DUVYZAT

Indicated For

Duchenne muscular dystrophy (DMD)

About This Medication

# ITF ARC Patient Assistance Program Patient Guide: How to Get DUVYZAT (givinostat) at Low or No Cost DUVYZAT (givinostat) is the only nonsteroidal treatment approved for Duchenne muscular dystrophy (DMD) in people 6 years and older, helping to preserve muscle strength and function when used with corticosteroids.[5][10] The **ITF ARC Patient Assistance Program** from Italfarmaco provides this medication **free of charge** to eligible uninsured or underinsured patients whose insurance does not cover DUVYZAT, making treatment accessible for those facing financial barriers.[1][2][3] ## About DUVYZAT (givinostat) **DUVYZAT** is an oral histone deacetylase (HDAC) inhibitor that slows DMD progression by reducing muscle inflammation and fibrosis. It's indicated for patients 6 years and older, regardless of genetic mutation, but clinical trials focused on ambulatory patients (those who can walk without assistance). It must be taken with a corticosteroid like prednisone or deflazacort.[5][9][10] Common side effects include diarrhea, vomiting, and increased platelets—your doctor will monitor these. DUVYZAT offers hope for maintaining daily function, like climbing stairs, compared to steroids alone.[5] ## Who Qualifies for the ITF ARC Patient Assistance Program? This program targets patients who **cannot afford DUVYZAT** due to lack of coverage. Key qualifications: - **Uninsured** or **underinsured** (insurance denies coverage or doesn't cover the prescription).[1][2][3] - **US residents** with a valid prescription for DMD.[8] - **Financial need**: Income evaluated individually, often below **200-400% of the Federal Poverty Level (FPL)** based on household size—exact thresholds not publicly fixed, so cases are reviewed personally.[8] - Not eligible if enrolled in government programs for copay assistance (though PAP may still apply for free drug).[1][8] **Commercially insured patients** may qualify for the separate **Copay Program** (as low as $0/month), but government-insured (Medicare, Medicaid, VA, etc.) cannot use copay help.[1][2] ## Income Eligibility Breakdown Eligibility hinges on a financial assessment, including third-party income verification.[4] While specific ITF ARC thresholds aren't listed publicly, patient assistance programs typically use FPL guidelines. Here's a general table for **2026 FPL** (approximate; confirm current levels): | Household Size | 200% FPL | 300% FPL | 400% FPL | |----------------|----------|----------|----------| | 1 person | $30,120 | $45,180 | $60,240 | | 2 people | $40,880 | $61,320 | $81,760 | | 3 people | $51,640 | $77,460 | $103,280| | 4 people | $62,400 | $93,600 | $124,800| *Add ~$10,760 per additional person at 200% FPL. Your case may qualify up to 400% or higher based on individual review.*[8] Provide recent tax returns, pay stubs, or W-2s for verification.[4] ## Insurance Requirements - **Primary eligibility**: No insurance or insurance **does not cover DUVYZAT** (e.g., after prior authorization denial).[1][2][3] - **Commercial insurance**: Use the Copay Program instead if covered (not combinable with PAP).[1][2] - **Government insurance** (Medicare, Medicaid, VA, TRICARE): Ineligible for copay; check PAP for free drug if income-qualified.[1][8] - ITF ARC offers **insurance navigation**, including benefits verification and appeal support.[2] ## Step-by-Step Application Process Applications start **by phone**—no online form listed.[2] 1. **Talk to your doctor**: Get a prescription for DUVYZAT and have them complete the **physician enrollment form** (includes patient start form with financial screening).[4][7] 2. **Call ITF ARC**: Dial **(855) 448-3272** (1-855-4-ITF-ARC). A case manager assesses eligibility, explains requirements, and guides enrollment.[1][2][3] 3. **Submit documents**: - **Proof of income** (tax returns, pay stubs, bank statements). - **Proof of residency** (utility bill, lease). - **Prescription** from your neuromuscular specialist. - **Physician enrollment form** signed by prescriber.[4][8] 4. **Financial verification**: ITF may check credit bureaus (non-credit inquiry) to confirm income.[4] 5. **Approval wait**: Typically 2-6 weeks; temporary supply programs bridge gaps.[2][3][8] 6. **Receive medication**: Shipped free to your home or doctor's office.[2][8] Your doctor or pharmacy handles coordination.[7] ## Timeline and Delivery - **Processing**: 2-6 weeks after complete submission; call for status updates.[2][8] - **Temporary supply**: Free limited supply while waiting for approvals or insurance changes—no disruptions.[2][3] - **Delivery**: Direct ship to patient or physician; personalized pharmacist support included.[2] - **Refills**: **Reauthorization required** periodically—your team gets reminders.[2] ## Alternatives if Denied - **Appeal**: Work with ITF ARC for insurance prior authorization/appeals.[2] - **Copay Program**: If commercially insured ($0 possible).[1][2] - **Temporary supply**: For insurance delays.[2][3] - **Other PAPs**: Check PAN Foundation or RxAssist.org for DMD support. - **Manufacturer bridge**: Free supply during transitions.[2] - **Patient advocacy**: Parent Project Muscular Dystrophy (PPMD) offers resources.[7] ITF ARC also provides education, translation, refill reminders, and support groups.[2] ## Important Disclaimer This guide is for informational purposes only and not a substitute for professional medical or financial advice. Program details can change; eligibility not guaranteed. Contact ITF ARC at (855) 448-3272 for personalized help. Programs may end anytime due to regulations.[1][2] Always consult your healthcare provider about DUVYZAT suitability.

Program information last verified: March 30, 2026