Defitelio

Indicated For

Hepatic veno-occlusive disease (VOD), sinusoidal obstruction syndrome (SOS) with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT)

About This Medication

# JazzCares Patient Guide: How to Get Defitelio (defibrotide sodium) at Low or No Cost Defitelio (defibrotide sodium) is a vital treatment for patients facing hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), following hematopoietic stem-cell transplantation (HSCT). The **JazzCares** program from **Jazz Pharmaceuticals** helps **uninsured or underinsured patients** access this medication at low or no cost if they meet financial criteria. ## About Defitelio Defitelio is an intravenous medication approved for treating severe VOD/SOS in adult and pediatric patients after HSCT, especially when accompanied by renal or pulmonary issues. VOD/SOS is a serious condition where damage to the liver's sinusoidal endothelial cells leads to blockages, coagulation issues, and organ dysfunction. **Defitelio works by protecting these endothelial cells, restoring normal blood flow, and reducing clot formation.**[1][2] The standard dose is **6.25 mg/kg every 6 hours**, given as a 2-hour IV infusion, for at least 21 days or until symptoms resolve. It's administered in a hospital setting due to the need for careful monitoring, as it carries risks like bleeding (do not start if active bleeding is present) and common side effects including hypotension, diarrhea, vomiting, nausea, and nosebleeds.[1][3] **Important warnings:** Defitelio is contraindicated with systemic anticoagulants or fibrinolytic therapy, or if you're hypersensitive to it. Your doctor will monitor you closely.[1] ## Who Qualifies for JazzCares? JazzCares targets patients who cannot afford Defitelio due to lack of insurance coverage or high out-of-pocket costs. Primarily, this program serves **uninsured or underinsured individuals** who demonstrate **financial need** based on household income and expenses. Eligibility focuses on those with VOD/SOS post-HSCT who meet medical criteria (as prescribed by a doctor) and financial hardship. Patients with government insurance like Medicare may have limited options, but underinsured commercial insurance holders often qualify if copays are unaffordable. ## Income Eligibility Breakdown Specific income thresholds are not publicly detailed and are assessed case-by-case, considering household size, income, assets, and medical expenses. JazzCares typically follows federal poverty guidelines (FPG), often up to 400-500% FPG for free medication, with copay assistance up to 800% FPG. Here's a general **estimated income eligibility table** based on common PAP standards (confirm with JazzCares for 2026 guidelines): | Household Size | Up to 400% FPG (Free Drug) | 401-500% FPG (Low Copay) | Above 500% FPG (Possible Assistance) | |---------------|----------------------------|---------------------------|-------------------------------------| | 1 | $60,240 | $75,300 | Case-by-case | | 2 | $81,760 | $102,200 | Case-by-case | | 3 | $103,280 | $129,100 | Case-by-case | | 4 | $124,800 | $156,000 | Case-by-case | | +1 person | +$21,520 | +$26,900 | Case-by-case | *Notes: Figures based on 2026 projected FPG; actual eligibility requires full financial disclosure. Expenses like rent, debts, and medical bills can qualify higher incomes.* ## Insurance Requirements - **Uninsured patients:** Fully eligible if income criteria met. - **Underinsured (commercial insurance):** Eligible if copays/deductibles exceed affordability. - **Medicare/Medicaid:** Generally ineligible for free drug (bridge programs may exist); explore Medicare Part D Extra Help. - **No active coverage required,** but proof of denial or high costs strengthens applications. ## Step-by-Step Application Process JazzCares offers **multiple application methods** for convenience: 1. **Call the hotline:** Dial **(833) 533-5299** (Mon-Fri, 8 AM-8 PM ET) for personalized help. A coordinator guides you. 2. **Online:** Visit **jazzcares.com**, download forms, or start digitally. 3. **Fax/Mail:** Physician completes prescription; patient submits financial info. **Required steps:** - Doctor submits prescription and medical records confirming VOD/SOS diagnosis post-HSCT. - Patient provides proof of income (tax returns, pay stubs), insurance status, and household details. - Sign authorization for JazzCares to verify finances/insurance. Applications are free; approval hinges on medical necessity and finances. ## Timeline and Delivery Processing time varies (typically 1-3 business days for urgent cases, up to 2 weeks standard). Once approved, **Defitelio is shipped directly to the patient** or authorized facility (often hospital for IV use). Expect temperature-controlled shipping. Refills require doctor reauthorization; track via patient portal on jazzcares.com. ## Alternatives if Denied - **Appeal:** Submit additional financial docs or doctor letter. - **Other PAPs:** Check Partnership for Prescription Assistance (pparx.org) or NeedyMeds.org. - **Manufacturer copay cards:** JazzCares may offer for commercially insured. - **State programs:** Varies by location. - **Clinical trials:** Search clinicaltrials.gov for Defitelio studies. - **Financial aid:** Hospitals/social workers can help with grants (e.g., Patient Access Network). **No biosimilars exist for Defitelio.** ## 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 directly with JazzCares at (833) 533-5299 or jazzcares.com.** Consult your healthcare provider before starting treatment. Jazz Pharmaceuticals does not endorse this guide. Not legal/financial advice. *Word count: 950*

Program information last verified: March 30, 2026