Linvoseltamab-gcpt (Lynozyfic) for relapsed/refractory multiple myeloma
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Defines medical necessity, prior authorization, dosing limits, and coverage criteria for Linvoseltamab-gcpt (Lynozyfic) in adult patients with relapsed or refractory multiple myeloma across commercial, HIM, and Medicaid lines of business.
HCPCS J9601 (linvoseltamab-gcpt) was added and previous temporary codes removed/updated in the coding section.
Coverage Criteria for Linvoseltamab-gcpt (Lynozyfic)
Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
Dosing schedule specifics: Day 1: 5 mg; Day 8: 25 mg; Day 15: 200 mg; weekly 200 mg from week 4–13; week 14 onward 200 mg every 2 weeks (see policy).
Continuation Therapy — Covered when ALL of the following are met
Continuation therapy covered when ALL of the following are met
Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to member renewal date, whichever is longer.
Dosing and administration — Dosing/admin must follow prescribing schedule and product availability
Covered when dosing and administration follow the prescribing schedule and product availability
Product availability: single-dose vials 5 mg and 200 mg.
Requests for indications that are not FDA‑approved and are not specifically addressed by this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other governing evidence of coverage documents.
Use of linvoseltamab-gcpt in patients with known multiple myeloma brain lesions or meningeal involvement is not supported by the pivotal LINKER‑MM1 trial, as these populations were expressly excluded from that study.
Linvoseltamab-gcpt carries boxed warnings for cytokine release syndrome and neurologic toxicity, including immune effector cell‑associated neurotoxicity syndrome (ICANS). Use without appropriate monitoring and institution of recommended mitigation strategies for these risks is considered inappropriate.
Approved Induction and Maintenance Regimens
| Regimen | Dose / Schedule | Coverage |
|---|---|---|
| FDA‑approved induction and maintenance regimen for relapsed/refractory multiple myeloma | ||
| Day 1 (Step‑up 1): 5 mg IV; Day 8 (Step‑up 2): 25 mg IV; Day 15 (first treatment dose): 200 mg IV; One week after Day 15 and Weeks 4–13: 200 mg IV once weekly (10 weekly doses); Week 14 and every 2 weeks thereafter: 200 mg IV every 2 weeks | ||
| Prescribed regimen must be FDA‑approved or recommended by NCCN; requests exceeding schedule must be supported by guidelines/literature |
| Condition | Maintenance Dosing Option | Coverage |
|---|---|---|
| Standard responders (no sustained VGPR after specified dosing) | ||
| 200 mg IV every 2 weeks | ||
| Maintenance dosing limited to 200 mg every 2 weeks unless criteria for every‑4‑week dosing are met |
| Phase | Schedule summary | Notes / Coverage |
|---|---|---|
| Biweekly (maintenance) | ||
| Week 14 and every 2 weeks thereafter: 200 mg IV every 2 weeks | ||
| Alternate every‑4‑week maintenance (200 mg every 4 weeks) allowed only for patients with sustained VGPR or better at/after week 24 who have received ≥17 doses of 200 mg |
Line of Therapy and Prior Treatment Requirements
salvage
Indication per FDA-approved labeling.
salvage
See full policy references for citations.
Provider Actions — Authorization, Documentation, and Billing
Prior Authorization Required
Prior authorization required. Provider must document diagnosis, specialist involvement, patient age, relapsed/refractory status, measurable disease or progressive disease per IMWG, prior lines of therapy, and that step‑up and maintenance dosing follows the approved regimen or is supported by guideline/literature for off‑label use.
- Submit office chart notes, relevant lab results (e.g., serum/urine M‑protein, serum free light chain), and documentation of prior therapies including intolerance or resistance.
- Prescriber should be an oncologist or hematologist or request must include consultation note.
Required Clinical Documentation
Requests lacking required clinical documentation are at risk of denial. Include supporting evidence that the member meets all approval criteria (diagnosis, measurable disease or IMWG‑defined progressive disease, prior lines of therapy).
- Provide documentation of measurable disease within 28 days OR documentation of progressive disease per IMWG within 60 days following last dose of prior regimen.
- Document prior receipt of ≥4 prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti‑CD38 antibody.
- Non‑FDA indications require evidence per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or may be denied.
Specify Step‑up and Maintenance Dosing
Step‑up and maintenance dosing regimen must be specified on the authorization request. Requests exceeding the dosing schedule or missing step‑up/maintenance plans may be denied unless supported by practice guidelines or peer‑reviewed literature.
- Required step‑up dosing: Day 1 = 5 mg; Day 8 = 25 mg; Day 15 = 200 mg.
- Weekly dosing: Week 4–13 = 200 mg IV once weekly (10 doses). Maintenance dosing: Week 14 onward = 200 mg every 2 weeks; patients with VGPR or better at/after Week 24 and ≥17 doses of 200 mg may move to 200 mg every 4 weeks.
- If dosing differs for off‑label use, prescriber must submit supporting guideline or peer‑reviewed evidence.
Coding and Claim Submission
Billing and coding must use current HCPCS codes. Incorrect, outdated, or inappropriate code selection may result in claim denials or delays.
Coding and Billing
Background
Linvoseltamab-gcpt (Lynozyfic) is a bispecific BCMA‑directed CD3 T‑cell engager indicated under accelerated approval for adult patients with relapsed or refractory multiple myeloma who have received prior therapies. The policy references the LINKER‑MM1 pivotal trial and notes trial exclusions and IMWG response criteria used to define progressive disease.
Definitions and Abbreviations
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