Yescarta vs Tecartus CAR-T access guide: CD19-directed axi-cel vs brexu-cel payer coverage, REMS elimination, center certification, billing, and one-time authorization

Yescarta (axicabtagene ciloleucel, axi-cel) and Tecartus (brexucabtagene autoleucel, brexu-cel) are both CD19-directed autologous CAR T-cell therapies manufactured by Kite Pharma (a Gilead Sciences company). They share a parent company, a target antigen, and a manufacturing platform — but they treat different diseases, face different payer requirements, and have distinct access workflows.

Yescarta is approved for large B-cell lymphoma (LBCL) — including DLBCL, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma — in both the second-line-plus and first-line refractory/early-relapse settings, as well as for relapsed or refractory follicular lymphoma (FL) and marginal zone lymphoma (MZL) after two or more lines of therapy. Tecartus is approved for relapsed or refractory mantle cell lymphoma (MCL) and relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults.

A critical access development occurred on June 27, 2025, when the FDA removed the Risk Evaluation and Mitigation Strategy (REMS) requirements for all six approved autologous CAR T-cell therapies, including Yescarta and Tecartus. This elimination of REMS reduces the administrative burden on treatment centers and may expand the number of facilities capable of administering CAR T therapy. However, prior authorization, center certification, and payer-specific coverage criteria remain the primary access barriers.

This guide covers the indication-specific coverage requirements, payer PA criteria, billing and coding, center network routing, and patient support for both therapies.

Short-answer comparison

Indication landscape and why the drugs are not interchangeable

Although both target CD19, Yescarta and Tecartus are not interchangeable and payers will not approve one for the other's indication:

• Yescarta covers the large B-cell lymphoma spectrum: DLBCL NOS, primary mediastinal LBCL, high-grade B-cell lymphoma, DLBCL arising from FL, follicular lymphoma, and marginal zone lymphoma. In February 2026, the FDA approved a label update removing the previous limitations of use for CNS lymphoma in relapsed/refractory LBCL.
• Tecartus covers mantle cell lymphoma and B-ALL: Tecartus received full (traditional) FDA approval for MCL on April 2, 2026, converting its prior accelerated approval. The full approval now includes patients who have not received a BTK inhibitor after at least one prior line of therapy (ZUMA-2 Cohort 3). For ALL, Tecartus is approved for adult relapsed/refractory B-cell precursor ALL.

A payer will reject a Tecartus PA for DLBCL just as it will reject a Yescarta PA for MCL. The diseases, evidence bases, and compendia listings are entirely distinct.

Competitive landscape note

Yescarta and Tecartus are not the only CD19-directed CAR T therapies. Novartis's Kymriah (tisagenlecleucel) was the first FDA-approved CAR T therapy (2017, priced at $475,000), approved for pediatric/young adult ALL and adult DLBCL. BMS/2seventy bio's Breyanzi (lisocabtagene maraleucel) is approved for R/R LBCL. Autolus's Aucatzyl (obecabtagene autoleucel) was approved in late 2024 for adult R/R B-cell precursor ALL, creating a new competitor for Tecartus in the ALL space. UHC's 2026 clinical guidelines already include Aucatzyl as a preferred regimen for Ph-negative B-ALL per NCCN v1.2025. This expanding field means payers are developing more sophisticated, product-specific coverage criteria rather than treating all CAR T therapies interchangeably.

Medicare coverage: NCD 110.24

Both Yescarta and Tecartus are covered under Medicare National Coverage Determination (NCD) 110.24 for Chimeric Antigen Receptor (CAR) T-cell Therapy. Key provisions:

• Covered indications: FDA-approved indications for CAR T-cell therapies
• Setting: Inpatient or outpatient ( outpatient administration approved with specific attestations)
• Provider requirements: Must be administered at a facility with expertise in cell therapy, including the ability to manage cytokine release syndrome (CRS) and neurologic toxicities
• One-time treatment: NCD covers a single infusion per lifetime per CAR T product
• Cost: Medicare Part B covers the drug (Q2041/Q2043) and administration. The CAR T product is paid under the outpatient prospective payment system (OPPS) or inpatient DRG, depending on setting

Medicare Advantage plans must cover CAR T therapy consistent with NCD 110.24 but may impose prior authorization requirements for setting, facility, and clinical criteria.

Payer prior authorization criteria

Yescarta PA criteria (common across major payers)

Most commercial and Medicare Advantage plans require ALL of the following:

1. Age ≥ 18 years
2. Confirmed diagnosis of large B-cell lymphoma (DLBCL, PMBCL, HGBCL, DLBCL arising from FL), follicular lymphoma, or marginal zone lymphoma
3. Disease is relapsed or refractory:
   • LBCL: Refractory to first-line chemoimmunotherapy OR relapsed within 12 months of first-line chemoimmunotherapy OR relapsed/refractory after ≥ 2 lines of systemic therapy
   • FL: After ≥ 2 lines of systemic therapy
   • MZL: After ≥ 2 lines of systemic therapy
4. No prior CAR T-cell therapy (any product, including clinical trial)
5. No primary CNS lymphoma (though the February 2026 label update may shift this criterion)
6. Adequate organ function: Bone marrow, cardiac (LVEF), pulmonary, renal, hepatic
7. If prior allogeneic stem cell transplant: No active graft-versus-host disease
8. Prescribed by or in consultation with a hematologist/oncologist
9. Administration at a certified treatment center (previously REMS-certified; now simply a qualified center)

Tecartus PA criteria (common across major payers)

For MCL:

1. Age ≥ 18 years
2. Histologically confirmed mantle cell lymphoma
3. Relapsed or refractory disease after prior therapy:
   • Original accelerated approval: Must have received anthracycline- or bendamustine-containing chemotherapy, anti-CD20 antibody, and a BTK inhibitor (ibrutinib or acalabrutinib)
   • Full approval (April 2026): Expanded to include patients who have received at least one prior line of therapy, including BTK-inhibitor-naïve patients
4. No prior CAR T-cell therapy
5. Adequate organ and bone marrow function
6. Prescribed by or in consultation with hematologist/oncologist

For B-cell ALL:

1. Age ≥ 18 years
2. Confirmed B-cell precursor acute lymphoblastic leukemia
3. Relapsed or refractory:
   • Philadelphia chromosome-negative disease: Primary refractory or first relapse with remission duration ≤ 12 months, or second or later relapse, or relapse after allo-HSCT
   • Philadelphia chromosome-positive disease: Must have had therapy that included a tyrosine kinase inhibitor
4. No prior CAR T-cell therapy
5. Adequate organ function

Plans that explicitly distinguish Yescarta and Tecartus

UnitedHealthcare / Optum (clinical guideline, 2026): Separate criteria documents for axi-cel and brexu-cel. UHC requires documented failure of prior lines of systemic therapy matching the FDA label. For outpatient administration, the provider must attest that the patient has been assessed and outpatient administration is clinically appropriate.

Mass General Brigham Health Plan (Policy 059, effective March 2026): Yescarta criteria include LBCL, FL, and MZL with prior therapy requirements. Tecartus criteria include MCL and B-ALL with separate treatment history documentation. Both require one-time authorization.

Aetna (CPB 0980): Separate criteria for each product. For Tecartus MCL, requires documentation of anthracycline/bendamustine, anti-CD20, and BTK inhibitor therapy. For Yescarta LBCL, requires refractory to first-line or ≥ 2 prior lines.

CarePartners of Connecticut (effective May 2026): Authorization limited to one-time infusion. Members who have had prior CAR T-cell therapy (including clinical trial) are not approved.

Billing and coding

Product codes

Procedure codes (ASTCT 2026 Billing Guide)

Diagnosis codes

Reimbursement

Medicare OPPS payment for CAR T-cell therapy products is substantial. Q2041 (Yescarta) is paid at ASP + 6% under the pass-through or transitional pass-through pathway. The total episode cost — including leukapheresis, manufacturing, conditioning chemotherapy, infusion, and inpatient monitoring for CRS/neurotoxicity — can exceed $500,000 per patient. Hospitals must negotiate CAR T-specific contracts with commercial payers, often involving case-rate or episode-based payment arrangements.

REMS elimination and center access implications

On June 27, 2025, the FDA announced the removal of REMS requirements for all six approved autologous CAR T-cell therapies. Key implications:

1. Certified treatment centers no longer need REMS certification. The REMS requirement previously limited CAR T administration to centers that had completed Kite's REMS certification process, including staff training on CRS and neurotoxicity management.
2. Labeling replaces REMS for safety communication. CRS and neurologic toxicity risks are now conveyed through the product prescribing information and Medication Guide, which are part of the approved labeling.
3. Access may expand to additional centers. Facilities that were deterred by the REMS administrative burden may now consider offering CAR T therapy. The Cancer Support Community noted that this change "reduces some of the most onerous requirements that may have previously discouraged patients, particularly those who live far from a treatment center."
4. Payer PA criteria may still require center qualifications. Even without REMS, payers may require documentation that the treating facility has experience managing CRS, neurotoxicity, and the logistical requirements of cell therapy. UHC and other payers still reference center expertise in their clinical guidelines.

Transplant center routing and network considerations

CAR T-cell therapy is concentrated at academic medical centers and NCI-designated cancer centers. Access issues include:

• Geographic access: Patients often travel hundreds of miles to reach a certified CAR T center. Kite's Yescarta is available at approximately 90 qualified treatment centers in the US.
• Network status: Commercial payers may restrict CAR T therapy to in-network transplant/cell therapy centers. Out-of-network authorization requires demonstrating that no in-network center can provide the therapy within a clinically appropriate timeframe.
• Inpatient vs outpatient: Both Yescarta and Tecartus carry boxed warnings for CRS and neurologic toxicity. Some centers have established outpatient CAR T monitoring protocols with rapid inpatient admission pathways. Payers may require an attestation that outpatient administration is clinically appropriate.
• Leukapheresis scheduling: The leukapheresis-to-infusion timeline is approximately 3–4 weeks. Scheduling coordination between the referring oncologist, apheresis center, manufacturing facility, and treatment center is critical and often facilitated by Kite Konnect.

Patient support: Kite Konnect

Both Yescarta and Tecartus patients are supported through Kite Konnect, Kite's patient support program:

• Case Manager assignment: Each patient is assigned a dedicated Case Manager to coordinate the treatment journey
• Benefits investigation: Verifies insurance coverage and PA requirements
• Transportation and lodging assistance: Resources for patients traveling to treatment centers
• Support for uninsured and underinsured patients: Financial assistance pathways for patients without adequate coverage
• Hospital Portal: Healthcare professionals can register patients and track the manufacturing and delivery process
• Contact: 1-844-454-KITE (5483), Monday–Friday, 5 AM–6 PM PT
• Website: KiteKonnect.com

Key documentation checklist for PA submission

Yescarta PA

1. Pathology report confirming LBCL subtype (DLBCL, PMBCL, HGBCL, FL, MZL)
2. Treatment history: names, dates, and lines of systemic therapy, with documentation of refractory disease or relapse
3. If first-line setting: documentation of refractory disease or relapse within 12 months of first-line chemoimmunotherapy
4. No prior CAR T-cell therapy (any product) attestation
5. No primary CNS lymphoma attestation
6. Organ function assessment (LVEF, labs, pulmonary status)
7. If prior allo-HSCT: documentation of no active GVHD
8. Prescriber specialty documentation (hematologist/oncologist)
9. Treatment center information and qualifications
10. Correct HCPCS code Q2041

Tecartus PA

1. Pathology report confirming MCL or B-cell precursor ALL
2. For MCL: treatment history documenting anthracycline/bendamustine, anti-CD20, and BTK inhibitor therapy (for full approval: at least one prior line of therapy)
3. For ALL: Philadelphia chromosome status, prior treatment history including TKI use if Ph+
4. Relapsed or refractory documentation
5. No prior CAR T-cell therapy attestation
6. Organ function assessment
7. Prescriber specialty documentation
8. Treatment center information
9. Correct HCPCS code Q2043

Sources

• FDA. YESCARTA (axicabtagene ciloleucel) Prescribing Information. Updated 2026. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/yescarta
• FDA. TECARTUS (brexucabtagene autoleucel) Prescribing Information. Updated April 2026. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/tecartus
• FDA. REMS Elimination Approval Letter for YESCARTA and TECARTUS. June 26, 2025. https://www.fda.gov/media/187345/download
• Gilead Sciences. FDA Grants Full Approval of Tecartus for R/R Mantle Cell Lymphoma. April 2, 2026. https://www.gilead.com/company/company-statements/2026/us-fda-grants-full-approval-of-kite-tecartus-for-adult-patients-with-relapsed-or-refractory-mantle-cell-lymphoma
• CMS. National Coverage Determination (NCD) for CAR T-cell Therapy (110.24). https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?ncdid=374
• ASTCT. CAR-T Therapy Coding and Billing Guide, 2026. https://www.astct.org/Portals/0/Docs/Coverage_Coding/2026_BillingandCodingQ1_March.pdf
• UnitedHealthcare / Optum. Chimeric Antigen Receptor T-Cell Therapy Clinical Guideline. 2026. https://www.uhcprovider.com/content/dam/provider/docs/public/policies/clinical-guidelines/chimeric-antigen-receptor-tcell-therapy.pdf
• Aetna. Brexucabtagene Autoleucel (Tecartus) Medical Clinical Policy Bulletin 0980. https://www.aetna.com/cpb/medical/data/900_999/0980.html
• Mass General Brigham Health Plan. Yescarta Policy 059 and Tecartus Policy. March 2026. https://resources.massgeneralbrighamhealthplan.org/medicalpolicy/
• CarePartners of Connecticut. Yescarta Medical Necessity Guidelines. Effective May 2026. https://www.carepartnersct.com/cpct-pdoc-yescarta
• Kite Pharma. Kite Konnect Patient Support. https://www.yescartahcp.com/large-b-cell-lymphoma/resources