CurrentBlue Cross Blue Shield - IowaPolicy 05.06.01

Lynozyfic (linvoseltamab-gcpt) for relapsed or refractory multiple myeloma

Defines prior authorization criteria, documentation requirements, coverage duration, dosing limits, and billing codes for Lynozyfic (linvoseltamab-gcpt) when used to treat adult patients with relapsed or refractory multiple myeloma.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyLynozyfic (linvoseltamab-gcpt) for relapsed or refractory multiple myeloma

Policy CodePolicy 05.06.01

Change TypeNo material change

Effective DateSep 27, 2025

Next Review Date

Key ActionPrior authorization required; submit chart notes or medical record documentation demonstrating failure of previous lines of therapy and that patient meets the required prior therapies (>= 4 prior lines including proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody).

POLICY UPDATE CHANGES

No material clinical/coverage changes

1Covered Indication (FDA-approved)

4+Required prior lines of therapy

Coverage Summary

Scope: Lynozyfic (linvoseltamab-gcpt) is addressed for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Coverage stance: therapy is covered with criteria when the prior authorization criteria are met, with authorizations of up to 12 months for initial and continued treatment. Benefit determination depends on the member's contract and any applicable exclusions and limitations; medical necessity is determined only if the benefit exists and no contract exclusions apply.

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization required. Submit chart notes or the medical record demonstrating failure of previous lines of therapy and that the patient meets the required prior therapies (at least 4 prior lines including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody). Include supporting documentation for services reported with codes: J3490, J3590, J9999, C9399.

Documentation Required

Required documentation for review

Required documentation for review: provide chart notes or the medical record documenting failure of previous lines of therapy and evidence of the specific agents used in the required classes (proteasome inhibitor, immunomodulatory agent, anti‑CD38 monoclonal antibody).

Billing Rule

Dosing limits

Dosing limits: approvals may be subject to dosing limits in accordance with FDA‑approved labeling, accepted compendia, and/or evidence‑based practice guidelines.

Denial Risk

Not medically necessary if criteria not met

Not medically necessary if criteria not met: claims may be denied or considered not medically necessary for members who do not meet the specified criteria (for example, insufficient prior therapies or missing required drug classes).

Background & Definitions

Background: Lynozyfic (linvoseltamab-gcpt) is indicated for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Benefit determinations depend on the applicable member contract and any exclusions or limitations in effect at the time services are rendered. This policy defines prior authorization criteria and required documentation (chart notes or medical record evidence of prior therapy failures), specifies authorization durations (authorization of 12 months for initial and continued treatment when criteria are met), notes that approvals may be subject to dosing limits consistent with FDA labeling and evidence-based guidelines, and lists billing/reporting codes for provider services.

Definitions: Lynozyfic = Brand name for linvoseltamab-gcpt.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyLynozyfic (linvoseltamab-gcpt) for relapsed or refractory multiple myeloma

Policy CodePolicy 05.06.01

Change TypeNo material change

Effective DateSep 27, 2025

Next Review Date

On This Page

OpenPayer

Lynozyfic (linvoseltamab-gcpt) for relapsed or refractory multiple myeloma

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Not Medically Necessary / Exclusions

Provider Actions

Applicable Codes

Background & Definitions

Clinical Evidence

Revision History

J3490	unclassified drugs
J3590	unclassified biologics
J9999	not otherwise classified, antineoplastic drugs
C9399	unclassified drugs or biologicals