Last Review Date: 08/05/2025

Date of Origin: 08/05/2025                          

Dates Reviewed: 08/2025

1. Length of Authorization

• Initial: Prior authorization validity will be provided initially for 6 months, following initial inpatient administration of 2 doses (step-up dose 1, step-up dose 2).
• Renewal: Prior authorization validity may be renewed every 6 months thereafter.

2. Dosing Limits

Max Units (per dose and over time) [HCPCS Unit]:

2. • Step-up Dosing
     • Day 1: 5 mg
     • Day 8: 25 mg
   • Treatment Dosing
     • Day 15: 200 mg
     • Weekly (starting one week after day 15 through week 13 for ten doses): 200 mg
     • Bi-weekly (starting week 14 and every 2 weeks thereafter for at least 17 doses: 200 mg
   • Maintenance Dosing
     • Every 4 weeks (starting after at least week 24 and after at least 17 doses): 200 mg
3. Initial Approval Criteria ¹

Prior authorization validity is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Used as continuation therapy following inpatient administration of all step-up doses; AND
• Patient had an absence of unacceptable toxicity while on inpatient administration; AND

Universal Criteria ¹

• Patient does not have an active infection, including clinically important localized infections; AND
• Patient will be administered prophylaxis for infection (e.g., antimicrobials, antibiotics, antifungals, antivirals, vaccines, and subcutaneous or intravenous immunoglobulin (IVIG)) according to local guidelines; AND
• Patient immunoglobulin levels will be monitored prior to and during therapy and treated appropriately; AND
• Patient does not have active CNS involvement or clinical signs of meningeal involvement from multiple myeloma; AND

• Patient has not had an allogeneic stem cell transplant or an autologous stem cell transplant within the previous 12 weeks; AND

Multiple Myeloma † ^1-3

• Patient has relapsed or refractory disease; AND

• Used as a single agent; AND
• Patient has received at least four (4) prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Prior authorization validity may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: neurologic toxicity including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), severe administration-related/local injection-site reactions, cytokine release syndrome (CRS), hepatotoxicity, neutropenia/febrile neutropenia, severe infections, etc.

5. Dosage/Administration ^1,8

6. Billing Code/Availability Information

HCPCS Code:

• J9999 – Not otherwise classified, antineoplastic drugs

NDC:

• Lynozyfic 5 mg/2.5 mL (2 mg/mL) single-dose vial: 61755-0054-xx
• Lynozyfic 200 mg/10 mL (20 mg/mL) single-dose vial: 61755-0056-xx

7. References

1. Lynozyfic [package insert]. Tarrytown, NY; Regeneron Pharmaceuticals, Inc.; July 2025. Accessed July 2025.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for teclistamab. National Comprehensive Cancer Network, 2025. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed July 2025.
3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma Version 2.2025. National Comprehensive Cancer Network, 2025. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed July 2025.
4. BGM Durie, J-L Harousseau, J S Miguel, et al on behalf of the International Myeloma Working Group. International uniform response criteria for multiple myeloma. Leukemia. Sep; 20(9):1467-73.
5. Lee HC, Bumma N, Richter JR, et al. LINKER-MM1 study: Linvoseltamab (REGN5458) in patients with relapsed/refractory multiple myeloma. JCO 41, 8006-8006(2023). DOI:10.1200/JCO.2023.41.16_suppl.8006.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A