For more information, call VYLOY Support Solutions:
1-855-272-6609
Monday–Friday, 8:00 AM–8:00 PM ET
J1326
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.
You can also enroll your patient via fax by downloading the Patient Enrollment Form and faxing a completed form to 1-855-272-6653.
Once a patient is enrolled, VYLOY Support Solutions will conduct a benefits investigation and assess a patient's eligibility for financial assistance.
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).
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
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.
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.
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.
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
At least 1 ICD-10-CM diagnosis code must be included in all hospital and physician office claims.
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.
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 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.
Healthcare providers can obtain VYLOY from the participating specialty pharmacies and specialty distributors listed below.
Please call if you have any questions or need assistance.
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.
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