Last Review Date: 11/05/2024

Date of Origin:  11/05/2024

Dates Reviewed:  11/2024

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

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

• First Dose:
  • 2000 mg (20 vials) one time only
• Subsequent Doses:
  • 1500 mg (15 vials) every 3 weeks; OR
  • 1000 mg (10 vials) every 2 weeks

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Patient is not experiencing Grade 2 or greater nausea and/or vomiting prior to the first infusion; AND

Universal Criteria ¹

• Patient does not have a complete or partial gastric outlet syndrome; AND
• Patient does not have a history of central nervous system metastases; AND

Gastric, Gastro-Esophageal Junction Cancers † ‡ Ф ^1-5

• Patient has locally advanced unresectable, or metastatic adenocarcinoma; AND
• Used as first-line therapy; AND

• Patient has claudin (CLDN) 18.2-positive (defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining) disease as determined by an FDA-approved or CLIA-compliant testv; AND
• Patient has human epidermal growth factor receptor 2 (HER2)-negative disease; AND
• Used in combination with a fluoropyrimidine- and platinum-containing chemotherapy-based regimen

v If confirmed using an immunotherapy assay-http://www.fda.gov/companiondiagnostics

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

4. Renewal Criteria ^1,3,13

Coverage 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: severe hypersensitivity reactions including anaphylaxis, severe nausea and vomiting, etc.

5. Dosage/Administration ^{1,13-15,17,18,20}

6. Billing Code/Availability Information

HCPCS Code:

• J9999 – Not otherwise classified, antineoplastic drugs
• C9399 – Unclassified drugs or biologicals (hospital outpatient use)

NDC(s):

• Vyloy 100 mg powder in a single-dose vial: 00469-3425-xx

7. References

1. Vyloy [package insert]. Northbrook, IL; Astellas Pharma US, Inc.; October 2024. Accessed October 2024.
2. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium^®) for zolbetuximab. National Comprehensive Cancer Network, 2024. 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 October 2024.
3. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium^®) for Gastric Cancer, Version 4.2024. National Comprehensive Cancer Network, 2024. 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 October 2024.
4. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium^®) for Esophageal and Esophagogastric Junction Cancers, Version 4.2024. National Comprehensive Cancer Network, 2024. 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 October 2024.
5. Shitara K, Lordick F, Bang YJ, et al. Zolbetuximab + mFOLFOX6 as first-line (1L) treatment for patients (pts) withclaudin-18.2+ (CLDN18.2+) / HER2− locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG/GEJ) adenocarcinoma: Primary results from phase 3 SPOTLIGHT study. JCO 41, LBA292-LBA292(2023). DOI:10.1200/JCO.2023.41.4_suppl.LBA292
6. Shah MA, Ajani JA, Al-Batran SE, et al. Zolbetuximab + CAPOX versus CAPOX in first-line treatment of claudin18.2+/HER2– advanced/metastatic gastric or gastroesophageal junction adenocarcinoma: GLOW phase 3 study.. JCO 40, TPS365-TPS365(2022). DOI:10.1200/JCO.2022.40.4_suppl.TPS365

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