CurrentmhnPolicy CP.PHAR.743

Clinical Policy: Linvoseltamab-gcpt (Lynozyfic)

Defines medical necessity criteria, dosing limits, prior authorization and continuation requirements for Linvoseltamab-gcpt (Lynozyfic) for commercial, HIM and Medicaid lines of business. Includes excluded indications, dosing/administration, contraindications/boxed warnings, therapeutic alternatives, and coding implications.

Policy Summary

Payermhn

PolicyClinical Policy: Linvoseltamab-gcpt (Lynozyfic)

Policy CodePolicy CP.PHAR.743

Change TypeCoding and effective date update

Effective DateOct 1, 2025

Next Review Date

Key ActionProvider must submit documentation supporting all approval criteria including diagnosis, prior lines of therapy, measurable or progressive disease status, and prescriber specialty.

SourceLink

POLICY UPDATE CHANGES

Effective date updated to 10.01.25.

HCPCS code J9999 added; J3590 and C9399 removed.

Policy creation and P&T approval dates added (Policy created 07.17.25; P&T approval 08.25).

1FDA approved indication (MM, ≥4 prior lines)

4Required prior therapy classes

5Key dosing steps listed

Coverage Summary

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Coverage stance: covered_with_criteria for Linvoseltamab-gcpt (Lynozyfic) for adult patients with relapsed or refractory multiple myeloma who have received ≥ 4 prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody. This indication was granted under accelerated approval based on response rate and durability of response, and continued approval may depend on confirmatory trials (approval basis). Key measurable and treatment thresholds include: Serum M protein ≥ 0.5 g/dL; Urine M protein ≥ 200 mg/24 h; Involved serum FLC ≥ 10 mg/dL (100 mg/L) with abnormal kappa/lambda ratio; and the specified step-up and maintenance dosing thresholds (see dosing thresholds).

I. Initial Therapy Criteria — Multiple Myeloma

I. Initial Approval Criteria - Multiple Myeloma

Covered when ALL of the following are met:

ALL of the following

Diagnosis of multiple myeloma (MM).
Prescribed by or in consultation with an oncologist or hematologist.
Age ≥ 18 years.
Disease is relapsed or refractory.
ONE of
- ALL of the following
  - Serum M protein ≥ 0.5 g/dL.≥ 0.5 g/dL
  - Urine M protein ≥ 200 mg/24 h.≥ 200 mg/24 h
  - Serum free light chain (FLC) assay: involved FLC level ≥ 10 mg/dL (100 mg/L) provided serum kappa lambda FLC ratio is abnormal.≥ 10 mg/dL (100 mg/L) with abnormal kappa/lambda ratio
- Member has progressive disease as defined by IMWG response criteria assessed within 60 days following the last dose of the last anti-myeloma regimen received.IMWG progression within 60 days
ALL of the following
- One proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib).
- One immunomodulatory agent (e.g., lenalidomide, pomalidomide, thalidomide).
- One anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab).
Member does not have known MM brain lesions or meningeal involvement.
Patients with MM brain lesions or meningeal involvement were excluded from the pivotal trial.
Dose requirement
- Dose does not exceed all of the following step-up and maintenance schedule:Day 1: 5 mg; Day 8: 25 mg; Day 15: 200 mg; Week 4-13: 200 mg once weekly (10 doses); Week 14+: 200 mg every 2 weeks
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
Prescribed regimen must be FDA‑approved or recommended by NCCN.

The prescribed regimen must be FDA‑approved or recommended by NCCN to meet criteria. Therapy must be prescribed by or in consultation with an oncologist or hematologist, and the patient must be an adult (Age ≥ 18 years).

II. Continued Therapy Criteria — Multiple Myeloma

II. Continued Therapy - Multiple Myeloma

Continuation covered when ALL of the following are met:

ALL of the following

Member is currently receiving medication via Centene benefit, or documentation shows member has received Lynozyfic for a covered indication for at least 30 days.≥ 30 days or currently covered under Centene benefit
Continuation documentation required: positive response and ≥30 days (or current benefit).
Member is responding positively to therapy.
Provider must document positive response to therapy.
Dose increase criteria
- ALL of the following
  - 200 mg every 2 weeks.200 mg every 2 weeks
  - For members who have achieved and maintained VGPR or better at or after week 24 and received at least 17 doses of 200 mg: 200 mg every 4 weeks.200 mg every 4 weeks with VGPR maintained after week 24 and ≥17 doses
- New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
Prescribed regimen must be FDA‑approved or recommended by NCCN.

Documentation Required

Continuation documentation

Provider must document that the member is responding positively to Lynozyfic and that the member has received Lynozyfic for at least 30 days or is currently covered under the Centene benefit.

Member has received Lynozyfic for at least 30 days or is currently receiving via Centene benefit
Documented positive clinical response to therapy

III. Diagnoses / Indications Not Authorized

III. Diagnoses/Indications Not Authorized

Non‑FDA approved indications not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety is provided per off-label use policies.

Non‑FDA approved indications not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety provided per off-label use policies (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

Refer to off-label use policies for documentation requirements.

Provider Actions & Billing

Documentation Required

Documentation required for medical necessity

Provider must submit documentation supporting medical necessity, including office chart notes, laboratory results, prior therapy history, evidence of measurable disease or progressive disease status, and the prescriber specialty.

Office notes / chart documentation
Laboratory results (e.g., serum M protein, urine M protein, serum FLC)
Prior lines of therapy and intolerance documentation
Measurable disease or IMWG-defined progressive disease status
Prescriber specialty (oncologist or hematologist)

Prior Authorization

Prescriber specialty requirement

Prescription must be written by an oncologist or hematologist, or by another prescriber in consultation with an oncologist or hematologist.

Documentation Required

Measurable disease or progression timing

Measurable disease assessments must be performed within the last 28 days. If relying on progressive disease per IMWG, the progression assessment must be within 60 days following the last dose of the most recent anti-myeloma regimen.

Measurable disease: assessed within the last 28 days
IMWG-defined progressive disease: assessed within 60 days after last anti-myeloma regimen dose

Prior Authorization

Dose limit enforcement

Prior authorization requests that exceed the specified step-up or maintenance dosing schedule require submission of supporting practice guideline recommendations or peer-reviewed literature evidence to justify the off-label dosing.

Step-up and maintenance schedule must be followed unless guideline or peer-reviewed evidence is provided
Prescriber must submit supporting evidence for off-label dosing

Billing Rule

HCPCS coding

Use HCPCS code J9999 (Not otherwise classified, antineoplastic drugs) for Lynozyfic. Note that J3590 and C9399 were removed from the policy coding list; providers should reference the policy code list for billing.

J9999 — Not otherwise classified, antineoplastic drugs (use for Lynozyfic)
J3590 and C9399 — removed from policy coding

HCPCS codes referencedHCPCS

J9999

Not otherwise classified, antineoplastic drugs (added to policy)

HCPCS codes removedHCPCS

J3590	Unclassified biologics (removed from policy)
C9399	Unclassified drugs or biologicals (removed from policy)

Dosing / Administration & Thresholds

Step-up and maintenance dosing schedule: Day 1: 5 mg; Day 8: 25 mg; Day 15: 200 mg (first treatment dose); then 200 mg once weekly from Week 4 to Week 13 (10 treatment doses); thereafter 200 mg every 2 weeks. For patients who have achieved and maintained VGPR or better at or after week 24 and received at least 17 doses of 200 mg, dosing may be reduced to 200 mg every 4 weeks. Prescribers must submit supporting evidence for any off‑label or alternative schedules.

Thresholds and dosing

Serum M protein threshold≥ 0.5 g/dL

Urine M protein threshold≥ 200 mg/24 h

Involved serum FLC threshold≥ 10 mg/dL (100 mg/L) with abnormal kappa/lambda ratio

Prior lines of therapy requirement≥ 4 prior lines including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody

Dose step-up Day 15 mg IV

Dose step-up Day 825 mg IV

First treatment dose (Day 15)200 mg IV

Weekly dosing (Week 4–13)200 mg IV once weekly (10 treatment doses)

Maintenance dosing (Week 14+)200 mg IV every 2 weeks (or 200 mg every 4 weeks for patients with VGPR or better at/after week 24 with ≥17 doses)

Clinical Evidence & Regulatory Basis

AcceleratedApproval basis: accelerated approval based on response rate and durability; confirmatory trials required

LINKER-MM1Pivotal trial: LINKER-MM1 (NCT03761108) referenced

Jul 2025Reference labeling: Lynozyfic Prescriber Information July 2025 (FDA label)

Evidence summary: The accelerated approval was granted based on observed response rate and durability of response from pivotal studies (approval basis), with the LINKER-MM1 trial referenced as the pivotal study. Continued approval may be contingent on verification of clinical benefit in confirmatory trials per the labeling and approval basis.

Background

Background: Linvoseltamab-gcpt (Lynozyfic) is a bispecific BCMA-directed CD3 T-cell engager indicated for adult patients with relapsed or refractory multiple myeloma who have received ≥ 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 monoclonal antibody. Definitions: BCMA = B-cell maturation antigen; FLC = free light chain; IMWG = International Myeloma Working Group; VGPR = very good partial response.

Revision History

2025-10-01effective_date_updatedLatest

Effective date updated to 10.01.25.

2025-09-11coding_change

HCPCS code J9999 added and J3590/C9399 removed (coding implications).

2025-07-17policy_created

Policy created (Policy creation date 07.17.25).

2025-08-25pt_approval

P&T approval date 08.25.

Policy Summary

Payermhn

PolicyClinical Policy: Linvoseltamab-gcpt (Lynozyfic)

Policy CodePolicy CP.PHAR.743

Change TypeCoding and effective date update

Effective DateOct 1, 2025

Next Review Date

Key ActionProvider must submit documentation supporting all approval criteria including diagnosis, prior lines of therapy, measurable or progressive disease status, and prescriber specialty.

SourceLink

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