Fabrazyme

Indicated For

Fabry disease

About This Medication

# CareConnect Patient Assistance Program Patient Guide: How to Get Fabrazyme (agalsidase beta) at Low or No Cost Fabrazyme (agalsidase beta) is an enzyme replacement therapy used to treat Fabry disease, a rare genetic disorder affecting the lysosomal storage system, and the **CareConnect Patient Assistance Program (PAP)** from Sanofi provides this medication at no cost to eligible uninsured patients or those whose insurance has denied coverage.[1][2][6] This guide explains everything you need to know about qualifying for and applying to the program in simple terms, helping you access treatment without high costs. ## About Fabrazyme and Fabry Disease **Fabry disease** is a rare, inherited condition caused by a deficiency in the enzyme alpha-galactosidase A, leading to buildup of a fatty substance called globotriaosylceramide (Gb3) in blood vessels, kidneys, heart, and nervous system.[1] Symptoms can include pain in hands and feet, fatigue, gastrointestinal issues, kidney problems, heart disease, and stroke risk. **Fabrazyme (agalsidase beta)** is an intravenous infusion therapy that replaces the missing enzyme, reducing Gb3 buildup and slowing disease progression.[1][2] It's FDA-approved for adults and children over 2 years with confirmed Fabry disease. Treatment is lifelong, typically every two weeks at a specialized infusion center, and can be expensive without assistance—often tens of thousands per infusion. The CareConnect PAP steps in as a temporary bridge to provide **Fabrazyme free of charge** until you secure insurance coverage.[2][6][7] ## Who Qualifies for CareConnect PAP? This program targets patients facing financial barriers to Fabrazyme. Key eligibility: - **No insurance** or **insurance denial** specifically for Fabrazyme.[2][3][6] - **Household income** at or below **400% of the Federal Poverty Level (FPL)**.[5] - **U.S. resident** (proof required). - Not enrolled in any state or federally funded programs (e.g., Medicare, Medicaid) that cover prescriptions, even partially—for PAP; copay program has similar restrictions.[2][3] - Valid prescription for Fabrazyme from a U.S. healthcare provider.[1] **Note**: This is a temporary program to help until coverage is obtained. It's free, voluntary, and confidential.[4][6] ## Income Eligibility Breakdown Eligibility hinges on household income relative to the **Federal Poverty Level (FPL)**, updated annually by the U.S. Department of Health & Human Services. For 2026, use the latest guidelines (check www.aspe.hhs.gov for current figures). You qualify if your total household income is **≤400% FPL**.[5] Here's a sample table for the contiguous U.S. (Alaska/Hawaii have higher levels; add ~20-25%): | Household Size | 100% FPL | 200% FPL | 300% FPL | **400% FPL (Eligibility Limit)** | |----------------|----------|----------|----------|---------------------------------| | 1 person | $15,060 | $30,120 | $45,180 | **$60,240** | | 2 people | $20,440 | $40,880 | $61,320 | **$81,760** | | 3 people | $25,820 | $51,640 | $77,460 | **$103,280** | | 4 people | $31,200 | $62,400 | $93,600 | **$124,800** | | +1 person | +$5,380 | +$10,760| +$16,140| **+$21,520** | *Income includes wages, Social Security, pensions, etc. Deductions may apply (e.g., medical expenses). Provide recent tax returns, pay stubs, or W-2s as proof.*[5] ## Insurance Requirements - **Uninsured patients** qualify directly.[2][6] - **Insured patients** must have a **formal denial letter** from their insurer stating Fabrazyme is not covered.[2][3] - **Exclusions**: Cannot participate if receiving any prescription coverage from **Medicare, Medicaid, VA, Tricare, or similar federal/state programs**. Copay assistance also prohibits this.[2][3][6] If Medicaid-eligible, submit denial documentation first.[5] CareConnect offers separate **Copay Assistance** for commercially insured patients with out-of-pocket costs (copays, deductibles, coinsurance up to program max).[2][3] ## Step-by-Step Application Process Applying is straightforward with multiple options. Involves your doctor.[1][3] 1. **Confirm Eligibility**: Review income, insurance status. Call **1-800-745-4447 (option 3)** or visit **www.CareConnectPSS.com** for a case manager.[1][2] 2. **Gather Documents**: - Proof of income (tax return, pay stubs). - Proof of residency (utility bill, lease). - Prescription for Fabrazyme. - Completed enrollment form **signed by your prescribing physician**.[program details] 3. **Submit Application**: - **Online**: www.CareConnectPSS.com (easiest).[1] - **Phone**: Call 1-800-745-4447, option 3; staff guides you.[1][2] - **Paper**: Download from site, mail/fax with doctor.[2] 4. **Physician Involvement**: Doctor verifies diagnosis, completes section.[3] 5. **Follow Up**: Case manager contacts you. Processing: **2-6 weeks**.[program details] Enroll in CareConnect first for full support (education, navigation).[4] ## Timeline and Delivery - **Processing**: 2-6 weeks after complete submission.[program details] - **Approval Notification**: Via phone/email from case manager. - **Delivery**: Fabrazyme shipped free to **physician's office or your home**.[program details] - **Supply Duration**: Typically 1-3 months initially; reauthorization needed.[program details][7] **Reauthorization**: Annual or periodic; resubmit income/insurance proof.[program details] ## Alternatives if Denied or Ineligible - **Appeal**: Contact case manager to fix issues (e.g., missing docs).[1] - **Copay Program**: If commercially insured.[2] - **Sanofi Patient Connection**: Broader assistance ≤400% FPL.[5][8] - **Other Resources**: NeedyMeds.org, Partnership for Prescription Assistance, state programs, or manufacturer appeals. - **Clinical Trials**: Check ClinicalTrials.gov for Fabry studies. - No biosimilars available currently.[program details] ## Important Disclaimer This guide is for informational purposes only and based on publicly available data as of 2026. Program details can change; always verify with CareConnect at 1-800-745-4447 or www.CareConnectPSS.com.[1][2] Not medical advice—consult your doctor. Sanofi/CareConnect not liable for application outcomes. Eligibility not guaranteed.

Program information last verified: March 30, 2026