Viva Health Breyanzi Coverage Prior Auth

Coverage Criteria for Breyanzi (lisocabtagene maraleucel)

Initial Therapy — Covered when ALL of the following provider‑documented conditions are met (and when indication‑specific criteria below are met):

Covered when ALL of the following provider‑documented conditions are met (and when indication‑specific criteria below are met):

General eligibility: Submission of supporting clinical documentation (medical records, chart notes, lab results, and confirmatory diagnostics) is REQUIRED; patient is ≥18 years unless otherwise specified; no clinically significant active systemic infection or inflammatory disorder; no live vaccines within 6 weeks prior to lymphodepleting chemotherapy and none during treatment until immune recovery; screened for HBV, HCV, and HIV prior to leukapheresis; infection prophylaxis per institutional guidelines; no prior CAR‑T therapy; no prior anti‑CD19 therapy unless rebiopsy confirms CD19+ disease; used as single‑agent therapy (lymphodepleting or bridging chemotherapy excluded); patient does not have primary CNS lymphoma.

See policy initial approval criteria; documentation submission required (chunk 3)

Breyanzi is for autologous use only and is delivered intravenously. Confirm Breyanzi availability prior to beginning lymphodepleting chemotherapy and verify the patient’s identity against the shipper and the Certificate of Release for Infusion (RFI Certificate) immediately before infusion. Delay the infusion if the patient has unresolved serious adverse events from prior chemotherapies, an active uncontrolled infection, or active graft‑versus‑host disease (GVHD).

This product is not indicated for primary central nervous system (CNS) lymphoma. Breyanzi is intended to be used as a single‑agent CAR‑T infusion (lymphodepleting or bridging chemotherapy may be used while awaiting manufacture), and it must only be administered following the authorized lymphodepleting regimen and proper preparation steps.

Medicare Part B coverage for outpatient drugs, including CAR‑T therapies, is governed by the Medicare Benefit Policy Manual (Pub. 100‑2), Chapter 15 §50, and by any applicable National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs) and Local Coverage Articles (LCAs). Providers should consult those CMS sources for Medicare coverage, prior authorization, and billing requirements; the appendix content in this policy is intended for non‑Medicare determinations.

Material contained in the appendix is intended to support non‑Medicare coverage determinations. For Medicare members, providers must follow the Medicare Benefit Policy Manual and any applicable NCDs, LCDs, or LCAs; those Medicare policies take precedence and may impose different coverage or documentation requirements than those described in this appendix.

Use of Breyanzi is not permitted for patients who have previously received chimeric antigen receptor (CAR)‑T cell therapy. Prior receipt of CAR‑T is an exclusion to authorization under these criteria and must be documented in submitted records.

Billing and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

Q2054

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

NDCNDC

73153-0900-xx

Breyanzi suspension for intravenous infusion [Each vial contains between 6.9 × 10^6 and 322 x 10^6 CAR-positive viable T cells in 4.6 mL cell suspension (between 1.5 × 10^6 and 70 x 10^6 CAR-positive viable T cells/mL)]

Covered HCPCS CodesHCPCSCovered

Q2054

Lisocabtagene maraleucel, up to 110 million autologous anti-cd19 car-positive viable t cells, including leukapheresis and dose preparation procedures, per therapeutic dose

NDCNDCCovered

73153-0900-xx

Covered ICD-10 Diagnosis CodesICD-10Covered

C82.00 - C82.99	Multiple follicular lymphoma codes (grades I-IIIb, diffuse, cutaneous, other types, unspecified sites) as listed in Appendix 1
C83.00 - C83.99	Multiple small cell B-cell, mantle cell, diffuse large B-cell and other non-follicular lymphoma codes as listed in Appendix 1
C85.10 - C85.89	Unspecified B-cell lymphoma and other specified types of non-Hodgkin lymphoma codes as listed in Appendix 1
C91.10, C91.12	Chronic lymphocytic leukemia of B-cell type (not having achieved remission; in relapse)
D47.Z1	Post-transplant lymphoproliferative disorder (PTLD)

Medicare Part B Covered Diagnosis CodesICD-10

N/A	Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD)

Dose cell count — single dose

Standard adult single‑dose cell countA single dose contains 90 to 110 x10^6 CAR‑positive viable T cells (1:1 CD8:CD4 components supplied in 1–4 single‑dose vials)

Alternate range noted elsewhere in policyPolicy additionally references a 50 to 110 x10^6 range in one section for certain pediatric/indication dosing contexts

Billable HCPCS unit per infusionOne billable unit corresponds to a single infusion of up to 110 million CAR‑positive viable T cells

Component compositionDose consists of equal CD8 and CD4 CAR‑positive viable T‑cell components supplied separately

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required and is valid for a single treatment course (one dose). Prior authorization validity will be provided initially for one treatment course and renewals are not permitted.

Prior Authorization

Prior Authorization Consideration (NQTL)

Prior authorization is used as a utilization management tool based on consideration of indication, safety/efficacy, and drug cost per the NQTL factor checklist. These non‑quantitative treatment limitation (NQTL) factors were considered when designing and applying prior authorization for this therapy.

Note

Medicare Part B Prior Authorization and Coverage Note

For Medicare Part B patients, check applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) for any Part B prior authorization or coverage requirements. Medicare coverage policies may differ from non‑Medicare determinations and must be followed where applicable.

Lymphodepleting and Infusion Regimens

Regimen	Dose / Schedule	Coverage
Lymphodepleting chemotherapy (cyclophosphamide + fludarabine)
Cyclophosphamide 300 mg/m2 IV daily + fludarabine 30 mg/m2 IV daily for 3 days
Covered when administered prior to CAR‑T infusion per policy criteria

Parameter	Specification	Coverage
Infusion timing
Infuse 2 to 7 days after completion of lymphodepleting chemotherapy
Covered when timing requirement met per policy

Line of Therapy Requirements

mixed — indication‑specific prior‑line therapy requirements

Indication‑specific prior‑line therapy requirements (provider must document prior therapies as shown):

B‑Cell lymphoma indications: Diffuse large B‑cell lymphoma (DLBCL), high‑grade B‑cell lymphoma, primary mediastinal B‑cell lymphoma (PMBCL), follicular lymphoma grade 3b, HIV‑related B‑cell lymphoma, or post‑transplant lymphoproliferative disorder (PTLD). AND one of the following disease‑specific scenarios: primary refractory or relapsed within 12 months of first‑line therapy; relapsed/refractory after first‑line chemoimmunotherapy in patients not eligible for HSCT (excludes HIV‑related B‑cell lymphoma and PTLD); second‑line relapsed disease >12 months after first‑line if no plan for transplant; additional therapy for relapsed disease >12 months with partial response after second‑line; or relapsed/refractory after ≥2 systemic therapies.

See chunks 4-5 for branching details

Follicular lymphoma (grade 1–3a): Relapsed or refractory disease AND patient has received at least 2 prior lines of therapy.

chunk 4

Mantle cell lymphoma:

Pre-treatment Screening and Biomarker Requirements

HBV/HCV/HIV screening — pre‑infusion infectious disease screening

Required screening testsPatient must be screened for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines prior to leukapheresis

Timing of screeningScreening is required prior to collection of cells (leukapheresis)

Infection prophylaxisProphylaxis for infection should follow standard institutional guidelines

Delay considerationsDelay infusion if unresolved serious adverse events from prior chemotherapies, active uncontrolled infection, or active GVHD

Definitions and Product Information

Treatment course

Treatment sequenceLymphodepleting chemotherapy followed by a single intravenous infusion of Breyanzi prepared from the patient’s autologous T cells obtained by leukapheresis

Confirm product availabilityConfirm Breyanzi availability prior to starting the lymphodepleting regimen

Pre‑infusion delay criteriaDelay infusion for unresolved serious adverse events from preceding chemotherapies, active uncontrolled infection, or active graft‑versus‑host disease (GVHD)

Post‑infusion monitoringMonitor patients daily for at least 7 days post‑infusion and ensure proximity to a healthcare facility for at least 2 weeks

HCPCS Q2054 — billing definition

HCPCS code and descriptorQ2054 — Lisocabtagene maraleucel, up to 110 million autologous anti‑CD19 CAR‑positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose

Clinical Background

Breyanzi (lisocabtagene maraleucel) is an autologous anti‑CD19 CAR‑T cell therapy manufactured from the patient’s own T cells obtained by leukapheresis, followed by lymphodepleting chemotherapy and a single intravenous infusion. Patients require monitoring after infusion for expected toxicities such as cytokine release syndrome and neurologic events; tocilizumab availability and appropriate post‑infusion monitoring are part of standard management. One treatment course consists of lymphodepletion followed by a single infusion; confirm product availability and patient identity prior to infusion.

OpenPayer

Breyanzi® (lisocabtagene maraleucel) (Intravenous) - Coverage Criteria