CurrentmhnPolicy CP.PHAR.362

Axicabtagene Ciloleucel (Yescarta) coverage

Defines medical necessity criteria, limits, exclusions, and review processes for coverage of a single initial autologous CAR T-cell infusion of axicabtagene ciloleucel (Yescarta) across Commercial, HIM, and Medicaid lines of business affiliated with Centene.

Policy Summary

Payermhn

PolicyAxicabtagene Ciloleucel (Yescarta) coverage

Policy CodePolicy CP.PHAR.362

Change TypeMaterial updates (criteria, indications, boxed warning, administrative routing)

Effective DateDec 1, 2017

Next Review Date

Key ActionAll requests require PDAC Utilization Management Review and providers must submit documentation (office notes, labs) showing the member meets all approval criteria.

POLICY UPDATE CHANGES

Added pre-emptive indication for relapsed/refractory LBCL in the second-line setting per FDA approval (noted 10.19.21/02.22).

Added multiple NCCN Compendium supported LBCL uses over 2022-2025 (AIDS/HIV-related B-cell lymphomas, primary effusion lymphoma, HHV8-positive DLBCL, monomorphic post-transplant lymphoproliferative disorders, extranodal MZL gastric and nongastric, nodal MZL, Richter transformation).

Clarified MZL disease eligibility to require relapse/refractory after ≥2 lines including anti-CD20 and an alkylating agent per NCCN.

Added boxed warning language noting CRS, neurologic toxicities, and occurrence of T-cell malignancies per updated prescribing information.

Updated policy to redirect prior authorization reviews to Precision Drug Action Committee (PDAC) Utilization Management Review (11.03.25).

2Approval duration (months)

≥100/µLALC threshold

≤2x10^8Max CAR+ cells/dose

Coverage Summary & Scope

Axicabtagene ciloleucel (Yescarta) is a CD19-directed autologous CAR T-cell therapy indicated for relapsed/refractory large B-cell lymphomas and for relapsed/refractory follicular lymphoma after specified prior therapies. Coverage stance is covered_with_criteria across Commercial, HIM, and Medicaid lines of business. Only a single initial therapeutic dose will be authorized (continuation therapy is not authorized), with a per-administration limit of ≤ 2 x 10^8 CAR-positive viable T cells. Requests will be denied for members with a history of or current central nervous system (CNS) disease. This policy is documented as CP.PHAR.362 and effective 12.01.17 with last review date 02.26 (policy header).

Key Thresholds & Limits

ALC threshold≥ 100/µL

Max CAR+ viable T cells per dose≤ 2 x 10^8 CAR-positive viable T cells

Target dose per kg2 x 10^6 CAR-positive viable T cells per kg body weight

Authorized therapeutic doses (per member)1 (single initial dose only)

Approval duration3 months (covers 1 dose; includes up to 4 doses of tocilizumab at up to 800 mg per dose)

Initial Therapy Criteria - B-Cell Lymphoma

Initial Approval Criteria - B-Cell Lymphoma

Yescarta is medically necessary when ALL of the following are met (only for initial treatment dose; subsequent doses will not be covered):

ref

title

Initial Therapy Criteria - Follicular Lymphoma

Other Diagnoses / Off-Label Pathway

Continuation Therapy

Provider Actions & Authorization Requirements

Prior Authorization

Precision Drug Action Committee (PDAC) review required

All prior authorization requests for Yescarta are reviewed by the Precision Drug Action Committee (PDAC). Providers must submit supporting documentation (office chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria.

Documentation Required

Laboratory requirement

Provide a recent absolute lymphocyte count (ALC) obtained within the last 30 days that demonstrates ALC ≥ 100/µL.

Applicable Codes

HCPCS / Billing code for Yescarta therapeutic doseHCPCSCovered

Q2041

Axicabtagene Ciloleucel, up to 200 million autologous anti-CD19 CAR positive viable T Cells, including leukapheresis and dose preparation procedures, per therapeutic dose

Clinical Evidence & Guidance

Key evidence and guidance: ZUMA-1, ZUMA-7, and ZUMA-5 trials; Yescarta prescribing information; and the NCCN B-cell Lymphomas compendium. Real-world CNS experience reported by Bennani et al. 2019 described outcomes in patients with secondary CNS involvement treated with axicabtagene ciloleucel.

1Authorized therapeutic doses (per member)

2Approval duration (months)

Background & Definitions

Yescarta is a CD19-directed, genetically modified autologous T-cell immunotherapy indicated for adult patients with relapsed/refractory large B-cell lymphoma and relapsed/refractory follicular lymphoma after two or more lines of systemic therapy. The ZUMA trials excluded patients with history or presence of non-malignant CNS disorders and excluded patients with an absolute lymphocyte count (ALC) < 100/µL. The labeled target dose is 2 × 10^6 CAR-positive viable T cells per kg with a maximum per administration of 2 × 10^8 CAR-positive viable T cells.

ALC: absolute lymphocyte count — recent (within 30 days) ALC must be ≥ 100/µL to meet criteria.

CAR: chimeric antigen receptor — the therapeutic product is composed of CAR-positive viable T cells; maximum single administration is ≤ 2 × 10^8 CAR-positive viable T cells.

CNS: central nervous system — history of or current CNS disease is an exclusion for coverage under this policy.

DLBCL: diffuse large B-cell lymphoma — one of the primary indications covered for Yescarta.

FL: follicular lymphoma — relapsed/refractory FL after ≥ 2 lines of systemic therapy is an indication covered under this policy.

Revision History

10.19.21 / 02.22policy_revision

RT4 criteria revised per FDA approval to add a pre-emptive indication for relapsed/refractory LBCL in the second-line setting; references reviewed and updated. P&T approval recorded 02.22.

04.04.22 / 05.22policy_revision

Criteria clarified that PMBCL requests are for third-line or later (ZUMA‑7 excluded PMBCL in second-line trial); per NCCN Compendium added LBCL supported uses including AIDS/HIV-related B-cell lymphomas, gastric MALT (extranodal MZL stomach), splenic MZL, and nongastric MALT lymphoma; references reviewed and updated. P&T approval recorded 05.22.

10.27.22 / 02.23annual_review

Policy Summary

Payermhn

PolicyAxicabtagene Ciloleucel (Yescarta) coverage

Policy CodePolicy CP.PHAR.362

Change TypeMaterial updates (criteria, indications, boxed warning, administrative routing)

Effective DateDec 1, 2017

Next Review Date

Key ActionAll requests require PDAC Utilization Management Review and providers must submit documentation (office notes, labs) showing the member meets all approval criteria.

On This Page

Billing Rule

Single dose only

Only one initial therapeutic dose will be authorized; continuation therapy is not covered. Dose per administration must not exceed 2 × 10^8 CAR‑positive viable T cells.

Q2041

Denial Risk

CNS disease exclusion

Claims or prior authorization requests will not be authorized for members with a history of or current central nervous system (CNS) disease.

Documentation Required

Specialist prescribing requirement

Yescarta must be prescribed by, or in consultation with, an oncologist or hematologist; provider documentation must reflect this consultation or prescribing specialist.

Denial Risk

Prior CAR-T therapy exclusion

Requests will be denied if the member has previously received or is being prescribed concurrently another CAR T‑cell immunotherapy.

Billing Rule

Tocilizumab provision allowance

Approval includes coverage for up to four doses of tocilizumab (Actemra) if requested, at up to 800 mg per dose.

1Q 2023 annual review added NCCN Compendium–supported LBCL uses for primary effusion lymphoma and HHV8‑positive DLBCL; references reviewed and updated. P&T approval recorded 02.23.

10.04.23 / 02.24annual_review

1Q 2024 annual review added NCCN‑supported LBCL uses: monomorphic post‑transplant lymphoproliferative disorders (B‑cell type), extranodal marginal zone lymphoma of the stomach (gastric MALT), extranodal marginal zone lymphoma of nongastric sites (noncutaneous), and nodal marginal zone lymphoma; revised reference from AIDS to HIV; references reviewed and updated. P&T approval recorded 02.24.

10.17.24 / 02.25annual_review

1Q 2025 annual review added off‑label LBCL use for disease relapsed >12 months after first‑line therapy with partial response following second‑line therapy; consolidated extranodal MZL/Stomach and nongastric extranodal MZL terminology; added boxed warning language to Appendix C noting occurrence of T‑cell malignancies per updated prescribing information. P&T approval recorded 02.25.

11.03.25administrative_update

Administrative update to redirect prior authorization reviews to Precision Drug Action Committee (PDAC) Utilization Management Review; routing language under Policy/Criteria updated.

11.06.25 / 02.26.26annual_reviewLatest

1Q 2026 annual review added NCCN Compendium supported off‑label LBCL uses including Richter transformation, PMBCL for age <18 years, and HIV‑related plasmablastic lymphoma; clarified MZL eligibility requires relapse/refractory after ≥2 lines of systemic therapy per NCCN Compendium; references reviewed and updated. P&T approval recorded 02.26.