Myozyme

Indicated For

Pompe disease, infantile-onset

About This Medication

# Sanofi Patient Assistance Program Patient Guide: How to Get Myozyme (alglucosidase alfa) at Low or No Cost Myozyme (alglucosidase alfa) is an enzyme replacement therapy used to treat Pompe disease, a rare genetic disorder that causes muscle weakness and breathing problems due to a deficiency in the enzyme acid alpha-glucosidase. The **Sanofi Patient Assistance Program** (also known as Sanofi Patient Connection) provides this medication **at no cost** to eligible patients who are uninsured or underinsured and meet income guidelines, helping ensure access to life-saving treatment without financial burden. ## Who Qualifies for the Program? This program is designed for **U.S. residents** (including territories like Puerto Rico) facing financial hardship. Key eligibility criteria include: - Being under the care of a licensed U.S. healthcare provider (HCP) authorized to prescribe Sanofi medications. - **Household income at or below 400% of the Federal Poverty Level (FPL)**. Exact income limits are based on current FPL guidelines, which adjust annually—check the program's application for the latest figures. - **No or limited insurance coverage** for Myozyme: uninsured, underinsured with commercial insurance/Medicaid but no access to the drug, or Medicare Part B patients without supplemental coverage. **Medicare Part D patients are generally not eligible** but may qualify under specific conditions through the calendar year. - Proof of **FDA-approved diagnosis** of Pompe disease, along with a doctor's confirmation of medical necessity. If you're potentially eligible for Medicaid, you'll need to provide a denial letter first. ## About Myozyme (alglucosidase alfa) **Myozyme** is a biologic drug infused intravenously every two weeks to replace the missing enzyme in Pompe disease (glycogen storage disease type II). It helps break down glycogen buildup in muscles, improving strength, mobility, and respiratory function. Approved by the FDA in 2006, it's indicated for both infantile and late-onset forms. Common side effects include infusion reactions (fever, rash), but benefits often outweigh risks for diagnosed patients. Always discuss with your doctor; this guide is not medical advice. ## Income Eligibility Breakdown Eligibility hinges on **annual household income ≤400% FPL**. Here's a table with approximate 2026 FPL examples (verify current levels via program or ASPE.gov, as they update yearly): | Household Size | 100% FPL | 400% FPL Threshold | |---------------|----------|---------------------| | 1 | $15,060 | $60,240 | | 2 | $20,440 | $81,760 | | 3 | $25,820 | $103,280 | | 4 | $31,200 | $124,800 | | +1 person | +$5,380 | +$21,520 | **Notes**: Income includes all household sources (wages, benefits). Assets may factor in. Program reviews case-by-case; limits not always publicly detailed beyond FPL. ## Insurance Requirements - **Uninsured**: Fully eligible if other criteria met. - **Underinsured**: Commercial insurance or Medicaid, but no coverage/access to Myozyme. - **Medicare Part B**: Eligible if no supplemental coverage. - **Medicare Part D**: Typically ineligible; approved patients transition back at year-start. - Provide proof of denial or coverage gaps. Program notifies your insurer if enrolled. ## Step-by-Step Application Process 1. **Contact the Program**: Call **(888) 847-4877** (toll-free) or **(800) 745-4447** to request an application, or download from sanofipatientconnection.com. 2. **Gather Documents**: - Proof of income (tax returns, pay stubs, etc.). - Doctor's letter confirming intent to treat, medical necessity, and FDA-approved Pompe diagnosis. - HIPAA consent and income verification signatures. 3. **Complete the Form**: Fill patient section (page 2), have your HCP complete/sign page 3. No medical records needed. 4. **Submit**: HCP faxes to **1-888-847-1797** or mails to **Sanofi Patient Connection, PO Box 222138, Charlotte, NC 28222-2138**. Online provider portal available. 5. **Avoid Delays**: Ensure completeness; missing info triggers follow-up. **Third-party help**: Allowed, but fees aren't program-required. ## Timeline and Delivery - **Processing**: 5-7 business days for complete apps; longer if incomplete (monthly reviews noted in some details). - **Approval Notification**: Letters to you, HCP, and insurer (if applicable). - **Enrollment Duration**: Up to **12 months**; Medicare Part D through calendar year-end. - **Delivery**: Medication shipped free to your **HCP's office** or home in ~5-7 business days post-approval. HCP dispenses. - **Reauthorization**: Required annually; reapply before expiration. ## Alternatives if Denied - **Appeal**: Review denial letter; resubmit with more docs. - **Resource Connection**: Program may refer to other nonprofits if Patient Assistance doesn't fit. - **Other Options**: State programs, NeedyMeds, PAN Foundation, or manufacturer co-pay cards (if insured). Medicaid reapplication. No biosimilars for Myozyme listed. - **Reapply**: Anytime with updated info. ## Disclaimer This guide summarizes publicly available info as of 2026; eligibility/rules change. **Not official advice**—contact Sanofi at (888) 847-4877 for personalized guidance. Consult your doctor for treatment decisions. Program offers no-cost meds where eligible but isn't guaranteed. Income/FPL subject to verification; fraud voids enrollment.

Program information last verified: March 30, 2026