The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member's medical needs and condition.
MEDICALLY NECESSARY
Linvoseltamab-gcpt (Lynozyfic) is considered medically necessary and, therefore, covered as a single agent in adult individuals with refractory or relapsed multiple myeloma (RRMM) who have received at least four prior therapies, including all of the following National Comprehensive Cancer Network (NCCN)-preferred therapies:
EXPERIMENTAL/INVESTIGATIONAL
All other uses for linvoseltamab-gcpt (Lynozyfic) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.
REQUIRED DOCUMENTATIONThe individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.
The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
BLACK BOX WARNINGSRefer to the specific manufacturer's prescribing information for any applicable Black Box Warnings. BENEFIT APPLICATIONSubject to the terms and conditions of the applicable benefit contract, linvoseltamab-gcpt (Lynozyfic) is covered under the medical benefits of the Company's products when the medical necessity criteria listed in this medical policy are met.US FOOD AND DRUG ADMINISTRATION (FDA) STATUS
Linvoseltamab-gcpt (Lynozyfic) was approved by the FDA on July 2, 2025, for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Dosage and Frequency
Linvoseltamab-gcpt (Lynozyfic) is administered via intravenous (IV) infusion with a step-up dosing regimen; treatment doses of 200 mg weekly are then administered until transition to 200 mg every 2 weeks. After at least 24 weeks, linvoseltamab-gcpt (Lynozyfic) may be dosed every 4 weeks (Q4W) in patients who achieve a very good partial response (VGPR) or better.
INPATIENT ADMISSION FOR ADMINISTRATIONWhen the medical necessity criteria has been met, the inpatient admission for first cycle administration of linvoseltamab-gcpt (Lynozyfic), as recommended by the US Food and Drug Administration (FDA), is covered in accordance with the following timeframes*:
*Inpatient hospital stays that are longer than the preceding timeframes must be re-evaluated for medical necessity.
PEDIATRIC USE
The safety and effectiveness of linvoseltamab-gcpt (Lynozyfic) in pediatric individuals have not been established.
Multiple myeloma (MM) is a cancer of plasma cells. Healthy plasma cells grow and divide to make new cells; once cells grow old or get damaged, they die. Due to the genetic variations in MM, the myeloma cells replicate uncontrollably throughout the bone marrow, do not die when they get old or damaged, outnumber normal blood cells in the bone marrow, and destroy the bone tissue. The antibodies synthesized by myeloma cells do not fight infections in the same way as normal antibodies do. MM symptoms are low blood counts that cause anemia, bone pain, kidney damage due to elevated creatinine or serum protein, infection, fatigue, and hypercalcemia.Nearly all individuals with myeloma who receive standard therapies have relapse. Those with triple-class–refractory MM (i.e., disease that is refractory to a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody) or relapsed MM who receive standard treatment have a poor prognosis. Therefore, there is a high demand for agents that treat MM in individuals who do not respond or that progress after first- or subsequent-line therapy.
Linvoseltamab-gcpt (Lynozyfic) is a bispecific T-cell–engaging antibody that binds to the CD3 receptor expressed on the surface of T cells and B-cell maturation antigen (BCMA) expressed on the surface of MM cells and some healthy B-lineage cells. In vitro, linvoseltamab-gcpt (Lynozyfic) activated T cells, caused the release of various proinflammatory cytokines, and resulted in the lysis of MM cells. Linvoseltamab-gcpt (Lynozyfic) had antitumor activity in mouse models of MM.
PEER-REVIEWED LITERATURE
SUMMARY
The safety and efficacy of linvoseltamab-gcpt (Lynozyfic) were evaluated in a ongoing pivotal, open-label, multicenter, multicohort phase 1/2 dose escalation and dose expansion LINKER-MM1 trial. Among the efficacy population of 80 participants, the objective response rate was 70%, with 45% of participants achieving a complete response (CR) or stringent CR. The median duration of response (DOR) was not reached. With a median follow-up of 11.3 months among responders, the estimated DOR rate was 89% at 9 months and 72% at 12 months. Continued approval of linvoseltamab-gcpt (Lynozyfic) for relapsed or refractory MM may be contingent upon verification of clinical benefit in a confirmatory trial.
In the LINKER-MM1 trial, CRS occurred in 46% of participants who received linvoseltamab-gcpt (Lynozyfic), and neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome (ICANS), occurred in 54%.
OFF-LABEL INDICATIONSThere may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company's off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
American Cancer Society [website]. Multiple Myeloma. Revised 02/2/2018. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed August 8, 2025.
Elsevier Gold Standard's Clinical Pharmacology Compendium. Linvoseltamab-gcpt (Lynozyfic). [Clinical Pharmacology website]. 07/16/2025. Available at: https://www.clinicalkey.com/pharmacology/monograph/5480?n=. [via subscription only]. Accessed August 8, 2025.
Lexi-Drugs Compendium. Linvoseltamab-gcpt (Lynozyfic). 08/06/2025. [Lexicomp Online Website]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed August 8, 2025.Micromedex® Healthcare Series [Internet database]. Linvoseltamab-gcpt. Greenwood Village, CO: Thomson Micromedex. 07/18/2025. Available at: http://www.micromedexsolutions.com/micromedex2/librarian. Accessed August 8, 2025.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology – Multiple Myeloma. V2.2026. [NCCN Web site]. 07/16/2025. Available at: https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf [via subscription only]. Accessed August 8, 2025.
National Comprehensive Cancer Network (NCCN). NCCN Drugs and Biologics Compendium. Linvoseltamab-gcpt. [NCCN Web site]. 2025. Available at: https://www.nccn.org/professionals/drug_compendium/content/Reports/Report.aspx?DrugCompendiumIds=337420 [via subscription only]. Accessed August 8, 2025.
US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs @FDA. Prescribing Information. Linvoseltamab-gcpt (Lynozyfic). [FDA website]. 07/2025. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761400s000lbl.pdf. Accessed August 8, 2025.
This version of the policy will become effective 01/01/2026.
The following NOC code has been removed from this policy and is replaced by the following HCPCS code:
REMOVED: C9399: Unclassified drugs or biologicals
REPLACED WITH: C9307: Injection, linvoseltamab-gcpt, 1 mg
