For more information, call VYLOY Support Solutions:
1-855-272-6609
Monday–Friday, 8:00 AM–8:00 PM ET

Helping Patients
Access
VYLOY®
(zolbetuximab-clzb)

J1326

Effective
July 1, 2025

Permanent J-code
for VYLOY1

Click here for
more information

VYLOY Support Solutions offers support to help patients access their
prescribed treatment.

VYLOY Support Solutions can assist with:
  • Benefits investigations
  • Prior authorization and denial appeals informationa
  • Coding and billing informationb
  • Additional patient and caregiver support

Enroll your patients in VYLOY Support Solutions so they have access to the full range of support.c

aThe healthcare provider remains responsible for populating all clinical information.

bInformation and materials provided by VYLOY Support Solutions are to assist providers, but the responsibility to determine coverage, reimbursement, and appropriate coding for a particular patient and/or procedure remains at all times with the provider.

cProgram eligibility criteria, terms, and conditions apply.

Enrolling Patients

Monitor icon
Go to VYLOYaccess.com to complete the online Patient Enrollment Form.

You can also enroll your patient via fax by downloading the Patient Enrollment Form and faxing a completed form to 1-855-272-6653.

Financial Assistance

Once a patient is enrolled, VYLOY Support Solutions will conduct a benefits investigation and assess a patient's eligibility for financial assistance.

  • Astellas Patient Assistance Program for Uninsured Patients
    Uninsured patients, or patients whose insurer excludes coverage for VYLOY, may be eligible for the Astellas Patient Assistance Program, which provides VYLOY at no cost.d
  • VYLOY Copay Assistance Program for Commercially Insured Patients
    Patients who have private commercial insurance and are not insured by any federal or state healthcare program may be eligible for the VYLOY Copay Assistance Program,e which allows eligible patients to pay as little as $5 per dose. The Program helps patients save up to a maximum of $25,000 per calendar year.
  • Financial Assistance Information
    For patients who need additional financial assistance, VYLOY Support Solutions can provide information about other sources of support that may be able to help.

dSubject to eligibility. Program terms and conditions apply. Void where prohibited by law.

eBy enrolling in the VYLOY Copay Assistance Program ("Program"), the patient acknowledges that they currently meet the eligibility criteria and will comply with the following terms and conditions: The Program is for eligible patients with commercial prescription insurance for VYLOY® (zolbetuximab) and is good for use only with a valid prescription for VYLOY. The Program has an annual maximum copay assistance limit of $25,000, with the annual period starting on the date of Program card activation. After the annual maximum on copay assistance is reached, patient will be responsible for the remaining monthly out-of-pocket costs for VYLOY. The Program is not valid for patients whose prescription claims are reimbursed, in whole or in part, by any state or federal government program, including, but not limited to, Medicaid, Medicare, Medigap, Department of Defense (DoD), Veterans Affairs (VA), TRICARE, Puerto Rico Government Insurance, or any state patient or pharmaceutical assistance program. Patients who move from commercial insurance to federal or state prescription health insurance will no longer be eligible, and agree to notify the Program of any such change. This offer is not valid for cash paying patients. Patients agree not to seek reimbursement from any health insurance or third party for all or any part of the benefit received by the patient through the Program. This offer is not conditioned on any past, present, or future purchase of VYLOY. This offer is not transferrable, has no cash value, and cannot be combined with any other offer, free trial, prescription savings card, or discount (including any program offered by a third-party payer or pharmacy benefits manager, or an agent of either, that adjusts patient cost-sharing obligations, through arrangements that may be referred to as "accumulator" or "maximizer" programs). The full value of the Program benefits is intended to pass entirely to the eligible patient. The benefit available under this Program is valid only for the patient's out-of-pocket medication costs for VYLOY. The benefit is not valid for any other out-of-pocket costs such as medication administration charges or other healthcare provider services. No other individual or entity (including, without limitation, third party payers, pharmacy benefit managers, or the agents of either) is entitled to receive any benefit, discount, or other amount in connection with this Program. This offer is not health insurance and is only valid for patients in the 50 United States, Washington DC, and Puerto Rico. This Program is void where prohibited by law. No membership fees. Certain rules and restrictions apply. Astellas reserves the right to revoke, rescind, or amend this offer without notice for any reason (including to ensure that the offer is utilized solely for the patient's benefit).

Relevant Billing Codes

Properly coding claims can help facilitate timely claims processing and reduce the risk of denied claims. Coverage, coding, and reimbursement policies vary by payer, patient, and setting of care. Healthcare providers should verify coverage, coding, and reimbursement guidelines on a case-by-case basis. The coding systems in the following tables can assist you in proper coding for VYLOY.f

Healthcare Common Procedure Coding System (HCPCS)1

The HCPCS is used to identify products, supplies, and services that are billed to private and government payers by hospitals, physicians, and other healthcare professionals.

Code
Description
J1326
Injection, zolbetuximab-clzb, 2 mg
Billing Unit
Payers and Settings of Care
2 mg = 1 billing unit
Most payers (eg, commercial, Medicare, and Medicaid) and care settings (eg, hospital outpatient and physician office)

One billing unit of J1326 equals 2 mg of zolbetuximab-clzb.
As a result, 50 units equals 1 single-dose 100-mg vial and 150 units equals 1 single-dose 300-mg vial.
Actual units reported will vary by dosage required for each individual patient.

National Drug Code (NDC)2

Universal 11-digit product identifier for human drugs; each NDC identifies the labeler, product, and trade packaging size. The 10- and 11-digit NDCs are listed below.

Code
Description
0469-3425-10
00469-3425-10
Carton of one 100-mg single-dose vial
0469-4425-30
00469-4425-30
Carton of one 300-mg single-dose vial

Note that the product’s NDC has been “zero-filled” to ensure creation of an 11-digit code that meets the standards of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).3 The 11-digit NDC is to be preceded by the qualifier “N4” for payers that require it. This is typically followed by the quantity qualifier and the quantity administered.4

ICD-10-CM Codes5

At least 1 ICD-10-CM diagnosis code must be included in all hospital and physician office claims.

Code
Description
C15.5
Malignant neoplasm of lower third of esophagus
C15.8
Malignant neoplasm of overlapping sites of esophagus
C15.9
Malignant neoplasm of esophagus, unspecified
C16.0
Malignant neoplasm of cardia
C16.1
Malignant neoplasm of fundus of stomach
C16.2
Malignant neoplasm of body of stomach
C16.3
Malignant neoplasm of pyloric antrum
C16.4
Malignant neoplasm of pylorus
C16.5
Malignant neoplasm of lesser curvature of stomach, unspecified
C16.6
Malignant neoplasm of greater curvature of stomach, unspecified
C16.8
Malignant neoplasm of overlapping sites of stomach
C16.9
Malignant neoplasm of stomach, unspecified

Current Procedural Terminology (CPT®) Codes6,g,h

Some payers, such as Medicare, require certain combinations of revenue codes and HCPCS or CPT® codes. The appropriate CPT® code for the administration of VYLOY will depend on the actual service provided.

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)

fThese codes are for informational purposes only and are not intended to provide reimbursement or legal advice. Each healthcare provider is responsible for determining the appropriate codes, coverage, and payment for individual patients. Astellas does not guarantee third-party coverage, payment, or reimbursement for denied claims.

gCPT® codes and descriptions are ©2024 American Medical Association (AMA). All rights reserved. The AMA assumes no liability for data contained herein.

hHealthcare providers should consult the current CPT® manual and always select the code that accurately describes the administration service performed for the patient. Healthcare providers should also contact the payer for additional coding information required.

Patient and Caregiver Support

Helping Patients and Caregivers Manage Daily Living

Patient Connect is a program that helps connect patients and caregivers to resources that can provide emotional, logistical, and informational support to assist in managing daily life while being treated with VYLOY.h

Patients and their caregivers can request assistance by calling VYLOY Support Solutions and speaking to a Case Manager.

hSupport is provided through third-party organizations that operate independently and are not controlled or endorsed by Astellas. Availability of support and eligibility requirements are determined by these organizations.

Ordering VYLOY

Healthcare providers can obtain VYLOY from the participating specialty pharmacies and specialty distributors listed below.

Specialty Pharmacies

Pharmacy
Phone Number
Fax Number
Biologics, Inc.
1-800-850-4306
1-800-823-4506
Onco360 Pharmacy
1-877-662-6633
1-877-662-6355

Specialty Distributors

Distributor
Phone Number
Fax Number
ASD Healthcare
1-800-746-6273
1-800-547-9413
Besse Medical
1-800-543-2111
1-800-543-8695
Cardinal Health Specialty Distribution
1-855-855-0708
1-614-553-6301
McKesson Plasma and Biologics, LLC
1-877-625-2566
1-888-752-7626
McKesson Specialty Health
1-800-482-6700
1-800-289-9285
Oncology Supply
1-800-633-7555
1-800-248-8205
Specialty Distributor for Puerto Rico
Cesar Castillo, Inc.
1-787-641-5082
1-787-999-1614

Downloadable Resources

Questions?

VYLOY Support Solutions Is Here to Help

Telephone icon

Please call if you have any questions or need assistance.

1-855-272-6609
Monday–Friday,
8:00 AM–8:00 PM ET

References: 1. Centers for Medicare & Medicaid Services. Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) application summaries and coding determinations: first quarter, 2025 HCPCS coding cycle. Updated April 7, 2025. Accessed April 9, 2025. https://www.cms.gov/files/document/2025-hcpcs-application-summary-quarter-1-2025-drugs-and-biologicals.pdf 2. VYLOY [package insert]. Northbrook, IL: Astellas Pharma US, Inc. 3. U.S. Food and Drug Administration. National Drug Code database background information. Updated March 20, 2017. Accessed April 30, 2025. https://www.fda.gov/drugs/development-approval-process-drugs/national-drug-code-database-background-information 4. Centers for Medicare & Medicaid Services. Medicare claims processing manual chapter 26 – completing and processing form CMS-1500 data set. Updated December 14, 2023. Accessed April 30, 2025. https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c26pdf.pdf 5. Centers for Medicare & Medicaid Services. ICD-10-CM tabular list of diseases and injuries. Updated March 31, 2025. Accessed April 9, 2025. https://www.cms.gov/files/zip/2025-code-tables-tabular-and-index-april.zip 6. American Medical Association. CPT® 2024 Professional Edition. American Medical Association; 2024.