ELEVIDYS

SareptAssist Patient Guide: How to Get ELEVIDYS at Low or No Cost

ELEVIDYS (delandistrogene moxeparvovec-rokl) is a groundbreaking gene therapy for Duchenne muscular dystrophy (DMD), and SareptAssist from Sarepta Therapeutics helps eligible US patients access it with support for insurance navigation, financial aid for copays, coinsurance, and out-of-pocket costs, and treatment coordination.

About ELEVIDYS and Who It's For

ELEVIDYS is an FDA-approved one-time gene therapy designed to address the root cause of DMD, a genetic disorder that leads to progressive muscle weakness. It's indicated for:

• Ambulatory patients 4 years and older with a confirmed DMD gene mutation.
• Non-ambulatory patients 4 years and older with a confirmed DMD gene mutation.

Administered as a single intravenous infusion in a specialized treatment center equipped for potential infusion reactions, ELEVIDYS delivers a functional micro-dystrophin gene to help muscle cells produce a shortened but functional dystrophin protein. Key safety notes include monitoring for liver injury (elevated enzymes possible within 8 weeks post-infusion) and testing for preexisting anti-AAVrh74 antibodies (not recommended if titers ≥1:400). Always discuss risks with your doctor.[1][2][5]

SareptAssist is available exclusively to US patients prescribed ELEVIDYS, providing comprehensive support from enrollment to ongoing care—no reauthorization needed since it's a one-time treatment.[1][5]

Who Qualifies for SareptAssist?

SareptAssist supports patients navigating insurance and costs. It's open to those with commercial insurance, Medicare, Medicaid, or uninsured/underinsured status. Your dedicated Case Manager helps with:

• Benefits investigation: Determines your coverage, prior authorizations (PA), and out-of-pocket expectations.
• Financial assistance: Covers copays, coinsurance, and other costs for eligible families (specific income thresholds not publicly detailed; Case Manager assesses individually).
• Insurance appeals: Assistance if coverage is denied.
• Treatment logistics: Coordinates delivery to infusion centers.[1][3][4][9]

Income Eligibility Breakdown

Sources indicate financial assistance without fixed FPL percentages—eligibility is determined case-by-case. Call (888) 727-3782 for details.[9]

Insurance Requirements

Most insurers require prior authorization (PA), which can be lengthy and may involve appeals. SareptAssist handles:

• Verifying benefits and PA submission.
• Appeals and peer-to-peer reviews with insurers.
• Support for all US insurances, including Medicare (may have limitations for gene therapies).[1][3][9]

A confirmed DMD mutation via CLIA-certified lab genetic test is required. Patients must test negative/low for anti-AAVrh74 antibodies. Uninsured/underinsured patients may qualify for free drug via patient assistance.[2][4][9]

Step-by-Step Application Process

1. Get Prescribed: Confirm eligibility with your doctor (age ≥4, confirmed DMD mutation, ambulatory or non-ambulatory).[2]

2. Download and Complete Enrollment: Your doctor fills out the Sarepta Gene Therapy Enrollment Form (pages 1-2), including patient details, prescriber info, insurance, and infusion site. Sign the Patient Authorization (page 3).[4][7]

3. Gather Required Documents:

   • Genetic test report (CLIA-certified).
   • Both sides of insurance cards.
   • AAVrh74 Antibody Test order if needed (Sarepta-endorsed).[1][4]

4. Submit: Fax to 1-800-621-5203 or email SareptAssist@Sarepta.com. Patient carries a physical copy.[4]

5. Case Manager Contact: They'll call (primary/secondary phone provided) to welcome you, explain benefits, financial options, and next steps. Available Mon-Fri 8:30am-6:30pm ET; Spanish speakers available.[1][7]

6. Benefits Investigation & PA: Case Manager coordinates with your insurer.[1]

7. Financial Assessment: Discuss copay assistance or free drug if eligible.[9]

8. Schedule Infusion: Drug ships to your treatment center.[1]

Multiple application methods: Fax, email, or phone (888) 727-3782.[1][4]

Timeline and Delivery

Processing time varies due to PA (can take weeks/months with appeals). Case Manager provides updates. Once approved, ELEVIDYS is delivered directly to authorized treatment centers equipped for gene therapy. No home delivery; infusion requires medical monitoring. Ongoing support continues post-infusion (liver monitoring first 3 months).[1][2]

Alternatives if Denied

• Appeal: Use denial letter details; doctor submits Letter of Medical Necessity and requests peer-to-peer review. Case Manager guides you.[3]
• Other Assistance: Parent Project Muscular Dystrophy (PPMD) resources; Assistance Fund for DMD.[3][9]
• No Biosimilars: ELEVIDYS is unique; no alternatives listed.[program details]

Disclaimer

This guide is for informational purposes only and not a substitute for medical or financial advice. Eligibility, coverage, and assistance vary; contact SareptAssist at (888) 727-3782 for personalized help. See full Prescribing Information for ELEVIDYS risks. Program details current as of available sources; confirm with Sarepta.[1][2]