CurrentAgency for Health Care AdministrationPolicy N/A

BREYANZI (lisocabtagene maraleucel) Coverage Criteria

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This policy governs prior authorization for BREYANZI (lisocabtagene maraleucel) for adult patients with specified large B-cell lymphomas. It establishes eligibility criteria, authorization duration, dosing information, and administration through a REMS-certified healthcare facility.

Policy Summary

PayerAgency for Health Care Administration

PolicyBREYANZI (lisocabtagene maraleucel) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and administer BREYANZI at a BREYANZI REMS-certified healthcare facility.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18 yearsMinimum patient age

3Coverage pathways

Single doseAuthorization duration

REMS facilityAdministration setting

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CurrentAgency for Health Care AdministrationPolicy N/A

BREYANZI (lisocabtagene maraleucel) Coverage Criteria

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Policy Summary

PayerAgency for Health Care Administration

PolicyBREYANZI (lisocabtagene maraleucel) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and administer BREYANZI at a BREYANZI REMS-certified healthcare facility.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18 yearsMinimum patient age

3Coverage pathways

Single doseAuthorization duration

REMS facilityAdministration setting

Initial therapy eligibility

Covered when all of the following are met, including at least one qualifying disease-history pathway.

BREYANZI eligibility

Age: Patient is at least 18 years of age.≥18 years
Eligible large B-cell lymphoma: Patient has large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma arising from indolent lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, or follicular lymphoma grade 3B.
Qualifying disease history
- Early refractory or relapsed disease: Disease is refractory to first-line chemoimmunotherapy or relapsed within 12 months of first-line chemoimmunotherapy.Relapse within 12 months
- Transplant-ineligible disease: Disease is refractory to first-line chemoimmunotherapy or relapsed after first-line chemoimmunotherapy, and the patient is not eligible for hematopoietic stem cell transplantation because of comorbidities or age.
- Disease after multiple systemic therapies: Disease is relapsed or refractory after two or more lines of systemic therapy.≥2 lines of systemic therapy

Authorization and Administration Requirements

Prior Authorization

Obtain prior authorization for the date of service

Prior authorization is required for BREYANZI. Authorization is limited to the date of service and requires the patient to meet the stated age, diagnosis, and disease-history criteria.

Documentation Required

Document clinical eligibility

Prior authorization documentation should establish the patient's age, eligible large B-cell lymphoma diagnosis, and applicable refractory, relapse, transplant-ineligibility, or prior systemic-therapy history.

Document that the patient is at least 18 years of age.
Document an eligible large B-cell lymphoma diagnosis.
Document the applicable qualifying disease history.

Documentation Required

Document BREYANZI REMS-certified administration

Document administration through a healthcare facility certified under the BREYANZI REMS.

Denial Risk

Avoid clinical eligibility denial

Coverage may be denied when the patient is younger than 18 years or does not have an eligible large B-cell lymphoma and qualifying disease history, including the required refractory, relapse, transplant-ineligibility, or prior systemic-therapy history.

Patient must be at least 18 years of age.
The diagnosis must be an eligible large B-cell lymphoma.
At least one qualifying disease-history pathway must be documented.

Denial Risk

Do not administer outside the BREYANZI REMS

BREYANZI must be administered at a REMS-certified healthcare facility because of the risks of cytokine release syndrome and neurological toxicities.

Initial Authorization

Initial authorization

Initial authorization requires all age and disease requirements plus at least one qualifying disease-history pathway.

Initial BREYANZI authorization

Age: Patient must be at least 18 years of age.≥18 years
Eligible large B-cell lymphoma: Patient must have large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma arising from indolent lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, or follicular lymphoma grade 3B.
Qualifying disease history
- Early refractory or relapsed disease: Disease is refractory to first-line chemoimmunotherapy or relapsed within 12 months of first-line chemoimmunotherapy.Relapse within 12 months
- Transplant-ineligible disease: Disease is refractory to first-line chemoimmunotherapy or relapsed after first-line chemoimmunotherapy, and the patient is not eligible for hematopoietic stem cell transplantation because of comorbidities or age.
- Disease after multiple systemic therapies: Disease is relapsed or refractory after two or more lines of systemic therapy.≥2 lines of systemic therapy

Therapy Overview

BREYANZI (lisocabtagene maraleucel) is authorized for adults at least 18 years of age with specified large B-cell lymphomas, including diffuse large B-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma arising from indolent lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Coverage applies when the patient also has a qualifying refractory or relapsed disease history, including relapse within 12 months of first-line chemoimmunotherapy, transplant-ineligible disease, or relapsed/refractory disease after two or more lines of systemic therapy.

Policy Terms

Large B-Cell Lymphoma (LBCL)

LBCLLarge B-cell lymphoma

DLBCLDiffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from indolent lymphoma

High-grade B-cell lymphomaIncluded large B-cell lymphoma subtype

Primary mediastinal large B-cell lymphomaIncluded large B-cell lymphoma subtype

Follicular lymphoma grade 3BIncluded lymphoma subtype

Hematopoietic Stem Cell Transplantation (HSCT)

HSCTHematopoietic stem cell transplantation

Policy relevanceA qualifying pathway applies when the patient is not eligible for HSCT because of comorbidities or age

Disease-history contextThis pathway requires disease refractory to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy

BREYANZI REMS

ProgramBREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS

RationaleThe restricted program is required because of the risk of cytokine release syndrome and neurological toxicities

Administration requirementBREYANZI must be administered at a REMS-certified healthcare facility

Policy Summary

PayerAgency for Health Care Administration

PolicyBREYANZI (lisocabtagene maraleucel) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and administer BREYANZI at a BREYANZI REMS-certified healthcare facility.

SourceLink

On This Page

BREYANZI (lisocabtagene maraleucel) Coverage Criteria

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BREYANZI (lisocabtagene maraleucel) Coverage Criteria

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Eligibility Requirements

Authorization and Administration Requirements

Initial Authorization

Dose and Quantity

Administration Setting

Therapy Overview

Policy Terms