Clinical Policy: Linvoseltamab-gcpt (Lynozyfic)
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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.
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).
Coverage Summary
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.
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.
Refer to off-label use policies for documentation requirements.
Provider Actions & Billing
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)
Prescriber specialty requirement
Prescription must be written by an oncologist or hematologist, or by another prescriber in consultation with an oncologist or hematologist.
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
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
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.
Clinical Evidence & Regulatory Basis
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
Effective date updated to 10.01.25.
HCPCS code J9999 added and J3590/C9399 removed (coding implications).
Policy created (Policy creation date 07.17.25).
P&T approval date 08.25.
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