CUVITRU

Indicated For

Primary Humoral Immunodeficiency

About This Medication

# Takeda Patient Support Co-Pay Assistance Program Patient Guide: How to Get CUVITRU at Low or No Cost CUVITRU (Immune Globulin Subcutaneous (Human) 20% Solution) is a prescription medication used as replacement therapy for **primary humoral immunodeficiency (PI)** in adults and children 2 years and older. The **Takeda Patient Support Co-Pay Assistance Program** helps eligible patients with commercial insurance reduce out-of-pocket costs for CUVITRU, potentially covering up to 100% of co-pays, deductibles, coinsurance, and certain infusion charges—up to a **$20,000 annual maximum**.[1][5][6] This guide explains everything you need to know about the program in simple terms, from eligibility to applying and what to do if you're denied. It's designed for patients like you managing PI and seeking affordable access to treatment. ## About CUVITRU CUVITRU is an immunoglobulin therapy administered subcutaneously (under the skin) at home or in a doctor's office. It provides antibodies to help prevent infections in people with PI, a condition where the immune system doesn't produce enough of these protective proteins. Unlike intravenous options, CUVITRU offers flexible dosing—weekly, biweekly, or every 3-4 weeks—allowing tailored treatment that fits your lifestyle.[7][8] **Key benefits** include fewer systemic side effects and the convenience of self-infusion after training. Always follow your doctor's instructions, as CUVITRU is FDA-approved only for PI replacement therapy. Ask your healthcare provider if it's right for your approved condition.[1][7] ## Who Qualifies for the Program? To join the **Takeda Patient Support Co-Pay Assistance Program**, you must meet these core requirements: - Be prescribed **CUVITRU for an FDA-approved use** (primary humoral immunodeficiency in patients ≥2 years).[1][6] - Reside in the **United States, U.S. territories, or Puerto Rico**.[6] - Have **commercial insurance**, including Health Insurance Marketplace plans.[1][4] - Enroll in **Takeda Patient Support**.[1][7] **Important exclusions**: The program **cannot** be used if you're on Medicare (including Part D or Medicare Advantage), Medicaid, TRICARE, VA, DoD, or any federal/state government-funded program, even if only part of your prescription is covered. It also doesn't apply if your insurance pays 100% of costs or in certain states (Massachusetts, Michigan, Minnesota, Rhode Island, Vermont) for specific charges.[1][4][6] There are **no income thresholds** listed, making it accessible to a broad range of commercially insured patients. The program focuses on insurance type rather than household income.[1][5] ### Income Eligibility Breakdown Since no specific income limits apply, eligibility hinges on insurance and residency. Here's a quick table summarizing key qualifiers and disqualifiers: | Category | Eligible | Not Eligible | |----------|----------|--------------| | **Insurance** | Commercial (e.g., employer, Marketplace) | Government (Medicare, Medicaid, TRICARE, VA) | | **Income** | No limits | N/A | | **Residency** | US, territories, Puerto Rico | Outside US | | **Prescription** | CUVITRU for FDA-approved PI | Off-label use | | **Annual Max** | Up to $20,000 co-pay help | Exceeds limit (Takeda helps find alternatives) |[1][4][5][6] ## Insurance Requirements **Commercial insurance is required**—no government plans allowed. This ensures the program supplements private coverage without violating federal anti-kickback laws. If your plan covers CUVITRU but leaves high co-pays, deductibles, or coinsurance, the program steps in (up to $20,000/year). Coverage gap (donut hole) in Medicare Part D disqualifies you.[1][4] Takeda Patient Support specialists verify your benefits and assess co-pay eligibility during enrollment. They cover out-of-pocket costs like co-pays, deductibles, coinsurance, and some infusion fees.[5][6][7] ## Step-by-Step Application Process Applying is straightforward and starts with a **phone call**—no online form needed. 1. **Talk to your doctor**: Confirm CUVITRU is prescribed for your PI. Get a **Patient Start Form** if needed for enrollment and pharmacy coordination.[7] 2. **Call Takeda Patient Support**: Dial **1-866-861-1750** (Mon-Fri, 8 AM-8 PM ET). A specialist will review your insurance, confirm eligibility, and enroll you.[1][2][7] 3. **Provide info**: Share your prescription details, insurance card, and personal info. Sign a HIPAA authorization for them to handle benefits verification and co-pay support.[7] 4. **Benefits check**: The team contacts your insurer to confirm coverage and prior authorization (PA) status. They educate on appeals if needed.[4][7] 5. **Enroll in co-pay program**: If eligible, get a co-pay card or direct assistance at the pharmacy/infusion site.[1][5] 6. **Start treatment**: Receive CUVITRU via home/office infusion. Training for self-administration is available.[7] Your doctor or pharmacy may also initiate via the Patient Start Form, authorizing Takeda to manage everything.[7] ## Timeline and Delivery - **Processing**: Benefits verification is quick—often same-day during call hours. Co-pay activation follows shortly after enrollment.[2][7] - **Delivery**: CUVITRU ships to your **home or doctor's office** via specialty pharmacy. Supplies for self-infusion included if requested.[7][8] - **Refills**: Automatic with ongoing eligibility; track your $20,000 annual max via Takeda portal or support.[1][5] If you hit the max early, Takeda connects you to other resources.[1][6] ## Alternatives if Denied **Common denial reasons**: Government insurance, exceeded max, off-label use, or full insurance coverage.[1][4] - **Appeal PA denials**: Work with your doctor and Takeda support to resubmit with more info.[4] - **Government insurance?** Takeda helps explore coverage options or other programs.[4] - **Uninsured/low coverage?** Check **Help at Hand** for eligible uninsured patients (varies by product).[9] - **Free trial**: **HelloCUVITRU** covers your first four infusions + supplies to test the therapy.[8] - **PI support**: Join **MyIgSource** for education and advocates.[5] - **Other resources**: Independent foundations or state programs (not via Takeda co-pay).[1] Contact support at 1-866-861-1750 for personalized guidance.[2] ## Disclaimer This guide is for informational purposes only and based on program details as of March 2025. Eligibility, terms, and benefits can change—always verify with Takeda at 1-866-861-1750 or takedapatientsupport.com. Not a substitute for medical advice. Program not valid where prohibited by law. Maximum $20,000 annual assistance; certain restrictions in MA, MI, MN, RI, VT. See full terms at cuvitru.com/patient-support.[1][4][6]

Program information last verified: March 30, 2026