CurrentAvMedPolicy Pub. 100-2

Breyanzi (lisocabtagene maraleucel) medical prior authorization — coverage criteria

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Prior authorization form and clinical criteria for medical benefit coverage of Breyanzi (lisocabtagene maraleucel) for adult members with specified B-cell malignancies; applies to providers requesting AvMed coverage in North Carolina.

Policy Summary

PayerAvMed

PolicyBreyanzi (lisocabtagene maraleucel) medical prior authorization — coverage criteria

Policy CodePolicy Pub. 100-2

Change TypeMinor update (no material changes)

Effective Date

Next Review Date

Key ActionSubmit a completed prior authorization form with prescriber signature and required clinical documentation to AvMed for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1maximum units per member (medical benefit)

18+

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CurrentAvMedPolicy Pub. 100-2

Breyanzi (lisocabtagene maraleucel) medical prior authorization — coverage criteria

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Sign up for AvMed Policy Pub. 100-2 alerts

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Policy Summary

PayerAvMed

PolicyBreyanzi (lisocabtagene maraleucel) medical prior authorization — coverage criteria

Policy CodePolicy Pub. 100-2

Change TypeMinor update (no material changes)

Effective Date

Next Review Date

Key ActionSubmit a completed prior authorization form with prescriber signature and required clinical documentation to AvMed for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1maximum units per member (medical benefit)

18+

Coverage Criteria for Breyanzi (liso-cel)

Initial Therapy Coverage Criteria

Covered when ALL of the following are met:

General eligibility: Member is 18 years of age or older; no clinically significant active systemic infection or inflammatory disorder; no live vaccines within 6 weeks prior to lymphodepleting chemotherapy, during treatment, and until immune recovery; screened for HBV, HCV, and HIV prior to leukapheresis; infection prophylaxis per local guidelines; treating facility enrolled in the BREYANZI REMS Program with trained providers for CRS and neurologic toxicity management; member has not received prior CAR-T therapy; medication will be used as single-agent therapy (except lymphodepleting or bridging chemotherapy while awaiting manufacture); member does not have primary central nervous system lymphoma; if prior anti-CD19 therapy was given, re-biopsy must indicate CD19-positive disease.

All general criteria must be met

Indication: B-cell lymphomas: Member has one of the following diagnoses: diffuse large B-cell lymphoma (including transformed from indolent), high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, or follicular lymphoma Grade 3B; AND meets one of the treatment-failure conditions: refractory to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; refractory to or relapse after first-line chemoimmunotherapy and not eligible for hematopoietic stem cell transplantation due to comorbidities or age; relapsed or refractory after two or more lines of systemic therapy; for follicular lymphoma specifically, relapsed or refractory disease with at least two prior lines of therapy.

Select applicable diagnostic and treatment-history pathway

Indication: CLL/SLL: Member has chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with relapsed or refractory disease and has received at least 2 prior lines of therapy including BOTH a Bruton tyrosine kinase (BTK) inhibitor (e.g., acalabrutinib, ibrutinib, pirtobrutinib, zanubrutinib) AND a BCL-2 inhibitor (e.g., venetoclax).

All listed prior agents required

Indication: Mantle cell lymphoma: Confirmed relapsed or refractory mantle cell lymphoma; member has received previous systemic therapy including BOTH a BTK inhibitor (e.g., ibrutinib, acalabrutinib, zanubrutinib) AND a second systemic therapy (e.g., rituximab-based immunochemotherapy).

Both prior therapy categories required

Indication: Marginal zone lymphoma: Confirmed relapsed or refractory marginal zone lymphoma; member has received at least 2 previous lines of systemic therapy.

Member must not have primary central nervous system lymphoma. Requests for Breyanzi (lisocabtagene maraleucel) will be declined when the member has a diagnosis of primary CNS lymphoma, as this is an explicit exclusion in the approval criteria.

Breyanzi is approved only as a single-agent CAR T-cell therapy. Use in combination with other anti-cancer agents is not supported by these criteria except for lymphodepleting chemotherapy or bridging chemotherapy given while awaiting product manufacture.

Permitted Regimens and Administration

Regimen	Coverage status	Notes / Limits
Single-agent Breyanzi (lisocabtagene maraleucel) following leukapheresis and lymphodepleting chemotherapy	covered	Allowed as single-agent CAR T-cell therapy; lymphodepleting or bridging chemotherapy permitted while awaiting manufacture; member must meet all general eligibility criteria (age ≥18, no active systemic infection/inflammatory disorder, REMS enrollment, no prior CAR-T, CD19 requirements if prior anti‑CD19 therapy, not primary CNS lymphoma).

Indication by Line of Therapy

second-line|later

Reauthorization

ref':'b0_1'

title':'Reauthorization Criteria'

blocks_error_fix_notes

later

ref':'b2_1'

title':'later'

blocks_error_fix_notes

Biomarker and Testing Requirements

CD19 — Re-biopsy must indicate CD19-positive disease

Biomarker requirementIf member previously received anti-CD19 therapy, re-biopsy must demonstrate CD19-positive disease

When requiredRequired only when prior anti-CD19 therapy was given and re-treatment with Breyanzi is being considered

DocumentationSubmit re-biopsy pathology report confirming CD19 expression

Coding and Quantity Limits

Covered HCPCSHCPCSCovered

Q2054

Breyanzi (liso-cel) IV

NDCNDCCovered

73153-0900-08

Breyanzi suspension NDC

Max units per dose — 1 infusion

Maximum units per dose1 infusion of Breyanzi (medical benefit)

Pharmacy benefitN/A

NDC associatedBreyanzi suspension NDC 73153-0900-08

Provider Actions, Submission Requirements, and Documentation

Prior Authorization

Prior authorization required for Breyanzi (medical)

Prior authorization is required for Breyanzi (liso-cel) medical benefit. Submit the completed medical prior authorization/step-edit request form with the prescribing physician's signature and required clinical documentation to AvMed for review.

Step Therapy

Samples do not meet step-edit/preauthorization

Use of manufacturer or clinic samples to start therapy does not satisfy the step-edit/preauthorization requirement; prior therapies will be verified via pharmacy claims or submitted chart notes.

Documentation Required

Definitions and Program Requirements

REMS enrollment and provider training for CRS and neurologic toxicity management

ProgramBREYANZI REMS Program

PurposeREMS enrollment and provider training for management of cytokine release syndrome (CRS) and neurologic toxicities

Facility requirementHealthcare facility must be enrolled in the BREYANZI REMS and providers trained prior to administration

Medical benefit limited to 1 infusion of Breyanzi — Quantity Limit

Quantity limit (medical)Max units (per dose and over time): 1 infusion of Breyanzi only

Pharmacy benefitNot applicable (N/A)

Background and Clinical Context

Breyanzi (lisocabtagene maraleucel) is a CD19-directed CAR T‑cell therapy intended for adults with certain relapsed or refractory B‑cell malignancies. Administration requires leukapheresis and institutional participation in the BREYANZI REMS Program, and providers must be trained in recognition and management of cytokine release syndrome (CRS) and neurologic toxicities. Prior to collection, members must be screened for HBV, HCV, and HIV, must not have active significant systemic infection, and must meet other listed clinical eligibility conditions.