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Galafold

Generic: migalastat

Manufacturer: Amicus Therapeutics  ·  Program: Amicus Patient Assistance Program

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Eligibility Criteria

Insurance Requirement

Uninsured or underinsured

Residency

US resident or US territories

Eligible for uninsured or underinsured patients; specific income thresholds not detailed in sources

Program Information

Processing Time

2-4 weeks

Delivery Method

shipped to patient

Application Method

Multiple

Reauthorization

Required — annual

Typically Required Documents

ProvisionRX prepares and organizes all required documentation as part of your enrollment management. This list is provided for informational purposes.

  • Prescription
  • Proof of residency
  • Proof of income
  • Insurance information

Indicated For

Fabry disease

About This Medication

# Amicus Patient Assistance Program Patient Guide: How to Get Galafold at Low or No Cost ## About Galafold Galafold (migalastat) is a medication used to treat Fabry disease and late-onset Pompe disease (LOPD). It works by helping your body process certain proteins more effectively. Your healthcare provider has determined that Galafold is an appropriate treatment for your condition. ## Who Qualifies for the Amicus Patient Assistance Program The Amicus Patient Assistance Program is designed to help patients access Galafold when cost is a barrier to treatment. You may be eligible if you meet the following criteria: - You have a valid prescription for Galafold from your healthcare provider - You are uninsured or underinsured (meaning your current insurance does not adequately cover the cost of Galafold) - You are a U.S. resident or resident of U.S. territories (including Puerto Rico) - You are 18 years of age or older (or have a legal representative who can provide consent) The program is specifically designed for patients who lack adequate insurance coverage. This includes those with no insurance at all, as well as those whose existing insurance plans do not provide sufficient coverage for Galafold. ## Income Eligibility The Amicus Patient Assistance Program uses a needs-based approach to determine eligibility rather than strict income cutoffs. This means the program evaluates your individual financial situation to determine if you qualify for assistance. While specific income thresholds are not publicly detailed, the program considers factors such as your ability to afford the medication and your overall financial circumstances. If you are unsure whether your income level qualifies, the AMICUS ASSIST team can review your situation during the application process. There is no harm in applying—the team will work with you to determine your eligibility. ## Insurance Requirements and Restrictions The Amicus Patient Assistance Program has specific rules about which types of insurance coverage make you eligible: **You ARE eligible if you have:** - No insurance (uninsured) - Private/commercial insurance that does not adequately cover Galafold (underinsured) **You are NOT eligible if you have:** - Medicare - Medicaid - TRICARE - Veterans Affairs (VA) coverage - Department of Defense (DOD) coverage - State prescription drug assistance programs - Any state or federally funded insurance program If you are enrolled in any of these programs, you may still be able to access Galafold through other resources. Contact your healthcare provider or the AMICUS ASSIST team to explore alternative options. ## Co-Pay Assistance If you have commercial (private) prescription drug insurance, you may be eligible for co-pay assistance to help reduce your out-of-pocket costs. This assistance is only available to patients with private insurance and is subject to program maximum limits. Co-pay assistance is not available to patients with state or federally funded insurance programs. ## Step-by-Step Application Process ### Step 1: Get a Prescription Your healthcare provider must prescribe Galafold for your condition. The prescription will be included on the Patient Referral Form. ### Step 2: Complete the Patient Referral Form You and your healthcare provider will complete the Amicus Patient Referral Form together. This form serves two purposes: it registers you for AMICUS ASSIST and acts as your prescription for Galafold. The form requires: - Your complete personal information (name, date of birth, address, contact information) - Your healthcare provider's information and signature - Your insurance information (if applicable) - Copies of all insurance cards - Your written consent to enroll in the program ### Step 3: Submit the Form Your healthcare provider will submit the completed Patient Referral Form to AMICUS ASSIST using one of these methods: - **Fax:** 1-833-264-2873 - **Email:** assist@amicusrx.com - **Phone:** 1-833-AMICUS-A (1-833-264-2872), Monday–Friday, 8 AM–8 PM ET ### Step 4: Provide Documentation During the application process, you may be asked to provide: - Proof of residency (utility bill, lease agreement, or similar document) - Proof of income (recent pay stubs, tax returns, or benefit statements) - Insurance information and cards - Any other documentation needed to verify your eligibility ### Step 5: Enrollment Confirmation Once your application is approved, you will be enrolled in AMICUS ASSIST. You will be assigned a dedicated support team consisting of: - **Patient Education Liaison (PEL):** Provides education about Fabry disease, helps you establish a treatment routine, and assists with conversations with your care team - **Case Manager:** Helps navigate insurance coverage, coordinates prescription delivery, and identifies financial assistance options Your doctor only needs to submit the referral form once—no re-enrollment is necessary as long as you continue treatment with Galafold. ## Timeline and Delivery **Processing Time:** Your application typically takes 2–4 weeks to process after submission. **Delivery:** Once approved, Galafold will be shipped directly to you or your designated pharmacy. Your Case Manager will coordinate the delivery details with you. **Ongoing Support:** Your AMICUS ASSIST team remains available to support you throughout your treatment. You can contact them Monday–Friday, 8 AM–8 PM ET at 1-833-AMICUS-A (1-833-264-2872). ## What Happens If Your Application Is Denied If your application for the Amicus Patient Assistance Program is denied, you have several options: 1. **Appeal the Decision:** Contact your Case Manager to understand the reason for denial and explore whether additional information or documentation could support reconsideration. 2. **Explore Alternative Resources:** Your Case Manager can help identify other sources of financial assistance, including state pharmaceutical assistance programs, disease-specific foundations, or other patient support organizations. 3. **Discuss with Your Healthcare Provider:** Your doctor may have information about other resources or alternative treatment approaches. 4. **Contact Patient Advocacy Organizations:** Organizations focused on Fabry disease or LOPD may have additional resources or guidance. ## Reauthorization and Refills Reauthorization is required to continue receiving assistance through the program. Your AMICUS ASSIST team will contact you when reauthorization is needed and will guide you through the process. Your Case Manager will help coordinate prescription refills and ensure continuity of your treatment. ## Important Disclaimers - This program is only available to U.S. residents and residents of U.S. territories. - Amicus Therapeutics reserves the right to rescind, revoke, or amend this program without notice. - The program is subject to applicable laws and regulations. - Your Patient Education Liaison does not provide medical advice. Always consult your healthcare provider for medical questions or concerns. - This guide provides general information about the program. For specific details about your eligibility or application status, contact AMICUS ASSIST directly. ## Contact Information **AMICUS ASSIST Support Team** - **Phone:** 1-833-AMICUS-A (1-833-264-2872) - **Hours:** Monday–Friday, 8 AM–8 PM ET - **Fax:** 1-833-264-2873 - **Email:** assist@amicusrx.com - **Website:** www.AMICUSASSIST.com

Program information last verified: March 30, 2026

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