Bylvay

IPSEN CARES Patient Assistance Program Patient Guide: How to Get Bylvay (odevixibat) at Low or No Cost

This guide explains the IPSEN CARES Patient Assistance Program (PAP) from Ipsen, which provides Bylvay (odevixibat) free to eligible patients facing financial hardship. It covers eligibility, steps to apply, and support options in simple terms.[1][2][6][8]

About Bylvay (odevixibat)

Bylvay is a prescription medicine used to treat itching in:

• Patients 12 months and older with Alagille syndrome (ALGS).
• Patients 3 months and older with progressive familial intrahepatic cholestasis (PFIC).

Limitation: Not recommended for some PFIC type 2 patients with specific ABCB11 gene changes. Always talk to your doctor about if it's right for you.[7]

Bylvay is taken once daily by mouth. It's for conditions causing cholestasis, where bile flow is blocked, leading to intense itching that affects daily life. IPSEN CARES helps make it accessible by handling insurance checks, deliveries, and free medicine for those who qualify.[1][3][7]

Who Qualifies for the Program?

The IPSEN CARES PAP is for U.S. residents experiencing financial hardship who meet these key criteria:

• Uninsured or functionally uninsured: No primary or secondary insurance, and not enrolled in any state or federal healthcare program (like Medicare or Medicaid).[8]
• Financial need: Gross household income below 500% of the Federal Poverty Level (FPL), plus other financial factors like debts or expenses.[1][5][8]
• Valid prescription for on-label use of Bylvay.
• Under a doctor's care.[2][6][8]

Eligibility isn't guaranteed and depends on review. The program also offers copay help for commercially insured patients (as low as $0, up to $20,000/year) and a bridge program for short-term needs, but this guide focuses on the free drug PAP.[1][5]

Income Eligibility Breakdown

Eligibility is based on gross household income under 500% FPL. Use the table below for 2026 guidelines (FPL updates yearly; check HHS.gov for exact figures). "Other financial factors" like high medical bills or housing costs may help if slightly over.[1][5][8]

Notes: Figures are estimates; verify current FPL. Provide proof like tax returns. Program considers total household income before taxes.[1][8]

Insurance Requirements

You must be uninsured or functionally uninsured:

• No private primary/secondary insurance.
• Not on government programs (Medicare, Medicaid, VA, etc.).

IPSEN CARES starts with benefits verification to check coverage. If insured commercially, use copay assistance instead. They help with prior authorizations and appeals.[1][2][8]

Step-by-Step Application Process

Applying is straightforward with multiple options. Your doctor usually starts it, but you can too. Call (866) 435-5677 (Mon-Fri, 8 AM-8 PM ET) or visit **https://www.ipsencares.com**.[2][3]

1. Get a Prescription: Ask your doctor for Bylvay. Discuss if PAP is right.[7][8]
2. Contact IPSEN CARES: Call or go online for enrollment form. They guide you.[1][2]
3. Complete Forms:
   • Enrollment form (pages 2-7 required).[8]
   • Supplemental Patient Assistance Program Form (for PAP).[8]
4. Gather Documents:
   • Valid prescription.
   • Proof of income (tax returns, pay stubs, W-2s).
   • Proof of financial hardship (bills, bank statements).[1][8]
5. Submit (choose one):
   • Online: Fill/submit at ipsencares.com.[2]
   • Online + Fax: Print, sign, fax to 1-855-465-3820.[2]
   • Paper + Fax: Download, complete, fax.[2]
   • Phone help available.[3]
6. Sign Consents: Allow sharing info with Ipsen, pharmacies, insurers for processing.[8]

IPSEN CARES handles the rest: reviews, coordinates with specialty pharmacies.[1][6]

Timeline and Delivery

Processing time varies (not specified; typically weeks). Call for status. Once approved, Bylvay ships free directly to your home via specialty pharmacy. They assist with deliveries and track shipments.[1][2]

Reauthorization: Yes, required periodically. Your doctor submits updates; IPSEN CARES reminds you.[8]

Alternatives if Denied or Ineligible

• Copay Program: Commercially insured? Pay $0 copay (up to $20,000/year).[1][5]
• Bridge Program: Up to 60 days free if temporary issue.[5]
• Good Faith Replacement: 15-day supply if lost/damaged.[5]
• Appeal: Provide more docs; call for help.[2]
• Other Help: State programs, nonprofits, or doctor samples. IPSEN CARES offers benefits investigation and advocacy group info.[2][9]
• No biosimilars available.[program data]

Refills and Ongoing Support

Approved patients get ongoing supply. IPSEN CARES communicates with you, your doctor, and pharmacy to avoid delays. They provide education, lab info, and condition resources.[1][2][6]

Disclaimer

This guide is for information only, based on available program details as of 2026. Rules can change; always verify at ipsencares.com or (866) 435-5677. Not medical advice—consult your doctor. Approval not guaranteed. Ipsen/IPSEN CARES not liable for issues.[1][2][8]