ELEVIDYS

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]

*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]

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