VYLOY J Code: J1326

Drug & Product Overview

HCPCS Descriptor Injection, zolbetuximab-clzb, 2 mg

HCPCS Added Date July 1, 2025

Manufacturer Astellas Pharma

Route of Administration Intravenous

Generic Status Single-Source; Branded

Dosage Type Single-Dose

Dosage Form Injection, Powder, For Suspension

About VYLOY

Vyloy is a medication aligned to the HCPCS J Code: J1326 for billing, pricing, and reimbursement purposes in the United States. This Oncology medication is administered via the intravenous route and manufactured by Astellas Pharma.

According to CMS Drug Use Information: This medication is used to treat certain types of cancer (such as stomach, esophageal). Zolbetuximab works by slowing or stopping the growth of cancer cells.

Disclaimer: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional.

NDC Code Information

Based on publicly available CMS files. The list of NDCs below is not exhaustive.

NDC Code	Drug	Manufacturer	Billing Units / Pkg	Package Size
00469-3425-10	Vyloy	Astellas Pharma US, Inc.	50	100 MG / 5 ML
00469-4425-30	Vyloy	Astellas Pharma US, Inc.	150	300 MG / 15 ML

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VYLOY Pricing & Reimbursement

J1326 Private Payer Reimbursement

$34.47 / HCPCS unit as of Jan 2026

National median reimbursement across major commercial payers.

Create an account on PayerPrice for more information →

Historical Graphing and Billing Calculator

per HCPCS unit

As of Q3 2026

VYLOY Claims Performance

Claims from Jan 2026 – Aug 2026

Claim Denial Rate 19.92%

Avg. Days to File 11.7days

Avg. Days to Pay 30.8days

Real-world claims performance from FocalPoint, OnPoint Oncology's reimbursement analytics platform, with claims data accrued at the clearing house level.

Explore J1326 claims analytics on FocalPoint →

VYLOY CPT Administration Codes

CPT Code	Description
96413	Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug
96415	Chemotherapy administration, intravenous infusion technique; each additional hour (List separately in addition to code for primary procedure)

Not on the CMS JW / JZ list

This product is new and does not yet appear on the CMS list of HCPCS pertaining to single-dose containers. Wastage billing guide →

VYLOY Medically Unlikely Edits (MUE)

The most billing units of J1326 Medicare will pay for one patient in one day, as published by CMS. 1 unit = 2 mg.

Practitioner Office & Hospital Outpatient

1,200 units / day

= 2,400 mg per day

MAI 3 · Date of Service Edit: Clinical. Per-day limit based on clinical expectations; excess units are denied but may be appealed with documentation of medical necessity. See all MUE limits →

VYLOY Clinical Information

Indications and drug classification.

Treated Diseases & Conditions

This list of indications is not exhaustive and may be subject to errors. The information on BuyandBill.com is intended for informational purposes only and should not be used for medical advice.

locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma

Drug Class

Claudin 18.2-directed Antibody Interactions [MoA]Claudin 18.2-directed Cytolytic Antibody [EPC]

Frequently Asked Questions

Is there an available VYLOY billing and coding guide?

Billing and coding information for VYLOY can be found through Astellas Pharma US, Inc.. Visit Here →

Are there any available VYLOY patient assistance programs?

VYLOY patient assistance information can be found through Astellas Pharma US, Inc.. Visit Here →

Where can I find VYLOY prescribing information?

VYLOY prescribing information can be found at the link below. Visit Here →

Where can I find VYLOY side effect information?

Side effect information for VYLOY can be found through MedlinePlus. Visit Here →

Does billing VYLOY require JZ/JW wastage modifiers?

CMS does not include VYLOY (J1326) on its list of HCPCS pertaining to single-dose containers. Per CMS guidelines, the JZ/JW wastage modifiers may not apply when billing J1326. For more information, visit the link below.

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