CurrentAnthemPolicy CC-0232

Lunsumio (mosunetuzumab-axgb) coverage

Defines medical necessity and prior authorization criteria for Lunsumio (mosunetuzumab-axgb) for treatment of relapsed or refractory follicular lymphoma and select other B-cell lymphomas, and lists relevant codes. Applies to Anthem medical benefit reviews and prior authorization decisions.

Policy Summary

PayerAnthem

PolicyLunsumio (mosunetuzumab-axgb) coverage

Policy CodePolicy CC-0232

Change TypeMaterial clinical and coding updates

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization and document diagnosis, prior lines of systemic therapy, and intended regimen (single-agent or combination with polatuzumab when applicable).

SourceLink

POLICY UPDATE CHANGES

Added NCCN 2A recommendations for use in R/R HIV Related B-Cell lymphomas and Post-transplant Lymphoproliferative disorders and removed criteria requirements for CAR-T and transplant non-candidates.

Added ICD-10-CM codes B20, C83.80-C83.89, C85.20-C85.29, D47.Z1 to coding section.

2+ linesrequired prior systemic therapies for follicular lymphoma

J9350HCPCS code for mosunetuzumab-axgb (1 mg)

Black BoxCRS (cytokine release syndrome) warning

NCCN 2ARecommended for several other B-cell lymphomas

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Coverage Criteria for Lunsumio (mosunetuzumab-axgb)

inv-01: Initial approval — Follicular lymphoma

Requests for Lunsumio may be approved if the following ALL criteria are met for follicular lymphoma:

Follicular lymphoma diagnosis: I. Individual has a diagnosis of relapsed, refractory, or progressive follicular lymphoma

Prior systemic therapy: II. Individual has received two or more lines of systemic therapy>=2 prior systemic therapies

Indication approved under accelerated approval

Agent use: III. Individual is using Lunsumio as a single agent

inv-02: NCCN 2A indications — DLBCL and other B-cell lymphomas (in combination with Polivy)

Alternatively, requests may be approved for certain NCCN 2A B-cell lymphoma indications when ALL of the following are met:

Eligible diagnoses (NCCN 2A): IV. Individual has diagnosis of one of: relapsed/refractory Diffuse Large B-Cell Lymphoma OR relapsed/refractory High Grade B-Cell Lymphoma OR relapsed/refractory HIV-Related B-Cell Lymphomas OR relapsed/refractory Post-Transplant Lymphoproliferative Disorders

NCCN 2A recommendation referenced

Line of therapy for NCCN 2A indications: V. Individual is using as second-line and subsequent therapysecond-line or later

Combination requirement: VI. Using in combination with polatuzumab-vedotin-piiq (Polivy)

Regimen	Indication / NCCN mapping	Line of therapy	Coverage stance
Lunsumio (mosunetuzumab-axgb) — single agent	Relapsed or refractory follicular lymphoma (NCCN: single-agent option for third-line and subsequent therapy)	>=2 prior systemic therapies (third-line and beyond)	Covered with criteria
Lunsumio (mosunetuzumab-axgb) + Polivy (polatuzumab vedotin-piiq)	Select B‑cell lymphomas with NCCN 2A recommendation: relapsed/refractory Diffuse Large B‑Cell Lymphoma; High‑Grade B‑Cell Lymphoma; HIV‑Related B‑Cell Lymphomas; Post‑Transplant Lymphoproliferative Disorders	Second‑line and subsequent therapy	Covered with criteria

Requests for Lunsumio may not be approved for indications other than those specified in this policy. Approval is limited to the uses described above: treatment of relapsed or refractory follicular lymphoma meeting the stated criteria, or the specified NCCN 2A B‑cell lymphoma indications when used in combination with polatuzumab‑vedotin‑piiq (Polivy) and meeting the line‑of‑therapy requirements.

Use of Lunsumio for any other indications that do not meet the coverage criteria outlined in this policy is not approved.

Relevant Billing and Diagnosis Codes

HCPCSHCPCS

J9350

Injection, mosunetuzumab-axgb, 1 mg [Lunsumio]

ICD-10ICD-10

B20	Human immunodeficiency virus [HIV] disease [HIV-related B-cell lymphomas]
C82.00-C82.99	Follicular lymphoma
C83.30-C83.38	Diffuse large B-cell lymphoma
C83.398	Diffuse large B-cell lymphoma of other extranodal and solid organ sites
C83.80-C83.89	Other non-follicular lymphoma
C85.10-C85.19	Unspecified B-cell lymphoma
C85.20-C85.29	Mediastinal (thymic) large B-cell lymphoma
D47.Z1	Post-transplant lymphoproliferative disorder (PTLD)

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests for Lunsumio (mosunetuzumab-axgb) will be reviewed and may be approved only when clinical criteria are met for follicular lymphoma (relapsed/refractory/progressive) after two or more lines of systemic therapy as a single agent, or for specified B‑cell lymphomas (NCCN 2A) when used as second-line or subsequent therapy in combination with polatuzumab-vedotin-piiq. Requests that do not meet the clinical criteria or are for other indications may be denied.

Affected drug: Lunsumio (mosunetuzumab-axgb)
See clinical criteria: diagnosis, prior lines of systemic therapy, single-agent use or combination with polatuzumab as specified
Nonapproved when criteria not met or for all other indications

Step Therapy

Step-up Dosing Requirement

Lunsumio has a boxed warning for cytokine release syndrome (CRS). To reduce the incidence and severity of CRS, Lunsumio must be initiated using the recommended step-up dosing schedule per the product labeling. Monitor patients closely during and after dosing and withhold or permanently discontinue the drug based on CRS severity.

Required Prior Lines and Therapy Positioning

inv-16: third-line

Third-line requirement (follicular lymphoma): Approved after two or more lines of systemic therapy (third-line and beyond)>=2 prior systemic therapies

Accelerated approval indication; Lunsumio recommended as third-line and subsequent single-agent option per NCCN

inv-17: second-line

Second-line positioning (NCCN 2A indications): Second-line and subsequent therapy when used in combination with polatuzumab-vedotin-piiqsecond-line or later

Applies to NCCN 2A B-cell lymphoma indications (e.g., DLBCL, high-grade B-cell lymphoma, HIV-related B-cell lymphomas, PTLD)

Covered Regimens and Combinations

Regimen	Indication(s)	Required therapy setting / notes	Coverage stance
Lunsumio as single agent	Relapsed or refractory follicular lymphoma	>=2 prior systemic therapies; FDA accelerated approval indication; NCCN lists as third‑line and subsequent single‑agent option	Covered with criteria
Lunsumio + Polivy (polatuzumab vedotin‑piiq)	NCCN 2A B‑cell lymphoma indications: Diffuse Large B‑Cell Lymphoma; High‑Grade B‑Cell Lymphoma; HIV‑Related B‑Cell Lymphomas; Post‑Transplant Lymphoproliferative Disorders	Use as second‑line and subsequent therapy; combination required per NCCN 2A recommendation and supporting phase 1b/2 data	Covered with criteria

Background

Lunsumio (mosunetuzumab‑axgb) is a T‑cell engaging bispecific antibody that binds CD3 on T‑cells and CD20 on B‑cells to induce T‑cell mediated killing of malignant B cells. It is FDA‑approved under an accelerated approval pathway for adult patients with relapsed or refractory follicular lymphoma after two or more prior systemic therapies; continued approval may depend on confirmatory data. NCCN lists Lunsumio as a recommended third‑line or subsequent single‑agent option for follicular lymphoma and provides 2A recommendations for select other B‑cell lymphomas when used per the combinations and line‑of‑therapy described in this policy.

Definitions

Complete Response (CR)

TermComplete Response (CR) — Complete Remission

DefinitionThe disappearance of all signs of cancer as a result of treatment; also called complete remission; does not indicate the cancer has been cured.

Clinical implicationAbsence of detectable disease on assessment does not guarantee cure; continued monitoring may be required.

Partial Response (PR)

TermPartial Response (PR)

DefinitionA decrease in the size of a tumor, or in the amount of cancer in the body, resulting from treatment; also called partial remission.

Clinical implication

Policy Revision History

2025-05-16Select Review - material clinical changeLatest

Added NCCN 2A recommendations for relapsed/refractory HIV-related B‑cell lymphomas and post‑transplant lymphoproliferative disorders; removed criteria requiring CAR‑T and transplant non‑candidates.

2025-02-21Annual Review

Added NCCN 2A recommendations for Diffuse Large B‑Cell Lymphoma and High‑Grade B‑Cell Lymphoma; coding reviewed with ICD‑10‑CM additions (C83.30‑C83.38, C83.398, C85.10‑C85.19).

2024-02-23

Policy Summary

PayerAnthem

PolicyLunsumio (mosunetuzumab-axgb) coverage

Policy CodePolicy CC-0232

Change TypeMaterial clinical and coding updates

Effective DateJul 1, 2025

Next Review Date

Key ActionObtain prior authorization and document diagnosis, prior lines of systemic therapy, and intended regimen (single-agent or combination with polatuzumab when applicable).

SourceLink

On This Page

Initiate with step-up dosing schedule per prescribing information
Monitor for CRS and manage per severity; withhold or discontinue as indicated

Documentation Required

Documentation to Support Medical Necessity

Clinical documentation must support medical necessity. Provide records that confirm diagnosis, number and details of prior systemic therapy lines, intended use as single-agent or in combination with polatuzumab-vedotin-piiq, treatment line (second-line or subsequent when applicable), and relevant treatment rationale or supporting literature. Incomplete documentation may delay review or result in denial.

Confirm diagnosis (follicular lymphoma or specified B‑cell lymphoma subtypes)
Document ≥2 prior systemic therapies for follicular lymphoma cases
Specify whether Lunsumio is single-agent or combined with polatuzumab and the treatment line
Include prior treatment summaries, pathology reports, and relevant clinical notes

Denial Risk

Denial Risk When Criteria Unmet

Requests may be denied when the clinical criteria are unmet or for all other unlisted indications. Denial risk is increased when required documentation is incomplete, the step-up dosing schedule is not followed, or the drug is requested outside the specified single-agent or combination uses.

Denial when the policy clinical criteria are not fully met
Denial when required documentation is missing or inadequate
Denial when step-up dosing is not planned or documented
Denial for indications not specified in this policy

Indicates measurable benefit from therapy but not complete clearance of disease; may prompt continuation or change of therapy based on overall goals.

Refractory Disease

TermRefractory Disease

DefinitionIllness or disease that does not respond to treatment.

Clinical implicationLack of response may necessitate alternative therapies or clinical trial consideration.

Relapse/Recurrence

TermRelapse / Recurrence

DefinitionAfter a period of improvement during which disease could not be detected, the return of signs and symptoms of illness or disease; for cancer, may return to the original site or another location in the body.

Clinical implicationRepresents disease return after prior response and typically prompts re-evaluation of prior therapies and consideration of subsequent-line treatment options.

Updated to include progressive disease per NCCN; coding reviewed with no changes.

2023-02-24Annual Review / New policy creation

Created new clinical criteria document for Lunsumio; coding reviewed and HCPCS/diagnosis codes added (initially added J3490, J3590, J9999, C9399 then effective 2023‑07‑01 added J9350 and ICD‑10‑CM C82.00‑C82.99).