Zolgensma

Indicated For

Spinal Muscular Atrophy (SMA)

About This Medication

# Novartis Patient Assistance Program Guide: How to Get Zolgensma at Low or No Cost ## About This Guide This guide explains how to access Zolgensma (onasemnogene abeparvovec-xioi) through the Novartis Patient Assistance Program if you have difficulty affording this life-changing gene therapy for spinal muscular atrophy (SMA). Zolgensma is a one-time intravenous infusion designed to treat SMA by replacing the missing SMN1 gene. The Novartis Patient Assistance Program helps eligible patients access Zolgensma at reduced or no cost. ## What Is Zolgensma? Zolgensma is an FDA-approved gene replacement therapy for spinal muscular atrophy (SMA). Unlike traditional medicines, Zolgensma is a one-time treatment that works by delivering a functional copy of the SMN1 gene to help your body produce the survival motor neuron (SMN) protein. This protein is critical for nerve cell function and muscle movement. SMA occurs when the body cannot produce enough SMN protein, leading to progressive muscle weakness. Zolgensma is typically administered as a single intravenous infusion at a specialized medical center. ## Who Can Qualify for Assistance? The Novartis Patient Assistance Program is designed to help patients who: - Have been prescribed Zolgensma by their healthcare provider - Have a diagnosis of spinal muscular atrophy (SMA) - Have difficulty affording the medication - Are U.S. residents - Meet income eligibility requirements (see below) - Have insurance or are uninsured Qualification is also based on individual financial circumstances. Patients with commercial insurance, Medicare, Medicaid, or no insurance may be eligible. ## Income Eligibility Guidelines Income limits vary based on household size and individual circumstances. The program uses federal poverty guidelines as a reference point but evaluates each case individually. Below is a general reference table: | Household Size | Approximate Maximum Income (Guidelines) | |---|---| | 1 person | Varies by state | | 2 people | Varies by state | | 3 people | Varies by state | | 4 people | Varies by state | | 5 people | Varies by state | | 6+ people | Varies by state | **Important Note:** Income thresholds vary and the program evaluates financial need on a case-by-case basis. Even if your household income exceeds standard guidelines, you may still qualify based on medical expenses, debts, or other financial hardships. Contact the program directly to discuss your specific situation. ## Insurance Coverage and Copay Assistance ### Commercial Insurance If you have commercial health insurance, Novartis offers **CopayAssist** specifically for eligible U.S. residents. This program helps reduce out-of-pocket costs: - Copayment assistance for commercially insured patients - Program details available at: https://www.zolgensma-itvisma-copayassist.com - Designed to make your copayments more manageable ### Medicare and Medicaid The patient assistance program is available for eligible patients with Medicare or Medicaid coverage. Contact the program to verify your specific coverage details and eligibility. ### Uninsured Patients If you have no insurance, you may still qualify for full or partial assistance through the Novartis Patient Assistance Program. Your financial situation will be evaluated individually. ## Step-by-Step Application Process ### Step 1: Get a Prescription Your healthcare provider must prescribe Zolgensma and confirm your SMA diagnosis. Work with your care team to ensure all medical prerequisites are met before starting the application process. ### Step 2: Gather Required Documents Collect the following documents before applying: - **ZOLGENSMA Prescription Form** — completed and signed by your prescribing healthcare provider - **Patient Consent Form** — your authorization for the program to process your assistance request - **START Form** — contains your personal, household, and insurance information - Recent pay stubs or tax returns (proof of income) - Insurance card (if applicable) - Photo identification ### Step 3: Complete Your Application You can apply through multiple methods: - **Phone:** Call (855) 441-4363 to speak with a patient support representative - **Fax:** Send completed forms to 1-855-951-4363 - **Online/Mail:** Visit https://www.zolgensma-hcp.com/steps-to-treatment/patient-support for additional options A patient support specialist can help you complete applications over the phone if you need assistance. ### Step 4: Submit Your Application Ensure all required forms are completed accurately and all supporting documents are included. Incomplete applications may delay processing. ### Step 5: Wait for Approval The program typically processes applications in **4-8 weeks**. You'll be notified of approval status by phone, mail, or email as you prefer. ### Step 6: Receive Your Medication Once approved, Zolgensma will be **shipped directly to the site of administration** (your hospital or infusion center). You'll coordinate the delivery and administration appointment with your healthcare team. ## Timeline and What to Expect | Step | Timeline | |---|---| | Application submission | Day 1 | | Initial review | 1-2 weeks | | Verification of information | 2-4 weeks | | Approval decision | 4-8 weeks typical | | Medication shipped to treatment site | Upon approval | | Infusion appointment | Coordinated with your facility | **Note:** Processing times may vary based on completeness of applications and complexity of individual cases. Having all documents ready upfront can speed up approval. ## What If Your Application Is Denied? If you don't qualify for the Novartis Patient Assistance Program, consider these alternatives: - **Appeal the Decision:** Ask why you were denied and whether you can provide additional information to reapply - **Explore State Programs:** Many states have pharmaceutical assistance programs for uninsured or low-income residents - **CopayAssist:** If you have commercial insurance, apply for copay assistance separately - **Hospital Financial Aid:** Ask your treatment facility's financial counselor about hospital-based assistance programs - **NeedyMeds.org:** Visit this comprehensive database for additional patient assistance resources - **Patient Advocacy Organizations:** Organizations supporting SMA patients may have additional funding or resources - **Discuss with Your Doctor:** Your healthcare team may have information about alternative funding sources or payment plans ## Important Information About Reauthorization Because Zolgensma is a one-time gene therapy treatment (not a recurring prescription), reauthorization is not typically required. Once you receive your infusion, the treatment course is complete. However, if you have questions about your individual situation, contact the patient support team. ## Contact Information - **Phone:** (855) 441-4363 - **Fax:** 1-855-951-4363 - **Website:** https://www.zolgensma-hcp.com/steps-to-treatment/patient-support - **Copay Assistance Savings Card:** https://www.zolgensma-itvisma-copayassist.com ## Legal Disclaimer This guide provides general information about the Novartis Patient Assistance Program for Zolgensma. Program eligibility, requirements, and benefits may change. The information provided here is not a guarantee of assistance or coverage. Always verify current program details by contacting Novartis directly or visiting the official program website. This guide does not constitute medical advice. Consult with your healthcare provider about whether Zolgensma is appropriate for your medical condition. For the most current and accurate information, contact the Novartis Patient Assistance Program directly at the phone number or website listed above.

Program information last verified: March 25, 2026