CurrentBlue Cross Blue Shield - IowaPolicy 05.04.76

Axicabtagene ciloleucel (Yescarta) coverage and prior authorization criteria

Coverage and prior authorization criteria for Yescarta (axicabtagene ciloleucel) for treatment of specified relapsed or refractory B-cell lymphomas in adult members; applies to Wellmark Blue Cross and Blue Shield benefit plans and requires verification of member benefits.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyAxicabtagene ciloleucel (Yescarta) coverage and prior authorization criteria

Policy CodePolicy 05.04.76

Change TypeNo material change

Effective DateJan 1, 2023

Next Review Date

Key ActionSubmit prior authorization with chart notes/medical records showing prior lines of systemic therapy and required clinical documentation; authorization may be granted for a one-time 3-month treatment for eligible adults.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

age 18+adult population

3 monthsinitial auth duration

one lifetimetreatment limit

Q2041HCPCS

Coverage Criteria

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.

Authorization of 3 months may be granted as a one-time treatment of B-cell lymphomas in members 18 years of age or older when ALL of the specified conditions are met:

ALL of the following

Member is 18 years of age or older.
Member has not received a previous treatment course of the requested medication or another CD19-directed chimeric antigen receptor (CAR) T-cell therapy.
The member does not have primary central nervous system lymphoma.
Prior treatment requirements
- Prior treatment with two or more lines of systemic therapy for any of the following B-cell lymphoma subtypes: diffuse large B-cell lymphoma (DLBCL) arising from follicular lymphoma (histologic transformation), histologic transformation of nodal marginal zone lymphoma to DLBCL, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphomas (including translocation-associated double/triple-hit), monomorphic post-transplant lymphoproliferative disorder (B-cell type), AIDS-related B-cell lymphomas (including AIDS-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL), follicular lymphoma, gastric MALT lymphoma, nodal marginal zone lymphoma, splenic marginal zone lymphoma.
- Prior treatment with first-line chemoimmunotherapy and disease that is refractory to first-line therapy or relapsed within 12 months for any of the following B-cell lymphoma subtypes: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, AIDS-related B-cell lymphomas (including AIDS-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL).
Clinical and laboratory requirements
- ECOG performance status 0 to 2 (ambulatory and capable of all self-care; up and about >50% of waking hours).
- Absolute neutrophil count (ANC) ≥ 1000 cells/µL.
- Absolute lymphocyte count (ALC) ≥ 100 cells/µL.
- Platelet count ≥ 75,000 cells/µL.
- Adequate and stable kidney, liver, pulmonary and cardiac function as demonstrated by: creatinine clearance > 60 mL/min; ALT and AST < 2.5 × upper limit of normal for age; total bilirubin ≤ 1.5 mg/dL (patients with Gilbert‑Meulengracht syndrome may be included if total bilirubin ≤ 3.0 × ULN); left ventricular ejection fraction ≥ 50% with no evidence of pericardial effusion.
- No active infections including hepatitis B (HBsAg negative) or hepatitis C (anti-HCV negative); a history of hepatitis B or C is permitted if viral load is undetectable by quantitative PCR and/or nucleic acid testing.
The member will receive Yescarta at a treatment center that is certified to administer Yescarta per Yescarta REMS requirements.

Yescarta is not indicated for the treatment of primary central nervous system lymphoma; this use is excluded.

Repeat treatment of Yescarta for any indication is considered investigational and not covered due to insufficient evidence of safety and efficacy beyond one dose.

Initial Therapy Criteria

Initial therapy

Initial approval may be granted as a one-time 3‑month authorization when ALL of the following are satisfied:

Initial authorization: Authorization may be granted for 3 months as a one-time treatment for adults who meet disease subtype, prior therapy, performance status, laboratory and organ function criteria, and who will receive treatment at a REMS‑certified center.

Age requirement: Member is 18 years of age or older.

Disease subtype and prior therapy: Member has one of the B‑cell lymphoma subtypes listed in the policy and meets the required prior‑therapy criteria (e.g., received two or more lines of systemic therapy for most indications or meets specific labeled criteria for refractory/early relapse subtypes).

Performance status: ECOG performance status 0 to 2.

Treatment site: Member will receive Yescarta at a treatment center certified to administer Yescarta per Yescarta and Tecartus REMS requirements.

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

Maximum CAR-positive viable T-cells per dose

Maximum per-dose CAR+ viable T-cellsNo more than 2 x 10^8 CAR-positive viable T-cells per infusion

Source dosing guidanceFDA-recommended dosing and administration as specified in policy

Unit of measureCAR-positive viable T-cells (absolute cell count) per infusion

Dose specification

Weight-based dose2 x 10^6 CAR-positive viable T-cells per kg body weight (IV)

Maximum single-infusion capDo not exceed 2 x 10^8 CAR-positive viable T-cells per infusion

Administration routeIntravenous (per FDA-recommended administration)

Provider Actions & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Submit chart notes, medical records, or claims history documenting prior lines of systemic therapy and other clinical documentation to initiate review.

Submit prior therapy documentation (chart notes, medical records, claims history)

Step Therapy

Line‑of‑Therapy Requirements

Members must have relapsed or refractory disease after two or more lines of systemic therapy for most covered B‑cell lymphoma indications. Some subtypes (for example refractory to first‑line chemoimmunotherapy or relapse within 12 months) have specific line‑of‑therapy requirements — confirm the applicable subtype criteria.

Most indications: ≥ 2 prior lines of systemic therapy
Certain subtypes (e.g., refractory to first‑line chemoimmunotherapy or relapse ≤12 months) have different requirements

Documentation Required

Required Submission Materials

Chart notes, medical record documentation, or claims history supporting previous lines of therapy must be submitted to initiate prior authorization.

Include documentation of prior systemic therapies (names, dates, responses)

Denial Risk

Prior CAR T Exposure Exclusion

Previous treatment with the requested medication or any other CD19‑directed CAR T‑cell therapy disqualifies the member from approval.

Prior CD19‑directed CAR T therapy = not eligible

Denial Risk

Primary CNS Lymphoma Exclusion

Primary central nervous system (CNS) lymphoma is excluded from indication; presence of primary CNS lymphoma should trigger denial.

Primary CNS lymphoma = Not indicated / Deny

Step Therapy Requirements

Requirement	Details
Prior lines of systemic therapy
Member has received two or more lines of systemic therapy for most covered B‑cell lymphoma indications (e.g., DLBCL, primary mediastinal large B‑cell lymphoma, high‑grade B‑cell lymphomas, follicular lymphoma, transformed lymphomas, marginal zone lymphomas, monomorphic post‑transplant lymphoproliferative disorder, AIDS‑related B‑cell lymphomas)
Exceptions per labeled indications
For certain indications that are refractory to first‑line chemoimmunotherapy or that relapse within 12 months of first‑line chemoimmunotherapy, the labeled criterion allowing use with fewer prior lines (refractory or early relapse) applies

Background

Axicabtagene ciloleucel (Yescarta) is an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy indicated for certain relapsed or refractory adult B-cell lymphomas, including diffuse large B-cell lymphoma and other high-grade B-cell lymphomas, and for relapsed or refractory follicular lymphoma after specified prior lines of therapy. Coverage is aligned with FDA-labeled indications and requires treatment at REMS-certified centers and that the member meet specified clinical, performance status, and laboratory criteria.

Authorization may be granted as a one-time treatment for adults meeting the policy criteria; approvals are limited to one lifetime treatment and repeat dosing is considered investigational. Primary CNS lymphoma is explicitly excluded from indication.