EmblemHealth Yescarta Coverage Update Prior Auth

Coverage Criteria for Yescarta (axicabtagene ciloleucel)

Initial Approval Criteria

Covered when ALL of the following are met:

Initial Approval General Requirements: 1. Patient is at least 18 years of age; 2. No clinically significant active systemic infection or inflammatory disorder; 3. No live vaccines within 6 weeks prior to the start of lymphodepleting chemotherapy and none during axicabtagene ciloleucel treatment until immune recovery; 4. Patient screened for HBV, HCV, and HIV prior to leukapheresis; 5. Prophylaxis for infection per local guidelines; 6. Treating facility enrolled in and compliant with the YESCARTA & TECARTUS REMS Program; 7. No prior CAR-T therapy; 8. No prior other anti-CD19 therapy OR if prior anti-CD19 therapy given then re-biopsy demonstrates CD19-positive disease; 9. Used as a single agent (except lymphodepleting or bridging chemotherapy as applicable); 10. Patient has ECOG performance status of 0-1; 11. Patient does not have primary central nervous system lymphoma.

Provider must submit documentation (e.g., office notes, lab results) supporting that the patient meets all approval criteria.

B‑cell lymphoma specific situations (select applicable): i. Histologic transformation of follicular lymphoma to diffuse large B-cell lymphoma (DLBCL) AND (a) disease refractory to first-line chemoimmunotherapy OR (b) relapsed within 12 months of first-line chemoimmunotherapy; OR ii. Histologic transformation of marginal zone lymphoma to DLBCL OR Richter's transformation of CLL to DLBCL AND received >=2 prior lines of chemoimmunotherapy which must have included an anthracycline-based regimen unless contraindicated; OR iii. HIV-related large B-cell lymphoma (including HIV-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL), DLBCL, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, or monomorphic post-transplant lymphoproliferative disorder (B-cell) AND (a) used as additional therapy for relapsed disease >12 months after completion of first-line therapy with partial response following second-line therapy OR (b) used for primary refractory disease or relapsed disease <12 months after completion of first-line therapy OR (c) used for second or greater relapse following therapy for relapsed/refractory disease; OR iv-v-vi. Nodal, extranodal, splenic marginal zone lymphoma or follicular lymphoma used as third-line and subsequent therapy for relapsed/refractory/progressive disease.

Also requires treatment at a certified Yescarta administration center; monitoring for signs and symptoms of cytokine release syndrome (CRS) for at least 4 weeks after treatment; counseling to seek immediate medical attention for CRS or neurologic events; and remaining within ~2 hours of the infusion center for at least 4 weeks.

Initial Approval (partial — performance/exclusion additions)

Covered when ALL of the following are met (as updated):

Performance and disease exclusions: Patient has an ECOG performance status of 0-1 AND Patient does not have primary central nervous system lymphoma.

Added in 3/7/2025 revision.

Dose limits and Renewal

Quantity limits and renewal:

Dose and Renewal: Approval is granted for one single dose (one infusion) of Yescarta per lifetime; coverage cannot be renewed.1 lifetime infusion

Dosing limits (medical benefit): 1 infusion bag of up to 200 million autologous anti-CD19 CAR-positive viable T-cells (NDC); 1 billable HCPCS unit = 1 infusion of up to 200 million autologous anti-CD19 CAR-positive viable T-cells. Requests exceeding the dosing limit may be outside stated quantity limits.

Yescarta (axicabtagene ciloleucel) is not indicated for the treatment of patients with primary central nervous system lymphoma. This limitation of use is stated in the clinical indications and is reiterated in the initial approval criteria where the patient must not have primary CNS lymphoma to meet coverage requirements.

Primary central nervous system lymphoma was explicitly added to the policy exclusions in the March 7, 2025 revision: the policy now specifies that the patient does not have primary central nervous system lymphoma as part of the approval conditions and identifies primary CNS lymphoma as an excluded diagnosis.

Requests for Yescarta require that the patient have an ECOG performance status of 0-1 and must not have a clinically significant active systemic infection or inflammatory disorder. The policy also requires appropriate pre-treatment screening (HBV, HCV, HIV), avoidance of live vaccines within 6 weeks prior to lymphodepletion and until immune recovery, and enrollment/compliance of the treating facility in the YESCARTA & TECARTUS REMS program. Documentation supporting these items must be submitted with prior authorization requests.

Editorially, prior language that defined relapse within 1 year after autologous hematopoietic stem cell transplantation (HSCT) or described disease as refractory to the most recent therapy was removed in earlier revisions; this change is noted in the policy revision history as an editorial/criteria clarification rather than a clinical expansion of coverage.

Axicabtagene ciloleucel dosing

Target dose2 x 10^6 CAR-positive viable T cells per kg body weight

Maximum per infusionMaximum 2 x 10^8 CAR-positive viable T cells

Formulation volumeApproximately 68 mL cell suspension per approved maximum dose

Max cells per infusion

Per-infusion cell limitUp to 200 million autologous anti-CD19 CAR-positive viable T‑cells per infusion (quantity limit)

HCPCS billing unit1 billable unit = 1 infusion of up to 200 million autologous anti-CD19 CAR-positive viable T‑cells

NDC quantity limit1 infusion bag of up to 200 million autologous anti-CD19 CAR-positive viable T‑cells

Applicable Codes and Coding Details

Applicable Procedure CodesHCPCSCovered

Q2041

Axicabtagene Ciloleucel, up to 200 million autologous Anti-CD19 CAR T Cells, including leukapheresis and dose preparation procedures, per infusion

Applicable NDCsNDC

71287-0119-02	Yescarta Plastic Bag, Injection
71287-0119-01	Yescarta Plastic Bag, Injection

Applicable ICD-10 Diagnoses (partial list shown)ICD-10Covered

C82.00	Follicular lymphoma grade I, unspecified site
C82.01	Follicular lymphoma grade I, lymph nodes of head, face and neck

ICD-10 Diagnoses (lymphomas listed)ICD-10Covered

C82.22	Follicular lymphoma, grade III, unspecified, intrathoracic lymph nodes
C82.23	Follicular lymphoma grade III, unspecified, intra-abdominal lymph nodes
C82.24	Follicular lymphoma grade III, unspecified, lymph nodes of axilla and upper limb
C82.25	Follicular lymphoma grade III, unspecified, lymph nodes of inguinal region and lower limb
C82.26	Follicular lymphoma grade III, unspecified, intrapelvic lymph nodes
C82.27	Follicular lymphoma grade III, unspecified, spleen
C82.28	Follicular lymphoma grade III, unspecified, lymph nodes of multiple sites
C82.29	Follicular lymphoma grade III, unspecified, extranodal and solid organ sites
C82.30	Follicular lymphoma grade IIIa, unspecified site
C82.31	Follicular lymphoma grade IIIa, lymph nodes of head, face and neck

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Target CAR T-cell dose

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

Maximum absolute doseMaximum 2 x 10^8 CAR-positive viable T cells per infusion

Dosing basisDose based on number of CAR-positive viable T cells in the product

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval will be granted for a single lifetime dose (one infusion) of Yescarta (axicabtagene ciloleucel) when all clinical criteria and documentation supporting medical necessity are provided.

Single lifetime dose: 1 infusion (one billable HCPCS unit) per patient

Prior Authorization

Prior Authorization and Dosing Limits

Prior authorization is subject to dosing limits. Quantity is limited to 1 infusion bag of up to 200 million autologous anti‑CD19 CAR‑positive viable T‑cells (Max: 1 HCPCS billable unit per dose and over time). Requests exceeding these dosing limits (e.g., more than one infusion bag or >200 million CAR‑positive viable T‑cells per infusion) may be denied or require an exception review.

Dosing limit: 1 infusion of up to 200 million autologous anti‑CD19 CAR‑positive viable T‑cells
Billing unit: 1 HCPCS unit (1 infusion)

Line-of-Therapy Specific Criteria

second-line | subsequent

Lines of therapy conditions (second-line or subsequent): Used for disease refractory to first-line chemoimmunotherapy OR relapsed within 12 months of first-line chemoimmunotherapy; OR relapsed/refractory after >=2 lines of systemic chemoimmunotherapy (must have included an anthracycline-based regimen unless contraindicated); OR used as third-line or subsequent therapy for certain indolent histologies (e.g., nodal/extranodal/splenic MZL or follicular lymphoma).

Anthracycline-containing regimen required unless contraindicated where specified.

mixed

Line of therapy — mixed/administrative note: Initial approval criteria and individual diagnosis requirements have been separated in the policy; explicit line-of-therapy definitions were revised and some prior requirements removed (see full policy revision history).

See full policy for current diagnosis-specific line-of-therapy details.

Biomarker and Test Requirements

CD19 (biomarker requirement)

BiomarkerCD19

When requiredRequired if patient previously received other anti-CD19 therapy — re-biopsy must demonstrate CD19‑positive disease

ContextCD19 requirement historically referenced in earlier revisions and may have been modified in later updates; see clinical documentation

CD19 (biomarker requirement, updated)

BiomarkerCD19

Revision noteCD19-positive disease requirement was removed in some revisions but remains required when prior anti‑CD19 therapy was given and re‑biopsy is performed

Regimens and Lymphodepleting Chemotherapy

Regimen	Dose / Administration	Coverage stance
Axicabtagene ciloleucel (Yescarta)	Target dose: 2 x 10^6 CAR-positive viable T cells per kg body weight; maximum 2 x 10^8 CAR-positive viable T cells per infusion (approximately 68 mL). Dosing based on number of CAR-positive viable T cells.	Covered

Historical regimen (editorial note)	Details	Coverage stance
Fludarabine + cyclophosphamide lymphodepletion (historical)	Previously specified regimen: fludarabine 30 mg/m2 daily for 3 days and cyclophosphamide 500 mg/m2 daily on the fifth, fourth, and third day before infusion — language removed in revisions.	Neutral (informational, removed)

Definitions and Terms

Yescarta (axicabtagene ciloleucel)

Product nameYescarta (axicabtagene ciloleucel)

DescriptionCD19-directed genetically modified autologous T cell immunotherapy produced by retroviral transduction to express a chimeric antigen receptor with CD28 and CD3‑zeta co‑stimulatory domains

Indication summaryAutologous CAR‑T therapy targeting CD19‑expressing B‑cell malignancies per policy criteria

ECOG 0-1

ECOG rangeECOG performance status 0-1

RequirementRequired for initial approval per policy criteria

Background

Yescarta (axicabtagene ciloleucel) is an autologous CD19-directed, genetically modified T‑cell immunotherapy produced by retroviral transduction to express a chimeric antigen receptor (CAR) targeting CD19. It is manufactured from the patient’s own T cells and administered as a single CAR‑T infusion following appropriate lymphodepleting chemotherapy when indicated. Monitoring for cytokine release syndrome and neurologic toxicities is required, and treatment must be delivered at facilities enrolled in the YESCARTA & TECARTUS REMS program.

Revision History and Changes

2025-03-07material_additionLatest

Added requirement that patient has ECOG performance status 0-1 and explicit exclusion of primary central nervous system lymphoma; added dosing limits for medical benefit (NDC: 1 infusion bag up to 200 million autologous anti‑CD19 CAR‑positive viable T‑cells; HCPCS: 1 billable unit per infusion up to 200 million cells).

2024-01-02material_revision

Separated initial approval criteria and individual diagnosis requirements; replaced 'AIDS' with 'HIV'-related B‑cell lymphoma; added primary effusion lymphoma; removed prior definition of relapse/refractory timing.

2022-10-27

OpenPayer

Yescarta (axicabtagene ciloleucel) — one lifetime CAR‑T infusion coverage criteria