CurrentCentenePolicy CP.PHAR.618

Mosunetuzumab-axgb (Lunsumio) (PDF)

Defines medical necessity criteria, dosing limits, approved indications (FDA-approved follicular lymphoma and specified off-label B-cell lymphoma uses), authorization durations, continued therapy rules, and coding implications for mosunetuzumab-axgb across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyMosunetuzumab-axgb (Lunsumio) (PDF)

Policy CodePolicy CP.PHAR.618

Change TypeAdded HCPCS J9350; 1Q2026 off-label additions; references updated

Effective Date03.01.23

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical info) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J9350 (Injection, mosunetuzumab-axgb, 1 mg).

1Q 2026 annual review: per NCCN Compendium added off-label use in additional B-cell lymphomas subtypes.

Updated references and Appendix B therapeutics per annual reviews (2024, 2025).

1FDA-approved Indication (Follicular Lymphoma)

4Off-label B-cell lymphoma subtypes listed

8Initial treatment cycles authorized

17Maximum total cycles (initial + continued)

Coverage Summary & Scope

Coverage: Mosunetuzumab-axgb (Lunsumio / Lunsumio Velo) is covered with criteria for the FDA-approved indication of adult patients with relapsed or refractory follicular lymphoma after ≥2 prior lines of systemic therapy (must include an anti‑CD20 and an alkylating agent), per the policy. Initial authorization is for up to 8 treatment cycles of 21 days each (approval duration 9 months).

Off-label: Specific B‑cell lymphoma subtypes are listed as covered with criteria (e.g., diffuse large B‑cell lymphoma, high‑grade B‑cell lymphomas, HIV‑related B‑cell lymphomas, post‑transplant lymphoproliferative disorders) under off‑label B‑cell lymphoma criteria. Continued therapy: members with clinical benefit after initial therapy may receive up to 9 additional cycles (total 17 cycles) with continued authorization (approval duration 12 months). This policy applies across Commercial, HIM, and Medicaid lines of business.

Initial Therapy Criteria — Follicular Lymphoma

Initial Approval Criteria - Follicular Lymphoma

Covered when ALL of the following are met:

ALL of the following

ALL of the following
- Grade 1, 2 or 3a (low grade or slow growing)
- Presence of at least one bi-dimensionally measurable lesion (≥ 1.5 cm in its largest dimension for nodal lesions, or ≥1.0 cm in its largest dimension for extranodal lesions)nodal ≥1.5 cm; extranodal ≥1.0 cm
Prescribed by or in consultation with an oncologist or a hematologist
See provider specialty requirement
Age ≥ 18 years≥18
ALL of the following
- One anti-CD20-directed therapy (e.g., rituximab, Arzerra®, Gazyva®)
- One alkylating agent (e.g., bendamustine, cyclophosphamide)
Member does not have a known current or past central nervous system (CNS) lymphoma, or a history of CNS disease (e.g., stroke/TIA with residual neurologic deficits; epilepsy with seizures in the past 2 years; CNS vasculitis or neurodegenerative disease)
CNS exclusion
Request is for up to 8 treatment cycles of 21 days each≤8 cycles; cycle length = 21 days
Approval duration: 9 months (8 cycles)
Dose does not exceed one of the following (a, b, or c)
- a. For Lunsumio (IV)
  - i. Cycle 1: Cycle 1: Day 1: 1 mg; Day 8: 2 mg; Day 15: 60 mg
  - ii. Cycle 2: Cycle 2: Day 1: 60 mg
  - iii. Cycles 3+: Cycles 3+: Day 1: 30 mg
- b. For Lunsumio Velo (SC)
  - i. Cycle 1: Cycle 1: Day 1: 5 mg; Day 8: 45 mg; Day 15: 45 mg

*Prescribed regimen must be FDA-approved or recommended by NCCN

Initial Therapy Criteria — B‑Cell Lymphoma (Off‑Label)

Initial Approval Criteria - B-Cell Lymphoma (off-label)

Covered when ALL of the following are met:

ref": "b2_0

title": "Initial Approval Criteria - B-Cell Lymphoma (off-label)

title":

nodes_adjusted_for_parsing_error_fixing_needed":true}

Other Diagnoses / Off‑Label Handling

Continued Therapy Criteria

Diagnoses / Indications Not Authorized

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization requirement and approval duration

Requests require authorization. Initial approvals are granted for 9 months covering 8 treatment cycles of 21 days each. Continued therapy approvals may allow up to 9 additional cycles (for a total of 17 cycles) with an approval duration of 12 months. Re-authorization is required if treatment beyond the approved cycles is requested.

J9350

Documentation Required

Submission of supporting documentation

Provider must submit supporting documentation such as office chart notes, laboratory results, or other clinical information that demonstrates the member has met all approval criteria.

Applicable Codes

Billing HCPCS for drugHCPCSCovered

J9350

Injection, mosunetuzumab-axgb, 1 mg

Clinical Evidence & Sources

Key evidence cited in the policy includes early-phase clinical studies: a Phase 1 dose‑escalation study and a single‑arm Phase 2 study reporting responses in relapsed/refractory B‑cell lymphomas (J Clin Oncol 2022; Lancet Oncol 2022).

Sources referenced for efficacy and guidance in the policy are the Prescribing Information (Dec 2025), the NCCN B‑Cell Lymphomas v3.2025 compendium, and the clinical trial registry entry ClinicalTrials.gov NCT02500407.

Background & Definitions

Background: Mosunetuzumab‑axgb is a bispecific CD20‑directed CD3 T‑cell engager approved under accelerated approval for adults with relapsed or refractory follicular lymphoma after two or more prior systemic therapies; continued approval may be contingent on verification of clinical benefit in confirmatory trial(s).

Revision History

05.24.23coding

Added HCPCS code J9350 (Injection, mosunetuzumab-axgb, 1 mg) to coding implications.

1Q 2024annual_review

1Q 2024 annual review: no significant clinical policy changes; references reviewed and updated.

1Q 2025annual_review

1Q 2025 annual review: no significant clinical policy changes; Appendix B therapeutic alternatives updated per NCCN and references reviewed and updated.