CurrentViva HealthPolicy IC-0830

Lunsumio Velo (mosunetuzumab-axgb) (Subcutaneous)

Prior authorization and medical necessity criteria for use of subcutaneous mosunetuzumab (Lunsumio Velo) for follicular lymphoma in adult members, including dosing, authorization length, and renewal conditions.

Policy Summary

PayerViva Health

PolicyLunsumio Velo (mosunetuzumab-axgb) (Subcutaneous)

Policy CodePolicy IC-0830

Change TypeNo material changes

Effective Date

Next Review DateFeb 3, 2026

Key ActionObtain prior authorization for initial approval for eight 21-day cycles (168 days) and bill using HCPCS J9350 (1 mg unit).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8 cyclesInitial authorization duration

17 cyclesMaximum with renewal (total)

J9350HCPCS code

>=18Minimum age

Coverage Criteria for Subcutaneous Mosunetuzumab (Lunsumio Velo)

Initial Therapy — Covered when ALL of the following are met

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Age: Member is at least 18 years of age>=18

Infection and prophylaxis: Member does not have an active infection, including clinically important localized infections, and prophylaxis for infection will be followed according to standard institutional guidelines

CNS involvement: Member does not have central nervous system (CNS) lymphoma

Monotherapy and concomitant IV therapy: Used as single-agent therapy and will not be used concomitantly with intravenous mosunetuzumab

Diagnosis: Histologically confirmed follicular lymphoma, grade 1-3a

Prior therapies (line of therapy): Member has relapsed or refractory disease and the drug is being used after at least two prior lines of systemic therapy>=2 prior lines

Renewal/Continuation Therapy — Renewal approval provided when ALL of the following are met

Renewal approval provided when ALL of the following are met

Ongoing eligibility: Member continues to meet the universal and other indication-specific relevant criteria (excluding prerequisite therapy), including concomitant therapy requirements and performance status as identified in Section III

Duration limit: Duration of authorization has not been exceeded (refer to Section I)<= maximum cycles

Initial approval provided for eight 21-day cycles; up to an additional 9 cycles may be authorized for partial response or stable disease

Toxicity: Absence of unacceptable toxicity from the drug (examples include cytokine release syndrome [CRS], Immune Effector Cell–Associated Neurotoxicity Syndrome [ICANS], serious infections, severe cytopenias, tumor flare, severe hemophagocytic lymphohistiocytosis [HLH])

Response: Member achieved a partial response or has stable disease as evidenced by metabolic and radiologic response criteriapartial response or stable disease

Complete responders do not require further treatment beyond the initial 8 cycles

Regimen	Dosing schedule (per 21-day cycle)	Initial authorization length	Renewal / maximum
Subcutaneous mosunetuzumab (Lunsumio Velo) for relapsed or refractory follicular lymphoma (grade 1-3a) in adults after ≥2 prior systemic therapies	Cycle 1: 5 mg Day 1, 45 mg Day 8, 45 mg Day 15; Cycles 2+: 45 mg Day 1	Initial: 8 cycles (eight 21-day cycles)	For partial response or stable disease after 8 cycles: up to 9 additional cycles (maximum 17 cycles total), unless unacceptable toxicity or progression

Billing and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J9350

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

NDCsNDC

50242-0177-xx	Lunsumio Velo 5 mg/0.5 mL single-dose vial: 50242-0177-xx
50242-0201-xx	Lunsumio Velo 45 mg/mL single-dose vial: 50242-0201-xx

Covered ICD-10 Codes (Follicular lymphoma)ICD-10Covered

C82.*

Covered ICD-10 diagnosis codes for follicular lymphoma (see Appendix 1 for full list of C82.xx subcodes such as C82.00–C82.99)

Medicare Part B Covered Diagnosis CodesICD-10

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

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Validity and Billing

Prior authorization is required. Initial authorization will be provided for eight 21‑day cycles (168 days). For members who achieve a partial response or have stable disease after the initial eight 21‑day cycles, coverage may be renewed for an additional nine 21‑day cycles (17 cycles total, 189 days). Providers must bill using HCPCS code J9350 (mosunetuzumab-axgb), 1 mg = 1 billable unit.

Initial approval period: 8 x 21‑day cycles (168 days)
Renewal: may be granted to total 17 x 21‑day cycles (189 days) only if partial response or stable disease after initial period
Billing: HCPCS J9350 — Injection, mosunetuzumab-axgb, 1 mg (1 mg = 1 billable unit)

Note

Medicare Part B and Non‑Medicare Coverage Determinations

Medicare Part B coverage for outpatient drugs is governed by the Medicare Benefit Policy Manual (Pub. 100‑02), Chapter 15 §50, and by any applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs). Providers must comply with relevant NCDs/LCDs/LCAs where they exist. For non‑Medicare members, the plan’s non‑Medicare coverage determinations apply; additional indications or restrictions may be applied at the discretion of the health plan.

Medicare reference: Medicare Benefit Policy Manual (Pub. 100‑02), Chapter 15 §50
Search CMS coverage documents: https://www.cms.gov/medicare-coveragedatabase/search.aspx
Providers must follow applicable NCDs/LCDs/LCAs for Medicare members; non‑Medicare determinations follow the health plan's policies

Documentation Required

Required Documentation for Initial Authorization

Required documentation to support an initial authorization includes: patient age, absence of active infection and planned infection prophylaxis per institutional guidelines, confirmation of no CNS lymphoma, statement that therapy will be used as a single agent and not concomitantly with intravenous mosunetuzumab, histologic confirmation of follicular lymphoma grade 1–3a, documentation of relapsed or refractory disease, and documentation of at least two prior lines of systemic therapy.

Age: member ≥ 18 years
Infection: no active or clinically important localized infections; infection prophylaxis plan per institutional guidelines
CNS involvement: no CNS lymphoma
Concomitant therapy: single‑agent use; not to be used with IV mosunetuzumab
Diagnosis: histologically confirmed follicular lymphoma grade 1–3a
Prior therapy: relapsed/refractory disease after at least two prior lines of systemic therapy

Step Therapy

Prerequisite Therapy

Prerequisite therapy: For follicular lymphoma (grade 1–3a), mosunetuzumab is indicated for relapsed or refractory disease and must be used after at least two prior lines of systemic therapy.

Indication: histologically confirmed follicular lymphoma grade 1–3a
Prerequisite: failure of or relapse after ≥ 2 prior systemic therapy lines

Denial Risk

Renewal Denial Triggers

Renewal may be denied for unacceptable toxicity. Examples include cytokine release syndrome (CRS), serious neurologic toxicity including ICANS, serious or opportunistic infections, severe cytopenias, tumor flare, severe hemophagocytic lymphohistiocytosis (HLH), or other clinically significant adverse events. Renewals also require continued meet of universal and indication‑specific criteria and that authorization duration limits have not been exceeded.

Unacceptable toxicity examples: CRS, ICANS, serious infections, severe cytopenias, tumor flare, HLH
Renewal requirements: continued fulfillment of universal and indication‑specific criteria; duration limits (see Prior Authorization Validity)

Line of Therapy Requirement

third-line_or_later — therapy indicated for patients who have received at least two prior systemic therapies

Line of therapy: Used after at least two prior lines of systemic therapy for relapsed or refractory disease>=2 prior lines

This criterion defines third-line or later use

Background on Mosunetuzumab

Mosunetuzumab is a bispecific antibody approved for use as single‑agent therapy in adults with relapsed or refractory follicular lymphoma (grade 1–3a) after at least two prior lines of systemic therapy. Administration requires appropriate monitoring and institutional plans for infection prophylaxis and management of severe immune‑mediated toxicities such as cytokine release syndrome and neurotoxicity.

Definitions and Unacceptable Toxicity

Unacceptable toxicity — Serious adverse events that preclude continuation or renewal

DefinitionSerious adverse events that preclude continuation or renewal of mosunetuzumab therapy

Included eventsCytokine release syndrome (CRS); immune effector cell-associated neurotoxicity syndrome (ICANS) and other serious neurologic toxicity; serious infections (including opportunistic infections); severe cytopenias; tumor flare; severe hemophagocytic lymphohistiocytosis (HLH)

Clinical consequenceOccurrence of these toxicities may result in withholding further doses, dose discontinuation, and denial of renewal authorization

Monitoring/payment implicationAuthorization for additional cycles will not be approved if unacceptable toxicity is present; therapy should be administered where severe reactions (e.g., CRS, ICANS) can be managed

NCD/LCD/LCA definitions — CMS documents that define Medicare coverage parameters

NCDNational Coverage Determination: CMS policy documents that define Medicare coverage and payment for Part B services and drugs

LCDLocal Coverage Determination: Contractor-specific policies establishing Medicare coverage rules within a Medicare Administrative Contractor jurisdiction

LCALocal Coverage Article: Contractor guidance used for claims payment or to clarify benefit eligibility under Part B for drugs

Provider actionProviders must comply with applicable NCDs/LCDs/LCAs and the Medicare Benefit Policy Manual Chapter 15 §50 when making coverage determinations for Medicare Part B drugs

Reference/searchCMS coverage database: https://www.cms.gov/medicare-coveragedatabase/search.aspx