ELEVIDYS

Indicated For

Duchenne muscular dystrophy

About This Medication

# SareptAssist Patient Guide: How to Get ELEVIDYS (delandistrogene moxeparvovec-rokl) at Low or No Cost ELEVIDYS (delandistrogene moxeparvovec-rokl) is a gene therapy treatment for Duchenne muscular dystrophy (DMD) in eligible patients, and the **SareptAssist** program from Sarepta Therapeutics helps uninsured or underinsured U.S. residents access it at low or no cost.[1][2] This guide explains eligibility, the application process, and support options in simple terms to help you get started. ## About ELEVIDYS and Why It Matters **ELEVIDYS** is an FDA-approved gene therapy designed to address the underlying cause of DMD, a rare genetic disorder that leads to progressive muscle weakness, typically affecting boys.[1] Unlike traditional treatments, ELEVIDYS delivers a functional version of the dystrophin gene via a one-time intravenous infusion, aiming to slow disease progression.[2] It's indicated for ambulatory and non-ambulatory patients aged 4 and older with a confirmed DMD gene mutation amenable to the therapy.[2] DMD has no cure, and ELEVIDYS represents a breakthrough for families facing high treatment costs, which can exceed millions without assistance. SareptAssist bridges this gap by offering free medication to qualifying patients and coordinating logistics.[1][3] ## Who Qualifies for SareptAssist? The program targets **uninsured or underinsured patients** residing in the U.S. or Puerto Rico, under the care of a U.S. physician, with an FDA-approved diagnosis for ELEVIDYS.[1][4] Key requirements include: - Confirmed genetic mutation via a CLIA-certified lab test.[2] - No insurance coverage required, but underinsured patients (high copays/deductibles) may qualify for co-pay help or free drug.[1][7] - Needs-based evaluation; specific income thresholds aren't publicly detailed but focus on financial need.[1] **Medicare and government insurance**: Patients must generally be uninsured or 'rendered uninsured' (insurance denies coverage). Medicare patients may not qualify for free drug but could access other support—confirm via phone.[4][6] ## Income Eligibility Breakdown SareptAssist is **needs-based** without fixed income thresholds listed publicly, prioritizing uninsured/underinsured status over strict FPL (Federal Poverty Level) cutoffs.[1] Eligibility hinges on a case-by-case review after benefits investigation. Here's a general overview based on similar programs: | Category | Description | Likely Eligible? | |----------|-------------|------------------| | **Uninsured** | No health insurance at all | Yes[1][4] | | **Underinsured** | Commercial insurance with high out-of-pocket costs | Yes, via co-pay or free drug[1][7] | | **Medicare/Medicaid** | Government insurance | Limited; may be 'rendered uninsured' if denied[4] | | **Income <400% FPL** | Household income below ~$60,000 (single)/$124,000 (family of 4, 2026 est.) | High likelihood if uninsured[1] | | **Income >400% FPL** | Higher earners | Possible if functionally uninsured[7] | Contact SareptAssist for personalized assessment—no upfront income proof specified beyond insurance details.[1][2] ## Insurance Requirements **No insurance required**—that's the program's strength for uninsured patients.[1] For insured: - Submit insurance cards (both sides).[2] - Case Manager performs **benefits investigation** to check coverage, denials, or appeals.[3][5] - Commercial insurance patients may get **co-pay assistance** to cap costs at $0–$5/month (separate program).[6][7] - If insurance denies, patients can be 'rendered uninsured' for free ELEVIDYS.[4] Patients cover infusion/administration costs separately.[1] ## Step-by-Step Application Process Enrollment is straightforward and doctor-led. Follow these **3 simple steps**:[3] 1. **Discuss with your doctor**: Confirm ELEVIDYS prescription and DMD eligibility (genetic test).[2] 2. **Complete the Sarepta Gene Therapy Enrollment Form**: Doctor fills pages 1–2 (patient info, insurance, treatment site, physician declaration). Patient/caregiver signs page 3 (authorization).[2] Download from Sarepta site.[3] 3. **Gather and submit documents**: - Genetic Test Report (CLIA-certified).[2] - Insurance cards (both sides).[2] - Fax to **1-800-621-5203** or email **SareptAssist@Sarepta.com**.[2][3] 4. **Phone enrollment option**: Call **(888) 727-3782** (Mon–Fri, 8:30am–6:30pm ET) for guidance or START Form.[1][6] A dedicated **Case Manager** calls within days to review eligibility, explain benefits, and coordinate.[1][5] ## Timeline and Delivery - **Submission to contact**: 1–3 business days for Case Manager call.[1][3] - **Approval**: Varies (1–4 weeks typical for gene therapies); depends on documents/insurance verification.[5] - **Delivery**: Once approved, therapy ships to infusion center. Case Manager handles logistics, education, and follow-up.[3][7] Track progress via your Case Manager—no fixed processing time published.[1] ## Alternatives if Denied or Ineligible - **Appeal insurance denial**: Case Manager assists.[5] - **Co-pay program** for commercial insurance: Call (888) 727-3782.[6] - **Independent foundations**: Case Manager refers to charities for grants.[7] - **Other Sarepta therapies** (e.g., Exondys 51) if applicable.[1] - **State programs** or clinical trials via Parent Project Muscular Dystrophy.[10] Reapply if circumstances change (e.g., lose insurance).[4] ## Important Disclaimer This guide is for informational purposes based on available program details as of 2026 and is not medical/financial advice. Eligibility, benefits, and terms can change—**always verify with SareptAssist at (888) 727-3782**.[1] Patients may owe infusion costs. Consult your doctor for treatment suitability. Sarepta disclaims liability for third-party info.[2]

Program information last verified: March 25, 2026