Currentculinary health fundPolicy N/A

Yescarta (axicabtagene ciloleucel) CAR-T therapy coverage

Defines prior authorization and medical necessity criteria for coverage of a single dose of Yescarta for adults with specific relapsed/refractory B-cell lymphomas; intended for clinicians and billing/authorization staff.

Policy Summary

Payerculinary health fund

PolicyYescarta (axicabtagene ciloleucel) CAR-T therapy coverage

Policy CodePolicy N/A

Change TypeAnnual revision (03/05/2025) — clinical criteria updated, new indication added

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of specialist involvement, planned or completed lymphodepleting chemotherapy, and absence of prior CAR‑T exposure to request approval for a single dose.

SourceLink

POLICY UPDATE CHANGES

Gastric MALT lymphoma terminology updated to 'extranodal marginal zone lymphoma of the stomach' and nongastric MALT changed to 'extranodal marginal zone lymphoma of nongastric sites (noncutaneous)'; AIDS changed to HIV; primary effusion lymphoma added as an option for approval.

HIV-related plasmablastic lymphoma added as a new option for approval.

Single doseAuthorized dosing regimen (maximum per approval)

6 monthsAuthorization duration to allow preparation and administration

≥18Age threshold for FDA-approved indication covered

≤ 2 x 10^8

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Medical Necessity Criteria for Yescarta (axicabtagene ciloleucel)

FDA-Approved Indication — B-Cell Lymphoma (initial authorization)

Approve a single dose if the patient meets ALL of the following (A, B, C, D, and E):

Top-level criteria group

Product / Drug Coding

Drug / ProductNDC|productCovered

axicabtagene ciloleucel

Yescarta (CAR‑T cell therapy) — autologous CD19-directed genetically modified T‑cell immunotherapy

Authorization, Documentation, and Safety Requirements

Prior Authorization

Prior authorization required

Prior Authorization is recommended for medical benefit coverage of Yescarta. Approval requires meeting the listed clinical criteria and dosing and is for a single dose; the authorization duration is 6 months to allow preparation and administration.

Single-dose approval
Authorization duration: 6 months

Documentation Required

Specialist involvement required

Yescarta must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist); documentation of specialist involvement should be provided with the prior authorization request.

Documentation Required

Lymphodepleting chemotherapy requirement

Document that the patient received or plans to receive lymphodepleting chemotherapy prior to Yescarta infusion; examples of typical lymphodepleting regimens (e.g., cyclophosphamide and fludarabine combinations) are included in the policy definitions.

Denial Risk

Previous CAR-T therapy exclusion

Coverage is not recommended for patients previously treated with CAR‑T therapy; prior CAR‑T exposure should be documented and may lead to denial of coverage.

Examples of CAR‑T therapies to document include Yescarta, Breyanzi, Kymriah, Tecartus, Abecma, and Carvykti.

Documentation Required

REMS program and safety monitoring

Yescarta is available only through the Yescarta REMS because of boxed warnings for cytokine release syndrome, neurological toxicities, and secondary hematologic malignancies; documentation of REMS program enrollment/center capability and plans for monitoring may be required with the authorization request.

Boxed warnings: cytokine release syndrome, neurological toxicities, secondary hematologic malignancies
REMS distribution requirement — Yescarta REMS
Document REMS enrollment/center capability and monitoring plans

Clinical and Safety Context

Yescarta (axicabtagene ciloleucel) is an autologous, CD19-directed, genetically modified T‑cell immunotherapy (CAR‑T) supplied as a frozen infusion product for intravenous administration. It is indicated in adults for a range of relapsed or refractory B‑cell lymphomas, including follicular lymphoma and several large B‑cell and related histologies, per FDA‑approved indications and guideline recommendations (NCCN).

Yescarta carries a boxed warning for cytokine release syndrome, neurologic toxicities, and secondary hematologic malignancies. Because of these serious risks, Yescarta is available only through a restricted distribution program, the Yescarta REMS, which imposes requirements on training, certification, and monitoring of treating centers.

Treatment with Yescarta requires specialized multidisciplinary expertise: the product must be prescribed by or in consultation with an oncologist experienced in managing CAR‑T recipients, and centers must have the capability to deliver lymphodepleting chemotherapy, administer the CAR‑T infusion, and monitor and manage acute and long‑term toxicities. Prior authorization processes reflect these requirements and the complexity of preparation and administration.

Age, Dose Thresholds, and Defined Terms

Thresholds

Age threshold>= 18 years

Maximum doseUp to 2 x 10^8 CAR-positive viable T-cells administered intravenously

Definitions

Lymphodepleting chemotherapyChemotherapy administered prior to CAR‑T infusion to reduce host lymphocytes (examples not exhaustively listed; typical regimens include cyclophosphamide and fludarabine combinations).

Primary refractory diseaseDisease that did not achieve an adequate response to first‑line therapy (as used in the policy context).

Policy Changes and Material Updates

2025-03-05Annual revision (material)Latest

Added HIV-related plasmablastic lymphoma as a new option for approval in the B‑cell lymphoma indication.

2025-03-05Annual revision (material)

Updated terminology: gastric MALT lymphoma changed to 'extranodal marginal zone lymphoma of the stomach' and nongastric MALT lymphoma changed to 'extranodal marginal zone lymphoma of nongastric sites (noncutaneous)'; 'AIDS' changed to 'human immunodeficiency virus (HIV)'; primary effusion lymphoma added as an option for approval.

2024-03-27