CurrentBlue Cross Blue Shield - IowaPolicy 05.04.75

Lisocabtagene maraleucel (Breyanzi) — Coverage Criteria and Prior Authorization

Defines prior authorization, coverage criteria, dosing limits, exclusions, and billing codes for lisocabtagene maraleucel (Breyanzi) for Wellmark/Blue Cross Blue Shield - Iowa members. Affects providers requesting coverage for Breyanzi for adult and pediatric B‑cell malignancies and CLL/SLL.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyLisocabtagene maraleucel (Breyanzi) — Coverage Criteria and Prior Authorization

Policy CodePolicy 05.04.75

Change TypeNo material change

Effective DateJan 18, 2026

Next Review DateJan 1, 2026

Key ActionSubmit prior authorization request with chart documentation showing prior therapy failure to request a single 3-month authorization (one dose).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

one lifetimetreatment course limit

3 monthsauthorization period

Q2054HCPCS

No primary CNSlimitation

Coverage Criteria

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Adult Large B‑cell Lymphomas (Initial Therapy)

Covered when ALL of the following are met for adult large B‑cell lymphomas

Age: Member is ≥18 years of age

Prior therapy: Member has received prior treatment with two or more lines of systemic therapy OR has relapsed/refractory disease after first-line chemoimmunotherapy as specified in subcriteria

See subcriteria for exceptions (e.g., relapse within 12 months, ineligibility for HSCT)

Eligible lymphoma subtypes (any of the following): Member has one of the following B-cell lymphoma subtypes: diffuse large B-cell lymphoma (DLBCL) including DLBCL NOS and DLBCL arising from indolent lymphomas; high-grade B-cell lymphoma (including double/triple‑hit); primary mediastinal large B-cell lymphoma; follicular lymphoma grade 3B; marginal zone lymphoma; HIV-related B-cell lymphomas (including primary effusion lymphoma and HHV8-positive DLBCL); or monomorphic post-transplant lymphoproliferative disorder (B-cell type)

Includes subtypes listed in the FDA indications and policy

CLL/SLL (Initial Therapy)

Covered when ALL of the following are met for CLL/SLL

Age: Member is ≥18 years of age

Prior therapy: Member has received prior therapy with a Bruton tyrosine kinase (BTK) inhibitor (e.g., acalabrutinib, ibrutinib, zanubrutinib) AND a BCL-2 inhibitor (e.g., venetoclax)

Histologic (Richter) Transformation

Covered when ANY of the following are met for Richter transformation to DLBCL

Clonally related or unknown: Disease is clonally related or clonal status is unknown in members with del(17p)/TP53 mutation OR who are chemotherapy refractory or unable to receive chemoimmunotherapy

Clonally unrelated or prior CLL with progression: Disease is clonally unrelated OR member has previously untreated CLL with partial response, refractory disease, or progression on chemoimmunotherapy

Pediatric Primary Mediastinal Large B‑cell Lymphoma

Covered when ALL of the following are met for pediatric primary mediastinal large B‑cell lymphoma

Age: Member is <18 years of age

Prior therapy: Member has received at least two chemoimmunotherapy regimens and achieved a partial response

Coverage is excluded for treatment of primary central nervous system (CNS) lymphoma. The policy explicitly states that Breyanzi is not indicated for primary CNS lymphoma and will not be covered for this diagnosis.

Coverage will also be denied for members who have had a previous treatment course with the requested medication or another CD19-directed CAR T-cell therapy. This exclusion applies regardless of current disease status or intent to retreat.

Requests will be considered not medically necessary and are excluded for members with an ECOG performance status ≥3 (not ambulatory and not capable of all self-care, confined to bed or chair more than 50% of waking hours).

Coverage is also excluded for members with inadequate or unstable kidney, liver, pulmonary, or cardiac function, or with any active uncontrolled infection including active hepatitis B or C.

Additional exclusions include active graft‑versus‑host disease and any active inflammatory disorder.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. A single 3-month authorization (one dose) may be granted when the applicable indication-specific prior therapy criteria are met. Submit a prior authorization request before administration when possible.

Authorization = 3 months (one dose) for eligible indications
Submit prior authorization prior to administration

Step Therapy

Prior Therapy Requirements

The following prior therapy requirements must be documented for the indicated diagnoses before an authorization for the requested therapy will be considered.

A. Adult large B-cell lymphomas: member has received two or more lines of systemic therapy (or meets the FDA‑approved refractory/relapse criteria listed under FDA‑Approved Indications).
B. CLL/SLL: member has received prior therapy including a Bruton tyrosine kinase (BTK) inhibitor and a BCL‑2 inhibitor (e.g., ibrutinib/acalabrutinib/zanubrutinib and venetoclax).
C. Richter transformation to DLBCL: meets clonally related/clonally unrelated criteria described (e.g., del(17p)/TP53 mutation, chemotherapy refractory or progression as specified).
D. Pediatric primary mediastinal large B‑cell lymphoma (<18 years): received at least two chemoimmunotherapy regimens and achieved partial response.
E. Other FDA‑listed indications (FL grade 3B, MCL, MZL, HIV‑related B‑cell lymphomas, post‑transplant B‑cell PTLD): documentation of ≥2 prior lines of systemic therapy or specific prior agents as indicated.

Documentation Required

Required Documentation

Submit chart notes or medical record documentation that clearly support the prior therapy history and clinical need. At minimum include: diagnosis, prior systemic regimens (agents, start/stop dates), response to each regimen (refractory, partial response, progression, or relapse), reasons for ineligibility for HSCT if asserted, relevant molecular/cytogenetic results (e.g., del(17p)/TP53), and ECOG performance status.

Chart notes or medical records showing prior lines of therapy with dates and outcomes
Documentation of prior use of required agents (e.g., BTK inhibitor, BCL‑2 inhibitor) for CLL/SLL
If claiming HSCT ineligibility, documentation of comorbidities or age that preclude HSCT
Relevant labs/genetic testing and ECOG performance status
Avoid submission if member has exclusion criteria (see exclusions): prior CD19‑directed CAR T, primary CNS lymphoma, ECOG ≥3, active uncontrolled infection, active GVHD, inadequate organ function

Denial Risk

Common Exclusion Triggers (Denial Risk)

Coverage will be denied when exclusion criteria are met or documentation is insufficient. Common denial triggers include prior receipt of a CD19‑directed CAR T therapy, diagnosis of primary CNS lymphoma, ECOG performance status ≥3, inadequate/unstable organ function, active uncontrolled infection (including active HBV/HCV), active graft‑versus‑host disease, or active inflammatory disorder.

Prior CD19‑directed CAR T or prior course with the requested medication
Primary central nervous system (CNS) lymphoma
ECOG performance status ≥ 3
Inadequate or unstable kidney, liver, pulmonary, or cardiac function
Active hepatitis B or C, active uncontrolled infection, active graft‑versus‑host disease, or active inflammatory disorder

Step Therapy Requirements

Indication	Prior therapies required before authorization
Adult large B-cell lymphomas (members ≥18 years)	Received prior treatment with two or more lines of systemic therapy (or refractory/relapsed after first-line chemoimmunotherapy as specified); eligible subtypes include DLBCL (NOS and arising from indolent lymphomas), high-grade B‑cell lymphoma, primary mediastinal large B‑cell lymphoma, follicular lymphoma grade 3B, marginal zone lymphoma, HIV‑related B‑cell lymphomas, and monomorphic post‑transplant lymphoproliferative disorder (B‑cell type)
Chronic lymphocytic leukemia (CLL) / Small lymphocytic lymphoma (SLL) (members ≥18 years)	Received at least 2 prior lines of therapy including a Bruton tyrosine kinase (BTK) inhibitor (e.g., acalabrutinib, ibrutinib, zanubrutinib) and a BCL‑2 inhibitor (e.g., venetoclax)
Pediatric primary mediastinal large B‑cell lymphoma (members <18 years)	Received at least two chemoimmunotherapy regimens and achieved partial response

OpenPayer

Lisocabtagene maraleucel (Breyanzi) — Coverage Criteria and Prior Authorization

Coverage Criteria

Provider Actions & Requirements

Initial Therapy Authorization

Step Therapy Requirements

Coding and Billing

Quantity and Treatment Limits

Definitions

Background