Bylvay

Indicated For

Alagille syndrome, progressive familial intrahepatic cholestasis

About This Medication

# IPSEN CARES Patient Assistance Program Patient Guide: How to Get Bylvay (odevixibat) at Low or No Cost Bylvay (odevixibat) is a prescription medication used to treat itching in patients with **Alagille syndrome (ALGS)** (ages 12 months and older) or **progressive familial intrahepatic cholestasis (PFIC)** (ages 3 months and older, with limitations for some PFIC type 2 patients).[3] The **IPSEN CARES Patient Assistance Program** from Ipsen helps eligible patients—especially those who are uninsured or functionally uninsured—access Bylvay at low or no cost through financial assistance, copay support, and other services.[1][4][7] This guide explains everything you need to know about qualifying for the program, applying, and getting your medication. It's designed for patients and caregivers facing financial challenges with this important treatment. ## About Bylvay (odevixibat) **Bylvay** is an oral, once-daily medication that helps reduce itching caused by cholestasis (buildup of bile in the liver) in specific rare liver conditions.[3] - **Approved for**: - Itching due to **Alagille syndrome (ALGS)** in children 12 months and older. - Itching due to **PFIC** in children 3 months and older. - **Limitation**: Not recommended for PFIC type 2 patients with specific *ABCB11* gene changes—discuss with your doctor.[3] Bylvay is prepared as a liquid and taken with food or milk. Your healthcare provider (HCP) will guide dosing based on weight and condition. IPSEN CARES offers free educational brochures on preparation, dosing flashcards, and patient guides for PFIC and ALGS to make daily use easier.[2][7] Starting treatment can feel overwhelming, but IPSEN CARES provides **personalized support** including benefits verification, prior authorization help, specialty pharmacy coordination, and ongoing check-ins to keep you on track.[1][4] ## Who Qualifies for IPSEN CARES Patient Assistance? The program targets patients experiencing **financial hardship** who meet specific eligibility criteria. It's ideal for those unable to afford Bylvay due to lack of insurance coverage or high costs.[9] Key requirements: - **Financial need**: Based on income and other factors (older program info referenced <500% of the Federal Poverty Level, or FPL; exact current thresholds not publicly detailed—call to confirm).[6][9] - **Insurance status**: Uninsured or **functionally uninsured** (insurance doesn't cover Bylvay).[7][9] - **Prescription**: Valid prescription from an HCP for Bylvay. - **U.S. residency**: Program for U.S. patients only. **Note**: Separate **copay assistance** is available for commercially insured patients (as low as $0 copay, with limits).[1][7] Medicare Part D patients are **not eligible** for the patient assistance program.[9] ## Income Eligibility Breakdown Specific income thresholds aren't publicly listed on current Ipsen sites, but eligibility is determined case-by-case for financial hardship. Historical data from program launch (pre-Ipsen acquisition) indicated **gross household income below 500% FPL**.[6] Always verify with IPSEN CARES, as guidelines may update. Here's a table showing **approximate 500% FPL examples** (2026 guidelines; use for reference—actual eligibility may vary): | Household Size | 100% FPL (Annual) | 500% FPL (Annual) | |---------------|-------------------|--------------------| | 1 person | $15,060 | $75,300 | | 2 people | $20,440 | $102,200 | | 3 people | $25,820 | $129,100 | | 4 people | $31,200 | $156,000 | *Source: U.S. HHS Poverty Guidelines (adjusted for 2026). Call (866) 435-5677 for your exact assessment.*[6] ## Insurance Requirements - **Primary focus**: **Uninsured or functionally uninsured** patients (e.g., denied coverage, high out-of-pocket costs).[7][9] - **No Medicare Part D**: Patients enrolled in Medicare Part D do not qualify for free drug assistance.[9] - **Commercial insurance**: May use copay program instead (pay $0 if eligible).[1] IPSEN CARES starts with **benefits investigation** to check your coverage and explore options like prior authorizations or appeals.[4] ## Step-by-Step Application Process Applying is straightforward with **multiple methods**. Your HCP typically starts the process, but patients can too.[4] 1. **Get a prescription**: Discuss Bylvay with your HCP. They'll provide details on your condition and why it's right for you. 2. **Contact IPSEN CARES**: Visit **https://www.ipsencares.com** or call **(866) 435-5677** (Mon-Fri, 8 AM-8 PM ET).[4][5] 3. **Choose enrollment method**:[4] - **Online**: Fill and submit forms at IPSENCARES.com (easiest). - **Online + Fax**: Complete online, print/sign, fax to 1-855-465-3820. - **Paper + Fax**: Download form from site, complete, fax. - Patients can sign a **Patient Authorization Form** online. 4. **Submit required documents**: - **Enrollment Form** (HCP and patient signatures). - **Supplemental Patient Assistance Program Form** (income proof, etc.).[Program details] - Proof of income (e.g., tax returns, pay stubs), residency, and prescription. 5. **IPSEN CARES reviews**: Team contacts you quickly post-enrollment for next steps.[4] ## Timeline and Delivery - **Processing time**: Not specified—expect contact soon after submission; call for status.[4] - **Delivery**: **Shipped directly to patient** via specialty pharmacy. IPSEN CARES coordinates to avoid delays.[1][Program details] - **Refills**: **Reauthorization required** periodically—your HCP resubmits.[Program details] **Pro tip**: Enroll early. Team handles insurance hurdles and provides updates. ## Alternatives if Denied - **Copay program**: For commercial insurance ($0 copay if eligible).[1] - **Bridge program**: Short-term supply (historically up to 60 days) for temporary issues.[6] - **Appeal**: Work with IPSEN CARES on prior auth/appeals.[4] - **Other resources**: Advocacy groups for PFIC/ALGS (info via IPSEN CARES), state programs, or generic alternatives (none currently).[2][4] - **Good faith replacement**: For lost/damaged meds (historically 15 days).[6] If ineligible, ask about financial counseling or lab testing support.[4] ## Disclaimer This guide is for informational purposes based on available program details as of 2026. Eligibility, terms, and benefits can change—**always confirm with IPSEN CARES at (866) 435-5677 or https://www.ipsencares.com**. Not a guarantee of coverage. Consult your HCP for medical advice. Ipsen does not endorse off-label use. Word count: 1028.

Program information last verified: March 25, 2026