XENPOZYME

Sanofi Patient Assistance Program Patient Guide: How to Get XENPOZYME (olipudase alfa-rpcp) at Low or No Cost

XENPOZYME (olipudase alfa-rpcp) is an enzyme replacement therapy approved for treating non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD), a rare genetic disorder also known as Niemann-Pick disease type B. The Sanofi Patient Assistance Program (also called Sanofi Patient Connection®) provides this medication at no cost to eligible patients who meet specific residency, insurance, and income criteria.[1][2][3][4]

About XENPOZYME and Who It Helps

XENPOZYME is administered intravenously and helps break down sphingomyelin buildup in cells, addressing symptoms like enlarged spleen and liver, lung issues, and low blood cell counts in ASMD patients. It's particularly vital for those with limited access to treatment due to high costs or insurance gaps. This program ensures uninsured, underinsured, or low-income patients in the US can receive it free through their healthcare provider (HCP).[1][3][7]

Who Qualifies for the Program?

To qualify, you must:

• Be a resident of the US or US territories (including Puerto Rico).
• Be under the care of a licensed HCP authorized to prescribe, dispense, and administer the medication.
• Have no insurance, commercial insurance or Medicaid without coverage/access to XENPOZYME, Medicare Part B with no supplemental coverage (and meet other criteria), or be underinsured.
• Have an annual household income at or below 400% of the Federal Poverty Level (FPL).

If potentially eligible for Medicaid, you must provide proof of denial before program assessment.[1][2][4][6][7]

Income Eligibility Breakdown

The program uses 400% FPL as the threshold. Exact dollar amounts adjust yearly based on HHS guidelines. Here's a table for 2026 estimates (check www.aspe.hhs.gov for current FPL):

Add ~$5,380 per additional person for 100% FPL, scaling to 400%. Income verification (e.g., W-2, 1040, paystubs) is required. Specific thresholds beyond FPL% not detailed; contact program for exacts.[4][10]

Insurance Requirements

The program supports:

• Uninsured patients.
• Commercially insured or Medicaid patients without coverage/access to XENPOZYME.
• Medicare Part B patients with no supplemental coverage who meet other criteria.
• Medicare Part D patients (enrollment through calendar year end; transitioned back annually).

Medicaid applicants need denial proof. No coverage required overall, but specific gaps must exist.[1][2][6][7]

Step-by-Step Application Process

1. Download or Request Form: Get the application from sanofipatientconnection.com or call 1-888-847-4877.[5]
2. Complete Patient Section: Fill page 2 with personal info, sign HIPAA consent and income verification authorizations.[1][2]
3. HCP Completes Their Section: Doctor fills page 3, signs/dates.[1][2]
4. Gather Docs: Income proof (W-2, tax return, paystub); Medicaid denial if applicable. No medical records needed.[1][10]
5. Submit via HCP: Fax to 1-888-847-1797 or mail to Sanofi Patient Connection, PO Box 222138, Charlotte, NC 28222-2138. HCP can use Provider Portal.[1][2][5][6]

Third-party fees not required by Sanofi.[1]

Timeline and Delivery

• Processing: 5-7 business days if complete; longer if missing info.[2][5][6]
• Approval Notification: Letter to you, HCP, and Medicare Part D plan (if applicable).[1][2]
• Enrollment: Up to 12 months; Medicare Part D through calendar year end.[1][2][5]
• Delivery: Medication shipped to HCP's office in ~5-7 business days post-approval.[2][6]

Alternatives if Denied

• Receive denial letter with reason; reapply if circumstances change.[1]
• Check Resource Connection (opt-in on form) for other organizations.[8]
• Explore state programs, generic/biosimilar options (none listed for XENPOZYME), or manufacturer copay cards.[6]
• Call 888-847-4877 for guidance.[5][9]

Reauthorization

Reapply yearly for continued assistance. Medicare patients reapply annually.[1][5]

Important Disclaimer

This guide is for informational purposes based on available program details as of 2026. Eligibility, terms, and FPL change; always verify with Sanofi Patient Connection at 1-888-847-4877 or sanofipatientconnection.com. Not legal/medical advice. Consult your HCP. Sanofi may update criteria without notice.[1][2][4][5]