Amondys 45

Indicated For

Duchenne muscular dystrophy (DMD)

About This Medication

# SareptAssist Patient Guide: How to Get Amondys 45 at Low or No Cost Amondys 45 (casimersen) is an FDA-approved treatment for Duchenne muscular dystrophy (DMD) in patients with a confirmed dystrophin gene mutation amenable to exon 45 skipping, available through Sarepta Therapeutics' **SareptAssist** patient support program.[1][2] This guide explains eligibility, application steps, and support options to help you access the medication at low or no cost. ## About Amondys 45 (Casimersen) **Amondys 45** is an antisense oligonucleotide administered via weekly intravenous (IV) infusion, designed to skip exon 45 in the dystrophin gene, increasing dystrophin production in skeletal muscle.[1][2][4] It received accelerated FDA approval based on increased dystrophin levels; continued approval depends on confirmatory trials showing clinical benefit.[1][2] It's indicated for DMD patients with a confirmed exon 45-skippable mutation. Common side effects (occurring in ≥20% of patients and ≥5% more than placebo) include upper respiratory tract infection (65%), cough (33%), fever (33%), headache (32%), joint pain (21%), and mouth/throat pain (21%).[1] Serious risks include anaphylaxis; do not use if allergic to casimersen.[1] DMD is a progressive muscle-wasting disease primarily affecting boys. Amondys 45 must be prescribed by or in consultation with a neurologist experienced in DMD.[4][7][9] Patients are typically on stable corticosteroids (e.g., prednisone) for ≥24 weeks prior.[4][9] ## Who Qualifies for SareptAssist? SareptAssist provides comprehensive support, including financial assistance, insurance navigation, and free medication for eligible patients.[1][2][3] Qualification focuses on medical criteria rather than strict income thresholds, as specific FPL limits are not publicly detailed.[3] Key medical eligibility: - Confirmed DMD diagnosis with dystrophin mutation amenable to exon 45 skipping. - Stable corticosteroid dose for ≥24 weeks (unless contraindicated).[4][9] - Prescription by DMD-experienced neurologist.[4][7][9] - Ambulatory status or preserved function (e.g., NSAA score >17, Gower's test <7 seconds, or no assistive devices).[7] The program helps uninsured, underinsured, or commercially insured patients. Medicare patients may access via patient assistance programs (PAPs).[8] Medicaid often requires prior authorization (PA) with similar criteria.[4][5][9] ## Income Eligibility Breakdown SareptAssist does not publish fixed income thresholds online; eligibility is assessed case-by-case via a dedicated Case Manager.[1][2] Many PAPs cover incomes up to 400-500% of the Federal Poverty Level (FPL), but confirm with Sarepta. | Household Size | Estimated Threshold (400% FPL, 2026) | Notes | |---------------|-------------------------------------|-------| | Individual | ~$60,000 | Case-by-case; commercial insurance often prioritized.[3] | | Couple | ~$81,000 | Medicare PAPs available.[8] | | Family of 3 | ~$102,000 | Medicaid PA may apply separately.[4] | | Family of 4 | ~$123,000 | Highest need for uninsured.[1] | *Table based on general PAP guidelines; contact SareptAssist for exact criteria. FPL adjusted annually.* ## Insurance Requirements SareptAssist investigates coverage and provides copay assistance or free drug for gaps.[1][2] - **Commercial Insurance**: Program bridges deductibles/copays.[3] - **Medicare**: Limited coverage; PAPs offer free/low-cost options.[8] - **Medicaid**: PA required (e.g., genetic confirmation, neurologist Rx, function preserved).[4][5][9] - **Uninsured**: Direct free medication possible.[1] No concomitant use with other exon skippers.[7] ## Step-by-Step Application Process 1. **Get Prescribed**: Ensure neurologist confirms exon 45 mutation and eligibility.[1][4] 2. **Enroll in SareptAssist**: Doctor prescribes; print/enroll via website or call. Receive dedicated Case Manager.[1][2] 3. **Submit Documents**: Prescription, proof of income/insurance, genetic test, corticosteroid history, functional assessment (e.g., NSAA).[4][7][9] 4. **Coverage Check**: Case Manager verifies benefits, appeals denials.[1] 5. **Approval**: Receive medication via specialty pharmacy; infusions arranged.[2] Application is straightforward—start at amondys45.com.[1][2] ## Timeline and Delivery Processing: Typically 1-4 weeks, depending on insurance/PA.[5] Initial Medicaid approvals: 6-12 months; renewals every 6 months with function proof.[7][9] Case Manager coordinates weekly IV infusions at home/clinic.[2] Delivery via specialty pharmacy.[8] ## Alternatives if Denied - Appeal with more records (e.g., updated function tests).[7] - Copay cards/savings programs.[3] - Other exon skippers (e.g., Exondys 51) if mutation matches (not concomitant).[7] - Clinical trials or compassionate use via Sarepta. - State Medicaid exceptions or manufacturer bridge programs.[5] No biosimilars available.[ ] ## Disclaimer This guide is for informational purposes based on available sources as of 2026.[1-9] Not medical/financial advice. Eligibility varies; consult healthcare provider and SareptAssist (via website or Case Manager).[1][2] Criteria may change; verify with manufacturer. Accelerated approval means unconfirmed clinical benefit.[1]

Program information last verified: March 30, 2026