CurrentBlue Cross Blue Shield - IowaPolicy 05.06.01

Lynozyfic (linvoseltamab-gcpt) — Coverage Criteria and Prior Authorization

Defines prior authorization, coverage criteria, dosing limits, and billing codes for Lynozyfic for Blue Cross Blue Shield - Iowa members when used to treat relapsed or refractory multiple myeloma.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyLynozyfic (linvoseltamab-gcpt) — Coverage Criteria and Prior Authorization

Policy CodePolicy 05.06.01

Change TypeNo material change

Effective DateSep 27, 2025

Next Review Date

Key ActionObtain prior authorization with chart notes documenting at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 antibody.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=4prior lines of therapy required for coverage

12 monthsauthorization period

linvoseltamab-gcptactive ingredient

C9307→J9601HCPCS code transition

Coverage Criteria

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inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial approval requirements: Member is an adult with relapsed or refractory multiple myeloma; member has received at least four prior lines of therapy including: (1) a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib), (2) an immunomodulatory agent (e.g., lenalidomide, pomalidomide, thalidomide), and (3) an anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab)

Authorization of 12 months may be granted for initial treatment

inv-02: Continuation Therapy / Reauthorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Reauthorization: Member previously approved for Lynozyfic for an indication listed in the initial approval criteria; no evidence of unacceptable toxicity or disease progression while on the current regimen

Authorization of 12 months may be granted for continued treatment

Initial Authorization Criteria

inv-14: Initial Authorization — Initial authorization criteria (detailed nodes)

Initial authorization criteria

Initial Authorization: FDA‑approved indication: adult with relapsed or refractory multiple myeloma who has received ≥4 prior lines of therapy; documentation must show prior exposure to at least one agent from each required class: (a) proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib), (b) immunomodulatory agent (e.g., lenalidomide, pomalidomide, thalidomide), and (c) anti‑CD38 monoclonal antibody (e.g., daratumumab, isatuximab)>= 4 prior lines of therapy

Authorization up to 12 months may be granted

Reauthorization / Continuation Criteria

inv-15: Reauthorization — Reauthorization rules when continuing therapy

Reauthorization rules when continuing therapy

Reauthorization: Member was previously approved for Lynozyfic for an indication meeting initial authorization criteria; there is no evidence of unacceptable toxicity and no disease progression while on the current regimen

Authorization of 12 months may be granted for continued treatment

Provider Actions & Requirements

Prior Authorization

Prior Authorization Requirement

Prior authorization is required. Authorization of up to 12 months may be granted for treatment of relapsed or refractory multiple myeloma when the member has received at least four prior therapies. Documentation must demonstrate prior exposure to required drug classes and failure of previous lines of therapy.

Authorization duration: up to 12 months for initial approval and reauthorization when no unacceptable toxicity or disease progression is present.
Required prior therapies must include at least one agent from each class: proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody.

Step Therapy

Class-based Step Requirement

Policy requires prior exposure to specified drug classes before approval. At least one agent from each of the following categories must have been used in prior lines of therapy: proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib), immunomodulatory agent (e.g., lenalidomide, pomalidomide, thalidomide), and anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab).

Minimum of 4 prior therapies in total, including agents from the three specified classes.

Documentation Required

Required Documentation

Submit chart notes or medical record documentation demonstrating failure of previous lines of therapy. Include treatment history, dates, reasons for discontinuation (progression or intolerance), and relevant clinical assessments.

Attach medication administration records, clinic notes, and imaging or laboratory data when applicable.
Clearly document prior agents tried and clinical response or reason for discontinuation.

Denial Risk

Not Medically Necessary Trigger

Lynozyfic (linvoseltamab-gcpt) will be denied as not medically necessary for members who do not meet the criteria above, including insufficient prior therapies or missing required class exposure and supporting documentation.

Denial reason examples: fewer than 4 prior therapies; no prior exposure to a proteasome inhibitor, immunomodulatory agent, or anti-CD38 antibody; lack of medical record evidence of treatment failure or intolerance.

Step Therapy / Prior Exposure Requirements

Step	Requirement	Evidence needed
1	Prior exposure to specified drug classes: member must have received ≥4 prior therapies including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody	Chart notes or medical records documenting prior treatments that demonstrate use of agents from each required class (examples: bortezomib, carfilzomib; lenalidomide, pomalidomide; daratumumab, isatuximab).

Background

Lynozyfic (linvoseltamab-gcpt) is a biologic agent FDA-approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. Treatment decisions and any dosing limits should align with FDA labeling and accepted compendia or evidence-based guidelines; approvals may be granted for an authorization period of up to 12 months.

Site of Care Considerations

Billing Rule

Approvals may be subject to dosing limits per FDA labeling and guidelines

Approvals may be subject to dosing limits consistent with FDA labeling, accepted compendia, and evidence‑based practice guidelines when administered in an infusion center.

Dosing and administration must align with FDA‑approved labeling, accepted compendia, and/or evidence‑based practice guidelines.