VYLOY
Generic: zolbetuximab-clzb
Manufacturer: Astellas Pharma US, Inc. · Program: Astellas Patient Assistance Program
Apply for AssistanceEligibility Criteria
Insurance Requirement
Uninsured or insurance does not cover VYLOY; commercial insurance for copay program
Residency
US resident
Income Threshold
Up to 400% FPL
Individual Income Limit
$58,320/year
Income limits vary by drug; call to verify
Program Information
Processing Time
2–3 weeks
Delivery Method
shipped to patient or physician office
Application Method
Multiple
Reauthorization
Required — annual
Typically Required Documents
ProvisionRX prepares and organizes all required documentation as part of your enrollment management. This list is provided for informational purposes.
- proof of residency
- proof of income
- prescription
- insurance information
Indicated For
gastric cancer, gastroesophageal junction adenocarcinoma
About This Medication
# Astellas Patient Assistance Program Patient Guide: How to Get VYLOY (zolbetuximab-clzb) at Low or No Cost VYLOY (zolbetuximab-clzb) is a prescription medication used to treat certain types of gastric (stomach) cancer in adults, specifically in combination with chemotherapy for tumors that express a protein called CLDN18.2. The **Astellas Patient Assistance Program** helps eligible uninsured or underinsured patients get VYLOY at no cost if their insurance doesn't cover it. ## About VYLOY (zolbetuximab-clzb) VYLOY is an intravenous (IV) infusion given by a healthcare professional every 3 weeks as part of a treatment regimen for **HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma** that is locally advanced or metastatic and positive for CLDN18.2 expression (≥75% of tumor cells). It's not a cure but can help control the cancer when combined with specific chemotherapies like CAPOX (capecitabine and oxaliplatin). Common side effects include nausea, vomiting, decreased appetite, diarrhea, fatigue, and low blood counts—always discuss risks with your doctor. Full prescribing information is available through your healthcare provider or VYLOYSupportSolutions.com.[1][2][3] This guide focuses on the **Astellas Patient Assistance Program** (PAP), which provides free medication to those who qualify. There's also a separate **VYLOY Copay Assistance Program** for commercially insured patients (not government insurance), covering up to $25,000 per year, reducing copays to as low as $5 per dose.[2][3][4] ## Who Qualifies for the Astellas Patient Assistance Program? You may qualify if: - You are **uninsured** or your insurance **does not cover VYLOY**. - You have a valid prescription for an FDA-approved use. - You meet **financial eligibility requirements** (income-based, though exact limits like Federal Poverty Level percentages are not publicly detailed—call to confirm).[1][2][3][10] **Note:** Patients with Medicare, Medicaid, or other federal/state programs are generally ineligible for the PAP but may get copay help or referrals to other resources. VYLOY Support Solutions can connect you to additional support.[3][4][9] ## Income Eligibility Breakdown Specific income thresholds (e.g., 400% of Federal Poverty Level) are not detailed in public sources. Eligibility is assessed case-by-case based on annual household income and family size. Contact VYLOY Support Solutions at **(855) 272-6609** for your situation—they'll review your proof of income.[1][10] Here's a general table of how PAPs often work (call for VYLOY-specific confirmation): | Household Size | Example Max Annual Income (300% FPL estimate)* | |----------------|-----------------------------------------------| | 1 (Individual) | ~$45,000 | | 2 (Couple) | ~$61,000 | | 3 | ~$77,000 | | 4 | ~$92,000 | *Estimates only; actual limits vary. Provide last year's tax return or pay stubs. Larger families get higher thresholds.[1] ## Insurance Requirements - **Eligible:** Uninsured or insurance excludes VYLOY coverage (e.g., prior authorization denied).[2][3][5] - **Ineligible for PAP:** Commercial insurance that covers VYLOY (use Copay Program instead); Medicare, Medicaid, VA, TRICARE, etc.[3][4] VYLOY Support Solutions offers **benefits investigation** to check coverage, prior auth help, and denial appeals before applying for PAP.[3] ## Step-by-Step Application Process 1. **Talk to Your Doctor:** They must prescribe VYLOY and complete the enrollment form. Download it from VYLOYSupportSolutions.com.[1][5] 2. **Call VYLOY Support Solutions:** Dial **(855) 272-6609** (Mon-Fri, 8 AM-8 PM ET) to start enrollment and confirm eligibility.[1][2][4] 3. **Gather Documents:** - Proof of residency (e.g., utility bill). - Proof of income (tax returns, W-2s, pay stubs). - Prescription. - Insurance info (or proof of no coverage/denial).[1] 4. **Complete & Submit Form:** Your doctor fills patient info, prescription details, and signs. Patient signs authorization. Fax to **(855) 272-6653** or upload via portal.[1][5] 5. **Wait for Approval:** If eligible, you'll be notified. Medication ships free.[2][5] Applications can be submitted by phone, fax, or online portal.[1] ## Timeline and Delivery Processing time isn't specified but typically 1-2 weeks after complete submission—call for updates. Approved VYLOY is **shipped directly to your home or doctor's office** at no cost. Reauthorization is required periodically (e.g., annually).[1][5][7] ## Alternatives if Denied or Ineligible - **Copay Program:** For commercial insurance—up to $25,000/year assistance.[2][3] - **Other Resources:** VYLOY Support Solutions refers to independent programs, state assistance, or generics (none currently for VYLOY).[2][4] - **Patient Connect:** Emotional/logistical support.[4] - **RxAssist.org or ACCC Cancer resources** for more options.[7][9] No biosimilar alternatives exist yet.[ ] ## Important Disclaimer This guide is for informational purposes only and based on publicly available data as of 2026. Eligibility, terms, and availability can change—**always verify with VYLOY Support Solutions at (855) 272-6609** or your doctor. The program is void where prohibited by law. Not a substitute for medical advice. Program terms apply; financial info is kept confidential.[1][2][3] **Word count: ~950**
Program information last verified: March 30, 2026
Ready to apply for VYLOY assistance?
ProvisionRX manages the complete application process. Start your application in about 15 minutes.