Spevigo

Indicated For

Generalized Pustular Psoriasis (GPP) flares

About This Medication

# SPEVIGO® Patient Assistance Program Patient Guide: How to Get Spevigo (spesolimab-sbzo) at Low or No Cost Spevigo (spesolimab-sbzo) is an FDA-approved biologic medication used to treat **generalized pustular psoriasis (GPP)** in adults and pediatric patients 12 years and older. The **SPEVIGO® Patient Assistance Program** from **LEO Pharma** helps eligible **uninsured or underinsured patients** access this important treatment at low or no cost by demonstrating financial need. ## About Spevigo and Generalized Pustular Psoriasis (GPP) **Generalized pustular psoriasis (GPP)** is a rare, severe form of psoriasis causing widespread painful pustules, fever, fatigue, and skin redness that can lead to hospitalization during flares. Spevigo is the **only FDA-approved therapy specifically for GPP**. It works as an **interleukin-36 (IL-36) receptor antagonist**, targeting the inflammation pathway that drives GPP flares. Spevigo comes in **two forms**: - **SPEVIGO IV (intravenous)**: Given at an infusion center or hospital to treat **active GPP flares** (typically up to 2 doses, at least 1 week apart). - **SPEVIGO SC (subcutaneous)**: A monthly self-injection at home to **help prevent future flares** after an initial IV treatment. Your doctor—a dermatologist or specialist—will decide the best form based on whether you're treating a flare or maintaining remission. Common side effects include injection site reactions, upper respiratory infections, and fatigue. Always discuss risks with your healthcare provider. ## Who Qualifies for the SPEVIGO® Patient Assistance Program? This program is for patients who: - Have a confirmed diagnosis of **GPP**. - Are **uninsured for Spevigo**, **underinsured**, or have been **denied Medicaid** (if applicable). - Can **demonstrate financial need** (specific income limits like Federal Poverty Level percentages are not published; eligibility is based on individual financial review). **Medicare Part D patients** must notify their plan and exhaust coverage options through the end of the year before using this program. The program does not specify exact household size thresholds, focusing instead on overall financial hardship. ## Income Eligibility Breakdown Unlike some programs with fixed Federal Poverty Level (FPL) cutoffs, the SPEVIGO® Patient Assistance Program evaluates **financial need** case-by-case. No public income thresholds (e.g., 400% FPL) are listed, but you must provide proof like tax returns or pay stubs. | Household Size | Income Threshold | Notes | |---------------|------------------|-------| | Individual | Not specified | Demonstrate financial need; proof required | | Couple | Not specified | Underinsured/uninsured prioritized | | Family of 3 | Not specified | Medicaid denial needed if applicable | | Family of 4+ | Not specified | Case-by-case review | If your income is near common PAP levels (e.g., 300-500% FPL), apply anyway—approvals consider household size, expenses, and debts. ## Insurance Requirements - **No insurance** for Spevigo or **underinsured** (high copays/deductibles). - **Medicaid applicants** must submit a denial letter. - **Medicare Part D**: Inform your plan; use program only after coverage gap or denial, through year-end. - **Commercial insurance**: Explore copay cards first (e.g., BI Solutions Plus or PAF Co-Pay Relief, offering $0-$2500/year savings), then apply if ineligible. Do not use manufacturer samples or free trials to bypass insurance requirements for prior authorizations. ## Step-by-Step Application Process The program offers **multiple application methods** (call, download forms, or online portal via LEO Pharma support). 1. **Talk to your doctor**: Confirm GPP diagnosis and get a signed prescription. They may handle prior authorizations from insurers. 2. **Contact the program**: Call LEO Pharma support at **1-833-SPEVIGO (1-833-773-8446)**, Monday-Friday 8AM-8PM ET, for enrollment forms and guidance. 3. **Gather documents**: - **Proof of financial need** (e.g., 2025 tax return, pay stubs, bank statements). - **Medicaid denial letter** (if applicable). - **Signed enrollment form** from you and your doctor. 4. **Submit application**: Fax, mail, or upload via multiple methods provided. 5. **Wait for approval**: Processing time varies (typically 2-4 weeks; see FAQ for details). 6. **Receive medication**: Shipped free to your **home or doctor's office**. **Reauthorization is required** annually or as needed—resubmit updated financials and doctor's note confirming ongoing need. ## Timeline and Delivery - **Processing**: 2-4 weeks after complete submission (delays if documents missing). - **Delivery**: Free shipping to patient or physician; SC form for home use after training. - **Supply duration**: Varies by approval (e.g., 6-12 months for maintenance; flares as needed). Track status by calling 1-833-SPEVIGO. ## Alternatives if Denied - **Copay assistance**: BI Solutions Plus ($0/fill for commercial), PAF Co-Pay Relief (up to $2500/year), PAN Foundation (income <400% FPL). - **Other PAPs**: Boehringer Cares (if eligible), Patient Advocate Foundation. - **Low-Income Subsidy (LIS)**: For Medicare; apply via SSA (1-800-772-1213). - **State programs**: Check Medicaid appeals or 340B clinics. - **Biosimilars**: None available. Appeal denials with more financial proof or doctor letter. ## Important Disclaimer This guide is for informational purposes only and based on publicly available data as of 2026. Program details can change—**always verify with LEO Pharma at 1-833-SPEVIGO**. Not medical advice; consult your doctor. LEO Pharma does not guarantee approval. Financial assistance availability subject to funding.

Program information last verified: March 30, 2026