GOHIBIC

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]

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.