For HCPs > What to expect

Assisting you along the path.

Your case manager will continue to provide ongoing product support, from the first prescription to your patient's front door and beyond.

Here’s a look at the path to Galafold® (migalastat):

  1. You decide to prescribe Galafold

Once you complete the Patient Referral Form (PRF), send it to Amicus AssistTM.*
Fax number: 1-833-264-2873
Email: assist@amicusrx.com

  1. A case manager reaches out to your patient in 1 business day:

For HCPs: Informs your office if prior authorization (PA) is required and can provide support.
For patients: Tells your patient when to expect a Welcome Kit and answers any questions regarding access to Galafold.

  1. Amicus Assist gets in touch with the specialty pharmacy

Once they confirm the PA (if required), the specialty pharmacy will coordinate the delivery of Galafold and refer your patient to a patient assistance program, if needed.

  1. Galafold is shipped directly to your patient’s door

The case manager will continue to provide ongoing support.

*Patients must be prescribed Galafold for an approved indication to be eligible for support from Amicus Assist.

Financial Support

We are committed to helping your patients get access to Galafold.

Amicus AssistTM is proud to help identify possible sources of financial assistance including:

  • Co-Pay Assistance*: Eligible, commercially insured patients may pay as little as $0 per month for Galafold
  • Patient Assistance Program for eligible, uninsured or underinsured patients
  • Support from independent charitable foundations: Amicus AssistTM can help identify independent charitable foundations who may be able to provide support. These foundations exist independently of Amicus and have their own eligibility criteria and application processes. Availability of support from the foundations is determined solely by the foundations.

* Co-pay assistance is only available for patients with commercial (private) prescription drug insurance. Patients are not eligible for co-pay assistance if they are enrolled in a state or federally-funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, VA, DOD, or a state prescription drug assistance program or where prohibited by law. Offer is subject to program maximum limits. Offer is only available for U.S. residents who have a valid prescription for an Amicus product. Amicus reserves the right to rescind, revoke, or amend this offer without notice.

The Patient Assistance Program provides free product to those who qualify. Contact Amicus Assist for details.

Amicus makes no representation or guarantee concerning reimbursement or coverage for any service or item. Information provided through the Amicus Assist program does not constitute medical advice and is not intended to be a substitute for a consultation with a licensed healthcare provider or applicable third-party payer(s). Amicus reserves the right to modify the program at any time without notice.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE

Galafold® (migalastat) is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.

This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION
Adverse Reactions
The most common adverse drug reactions reported with Galafold (≥10 %) are headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia.

Use in Specific Populations
There is insufficient clinical data on Galafold use in pregnant women to inform a drug associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus.

It is not known if Galafold is present in human milk. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Galafold and any potential adverse effects on the breastfed child from Galafold or from the underlying maternal condition.

Galafold is not recommended for use in patients with severe renal impairment or end-stage renal disease requiring dialysis.

The safety and effectiveness of Galafold have not been established in pediatric patients.

To report Suspected Adverse Reactions, contact Amicus Therapeutics at 1-877-4AMICUS or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here for Full Prescribing Information.

Referral Form