CurrentEmblemHealthPolicy N/A

Medicare Advantage Medical Utilization Review Policy

Medicare Advantage medical utilization review policy for coverage and prior authorization of Breyanzi (lisocabtagene maraleucel) for adult patients with specified large B-cell lymphomas. Defines eligible diagnoses, prior systemic therapy requirements, age and prior CAR-T exclusion, dosing, REMS and approval duration.

Policy Summary

PayerEmblemHealth

PolicyMedicare Advantage Medical Utilization Review Policy

Policy CodePolicy N/A

Change TypeRevised criteria and approval duration

Effective DateJul 26, 2023

Next Review Date

Key ActionPrior authorization is recommended; document histologic diagnosis, prior systemic therapy lines, plan/receipt of lymphodepletion, age, and absence of prior CAR-T therapy; approval duration is 6 months.

SourceLink

POLICY UPDATE CHANGES

Approval duration added: 6 months to allow adequate time to prepare and administer one dose of therapy.

Requirement for number of prior systemic therapy lines revised historically from >=2 to >=1 for specified B-cell lymphoma histologies.

Added wording 'received or plan to receive' lymphodepleting chemotherapy prior to infusion.

1Dose approvals per patient

6Approval duration (months)

>=18Minimum age (years)

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Coverage Summary

Medicare Advantage medical utilization review policy for coverage and prior authorization of Breyanzi (lisocabtagene maraleucel) for adult patients with specified large B-cell lymphomas. Indicated for certain relapsed/refractory large B-cell lymphomas including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, follicular lymphoma Grade 3B, HHV8-positive DLBCL, post-transplant lymphoproliferative disorders, primary effusion lymphoma, and transformed indolent lymphoma to DLBCL. The product carries boxed warnings for cytokine release syndrome (CRS) and neurologic toxicities and is distributed under the Breyanzi REMS. Dosing is a single intravenous dose of 50 to 110 x 10^6 CAR-positive viable T cells administered as a 1:1 mixture of CD8 and CD4 components; the product is supplied as separate frozen CD8 and CD4 components. Coverage stance: covered_with_criteria. Effective and last review date: 07/26/2023.

Key policy thresholds

Minimum age (years)>= 18

Dose50 to 110 x 10^6 CAR-positive viable T cells (single IV dose, 1:1 CD8:CD4 components)

Dose approvals per patient1

Approval duration6 months

Initial Therapy Criteria (B‑Cell Lymphoma)

Continuation / Duration

Approval duration is 6 months to allow adequate time to prepare and administer one dose of therapy. Authorization is for a single dose per patient as the standard dosing approach.

Not Recommended / Exclusions

Not Recommended for Approval

Coverage not recommended when conditions below are met:

Circumstances not listed in the Recommended Authorization Criteria

Criteria will be updated as new published data are available.

Patients previously treated with CAR‑T therapy are excluded from approval. Operational examples of CAR‑T therapies noted in the policy include Breyanzi, Kymriah (tisagenlecleucel), Tecartus (brexucabtagene), and axicabtagene (axi‑cel).

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of Breyanzi; approval is recommended only for patients meeting the specified criteria. Approval duration is 6 months to allow preparation and administration of one dose.

Documentation Required

Document systemic therapy history and planned lymphodepletion

Providers must document histologic diagnosis, number of prior systemic therapy lines, plan for or receipt of lymphodepleting chemotherapy, patient age, and absence of prior CAR‑T therapy to support approval.

Histologic diagnosis (specific B-cell lymphoma subtype)
Number of prior systemic therapy lines received
Documentation that patient has received or plans to receive lymphodepleting chemotherapy prior to infusion
Patient age (≥ 18 years)

Applicable Codes

HCPCS / ICD-10 lists referenced for billing (informational guidance only)mixed

No codes listed

Clinical Evidence & Guidelines

Evidence and referenced sources informing the policy: NCCN B-Cell Lymphoma Clinical Practice Guidelines (version 5.2022) — recommend Breyanzi for various lymphomas as second-line and subsequent therapy; FDA prescribing information / product labeling (Juno Therapeutics, June 2022) and REMS requirements — referenced for safety, boxed warnings, and distribution; Centers for Medicare & Medicaid Services National Coverage Determination (NCD) for CAR T-cell (110.24) — cited and incorporated into Medicare coverage considerations.

Evidence sources

NCCN guidelineB-Cell Lymphoma Clinical Practice Guidelines (version 5.2022)

FDA PIPrescribing information (Juno Therapeutics, June 2022)

CMS NCDNCD 110.24 (original effective date 8/7/2019; implementation 2/16/2021)

Background & Definitions

Breyanzi (lisocabtagene maraleucel) is an autologous CAR‑T cell therapy indicated for certain relapsed/refractory large B‑cell lymphomas. The product has boxed warnings for cytokine release syndrome (CRS) and neurologic toxicities and is available only through the Breyanzi REMS. It is stored in the vapor phase of liquid nitrogen and is supplied as separate frozen CD8 and CD4 components.

Lymphodepleting chemotherapy: Chemotherapy given prior to CAR‑T cell infusion to reduce endogenous lymphocytes and optimize CAR‑T cell expansion.

CAR‑T therapy: Chimeric antigen receptor T‑cell therapies; examples include Breyanzi, Kymriah, Tecartus, and axicabtagene.

Revision History

07/26/2023policy_statement_additionLatest

Approval duration added to Policy Statement: approval duration is 6 months to allow adequate time to prepare and administer one dose of therapy.

01/14/2022historical_revision

Policy history revised requirement for number of prior systemic therapy lines: for specified B-cell lymphoma histologies the criterion was changed from two or more prior systemic therapy lines to at least one prior systemic therapy line; additional lymphoma subtypes were added.

01/14/2022