GOHIBIC

Indicated For

COVID-19

About This Medication

# InflaRx Commitment Program Patient Guide: How to Get GOHIBIC (vilobelimab) at Low or No Cost GOHIBIC (vilobelimab) is available through the **InflaRx Commitment Program**, which refunds the full treatment cost to eligible healthcare facilities if a patient treated per its Emergency Use Authorization (EUA) does not survive due to COVID-19.[1] This guide explains eligibility, the drug, application steps, and more for patients, caregivers, and facilities seeking access to this therapy for critically ill COVID-19 cases.[1][2] ## About GOHIBIC (vilobelimab) **GOHIBIC** is a first-in-class monoclonal antibody targeting complement factor C5a, authorized by the FDA under an Emergency Use Authorization (EUA) for treating hospitalized adults with COVID-19.[1][2][4] It is specifically for patients who start treatment within **48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO)**—life support for the sickest cases.[2][3][5] Clinical data from the phase 3 PANAMO trial showed GOHIBIC reduced the risk of death by day 28 and 60 compared to placebo.[2][4] It works by blocking C5a, a key driver of inflammation, endothelial damage, and clotting in severe COVID-19, offering a unique mechanism independent of viral variants.[1][4] The full course is up to **six 800 mg IV doses** on Days 1 (within 48 hours of IMV/ECMO), 2, 4, 8, 15, and 22, if hospitalized.[4][5][6] Common side effects include pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, and deep vein thrombosis.[6] Report serious events to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, and to InflaRx at pvusa@inflarx.de.[1] **Note:** GOHIBIC is not FDA-approved; it's under EUA due to COVID-19's ongoing impact.[2][5] Always discuss risks/benefits with your doctor. ## Who Qualifies for the Commitment Program? This program targets **healthcare facilities (hospitals/ICUs)**, not individual patients directly.[1] Eligibility requires: - Administering GOHIBIC per EUA: Hospitalized adults starting within 48 hours of IMV/ECMO for COVID-19.[1][2] - Patient does not survive due to COVID-19 in the ICU.[1] - Up to six inpatient doses (full course).[1] The goal is to encourage hospitals to stock GOHIBIC for time-critical use, broadening access for critically ill patients amid rising COVID-19 deaths (about 1,500/week reported in early 2024).[1] Patients don't apply; your hospital/doctor coordinates.[1] ## Income Eligibility No income requirements apply—this is **not a patient assistance program based on financial need**.[1] It's a risk-sharing initiative for facilities to ensure access regardless of ability to pay, refunding costs only if the outcome is fatal per criteria.[1] State programs may help with other COVID-19 drugs if applicable.[7] | Household Size | Income Threshold | FPL % | Notes | |---------------|------------------|-------|-------| | Individual | None | None | Facility-focused; no patient income test[1] | | Couple | None | None | Refunds to hospitals for non-surviving patients[1] | | Family of 3 | None | None | Encourages stocking for urgent ICU use[1] | | Family of 4 | None | None | N/A[1] | ## Insurance Requirements Insurance details are **not specified** in program guidelines.[1] GOHIBIC may be covered under Medicare or private plans for EUA therapies, but check with your provider.[7] The Commitment Program refunds facilities directly for eligible non-surviving cases, potentially easing financial barriers even if insurance denies.[1] Hospitals handle billing; patients may face copays unless covered by Medicare Part D or state assistance.[7] No explicit Medicare restrictions noted.[7] ## Step-by-Step Application Process Patients don't apply—**facilities order and claim refunds**.[1] Here's how it works: 1. **Confirm Patient Eligibility:** Doctor verifies hospitalized adult with COVID-19 needing IMV/ECMO; start GOHIBIC within 48 hours.[2][5] 2. **Order GOHIBIC:** Facilities contact **ASD Healthcare** at **1-800-746-6273** or **service@asdhealthcare.com**. Use NDC: 83000-0110-04.[1] 3. **Administer Treatment:** Give 800 mg IV (diluted) up to 6 doses per schedule.[4][6] 4. **Monitor Outcome:** If patient dies from COVID-19 in ICU despite EUA-compliant treatment, facility qualifies for refund of up to 6 doses.[1] 5. **Submit for Refund:** Facilities follow InflaRx process (contact InflaRx for details via pvusa@inflarx.de).[1] 6. **Report Adverse Events:** Mandatory FDA MedWatch for errors/deaths potentially linked to GOHIBIC.[1] Advocate for your hospital to participate—time is critical![1] ## Timeline and Delivery - **Ordering/Processing:** Call/email ASD Healthcare; expect standard pharmaceutical distribution (days, depending on stock).[1] - **Treatment Timeline:** Dose 1: Day 1 (≤48 hrs post-IMV/ECMO); then Days 2,4,8,15,22 if hospitalized.[4][5] - **Refund Processing:** Not specified; post-outcome claim to InflaRx.[1] Delivery via ASD to facilities IV infusion only—no home use.[3] ## Alternatives if Denied or Ineligible - **Other COVID-19 EUA/Approved Therapies:** Baricitinib, tocilizumab, dexamethasone, remdesivir, etc., per standard of care.[4] - **No Biosimilars:** None listed for vilobelimab.[1] - **Financial Aid:** GoodRx, state pharmaceutical assistance, or Medicare for copays.[7] - **Contact InflaRx:** For questions, pvusa@inflarx.de.[1] If ineligible (e.g., >48 hrs post-IMV, non-COVID), discuss alternatives with your ICU team.[2] ## Disclaimer This guide is for informational purposes based on available data as of 2024.[1][2] It is **not medical advice**. EUA status means benefits may outweigh risks for eligible patients, but consult your healthcare provider. Program details may change; verify with InflaRx or facilities. InflaRx covers facility refunds only for specified non-survival cases—no guarantee of access or survival. Report side effects promptly.[1][5] Word count: 1028.

Program information last verified: March 25, 2026