Xenpozyme

Indicated For

acid sphingomyelinase deficiency, ASMD

About This Medication

# Sanofi Patient Connection Patient Guide: How to Get Xenpozyme (olipudase alfa-rpcp) at Low or No Cost Xenpozyme (olipudase alfa-rpcp) is an FDA-approved enzyme replacement therapy for acid sphingomyelinase deficiency (ASMD), a rare genetic disorder, administered intravenously every two weeks after dose escalation.[7] Sanofi Patient Connection, including CareConnect Patient Support Services (PSS), offers this medication **at no cost** to eligible uninsured or underinsured patients through its Patient Assistance Program, with income limits up to **400% of the Federal Poverty Level (FPL)** or higher for certain programs.[1][4][6] ## About Xenpozyme and ASMD **Xenpozyme** is the first and only FDA-approved treatment specifically for ASMD, a rare lysosomal storage disorder caused by enzyme deficiency leading to fat buildup in organs like the liver, spleen, and lungs.[7] It works by replacing the missing enzyme (olipudase alfa-rpcp), infused every two weeks following an initial dose escalation to minimize infusion reactions, then maintenance dosing.[7] Common side effects include infusion-related reactions, fatigue, and headaches—your doctor will monitor these closely. The list price is high at $7,142 per vial, but patient support programs like Sanofi Patient Connection make it accessible at **no out-of-pocket cost** for qualifiers.[7] Sanofi provides comprehensive support via **CareConnect PSS** for ASMD patients, including financial aid, insurance navigation, and infusion coordination. Call 1-800-745-4447 (Option 3 for English) or email info@CareConnectPSS.com to connect with a case manager.[4][7] ## Who Qualifies for the Program? The **Sanofi Patient Connection Patient Assistance Program** targets patients facing high costs. Key qualifiers include: - **Residency**: U.S. resident or U.S. territories, under care of a U.S.-licensed healthcare provider.[1][5][6] - **Insurance Status**: Uninsured, underinsured, or unable to access the drug via insurance. Medicare Part B patients without supplemental coverage may qualify; government-insured (Medicaid, Medicare Part D, VA, etc.) typically do not for copay aid but check for patient assistance.[4][5][6] - **Income**: Household income ≤**400% FPL** (Sanofi Patient Connection) or up to the greater of $100,000 or **500% FPL** (some CareASSIST variants).[1][6] Must provide denial from Medicaid if applicable.[1] - **Other**: Medication cannot be submitted for reimbursement; notify program of insurance changes.[5] **Note**: This is a bridge program until insurance coverage is secured.[4] ## Income Eligibility Breakdown Eligibility hinges on **annual household income** compared to the Federal Poverty Level (FPL), which updates yearly. For 2026, use current HHS guidelines (e.g., ~$15,060 individual base). Here's a sample table for Sanofi Patient Connection at **400% FPL**—verify exact figures via program or HHS.gov: | Household Size | Max Annual Income (400% FPL, approx.) | |----------------|--------------------------------------| | 1 (Individual) | $60,240 | | 2 (Couple) | $81,760 | | 3 | $103,280 | | 4 | $124,800 | | +1 Member | +$21,520 each | *Higher limits (500% FPL or $100k cap) may apply via CareASSIST.*[1][6] Provide proof like tax returns. Program verifies income annually. ## Insurance Requirements - **Uninsured/Underinsured**: Primary candidates—get free medication.[4] - **Commercial Insurance**: Explore **CareConnect Copay Program** first for copays/coinsurance up to program max (not for gov't insurance).[4] - **Medicare/Medicaid**: Patient Assistance may cover Medicare Part B without supplemental; Medicaid requires denial letter. No copay aid for federal programs.[1][4][5][6] - **Prohibited**: Cannot combine with gov't reimbursement or submit free drug claims to payers.[5] Your CareConnect case manager assesses coverage and guides options.[2][4] ## Step-by-Step Application Process 1. **Contact Support**: Call 1-800-745-4447 (Opt. 3) or visit sanofipatientconnection.com to speak with a specialist. For Xenpozyme, use CareConnectPSS.com.[1][4][7] 2. **Download/Request Application**: Get the Sanofi Patient Connection form (PDF) or have it sent.[1][5] 3. **Gather Documents**: Proof of income (tax return, W-2, paystubs), residency, prescription, HCP details, insurance denial (if needed). Full list confirmed by case manager.[1][5] 4. **Complete & Submit**: Patient/HCP signs; mail/fax/upload. Third-party help OK but no fees to Sanofi.[5] 5. **Follow Up**: Case manager tracks status; approval notification via mail/call. Spanish: Press 7 on phone.[4] ## Timeline and Delivery - **Processing**: Typically 2-4 weeks, but varies—expedited for urgent cases.[1] - **Delivery**: Free medication shipped to your home or doctor's office/specialty pharmacy. Infusion coordinated via CareConnect.[2][4] - **Duration**: Temporary until insured; reapply/reauthorize yearly with income/insurance verification.[5] ## Alternatives if Denied or Ineligible - **Copay Programs**: CareConnect Copay for commercial insurance (up to $25k/year in some cases).[4][6] - **Other Assistance**: State programs, ACCC resources, or manufacturer appeals.[6] - **Appeal**: Contact case manager to review denial (e.g., income miscalculation).[1] - **Biosimilars**: None currently for Xenpozyme.[ ] - **General Aid**: NeedyMeds.org, RxAssist.org, or HHS resources. ## Important Disclaimer This guide summarizes publicly available info as of March 2026—**programs change**. Contact Sanofi directly (1-800-745-4447) for personalized advice. Not legal/medical advice; consult your doctor. Eligibility not guaranteed; free drug cannot be resold or reimbursed. Income tables approximate—use official FPL charts. Sanofi disclaims liability for third-party fees.[1][4][5][7] (Word count: 942)

Program information last verified: March 30, 2026