIV-related B-cell lymphoma, post-transplant lymphoproliferative disorders, plasmablastic lymphoma and related entities (IC-COMP).

For these histologies Yescarta may be used for relapsed/refractory disease after >=2 lines, primary refractory disease, relapse >=12 months after first-line therapy, or relapse >12 months with response to second-line therapy as detailed in policy; examples of systemic therapy include R-CHOP, dose-adjusted EPOCH, DHA + platinum + rituximab.

Additional operational criteria: Patient is >=18 years old; patient has received or plans to receive lymphodepleting chemotherapy prior to Yescarta infusion; and patient has not previously received any CAR-T therapy.age >=18

Examples of CAR-T therapies listed for prior-therapy exclusion include Yescarta, Breyanzi, Kymriah, Tecartus, Abecma, and Carvykti.

Coverage of Yescarta is limited to the situations explicitly described in the Recommended Authorization Criteria. Requests that do not meet those criteria are not recommended for coverage and are at risk for denial. The authorization criteria will be updated as new published evidence becomes available, and providers should submit documentation that demonstrates how a patient meets the listed indications and operational requirements when requesting prior authorization.

Prior systemic therapy (examples)	Lymphodepleting chemotherapy requirement
CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)
Lymphodepleting chemotherapy is required prior to Yescarta infusion (patient received or plans to receive lymphodepleting chemotherapy).

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for medical benefit coverage of a single dose of Yescarta. Approval is recommended for those who meet the policy Criteria and Dosing for the listed indication(s). The approval duration is 6 months to allow adequate time to prepare and administer one dose of therapy.

Approval duration: 6 months
Applies to single dose of Yescarta (medical benefit)

Step Therapy

Prior Systemic Therapy Requirements

Policy requires prior systemic therapy for many indications. For B‑cell lymphoma indications, Yescarta is indicated for disease that is relapsed or refractory after two or more lines of systemic therapy, or in specified scenarios such as primary refractory disease or relapse ≥12 months after completion of first‑line therapy (see clinical criteria). Examples of systemic therapy include regimens such as R‑CHOP, dose‑adjusted EPOCH, RCDOP, CHOP (+/‑ anti‑CD20 agents), CVP (+ anti‑CD20), DHA + platinum + rituximab, and lenalidomide + rituximab.

Relapsed or refractory disease after ≥2 lines of systemic therapy (general requirement)
Examples of systemic therapy: R-CHOP, dose‑adjusted EPOCH, RCDOP, CHOP/CVP ± rituximab or obinutuzumab, DHA + platinum + rituximab, lenalidomide + rituximab

Documentation Required

Required Documentation for Prior Authorization

Submit documentation demonstrating the diagnosis, number and details of prior lines of systemic therapy, intent to receive or receipt of lymphodepleting chemotherapy, planned site/intent to administer Yescarta, and that the patient has not previously received CAR‑T therapy. Include relevant clinical notes, pathology reports, and treatment history to support that criteria (e.g., relapsed/refractory status, timing of relapse relative to first‑line therapy).

Documentation of diagnosis and subtype (pathology)
Detailed prior systemic therapy history (agents, dates, responses)
Evidence of intent to receive lymphodepleting chemotherapy or receipt thereof
Documentation that patient has not previously received CAR‑T therapy
Clinical notes supporting relapsed/refractory status or timing of relapse

Denial Risk

Out‑of‑Criteria Denials

Coverage is not recommended for requests that do not meet the Recommended Authorization Criteria. Requests outside the listed criteria (including insufficient prior therapy, absence of required documentation, prior CAR‑T treatment, or indications not specified) risk denial.

Requests outside Recommended Authorization Criteria may be denied
Insufficient documentation or unmet prior therapy requirements are grounds for non‑approval

Additional regimen examples	Operational note
R‑CHOP (rituximab + cyclophosphamide, doxorubicin, vincristine, prednisone); dose‑adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) ± rituximab; RCDOP (rituximab, cyclophosphamide, liposomal doxorubicin, vincristine, prednisone); CVP; lenalidomide + rituximab; DHA + platinum + rituximab.
Approve single dose when patient has relapsed/refractory disease after specified prior systemic therapy or meets timing-based criteria; lymphodepleting chemotherapy is expected prior to infusion.

Background and Therapeutic Context

Yescarta (axicabtagene ciloleucel) is a CD19-directed, autologous CAR‑T cell therapy indicated for adults with certain relapsed or refractory B‑cell lymphomas. Treatment carries significant risks including cytokine release syndrome and neurologic toxicities, and is available only through a restricted program (REMS). Dosing for a single approved infusion is limited to up to 2 x 10^8 CAR‑positive viable T‑cells, and lymphodepleting chemotherapy is expected before administration. Guideline and regulatory sources (FDA labeling, NCCN compendia, and CMS NCD guidance) support use in patients meeting the policy’s specified diagnosis, prior‑therapy, age, and prior‑CAR‑T exclusion criteria.

Policy Summary

PayerCareSource

PolicyYescarta (axicabtagene ciloleucel) — CAR‑T therapy coverage criteria

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical changes

Effective DateN/A

Next Review DateJun 3, 2025

Key ActionSubmit prior authorization with documentation of diagnosis, prior systemic therapies, intent/receipt of lymphodepleting chemotherapy, age, and prior CAR‑T exposure status.

SourceLink

On This Page

OpenPayer

Yescarta (axicabtagene ciloleucel) — CAR‑T therapy coverage criteria

Coverage Criteria for Yescarta (axicabtagene ciloleucel)

Coding and Dosing Information

Prior Authorization and Documentation Requirements

Line-of-Therapy Requirements

Permitted Prior and Concomitant Regimens

Definitions and REMS

Background and Therapeutic Context