CurrentEmblemHealthPolicy UM ONC_ 1474

Lunsumio_Usage_Policy

Defines accepted indications, continuation and exclusion criteria, dosing limits, and billing code for Lunsumio (mosunetuzumab-axgb) within Evolent/EmblemHealth lines of business; describes evidence sources required for authorization and continuation rules.

Policy Summary

PayerEmblemHealth

PolicyLunsumio_Usage_Policy

Policy CodePolicy UM ONC_ 1474

Change TypeTemplate conversion and verbiage updates

Effective Date

Next Review Date

Key ActionProcess medication requests through Evolent and ensure use is supported by FDA labeling, CMS compendia, NCCN, ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template in February 2025; replaced prior UM ONC_ 1474 Lunsumio policy.

Updated exclusion criteria and updated NCH verbiage to Evolent in February 2024.

1Covered Indication(s)

1Drug HCPCS Code

4Primary Exclusion Reasons Listed

Coverage Summary

Covered with criteria: Lunsumio (mosunetuzumab-axgb) is covered with criteria for the treatment of relapsed or refractory CD20‑positive follicular lymphoma (FL) when the member has relapsed after or failed to respond to at least two prior lines of systemic therapy that include an anti‑CD20 therapy (e.g., rituximab, biosimilars, obinutuzumab) and an alkylating agent (e.g., bendamustine, cyclophosphamide). The policy applies to monotherapy use and defines continuation and exclusion rules including dosing and duration limits as part of the coverage criteria.

Continuation Therapy

Continuation requests for a not-approvable medication shall be exempt from this Evolent policy when ALL of the following conditions are met:

{

"operator":"all",

"children":[

{"text":"The member has not experienced disease progression on the requested medication."},

{"text":"The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.", "note":"Operationally, a lapse >30 days between authorized periods disqualifies the exemption."},

Additional medication(s) are not being added to the continuation request (i.e., the request is for the same regimen previously authorized).

]

}

Documentation Required

Continuation request exemption

Continuation request exemption: A continuation request may be processed without full reauthorization when the operational definition below and ALL three continuation conditions are met. Provider must still submit supporting documentation as outlined under Authorization requirement and supporting evidence.

The member has not experienced disease progression on Lunsumio (mosunetuzumab-axgb).
Lunsumio was used within the last year without a lapse of more than 30 days of active authorization.
No additional medication(s) are being added to the continuation request; request is for ongoing use of the previously authorized regimen.

Exclusions / Not Medically Necessary

Denial Risk

Denial for excluded conditions or dosing violations

Claims may be denied for the following excluded conditions or dosing violations for Lunsumio (mosunetuzumab-axgb). Providers should expect denial when any of these apply.

Affected code: J9350
Diagnosis of follicular lymphoma transformed to diffuse large B‑cell lymphoma (DLBCL)
Disease progression while taking Lunsumio
Concurrent use with other anticancer therapies
Single-dose limits exceeded: >60 mg for cycles 1 and 2 (including step-up dosing) or >30 mg for cycle 3 and beyond
Maximum treatment duration exceeded: >8 months for complete response or >17 months for partial response/stable disease

Applicable Codes

Drug HCPCS/J-codeHCPCS

J9350

Injection, mosunetuzumab-axgb, 1 mg

Billing Rule

Billing / Processing Note

Medication requests for Lunsumio must be processed by Evolent. Use must be supported by appropriate evidence consistent with CMS Medicare Benefit Policy Manual Chapter 15.

J9350

Provider Actions & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required; medication requests must be processed by Evolent and supported by one of the following evidence sources per CMS Chapter 15 standards.

FDA-approved product labeling
CMS-recognized compendia
National Comprehensive Cancer Network (NCCN) guidelines
American Society of Clinical Oncology (ASCO) clinical guidelines
Acceptable peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15

Documentation Required

Documentation of prior therapies

Providers must document prior systemic therapies showing relapse or non-response to at least two lines of systemic therapy, including an anti‑CD20‑directed therapy and an alkylating agent.

Documentation of at least two prior lines of systemic therapy showing relapse or non‑response
One prior regimen must include an anti‑CD20‑directed therapy (e.g., rituximab, rituximab biosimilars, obinutuzumab)
One prior regimen must include an alkylating agent (e.g., bendamustine, cyclophosphamide)

Clinical Evidence & References

Budde LE et al., Lancet Oncol. 2022 (phase 2)Key trial

Lunsumio PI, Genentech, 2024Prescribing information

Evidence and authorization requirements: Authorization requirements follow the FDA labeling and major guideline sources (NCCN, ASCO) or CMS‑recognized compendia, and must meet CMS Medicare Benefit Policy Manual Chapter 15 standards for acceptable peer‑reviewed literature. The single‑arm phase 2 study by Budde et al. (Lancet Oncology 2022) is cited as the key clinical evidence supporting safety and efficacy in relapsed/refractory FL and is used alongside the Lunsumio prescribing information to align evidence with labeling and guideline expectations.

Background

Background: This policy governs the use of mosunetuzumab-axgb (Lunsumio) for relapsed/refractory CD20‑positive follicular lymphoma after at least two prior systemic therapies and specifies that Lunsumio is used as monotherapy and excludes cases with histologic transformation to diffuse large B‑cell lymphoma. Continuation rules permit ongoing therapy without a full reauthorization when the member has not experienced disease progression on Lunsumio, the medication was used within the last year without >30 days lapse in active authorization, and no additional medications are added. Evidence alignment statements indicate that requests must be supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15.

Revision History

February 2025revisedLatest

Converted to new Evolent guideline template; replaced prior UM ONC_ 1474 Lunsumio policy; no clinical policy statement changes indicated.

February 2024revised

Updated exclusion criteria and updated continuation request verbiage (NCH verbiage changed to Evolent).