The InflaRx Commitment

The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the emergency use of GOHIBIC® (vilobelimab) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). GOHIBIC® is not FDA-approved for this use.¹

InflaRx is committed to helping make the potentially life-saving drug GOHIBIC available for patients in line with its FDA emergency use authorization. When time is critical, administer GOHIBIC knowing the InflaRx Commitment to patients, caregivers, and their healthcare providers …

If your patient had a positive COVID-19 diagnosis, was administered GOHIBIC (vilobelimab) in line with the emergency use authorization and died in the ICU due to complications from COVID-19 disease (i.e., patient was not discharged from the unit alive) your institution may be eligible for a full refund equal to the total price paid for the administered drug. If the product was purchased at a discount, the refund will equal the amount administered times the discounted price*.

*Additional Eligibility Requirements, Terms and Conditions apply. Please see the full Terms and Conditions below.

The InflaRx Commitment*‡:

For institutions who meet the eligibility requirements, the cost of GOHIBIC will be refunded for up to six (6) administered inpatient doses (this can include a maximum of one dose prepared for infusion, no more than 24 hours in advance of next scheduled dose, and not utilized) **‡ for patients who had a positive COVID-19 diagnosis, were administered GOHIBIC in line with the emergency use authorization (i.e.; Healthcare Provider Fact Sheet) and died in the ICU (i.e., patient was not discharged from the unit alive) due to complications from COVID-19 disease. Patient must have died in the same ICU in which the drug was administered.

** 6 doses = one complete course of treatment

‡ Updated 4/2024 to include the following statement regarding administered/prepared doses eligible for reimbursement: ‘the cost of GOHIBIC will be refunded for up to six (6) administered inpatient doses (this can include a maximum of one dose prepared for infusion, no more than 24 hours in advance of next scheduled dose, and not utilized)’

IMPORTANT TO NOTE:

GOHIBIC must be administered according to the FDA-authorized labeling (Healthcare Provider Fact Sheet/Prescribing Information).
The refund amount will be based on what was paid for the administered product/actual acquisition cost.
A refund will not be provided if the product was obtained via a donation program (i.e., the product was donated to the institution).

*Additional Eligibility Requirements, Terms and Conditions apply. Please see the full Terms and Conditions below.

ELIGIBILITY OVERVIEW*

Patient must have had a positive COVID-19 diagnosis, was administered GOHBIC in line with the emergency use authorization and must have died in the ICU (i.e., patient was not discharged from the ICU alive) where GOHIBIC treatment was administered.
GOHIBIC must be administered in the 50 United States, District of Columbia, or Puerto Rico and administered according to its FDA-authorized labeling (Healthcare Provider Fact Sheet).

*Additional Eligibility Requirements, Terms and Conditions apply. Please see the full Terms and Conditions below.

FILING A CLAIM*

To file a claim, you must fully complete and sign the Program Claim Form, Hospital Declarations and Authorizations Form, and Physician Attestation Form (available for download below) within 90 days following the date of the related patient’s death.

You can submit the forms by:

EMAIL: InflaRxCommitment@inflarx.com

FAX: 1-734-249-5300

For questions, please call 1-(888) 618-7445. The information you provide will be used by InflaRx’s administrator to determine eligibility and administer program claims.

*Additional Eligibility Requirements, Terms and Conditions apply. Please see the full Terms and Conditions below.

TO SUCCESSFULLY FILE A CLAIM, THE FOLLOWING 3 FORMS MUST BE COMPLETED AND SUBMITTED:

Commitment Claim Form

this form enables you to submit the required documentation needed for filing a claim.

THE COMMITMENT CLAIM FORM

Hospital Declarations and Authorizations Form

this form certifies that administration of GOHIBIC (vilobelimab) was aligned with the FDA authorized labeling and the Terms and Conditions of the program.

HOSPITAL DECLARATIONS AND AUTHORIZATIONS FORM

Physician Attestation Form

this form includes required details provided by the physician and includes consent to proceed with the processing of the claim.

PHYSICIAN ATTESTATION FORM

Overview of Program

For institutions who meet the eligibility requirements, the cost of GOHIBIC will be refunded for up to six (6) administered inpatient doses (this can include a maximum of one dose prepared for infusion, no more than 24 hours in advance of next scheduled dose, and not utilized) **‡ for patients who had a positive COVID-19 diagnosis, were administered GOHIBIC in line with the emergency use authorization and died in the ICU (i.e., patient was not discharged from the unit alive) due to complications from COVID-19 disease. Patient must have died in the same ICU in which the drug was administered.

GOHIBIC must be administered according to the FDA-authorized labeling (Healthcare Provider Fact Sheet). The refund amount will be based on what was actually paid for the administered product/actual acquisition cost. A refund will not be provided if the product was obtained via a donation program (i.e., the product was donated to the institution).

*Additional Eligibility Requirements, Terms and Conditions apply. Please see the full Terms and Conditions below.

** 6 doses = one complete course of treatment

Medication Eligible for the Program

GOHIBIC (vilobelimab)

*Terms and Conditions

InflaRx (referred to as “us”, “we” and similar terms) is proud to offer the InflaRx Commitment Program (the “Program”) to each institution that purchases GOHIBIC (referred to as “you”, “your” and similar terms) and who meets the Eligibility Requirements and follows the Benefit Request Process described below (the “Terms”). You should carefully review these Terms. Coverage is subject to certain terms, conditions, and limitations, including limitations on the amount of coverage.

*Eligibility Requirements

To be eligible to use the Program, the following criteria* must be satisfied as listed below:

GOHIBIC was administered in the 50 United States, District of Columbia, or Puerto Rico to a patient within the inpatient/institutional setting.
GOHIBIC was administered in accordance with its Food and Drug Administration (FDA) Emergency Use Authorization (authorized labeling) and Healthcare Provider Fact Sheet. GOHIBIC is authorized for the treatment of coronavirus disease 19 (COVID-19) in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO). GOHIBIC is not FDA-approved for this use.
Patient must have a positive COVID-19 diagnosis.
Patient died in the Intensive Care Unit (ICU) due to complications from COVID-19 disease while actively being treated with GOHIBIC or following administration of all 6 doses of GOHIBIC.
Patient must have died in the same ICU in which the drug was administered.
You purchased all doses of GOHIBIC administered to the patient directly from an InflaRx authorized distributor.
You have not requested reimbursement from any third party (e.g., insurance company, Medicaid, Medicare, patient, etc.) for the acquisition cost of GOHIBIC treatment subject to the Program.
GOHIBIC treatment administered in an out-patient setting is not eligible for the program.
The first dose of GOHIBIC must be administered on or after January 1, 2024.
You must submit proof of purchase and acquisition cost for all administered GOHIBIC doses subject to the program claim.
Institution must submit all Claims Information (as described below) within ninety (90) days following the patient becoming a non-responder to GOHIBIC (i.e. the date of the patient´s death).
Costs other than the acquisition price of the administered doses of GOHIBIC will not be reimbursed (i.e., administration costs).
You will fully and accurately report the amount refunded to you as part of the Program in the applicable cost reporting mechanism or claim for payment filed with the Department of Health and Human Services or a state Medicaid agency. Furthermore, you will provide, upon request by the Secretary of the Department of Health and Human Services or a state Medicaid agency. Furthermore, you will provide, upon request by the Secretary of the Department of Health and Human Services or a state Medicaid agency, information provided to by us or our partners regarding the amount returned to you under the Program.

Benefit Request Process

To be eligible for a refund under this Program, you must satisfy the requirements above and submit the information below (the “Claims Information”), within ninety (90) days following the date of the related patient’s death.

Download the 3 required forms (i.e., Commitment Claim Form, a Hospital Declarations and Authorizations Form, and a Physician Attestation Form) from this website.
You will then need to return a fully completed and signed (i) Commitment Claim Form, (ii) Hospital Declarations and Authorizations Form, and (iii) Physician Attestation Form in accordance with their instructions via one of the following:

EMAIL: InflaRxCommitment@inflarx.com
FAX: 1-734-249-5300

For questions, please call 1(888)618-7445. The information you provide will be used by InflaRx’s administrator to determine eligibility and administer program claims.
If your Claims Information passes the verification process, we will notify you via email and telephone that you have been approved for coverage.
If your Claims Information does not pass the verification process, we will notify you via telephone and email that your Request has been denied and the email will include the reason for the denial (such as, incomplete information, mismatched information, etc.).

You will be given the opportunity to resubmit your Claims Information within thirty (30) days of the email notification.

*Additional Terms and Conditions

We reserve the right to modify the processes, procedures, parameters, or other terms of the Program, or terminate the Program entirely, at any time, without prior notice to you. If we terminate the Program, we will continue to honor valid claims related to initial doses of GOHIBIC, administered by the physician, dispensed during the Coverage Period, unless prohibited by law. The current status of the Program and applicable terms are available on this website.

LIMITATION OF LIABILITY

IN NO EVENT, UNDER ANY CAUSE OF ACTION OF THEORY OF LIABILITY, SHALL INFLARX, ITS DISTRIBUTORS OR SUPPLIERS BE LIABLE TO YOU OR ANY THIRD PARTY FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES, OF ANY NATURE WHATSOEVER, ARISING OUT OF OR IN CONNECTION WITH THE PROGRAM, EVEN IF INFLARX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

NOTWITHSTANDING ANY DAMAGES THAT YOU MIGHT INCUR FOR ANY REASON WHATSOEVER INCLUDING, WITHOUT LIMITATION, ALL DAMAGES REFERENCED HEREIN AND ALL DIRECT OR GENERAL DAMAGES IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, THE ENTIRE AGGREGATE LIABILITY OF INFLARX AND ANY OF ITS DISTRIBUTORS AND/OR SUPPLIERS SHALL BE LIMITED TO THE MAXIMUM AMOUNT SET FORTH ABOVE FOR THE PRODUCT THAT IS SUBJECT TO THE PROGRAM.

SOME STATES AND/OR JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO YOU. THE LIMITATIONS OF LIABILITY SET FORTH ABOVE SHALL APPLY TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAW.

ARBITRATION:

Read the following arbitration provision (“Provision”) carefully. It limits certain of your rights, including your right to obtain relief or damages through court action.

Any claim brought under this Program is subject to Arbitration. Either you or we must make a written demand to the other party for arbitration for the applicable claim (“Claim”). The Arbitration will take place before a single arbitrator. It will be administered in keeping with the Expedited Procedures of the Commercial Arbitration Rules (“Rules”) of the American Arbitration Association (“AAA”) in effect when the Claim is filed. You may get a copy of these AAA’s Rules by visiting www.adr.org. The filing fees to begin and carry out arbitration will be shared equally between you and us. This does not prohibit the arbitrator from giving the winning party their fees and expenses of the arbitration. Unless you and we agree, arbitration will take place in the county and state where you live. The Federal Arbitration Act, 9 U.S.C. Ch. 1, et seq., will govern and not any state law on arbitration. YOU AGREE AND UNDERSTAND THAT this arbitration provision means that you give up your right to go to court on any Claim covered by this provision. You also agree that any arbitration proceeding will only consider your Claim. Claims by, or on behalf of, other individuals will not be arbitrated in any proceeding that is considering your Claims.

THE DEGREE TO WHICH ARBITRATION CAN BE USED AS A DISPUTE RESOLUTION PROCESS FOR CONSUMER CLAIMS VARIES FROM STATE TO STATE, SO THIS ARBITRATION PROVISION MAY NOT APPLY TO YOU, DEPENDING ON YOUR STATE OF RESIDENCE. In the event this Arbitration provision is not approved by the appropriate state regulatory agency, and/or is stricken, severed, or otherwise deemed unenforceable by a court of competent jurisdiction, you and us specifically agree to waive and forever give up the right to a trial by jury. Instead, in the event any litigation arises between you and us, any such lawsuit will be tried before a judge, and a jury will not be impaneled or struck.

GOHIBIC has not been approved but has been authorized for emergency use by FDA under an EUA, for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).

The emergency use of GOHIBIC is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization revoked sooner.

AUTHORIZED USE FOR GOHIBIC

Fact Sheet for Patients and Caregivers

FDA Emergency Use Authorization Letter

Fact Sheet for Healthcare Providers

FDA Emergency Use Authorization (EUA) for Vilobelimab (FX-1) Center for Drug Evaluation and Research (CDER) Review

IMPORTANT SAFETY INFORMATION

Contraindications: No contraindications have been identified based on limited available data on emergency use of GOHIBIC authorized under this EUA

Warnings and Precautions: There are limited clinical data available for GOHIBIC. Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC use

Serious Infections: Serious infections due to bacterial, fungal, and viral pathogens have been reported in patients with COVID-19 receiving GOHIBIC. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC. There is limited information regarding the use of GOHIBIC in patients with COVID-19 and concomitant active serious infections. The risks and benefits of treatment with GOHIBIC in COVID-19 patients with other concurrent infections should be considered.

Hypersensitivity Reactions: Hypersensitivity reactions have been observed with GOHIBIC. If a severe hypersensitivity reaction occurs, administration of GOHIBIC should be discontinued and appropriate therapy initiated.

Adverse Reactions: The most common adverse reactions (adverse events reported with incidence ≥3% and >1% more commonly observed than in the placebo arm) are pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, herpes simplex, enterococcal infection, bronchopulmonary aspergillosis, hepatic enzyme increased, urinary tract infection, hypoxia, thrombocytopenia, pneumomediastinum, respiratory tract infection, supraventricular tachycardia, constipation, and rash.

USE IN SPECIFIC POPULATIONS

Pregnancy

There are no available data on GOHIBIC use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as GOHIBIC is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. In an enhanced pre- and post-natal (ePPND) study conducted in cynomolgus monkeys, placental transport of GOHIBIC was observed but there was no evidence of fetal harm following intravenous administration of GOHIBIC throughout pregnancy at doses 2.5 times the maximum recommended human dose (MRHD) of 800 mg on a mg/kg basis (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk for major birth defects and miscarriage in clinical recognized pregnancies are 2%–4% and 15%–20%, respectively.

Pediatric Use

GOHIBIC is not authorized or approved for the emergency use in pediatric patients for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized patients when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).

Geriatric Use

Of the total number of GOHIBIC-treated patients in clinical studies for COVID-19 receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO), 53 (30%) were >65 years. No overall differences in effectiveness or safety of GOHIBIC have been observed between patients 65 years of age and older and younger adult patients.

For additional information, please see:

Fact Sheet for Healthcare Providers: Emergency Use Authorization for GOHIBIC (fda.gov)

Fact Sheet for Patients and Caregivers (fda.gov)

Required Reporting for Serious Adverse Events and Medication Errors

The prescribing healthcare provider and/or the provider's designee is/are responsible for mandatory reporting of all serious adverse events (SAEs) and medication errors potentially related to GOHIBIC within 7 calendar days from the healthcare provider's awareness of the event.

To report adverse events and medication errors, complete and submit FDA Form 3500 to MedWatch online at http://www.fda.gov/medwatch/report.htm, or download FDA Form 3500 at https://www.fda.gov/media/76299/download and mail the completed form to MedWatch at 5600 Fishers Lane, Rockville, MD 20852-9787 or fax it to 1-800-FDA-0178. You may also request a reporting form by calling 1-800-FDA-1088.

In addition, please provide a copy of all FDA MedWatch forms to:
InflaRx GmbH Fax: 1-866-728-2630

Email: pvusa@inflarx.de, or call InflaRx GmbH at 1-888-254-0602 to report AEs

IMPORTANT TO NOTE: Submitted reports must state, "GOHIBIC use for COVID-19 under Emergency Use Authorization" at the beginning of the question "Describe Event" for further analysis. A copy of the completed FDA Form 3500 must also be provided to InflaRx per the instructions in the authorized labeling.

REFERENCE: ¹ GOHIBIC Fact Sheet for Healthcare Providers, InflaRx GmbH. April 2023. https://www.fda.gov/media/166824/download

Updated 4/2024.