ELEVIDYS

Indicated For

Duchenne muscular dystrophy (DMD)

About This Medication

# 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** | Household Size | FPL % Threshold | Notes | |---------------|-----------------|-------| | Individual | Not specified | Financial aid for out-of-pocket costs; contact Case Manager for personalized review | | Couple | Not specified | Specific thresholds not detailed; eligibility based on insurance and financial need | | Family of 3 | Not specified | Assistance available regardless of exact FPL; focuses on copay/coinsurance relief | | Family of 4+ | Not specified | Program helps eligible families; no strict FPL limit published | *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]

Program information last verified: March 30, 2026