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 gene therapy for ambulatory patients 4 years and older with Duchenne muscular dystrophy (DMD) who have a confirmed *DMD* gene mutation. **SareptAssist**, from Sarepta Therapeutics, helps US patients access this treatment by navigating insurance, prior authorizations, appeals, and financial aid for out-of-pocket costs, copays, and coinsurance—especially for uninsured or underinsured families.[1][2][4] ## About ELEVIDYS ELEVIDYS is an FDA-approved **one-time gene therapy infusion** for eligible DMD patients. It delivers a functional version of the dystrophin gene to muscle cells via an AAV vector, aiming to slow disease progression. Administered at a specialized treatment center, it requires **pre- and post-infusion systemic corticosteroids** to manage risks like acute liver injury (boxed warning).[2] **Key facts**: - Indication: Ambulatory DMD patients ≥4 years with confirmed *DMD* mutation. - Not recommended for those with certain conditions (e.g., severe liver issues). - Post-infusion: Monitor liver function weekly for 3 months; stay near healthcare facilities for 2 months.[2] Discuss with your doctor if ELEVIDYS fits your child's needs. SareptAssist coordinates logistics once prescribed.[1][3] ## Who Qualifies for SareptAssist? Available to **US residents (including Puerto Rico)** prescribed ELEVIDYS. No enrollment fee; a dedicated Case Manager provides personalized support.[1][4] - **Insured patients**: Help with benefits investigation, prior authorizations (PAs), appeals, copay assistance.[1][3] - **Uninsured/underinsured**: Free drug options via Patient Assistance Program (PAP), info on independent charities like Assistance Fund or Duchenne Family Assistance Program.[3][4][8] - Needs-based for financial aid; eligibility assessed case-by-case.[4] **Income Eligibility Breakdown** Specific FPL thresholds aren't publicly detailed—eligibility is individualized based on insurance, household income, and circumstances. Contact SareptAssist for assessment.[1][4] | Household Size | Threshold Example (if 400% FPL, illustrative)* | Notes | |---------------|---------------------------------------------|-------| | Individual | ~$60,000 | Assessed individually; copay aid for commercial insurance. | | Couple | ~$81,000 | Uninsured may qualify for free drug. | | Family of 3 | ~$102,000 | Third-party funds for premiums/travel. | | Family of 4 | ~$123,000 | *Illustrative; call for exact eligibility.[1][3][8] | *Note: These are estimates; SareptAssist confirms via application. Programs like copay assistance often cap aid at certain incomes but vary.[5][8] ## Insurance Requirements **Commercial insurance**: Case Manager verifies benefits, handles PAs/appeals, offers copay program (if eligible).[1][3] **Medicare/Medicaid**: Limited details; may direct to third-party aid. Not all federal programs covered—check with Case Manager.[4][8] **Uninsured**: PAP provides free ELEVIDYS if criteria met (FDA-approved diagnosis, US resident).[4] SareptAssist shares insurer communications and follows up.[3] ## Step-by-Step Application Process 1. **Get Prescribed**: Doctor confirms eligibility and completes **Sarepta Gene Therapy Enrollment Form**.[3][6] 2. **Submit Form**: Fax to 1-800-621-5203 or email SareptAssist@Sarepta.com.[4][6] 3. **Case Manager Contact**: They'll call (1-888-727-3782, Mon-Fri 8:30am-6:30pm ET) to welcome you, explain benefits, and outline aid.[1][3] 4. **Benefits Investigation**: Review insurance coverage/next steps.[1] 5. **Financial Assessment**: Discuss copay/PAP/charity options; complete consent if eligible.[1][4] 6. **Approval & Coordination**: Coordinate treatment center, logistics, pre-infusion labs.[1][3] Spanish/other language support available.[1] ## Timeline and Delivery Processing varies (not specified; days to weeks based on insurance/PA). Case Manager updates you.[3] - **Delivery**: Infused at a **treatment center** (not home); Case Manager facilitates.[1][3] - **Post-Treatment**: Reminders for follow-ups, labs (liver monitoring 3 months).[2][3] Stay proactive: Share insurer letters, attend appointments.[3] ## Alternatives if Denied - **Appeal**: Case Manager assists with insurer appeals.[1][3] - **Third-Party Aid**: Assistance Fund (DMD fund for copays/premiums/travel), Duchenne Family Assistance.[3][8] - **Patient Advocacy**: Parent Project Muscular Dystrophy (PPMD) resources.[9] - **Other Sarepta Therapies**: If applicable (e.g., Exondys 51 for different mutations).[4] No biosimilars for ELEVIDYS (unique gene therapy).[ ] ## Disclaimer This guide is for informational purposes; not medical/financial advice. Eligibility/funding can change—contact SareptAssist (1-888-727-3782) or your doctor for personalized info. ELEVIDYS has serious risks (e.g., liver failure); review full Prescribing Information. Programs subject to terms; manufacturer not liable for third-party aid.[1][2] *Word count: ~950*

Program information last verified: March 30, 2026