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Medical Policy Bulletin

Mosunetuzumab-axgb (Lunsumio™)
08.02.00b

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member's medical needs and condition.

MEDICALLY NECESSARY

INITIAL THERAPY
Mosunetuzumab-axgb (Lunsumio) is considered medically necessary and, therefore, covered for adult individuals ​with follicular lymphoma for a maximum of eight cycles when any of the following critieria are met:   
  • ​Relapsed or refractory follicular lymphoma (grade 1-3a)​ after two or more lines of systemic therapy* 
  • ​Partial response, no response, relapsed, or progressive follicular lymphoma (grade 1-3a)​​as third-line and subsequent therapy* (if not previously given) for individuals with any of the following indications for treatment (National Comprehensive Cancer Network-preferred regimen):
    • Candidate for clinical trial
    • Symptoms
    • Threatened end-organ function
    • Clinically significant or progressive cytopenia secondary to lymphoma
    • Clinically significant bulky disease
    • Steady or rapid progression​
*Prior systemic therapy includes an anti-CD20 monoclonal antibody (e.g., rituximab, obinutuzumab) and an alkylating agent (e.g., bendamustine, cyclophosphamide)  

CONTINUATION THERAPY (BEYOND INITIAL EIGHT CYCLES)
Mosunetuzumab-axgb (Lunsumio) is considered medically necessary and, therefore, covered for continuation therapy of up to nine additional cycles (17 total cycles of treatment) for adult individuals with follicular lymphoma who achieve partial response or have stable disease in response to eight cycles of treatment with mosunetuzumab-axgb (Lunsumio). (For individuals who achieve a complete response, no further treatment beyond eight cycles is required).

EXPERIMENTAL/INVESTIGATIONAL

 
All other uses for mosunetuzumab-axgb (Lunsumio)​​ are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.
 

MANDATES 
 
PENNSYLVANIA MEMBERS
In accordance with the Commonwealth of Pennsylvania's Act 6 of 2020 or Fair Access to Cancer Treatment Act, for members who are enrolled in Pennsylvania commercial products who have Stage 4, advanced metastatic cancer, refer to the Medical Policy titled "Coverage of Anticancer Prescription Oral and Injectable Drugs and Biologics and Supportive agents" (08.01.08) for additional information regarding the applicable coverage of drugs and biologics.


REQUIRED DOCUMENTATION
 
The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.


​The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.​


Guidelines

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

BENEFIT APPLICATION


Subject to the terms and conditions of the applicable benefit contract, mosunetuzumab-axgb (Lunsumio)​ is covered under the medical benefits of the Company's products when the medical necessity criteria listed in this medical policy are met.


US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Mosunetuzumab-axgb (Lunsumio) was approved by the US Food and Drug Administration (FDA) on December 22, 2022, ​for the treatment of adult individuals with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. 
Following an initial step-up dosing schedule, mosunetuzumab-axgb (Lunsumio)​ is administered once every 21 days for eight cycles, unless they experience unacceptable toxicity or disease progression. For individuals who achieve a complete response, no further treatment beyond eight cycles is required. For individuals who achieve a partial response or have stable disease in response to treatment after eight cycles, an additional nine cycles of treatment (17 cycles total) should be administered, unless they experience unacceptable toxicity or disease progression.


PEDIATRIC USE
The safety and effectiveness in pediatric individuals have not been established.


Description

FOLLICULAR LYMPHOMA

According to the American Cancer Society, about one out of five lymphomas in the United States is a follicular lymphoma (FL). They are usually a slow-growing (indolent) lymphoma that occurs in adults aged 60 years and older. 

MOSUNETUZUMAB-AXGB (LUNSUMIO)

Mosunetuzumab-axgb (Lunsumio) is a bispecific T-cell engager (BiTE) monoclonal antibody that creates a bridge between the T cell and the lymphoma cell, by binding to two different proteins at the same time (CD20 located on lymphoma cells and CD3 located on cytotoxic T cells). This binding triggers the release of proinflammatory cytokines and proliferation of T cells, which ultimately causes the death of the lymphoma cells.

CYTOKINE RELEASE SYNDROME
Cytokines are proteins that communicate with cells about the need for immune assistance. Cytokines are secreted by both healthy and cancerous cells. When mosunetuzumab-axgb (Lunsumio) infusion is initiated, a transient release (increase) of cytokines occurs in response to the T-cell activation, called cytokine release syndrome (CRS). The highest risk of CRS occurs during the first cycle of mosunetuzumab-axgb (Lunsumio), and typically subsides with subsequent doses. The risk is reduced by using a step-up dosing schedule and pretreatment medications. Symptoms may include serious or life-threatening reactions, including hypotensionfever, hypoxia, chills, tachycardia, and headache.

PEER-REVIEWED LITERATURE
Summary 

The efficacy of mosunetuzumab-axgb (Lunsumio)​ was evaluated in a Phase 2 open-label, single-arm, multicenter, multicohort study in 90 adults with relapsed or refractory grade 1-3a FL who had received at least two prior therapies, including an anti-CD20 monoclonal antibody and an alkylating agent. All participants had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and received a median of three prior therapies (range: 2 to 10). Mosunetuzumab-axgb (Lunsumio)​ ​was administered intravenously as an initial step-up dosing schedule for a median of eight cycles unless individuals experienced progressive disease or unacceptable toxicity. After eight cycles, individuals with a complete response (CR) discontinued therapy; individuals with a partial response (PR) or stable disease continued treatment up to 17 cycles, unless individuals experienced progressive disease or unacceptable toxicity. 

The primary efficacy endpoints, assessed by an independent review facility​, were objective response rate (ORR) (defined as CR or PR) and duration of response (DOR) (defined as the time from the initial occurrence of CR or PR ​to the first progressive disease or death due to any cause). The ORR was 80% (60%CR, 20% PR). The median DOR was 22.8 months.

​The most common adverse events were cytokine release syndrome (predominantly grade 1 or 2 and confined to the first cycle) (44%)​, fatigue (37%), and headache (31%). Grade 3-4 adverse events were reported in 51% of individuals (neutropenia or decreased neutrophil count, hypophosphataemia, hyperglycaemia, and anemia). Serious adverse events were reported in 47% of individuals.  ​

OFF-LABEL INDICATION

 

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company's off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.​


References

American Cancer Society. Types of B-cell lymphoma. 01/29/2019. Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html. Accessed February 12, 2024

American Hospital Formulary Service (AHFS). Drug Information 2024. Tisotumab vedotin-tftv (Tivdak). [Lexicomp Online Web site]. 01/16/2023. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 9, 2024. 

Budde LE, Sehn LH, Matasar M, et al. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. 2022;23(8):1055-1065.​

Elsevier's Clinical Pharmacology Compendium. Mosunetuzumab-axgb (Lunsumio). 01/09/2023. [Clinical Key Web site]. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed February 9, 2024. 

Lexi-Drugs Compendium. Mosunetuzumab-axgb (Lunsumio). 01/24/2024. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed February 9, 2024.  

Lunsumio. [prescribing information]. South San Francisco, CAGenentech, Inc.; original 12/2022Available at: Genentech: Lunsumio™ (mosunetuzumab-axgb) - Information for Healthcare Providers. Accessed February 9, 2024. 

National Comprehensive Cancer Network (NCCN).  NCCN Clinical Practice Guidelines in Oncology B-Cell Lymphomas V.1.2024. 01/18/2024. [NCCN Web site]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf [via free subscription]. Accessed February 9, 2024. 

PA House Bill – HB 427; Act 6. Signed February 12, 2020. Available at: https://www.legis.state.pa.us/cfdocs/billinfo/billinfo.cfm?syear=2019&sind=0&body=H&type=B&bn=0427. Accessed February 9, 2024. 

Truven Health Analytics. Micromedex® DrugDex® Compendium. Mosunetuzumab-axgb (Lunsumio). 12/12/2023. Greenwood Village, CO. [Micromedex® Solutions Web site]. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed February 9, 2024. 

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Mosunetuzumab-axgb (Lunsumio)​ prescribing information and approval letter [FDA Web site]. 12/22/2022. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed February 9, 2024. 

Coding

CPT Procedure Code Number(s)

N/A


ICD - 10 Procedure Code Number(s)
N/A

ICD - 10 Diagnosis Code Number(s)
C82.00 Follicular lymphoma grade l, unspecified site
C82.01 Follicular lymphoma grade l, lymph nodes of head, face and neck.
C82.02 Follicular lymphoma grade l, intrathoracic lymph nodes
C82.03 Follicular lymphoma grade l, intra-abdominal lymph nodes
C82.04 Follicular lymphoma grade l, lymph nodes of axilla and upper limb
C82.05 Follicular lymphoma grade l, lymph nodes of inguinal region and lower limb
C82.06 Follicular lymphoma grade l, intrapelvic lymph nodes
C82.07 Follicular lymphoma grade l, spleen
C82.08 Follicular lymphoma grade l, lymph nodes of multiple sites
C82.09 Follicular lymphoma grade l, extranodal and solid organ sites
C82.10 Follicular lymphoma grade ll, unspecified site
C82.11 Follicular lymphoma grade ll, lymph nodes of head, face, and neck
C82.12 Follicular lymphoma grade ll, intrathoracic lymph nodes
C82.13 Follicuar lymphoma grade ll, intra-abdominal lymph nodes
C82.14 Follicular lymphoma grade ll, lymph nodes of axilla and upper limb
C82.15 Follicular lymphoma grade ll, lymph nodes of inguinal region and lower limb
C82.16 Follicular lymphoma grade ll, intrapelvic lymph nodes
C82.17 Follicular lymphoma grade ll, spleen
C82.18 Follicular lymphoma grade ll, lymph nodes of multiple sites
C82.19 Follicular lymphoma grade ll, extranodal and solid organ sites
C82.30 Follicular lymphoma grade llla, unspecified site
C82.31 Follicular lymphoma grade llla, lymph nodes of head, face, and neck
C82.32 Follicular lymphoma grade llla, intrathoracic lymph nodes
C82.33 Follicular lymphoma grade llla, intra-abdominal lymph nodes
C82.34 Follicular lymphoma grade llla, lymph nodes of axilla and upper limb
C82.35 Follicular lymphoma grade llla, lymph nodes of inguinal region and lower limb
C82.36 Follicular lymphoma grade llla, intrapelvic lymph nodes
C82.37 Follicular lymphoma grade llla, spleen
C82.38 Follicular lymphoma grade llla, lymph nodes of mulitple sites
C82.39 Follicular lymphoma grade llla, extranodal and solid organ sites

HCPCS Level II Code Number(s)
J3590 Injection, mosunetuzumab-axgb, 1 mg

Revenue Code Number(s)
N/A

Coding and Billing Requirements




Policy History

Revisions From 08.02.00b:
04/08/2024

This version of the policy will become effective 04/08/2024.

This policy has been updated to communicate the Company's coverage position for mosunetuzumab-axgb (LunsumioTM), in accordance with National Comprehensive Cancer Network (NCCN), as a preferred regimen for ​partial response, no response, relapsed, or progressive follicular lymphoma (grade 1-3a)​.​​


​Revisions From 08.02.00a:
07/01/2023

This version of the policy will become effective 07/01/2023.

Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

The following HCPCS codes have been removed from this policy:
C9399 Unclassified drugs or biologicals
J3590 Unclassified biol​ogics​

The following HCPCS code has been added to this policy
J9350 Injection, mosunetuzumab-axgb, 1 mg


Revisions From 08.02.00:
03/27/2023

This version of the policy will become effective 03/27/2023.

The following new policy has been developed to communicate the Company's coverage criteria for mosunetuzumab-axgb (LunsumioTM).​


04/08/2024
04/08/2024
N/A
08.02.00
Medical Policy Bulletin
Commercial
No