CurrentViva HealthPolicy IC-0692

Lunsumio (mosunetuzumab-axgb) IV

Policy governing medical-benefit coverage, dosing, authorization length, renewal, and billing for Lunsumio (mosunetuzumab-axgb) for follicular lymphoma in adults, including HCPCS and NDC billing guidance and covered ICD-10 diagnosis codes.

Policy Summary

PayerViva Health

PolicyLunsumio (mosunetuzumab-axgb) IV

Policy CodePolicy IC-0692

Change TypeClarified (non-material)

Effective DateFeb 2, 2023

Next Review Date

Key ActionObtain authorization consistent with policy: initial approval for eight 21-day cycles; renewal for additional nine 21-day cycles only if renewal criteria met; do not exceed authorized duration.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed 01/06/2025; dates reviewed listed as 02/2023, 03/2024, 01/2025 with no material clinical policy statement changes indicated.

1Covered Indication (Follicular Lymphoma Grades 1-3a)

8Initial 21-day Cycles Authorized

17Maximum Cycles (with renewal)

J9350Primary HCPCS Code

Coverage Summary

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Coverage is provided for Lunsumio (mosunetuzumab-axgb) as a medical benefit for adult patients with relapsed or refractory follicular lymphoma grades 1-3a who have received at least two prior systemic therapies. Initial authorization is for eight 21-day cycles with the option to renew for an additional nine 21-day cycles (for a total of 17 cycles) when renewal criteria are met. Billing and dosing are managed under the medical benefit (HCPCS J9350) with per-cycle unit limits aligned to the dosing schedule.

Provider Actions & Billing

Prior Authorization

Authorization required with cycle limits

Obtain prior authorization consistent with policy limits. Initial approval is for eight 21-day cycles; renewal for an additional nine 21-day cycles (17 cycles total) is allowed only if renewal criteria are met. Do not exceed the authorized duration.

Affected code: J9350
Initial: 8 cycles (21-day cycles)
Renewal: additional 9 cycles (up to 17 cycles total) if renewal criteria met

Documentation Required

Clinical documentation required

Clinical documentation must be provided to support initiation and renewal decisions. Required elements include histologic confirmation of disease, record of prior systemic therapies, documentation that excluded conditions are absent, and objective evidence of response for renewal.

Histologic confirmation of follicular lymphoma grade 1-3a
Documentation of at least two prior systemic therapies
Absence of active infection and absence of CNS lymphoma (and adherence to institutional infection prophylaxis guidelines)
Evidence of response (partial response, stable disease, or complete response) for renewal decisions

Billing Rule

HCPCS unitization and dosing alignment

Bill J9350 with 1 billable unit = 1 mg, and apply the per-dose and per-cycle maxima consistent with dosing schedule. Map each scheduled dose to billable units as specified below.

J9350: 1 unit = 1 mg
Cycle 1: day 1 = 1 unit (1 mg); day 8 = 2 units (2 mg); day 15 = 60 units (60 mg)
Cycle 2: day 1 = 60 units (60 mg)
Cycle 3 and beyond: day 1 = 30 units (30 mg) every 21 days

Denial Risk

Denial risk for unsupported indication or insufficient prior therapy

Claims may be denied when key eligibility or clinical requirements are not met. Common denial scenarios include insufficient prior systemic therapy, incorrect histologic grade, and presence of excluded conditions.

Insufficient prior therapy (fewer than two prior systemic therapies)
Histologic grade outside approved range (not grade 1–3a)
Active infection or failure to document absence of clinically important localized infections
Presence of CNS lymphoma

Applicable Codes

HCPCS (drug billing)HCPCSCovered

J9350

Injection, mosunetuzumab-axgb, 1 mg; 1 billable unit = 1 mg

NDCs (product vials)NDC

50242-0159-xx	Lunsumio 1 mg/1 mL single-dose vial
50242-0142-xx	Lunsumio 30 mg/30 mL single-dose vial

Covered ICD-10 Diagnosis Codes (Follicular Lymphoma)ICD-10Covered

C82.00	Follicular lymphoma grade I unspecified site
C82.01	Follicular lymphoma grade I lymph nodes of head, face, and neck
C82.02	Follicular lymphoma grade I intrathoracic lymph nodes
C82.03	Follicular lymphoma grade I intra-abdominal lymph nodes
C82.04	Follicular lymphoma grade I lymph nodes of axilla and upper limb
C82.05	Follicular lymphoma grade I lymph nodes of inguinal region and lower limb
C82.06	Follicular lymphoma grade I intrapelvic lymph nodes
C82.07	Follicular lymphoma grade I spleen
C82.08	Follicular lymphoma grade I lymph nodes of multiple sites
C82.09	Follicular lymphoma grade I extranodal and solid organ sites

1–10 of 90

1/9

Background

Mosunetuzumab-axgb (Lunsumio) is a bispecific antibody indicated for adults with relapsed or refractory follicular lymphoma after ≥2 prior systemic therapies. The policy notes that dosing and authorization (including the step-up and maintenance dosing schedule and cycle limits) align with the product label and NCCN compendium recommendations.

Definitions

Billable unitFor HCPCS J9350, 1 billable unit = 1 mg of mosunetuzumab-axgb

Unacceptable toxicityIncludes events such as cytokine release syndrome (CRS), ICANS, serious infections, severe cytopenias, tumor flare, hemophagocytic lymphohistiocytosis

Revision History

2023-02-02policy_origin

Policy effective date / date of origin listed as 02/02/2023.

2023-02review

Date reviewed: 02/2023; revision history present but no material clinical policy statement changes documented.

2024-03review

Date reviewed: 03/2024; revision history present but no material clinical policy statement changes documented.

2025-01review

Date reviewed: 01/2025; revision history present but no material clinical policy statement changes documented.

2025-01-06policy_reviewLatest

Policy reviewed 01/06/2025; revision history present but no material clinical policy statement changes documented.