Asundexian

Indicated For

Secondary stroke prevention in patients with non-cardioembolic ischemic stroke or high-risk transient ischemic attack

About This Medication

# Bayer US Patient Assistance Foundation Patient Guide: How to Get Asundexian at Low or No Cost Asundexian (BAY2433334) is an **investigational oral Factor XIa inhibitor** developed by Bayer for preventing secondary strokes in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), potentially without increasing bleeding risk. This guide explains how to access it through the **Bayer US Patient Assistance Foundation** (PAF), a charitable program providing eligible US patients with Bayer prescription medicines at no cost, though asundexian is not yet FDA-approved and specific program details for it are unavailable as of March 2026[1][2][6][9]. ## About Asundexian Asundexian is Bayer's once-daily oral medication that targets **Factor XIa (FXIa)**, a clotting protein involved in thrombosis (blood clot formation). Unlike traditional anticoagulants, it aims to reduce ischemic stroke risk while minimizing bleeding complications. Key highlights from clinical trials: - In the Phase III **OCEANIC-STROKE** study (results November 2025), asundexian 50 mg daily plus antiplatelet therapy reduced ischemic stroke risk by 26% vs. placebo, meeting primary efficacy and safety endpoints with no increase in major bleeding[2][8][9]. - It's studied for secondary prevention after non-cardioembolic stroke or high-risk TIA, and other indications like atrial fibrillation and myocardial infarction[1][5][7]. - Granted **FDA Fast Track Designation** for stroke prevention (2022) and atrial fibrillation (2023); full results presented at International Stroke Conference 2026[3][5][9]. **Important note**: Asundexian remains investigational and unavailable commercially. Access may be limited to clinical trials or expanded access programs. Consult your doctor for trial enrollment via ClinicalTrials.gov or Bayer[1][3][9]. ## Who Qualifies for Bayer PAF? The Bayer US Patient Assistance Foundation helps uninsured or underinsured US patients (including Puerto Rico) get Bayer medicines free if they meet income limits and lack coverage for the drug[6]. While specific details for asundexian are not published, general Bayer PAF criteria apply: - **Residency**: US or Puerto Rico. - **Insurance**: No prescription insurance or no coverage for the Bayer medicine. - **Income**: Typically up to 400-500% of Federal Poverty Level (FPL), but exact thresholds vary; contact program for current limits. ## Income Eligibility Breakdown Bayer PAF bases eligibility on household income relative to FPL. Exact asundexian thresholds are unavailable, but here's a typical example based on Bayer's general programs (2026 FPL estimates; verify with program as FPL updates annually): | Household Size | Max Annual Income (400% FPL) | Max Annual Income (500% FPL) | Notes | |---------------|------------------------------|------------------------------|-------| | 1 (Individual) | $60,320 | $75,400 | Common threshold around 400-500% FPL[6] | | 2 (Couple) | $81,760 | $102,200 | Add ~$21,440 per person for 400% | | 3 | $103,200 | $129,000 | Household income includes all members | | 4 | $124,640 | $155,800 | Proof via tax returns required | **Notes**: Income includes wages, Social Security, etc. Assets may be considered. Call Bayer for precise asundexian guidelines, as they may adjust for new drugs. ## Insurance Requirements - **Uninsured or non-covered**: Ideal candidates have no prescription drug coverage or insurer denies the Bayer medicine[6]. - **Medicare/Medicaid**: Often ineligible if government insurance covers the drug; exceptions for gaps in coverage. - **Private insurance**: Must prove denial of coverage for asundexian specifically. PAF bridges gaps for patients whose insurance doesn't cover high-cost Bayer therapies. ## Step-by-Step Application Process 1. **Confirm eligibility**: Discuss with your doctor; verify you meet residency, income, and insurance criteria. 2. **Gather documents**: Proof of income (tax return, pay stubs, W-2s), residency (ID/utility bill), prescription, insurance denial letter (if applicable), doctor's statement. 3. **Get application**: Download from Bayer website, call helpline, or request via doctor/pharmacy. 4. **Complete and submit**: Patient, doctor, and pharmacist sign. Mail, fax, or upload online. 5. **Follow up**: Track status by phone; approval typically 2-4 weeks for similar programs. Contact Bayer Patient Assistance at 1-866-4BAYER (1-866-422-9371) or visit patientassistance.bayer.us for forms[6]. ## Timeline and Delivery - **Processing**: 2-4 weeks after complete submission; urgent cases may expedite. - **Delivery**: Free medication shipped directly to your home or doctor's office monthly/quarterly. - **Supply duration**: Up to 12 months, renewable with reauthorization. ## Alternatives if Denied or Ineligible - **Other assistance**: PAN Foundation, HealthWell Foundation, or NeedyMeds for stroke prevention drugs. - **Generic antiplatelets**: Aspirin or clopidogrel (often low-cost). - **Clinical trials**: Enroll in ongoing asundexian studies via ClinicalTrials.gov. - **Manufacturer copay cards**: Bayer may offer for commercial launch (post-approval). - **State programs**: Check Medicaid or 340B clinics. ## Disclaimer This guide is for informational purposes only and not medical or financial advice. Asundexian is **not FDA-approved** and unavailable outside trials as of March 2026[3][9]. Eligibility, terms, and availability change; contact Bayer directly for latest details. Consult your healthcare provider before starting any treatment. Bayer disclaims liability for use of this information. Word count: 942.

Program information last verified: March 30, 2026