Lunsumio (mosunetuzumab-axgb) and Lunsumio Velo (mosunetuzumab-axgb) - Coverage Criteria
Customize your policy alerts
Sign up for Anthem Policy CC-0232 alerts
Get alerted when Policy CC-0232 changes without checking for updates manually.
Monitor payer policy activity
Clinical criteria and coding guidance governing prior authorization and coverage considerations for Lunsumio (IV) and Lunsumio Velo (SC) for treatment of relapsed/refractory follicular lymphoma and certain NCCN 2A B-cell lymphoma indications; applies to Anthem medical benefit reviews.
Added Lunsumio Velo to criteria and to HCPCS J9350 and added ICD-10-CM C83.10-C83.19.
Updated criteria to include new NCCN 2A recommended use with Polivy for Mantle Cell Lymphoma and use as combination therapy with polatuzumab-vedotin-piiq for second-line+ therapy.
Coverage Criteria for Lunsumio and Lunsumio Velo
Approval criteria
Requests may be approved if ONE of the following branches is satisfied:
Approval pathways
- Pediatric approval: Individual is under 19 years of age
Pediatric criterion
- Adult follicular lymphoma single-agent: Individual has a diagnosis of relapsed, refractory, or progressive follicular lymphoma AND has received two or more lines of systemic therapy AND is using Lunsumio as a single agent>= 2 prior systemic therapies
Accelerated approval based on response rate; continued approval contingent on confirmatory trial
- NCCN 2A combination use with Polivy: Individual has one of the specified relapsed/refractory B-cell lymphomas (Diffuse Large B-Cell Lymphoma; High Grade B-Cell Lymphoma; HIV-Related B-Cell Lymphomas; Post-Transplant Lymphoproliferative Disorders; Progressive Mantle Cell Lymphoma after prior covalent BTKi therapy) AND is using as second-line or subsequent therapy AND is using in combination with polatuzumab-vedotin-piiq (Polivy)second-line or later
NCCN 2A recommended use
Denial triggers per policy
Requests for Lunsumio (mosunetuzumab-axgb) and Lunsumio Velo (mosunetuzumab-axgb) may not be approved when the above clinical criteria are not met. Denials will be issued for requests that do not satisfy one of the specified approval pathways (pediatric approval OR adult follicular lymphoma single‑agent pathway OR NCCN 2A combination use with polatuzumab-vedotin-piiq).
Use of Lunsumio for indications outside those listed in this policy — including requests that fail to meet required age, diagnosis, prior lines of systemic therapy (e.g., >= 2 where specified), or the required single‑agent versus combination with polatuzumab-vedotin-piiq conditions — is not approved under this criterion and may be denied.
Covered Regimens and Combination Use
| Regimen | Indication / Criteria | Coverage |
|---|---|---|
| Lunsumio (mosunetuzumab-axgb) or Lunsumio Velo (subcutaneous) | ||
| Relapsed, refractory, or progressive follicular lymphoma in adults AND prior receipt of two or more lines of systemic therapy; used as single‑agent therapy. Accelerated approval based on response rate; continued approval may be contingent on confirmatory trial results. | ||
| covered_with_criteria |
| Regimen | Indication / Criteria | Coverage |
|---|---|---|
| Lunsumio (mosunetuzumab-axgb) in combination with Polivy (polatuzumab-vedotin-piiq) | ||
| Relapsed or refractory Diffuse Large B‑Cell Lymphoma, High‑Grade B‑Cell Lymphoma, HIV‑Related B‑Cell Lymphomas, Post‑Transplant Lymphoproliferative Disorders, or Progressive Mantle Cell Lymphoma after prior covalent BTKi therapy; used as second‑line or subsequent therapy. Supported by NCCN 2A recommendation and phase 1b/2 dose‑expansion data for large B‑cell lymphoma. | ||
| covered |
Coding and Diagnosis Codes
| J9350 | Injection, mosunetuzumab-axgb, 1 mg [Lunsumio (IV), Lunsumio Velo (SC)] |
| B20 | Human immunodeficiency virus [HIV] disease (listed for HIV-related B-cell lymphomas) |
| C83.10-C83.19 | Mantle cell lymphoma (range added) |
| 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 | Monoclonal B-cell lymphocytosis and related (listed) |
Provider Actions and Authorization Requirements
Prior Authorization Required
Prior authorization is required for Lunsumio (mosunetuzumab-axgb) and Lunsumio Velo (mosunetuzumab-axgb). Requests will be reviewed against the clinical criteria (diagnosis, prior lines of therapy, single-agent vs combination use, age) and may be approved only when those specific criteria are met.
- Submit supporting documentation: diagnosis (relevant ICD-10 codes), prior systemic therapies, treatment intent, and clinical notes.
- HCPCS: J9350 (Injection, mosunetuzumab-axgb, 1 mg)
Dosing Safety / Step‑Up Dosing Required
Lunsumio carries a boxed warning for cytokine release syndrome (CRS). Initiation must follow the recommended step‑up dosing schedule to reduce CRS risk. Hold or permanently discontinue Lunsumio based on CRS severity per prescribing information.
- Ensure treatment plan documents planned step-up dosing and monitoring for CRS.
- Educate staff and patient on CRS signs/symptoms and management pathways prior to initiation.
Line-of-Therapy Criteria
third-line | subsequent
Single-agent use required for this follicular lymphoma indication (accelerated approval)
second-line | subsequent
Indication supported by NCCN 2A; combination required per criteria
Background and Clinical Context
Lunsumio is a T‑cell engaging bispecific antibody that directs T cells to CD20‑expressing B cells. It is used clinically as a single‑agent for relapsed/refractory follicular lymphoma after >= 2 prior systemic therapies (accelerated approval) and, per NCCN 2A guidance, may be used in combination with polatuzumab-vedotin-piiq (Polivy) for certain relapsed/refractory B‑cell lymphomas when given as second‑line or subsequent therapy. The therapy carries a boxed warning for cytokine release syndrome, and initiation should follow recommended step‑up dosing with appropriate monitoring and withholding or discontinuation as indicated by CRS severity.
Definitions
Policy Revision History
Added Lunsumio Velo to the criteria and to HCPCS J9350; updated criteria to include new NCCN 2A recommended use with Polivy for Mantle Cell Lymphoma and added ICD-10-CM C83.10-C83.19.
Added NCCN 2A recommendations for R/R HIV-related B-cell lymphomas and post-transplant lymphoproliferative disorders; removed CAR-T and transplant non-candidate requirements; coding updated with ICD-10-CM B20, C83.80-C83.89, C85.20-C85.29, D47.Z1.
Added NCCN 2A recommendations for Diffuse Large B-Cell Lymphoma and High Grade B-Cell Lymphoma; coding updated with ICD-10-CM C83.30-C83.38, C83.398, C85.10-C85.19.
Included progressive disease per NCCN; coding reviewed with no changes.
Created new clinical criteria document for Lunsumio; initial coding additions and later effective changes on 2023-07-01 added HCPCS J9350 and ICD-10-CM C82.00-C82.99.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.