Astegolimab anti-IL-33 asthma investigational

Indicated For

asthma, COPD (investigational)

About This Medication

# Astegolimab Patient Guide: How to Get Astegolimab at Low or No Cost **Important Notice:** Astegolimab is an investigational medication currently in clinical development by Roche for chronic obstructive pulmonary disease (COPD). As of the latest available data from July 2025, it has shown promising results in reducing COPD exacerbations in the phase IIb ALIENTO trial but did not meet its primary endpoint in the phase III ARNASA trial[1][7]. There is no FDA-approved patient assistance program for astegolimab because it is not yet commercially available. This guide provides general information on Roche/Genentech patient support options and steps to explore access through clinical trials or future programs. Always consult your healthcare provider for personalized advice. ## About Astegolimab Astegolimab (also known as RG6149 or AMG 282) is a fully human monoclonal antibody that targets the ST2 receptor to inhibit the binding of interleukin-33 (IL-33), a protein involved in inflammation[4]. It is being studied as a subcutaneous injection (under the skin) given every 2 or 4 weeks, added to standard COPD maintenance therapy[2][3]. Clinical trials have focused on adults aged 40-80 with moderate to very severe COPD, including former and current smokers with a history of frequent exacerbations, regardless of blood eosinophil levels[1][5][6]. In the phase IIb ALIENTO study (NCT05037929), astegolimab every 2 weeks reduced the annualized exacerbation rate (AER) by 15.4% compared to placebo over 52 weeks[1][7]. The phase III ARNASA study showed a numerical 14.5% reduction but did not achieve statistical significance[1][7]. Earlier trials like COPD-ST2OP also suggested potential benefits[8]. Safety data from over 580 patients across asthma, atopic dermatitis, COPD, and COVID-19 trials indicate good tolerability, with monitoring for infections and cardiac events[8]. Since astegolimab is not approved, access is primarily through ongoing clinical trials. Roche/Genentech provides patient support services, but specific assistance programs will likely launch post-approval, if approved. ## Who Qualifies for Access? Currently, no commercial patient assistance program exists. Qualification for **clinical trial participation** typically includes: - Diagnosis of moderate-to-very-severe COPD with frequent exacerbations. - Age 40-80 years. - Former or current smoker. - No alpha-1 antitrypsin deficiency, long-term high-flow oxygen (>4L/min), recent lung surgery, or intensive rehab[6]. For future Roche patient assistance (once approved), programs like the Genentech Patient Foundation often target: - Uninsured or underinsured patients. - Those with household income below specific Federal Poverty Level (FPL) thresholds. - US residents (programs are US-focused). ## Income Eligibility Breakdown Specific income thresholds for astegolimab are unavailable as no program exists yet. Roche/Genentech programs like the Genentech Patient Foundation generally follow these common structures for similar biologics (based on typical pharma PAP guidelines; confirm with Roche when available): | Household Size | Annual Income Limit (400% FPL example) | Notes | |---------------|---------------------------------------|-------| | 1 (Individual) | ~$60,000 | Up to 400-500% FPL common; varies by program | | 2 (Couple) | ~$81,000 | May exclude certain deductions | | 3 | ~$102,000 | Assets sometimes reviewed | | 4 | ~$123,000 | Additional per family member: ~$21,000 | **Notes:** Thresholds adjust annually with FPL. Programs may cap at 400-800% FPL. Roche often requires proof like tax returns[2]. Contact Roche for updates. ## Insurance Requirements Genentech programs typically require: - **Commercial insurance:** Coverage denial or high out-of-pocket costs (> program limits). - **Medicare patients:** Often ineligible for free drug but may qualify for copay assistance via separate funds. - **Uninsured:** Primary qualifiers. Astegolimab trial participants receive study drug at no cost, regardless of insurance[3][5]. ## Step-by-Step Application Process ### For Clinical Trials (Current Access): 1. **Discuss with your doctor:** Ask if you qualify for trials like NCT05595642 (phase 3 COPD study)[5]. 2. **Search trials:** Use forpatients.roche.com or clinicaltrials.gov. Contact Roche at details in trial listings[5][6]. 3. **Screening:** Complete eligibility checks; visits every 2 weeks for ~1 year[3]. 4. **Enrollment:** If selected, receive astegolimab or placebo free. ### For Future Patient Assistance Program (Post-Approval): 1. **Visit Genentech Access Solutions:** genentech-access.com or call 1-800-333-7410 (general Roche/Genentech line). 2. **Check eligibility:** Use online tools for income/insurance screener. 3. **Gather documents:** Tax returns, insurance cards, proof of income, prescription. 4. **Apply online/download form:** Submit via patientfoundation@gene.com or mail. 5. **Doctor completes section:** Prescriber verifies medical need. 6. **Track status:** Via portal or phone. ## Timeline and Delivery - **Trial timeline:** Screening to 52-62 weeks treatment + 3-month follow-up[3][6]. - **PAP processing (future):** 2-4 weeks typical for Roche programs. - **Delivery:** Shipped to doctor's office or home; self-injection possible for subcutaneous meds. ## Alternatives if Denied or Ineligible - **Other COPD treatments:** Inhalers (LABA/LAMA/ICS), roflumilast, or biologics like dupilumab (if eosinophilic). - **General assistance:** NeedyMeds.org, RxAssist.org, or Partnership for Prescription Assistance. - **Roche COPD support:** Genentech Access Solutions for co-pay cards. - **Trials:** Other Roche respiratory studies[2]. - **State programs:** Medicaid, COPD foundations like COPD Foundation. ## Disclaimer This guide is for informational purposes only and not medical or financial advice. Astegolimab is investigational; efficacy/safety not established. Program details may change. Consult your healthcare provider and visit official Roche/Genentech sites for latest info. Roche disclaims liability for use of this guide. Word count: 950.

Program information last verified: March 30, 2026