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Case Managers are available Monday – Friday 8:30am – 6:30pm ET.
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PERSONALIZED SUPPORT FOR YOUR PATIENTS.
SareptAssist is a patient support program designed to help your patients navigate the process of starting and staying on EXONDYS 51. Upon enrolling in SareptAssist, patients are assigned dedicated Case Managers, who can provide information on:
- Insurance benefits
- Treatment logistics
- Options for weekly infusions
- Financial assistance options
- Ongoing education and support
A TEAM TO HELP THROUGHOUT THE JOURNEY.
When your office contacts SareptAssist to enroll a patient, a Case Manager will be assigned to provide one-on-one, personalized support as they navigate the steps to starting therapy. SareptAssist Case Managers have experience in rare diseases (including knowledge of insurance plans and healthcare networks) and are available for your patients Monday – Friday 8:30am – 6:30pm ET.
SUPPORT FOR THE PRESCRIPTION FULFILLMENT PROCESS.
BENEFITS INVESTIGATION.
- The Case Manager contacts the insurance company to determine your patient’s coverage and can provide information on any specific authorization requirements and/or financial assistance options.
- You may be required to write a letter of medical necessity and/or a personal appeal letter on behalf of your patient.
FULFILLING THE PRESCRIPTION.
- Once insurance benefits have been confirmed, the Case Manager identifies and contacts specialty or hospital pharmacies to facilitate access to therapy.
- The Case Manager contacts your patient and coordinates drug delivery to the appropriate site of care (e.g., hospital, infusion center, or patient’s home).
COORDINATING THE FIRST INFUSION.
- The Case Manager contacts your patient to arrange for the first shipment of EXONDYS 51 from the specialty pharmacy.
- The Case Manager coordinates details with your office, infusion center, or home nurse for your patient’s first infusion.
FINANCIAL ASSISTANCE PROGRAMS.
Your patient’s SareptAssist Case Manager can provide information about programs (Sarepta-managed and independent third-party programs) that may offer financial assistance options to eligible insured and uninsured patients.
SAREPTA PATIENT CO-PAY ASSISTANCE PROGRAM.
The Co-Pay Assistance Program was created for eligible individuals with commercial health insurance in the United States who are prescribed EXONDYS 51 therapy. This program may help with some out-of-pocket costs related to receiving therapy, such as co-pays, co-insurance, and deductibles.
If your patient is eligible, their Case Manager will guide them through the consent and enrollment process for the Co-Pay Assistance Program.
SAREPTA PATIENT ASSISTANCE PROGRAM (PAP).
The Patient Assistance Program can help patients, who are uninsured or rendered uninsured and meet certain eligibility requirements, obtain access to the drug. They may be responsible for additional costs associated with administration of the drug. A SareptAssist Case Manager can provide information on eligibility as well as help facilitate program enrollment.
PATIENT ASSISTANCE FOUNDATION.
This foundation connects patients with independent charitable organizations that may offer financial assistance.
SAREPTASSIST BROCHURES.
An overview of SareptAssist, our patient support program, covering topics such as insurance benefits, treatment logistics, and infusion options.
This brochure will help English-speaking patients and families learn about the personalized support provided by SareptAssist dedicated Case Managers.
This brochure will help Spanish-speaking patients and families learn about the personalized support provided by SareptAssist dedicated Case Managers.
SareptAssist Case Managers are available Monday through Friday, 8:30am – 6:30pm ET.
Spanish-speaking Case Managers and interpreters for other languages are available.
SareptAssist is a resource available only to those who have been prescribed EXONDYS 51 (eteplirsen). SareptAssist is available only in the U.S.
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INDICATION
EXONDYS 51 (eteplirsen) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. This indication is approved under accelerated approval based on an increase in dystrophin in skeletal muscle observed in some patients treated with EXONDYS 51. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
Hypersensitivity reactions, including bronchospasm, chest pain, cough, tachycardia and urticaria, have occurred in patients who were treated with EXONDYS 51. If a hypersensitivity reaction occurs, institute appropriate medical treatment and consider slowing the infusion or interrupting the EXONDYS 51 therapy.
Adverse reactions in DMD patients (N=8) treated with EXONDYS 51 30 or 50 mg/kg/week by intravenous (IV) infusion with an incidence of at least 25% more than placebo (N=4) (Study 1, 24 weeks) were (EXONDYS 51, placebo): balance disorder (38%, 0%), vomiting (38%, 0%) and contact dermatitis (25%, 0%). The most common adverse reactions were balance disorder and vomiting. Because of the small numbers of patients, these represent crude frequencies that may not reflect the frequencies observed in practice. The 50 mg/kg once weekly dosing regimen of EXONDYS 51 is not recommended.
The most common adverse reactions from observational clinical studies (N=163) seen in greater than 10% of patients were headache, cough, rash, and vomiting.
Please see the full Prescribing Information for EXONDYS 51 (eteplirsen).