CurrentBaylor Scott & White Health PlanPolicy 291

MEDICAL COVERAGE POLICY

Defines medical necessity criteria, exclusions, and billing codes for lisocabtagene maraleucel (Breyanzie) for adult patients with specific B-cell malignancies; includes universal criteria applied to all requests and indication-specific criteria for LBCL, CLL/SLL, MCL, and FL. Also states lifetime limit of one treatment and that other indications are experimental/investigational.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyMEDICAL COVERAGE POLICY

Policy CodePolicy 291

Change TypeRevised (new indicationsformatting)

Effective DateSep 1, 2025

Next Review DateJul 23, 202640d

Key ActionRequests must include documentation demonstrating all universal and indication-specific criteria; therapy is subject to prior authorization per the plan's Evidence of Coverage/SPD and applicable Medicaid procedures.

SourceLink

POLICY UPDATE CHANGES

Added three new indications, updated treatment center to REMS, divided criteria into 'universal criteria' and 'indication specific criteria', added additional exclusion criteria, modified universal criteria, and updated ICD-10 codes (08/12/2024).

Updated formatting and standardized language for age requirement, dosing and administration, monotherapy criteria, REMS requirement, prescriber and no prior CAR T-cell therapy requirement; updated lifetime treatment and experimental/investigational language (07/23/2025).

4Covered Indications (LBCL, CLL/SLL, MCL, FL)

1Lifetime treatments allowed

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0540T, 96409, 96413Associated CPT codes

Coverage Summary

Defines medical necessity criteria, exclusions, and billing codes for lisocabtagene maraleucel (Breyanzie) for adult patients with specified B-cell malignancies, including universal and indication-specific criteria for LBCL, CLL/SLL, MCL, and FL. Effective date: 09/01/2025; Last review: 07/23/2025; Next review: 07/23/2026. Coverage stance is mixed: several labeled indications are covered with detailed eligibility and exclusion criteria, but other uses and repeat administration beyond one lifetime treatment are considered experimental/investigational.

Policy snapshot

Policy Number291

Document Typecoverage_criteria

Applies toAdults (>=18 years)

Lifetime treatments allowed1

Medical-Necessity Criteria

Coding

Covered HCPCSHCPCSCovered

Q2054

Lisocabtagene maraleucel, up to 110 million autologous anti-CD19 CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose

Covered CPTCPTCovered

0540T	Chimeric antigen receptor T cell (CAR-T) therapy; CAR-T cell administration, autologous
96409	Chemotherapy administration; intravenous, push technique, single or initial substance/drug
96413	Chemotherapy administration; intravenous infusion technique; up to 1 hour; single or initial substance/drug

Potential Applicable ICD-10 Diagnosis CodesICD-10

C82.00	Follicular lymphoma
C82.69	Follicular lymphoma
C82.80	Follicular lymphoma
C82.99	Follicular lymphoma
C83.00	Small cell B-cell lymphoma
C83.09	Small cell B-cell lymphoma
C83.10	Mantle cell lymphoma (entry for range)
C83.19	Mantle cell lymphoma (entry for range)
C83.30	Diffuse large B-cell lymphoma
C83.39	Diffuse large B-cell lymphoma

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Provider Actions and Billing Guidance

Prior Authorization

Prior authorization required

Requests must include documentation demonstrating all universal and indication-specific criteria; therapy is subject to prior authorization per the plan's Evidence of Coverage/SPD and applicable Medicaid procedures.

Q2054
0540T

Documentation Required

Document CD19 expression and prior therapies

Provider must document CD19 tumor expression and prior lines of systemic therapy (including specific agents for BTK and BCL-2 inhibitors where required) and assessment for apheresis candidacy.

Document CD19 tumor expression
List prior lines of systemic therapy
If CLL/SLL, document prior BTK inhibitor (e.g., ibrutinib, acalabrutinib, zanubrutinib, pirtobrutinib) and BCL-2 inhibitor (e.g., venetoclax)

Background & Evidence

Lisocabtagene maraleucel is an autologous, CD19-directed CAR T-cell therapy prepared from the patient’s T-cells obtained via leukapheresis. FDA approval and labeling note that the product is available only through a restricted REMS program because of risks of cytokine release syndrome (CRS) and neurologic toxicities; provider must attest that REMS requirements are met.

Study / Metric	Result
TRANSCEND overall response (LBCL cohort)	54% complete response, 19% partial response (single-arm trial)
TRANSFORM 1-year EFS	45% lisocabtagene vs 24% standard therapy; CR 66% vs 39%
TRANSCEND-FL ORR	95.7% (95% CI: 89.5, 98.8)

Definitions

REMSRisk Evaluation and Mitigation Strategy program; provider must attest REMS requirements are met

ECOG performance statusEastern Cooperative Oncology Group performance status scale; requirement ECOG 0-1

Revision History

08/12/2024revised

07/23/2025revisedLatest

Formatting and standardization updates: aligned beginning note language, reformatted age requirement, standardized dosing and administration language, monotherapy criteria, REMS requirement, prescriber language, no prior CAR T-cell therapy requirement, exclusion criteria formatting, lifetime treatment limit and experimental/investigational language; background simplified.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyMEDICAL COVERAGE POLICY

Policy CodePolicy 291

Change TypeRevised (new indicationsformatting)

Effective DateSep 1, 2025

Next Review DateJul 23, 202640d

SourceLink

On This Page

Assessment for apheresis candidacy

Documentation Required

REMS compliance and prescriber qualifications

Provider must attest that REMS program requirements are met and that lisocabtagene is prescribed by or in consultation with a board-certified hematologist or oncologist (treatment to be provided at REMS-certified center).

Treatment provided at a REMS-certified center
Prescribed by or in consultation with a board-certified hematologist or oncologist
Provider attestation that REMS requirements are met

Denial Risk

Exclusionary conditions

Claims may be denied if member has any listed exclusion (e.g., active uncontrolled infection, active HBV/HCV/HIV, primary CNS malignancy, recent allogeneic HSCT within 84 days, pregnancy, unmanaged thrombosis/embolism).

Active uncontrolled infection (including active hepatitis B, active hepatitis C, HIV infection)
Primary central nervous system (CNS) malignancy or history of CNS disorders (e.g., seizure disorder, cerebrovascular ischemia)
Allogeneic hematopoietic stem-cell transplantation within the preceding 84 days before leukapheresis
Pregnancy
Unmanaged venous thrombosis or embolism
Active inflammatory disorder requiring systemic immunosuppression
Active graft versus host disease (GVHD)
Richter transformation

Billing Rule

HCPCS Q2054 billing

Use HCPCS Q2054 for lisocabtagene maraleucel therapeutic dose (including leukapheresis and dose preparation procedures) per therapeutic dose.

Q2054 — Lisocabtagene maraleucel, up to 110 million autologous anti-CD19 CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose