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Monoclonal Therapeutics

What are monoclonal antibodies? 

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. A side-by-side comparison of the therapeutics is available from HHS.

This video, from HHS Combat COVID, provides an overview of monoclonal antibodies and how they can help high-risk patients. 

Patients interested in receiving monoclonal antibodies should contact their primary care provider.

What types of patients can benefit from treatment with monoclonal antibodies? 

Monoclonal antibodies are a treatment option to consider for people who have met all of the following criteria (see below for criteria specific to Evusheld):

  • A positive COVID-19   
  • Within 10 days of symptom onset.
  • At increased risk for severe COVID-19 or hospitalization (risks include age, vaccination status, or certain medical conditions).

Product-Specific exception Evusheld (tixagevimab and cilgavimab):

AstraZeneca’s FDA emergency use authorization (Evusheld) is for the pre-exposure prophylaxis (prevention) of COVID-19 in certain individuals 12 and older who do not currently have COVID-19 and have not recently been exposed to someone with COVID-19. Individuals may be eligible for this pre-exposure prevention treatment if they are moderate to severely immunocompromised and may not mount an adequate immune response to COVID-19 vaccination, or have a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) and are unable to get vaccinated. Evusheld is the only monoclonal antibody therapy that helps prevent COVID-19 infection before exposure to the virus. Pre-exposure prevention with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Evusheld can be administered as two separate consecutive intramuscular injections at a healthcare facility.

In Ohio, a patient must have a prescription order to receive monoclonal antibodies. Providers are strongly encouraged to ensure compliance with requirements for monoclonal ordering and administration under state law and the Public Readiness and Emergency Preparedness Act (PREP Act).

Monoclonal antibody treatment is still relatively new under emergency use authorization (EUA) and is recommended only for those at high risk for severe disease.  

  • Risk is generally based on age, specific comorbidities by age group (e.g., kidney disease, diabetes, cardiovascular disease, chronic respiratory disease, etc.) and/or a body mass index greater or equal to 25. Evaluating risk based upon these factors helps to ensure the treatments are being made available safely and to the Ohioans who need them the most.
  • The Centers for Disease Control and Prevention (CDC) website provides a list of risk factors for severe illness from COVID-19 on the webpage Underlying Medical Conditions Associated with High Risk for Severe COVID-19. The likelihood of developing severe COVID-19 increases when a person has multiple comorbidities.
  • Supplies of the treatments are limited.

Currently authorized monoclonal therapeutics

Clinicians who wish to consider or recommend use of these therapies should review the COVID-19 Treatment Guidelines published by the National Institutes of Health (NIH) as well as the FDA EUA for each therapy.

A number of these treatments are intended for outpatient intravenous infusion, so clinicians and health systems should be prepared to provide care in a location and manner in which patients with COVID-19 can be safely managed.

Currently available monoclonal antibodies include:

The list of monoclonal therapeutic options is subject to change as new research becomes available, and as the FDA provides EUAs for other therapeutics for the treatment of COVID-19.

Where can a patient find monoclonal antibodies? 

Once a high-risk individual is diagnosed, they need to know where they can go to get a monoclonal antibodies infusion.

Many hospitals, health systems, and independent providers are available throughout the state, and can provide an infusion or subcutaneous administration with a physician order or referral. Providers should check with their associated health systems to determine availability.

Additionally, this site allows healthcare providers to locate the nearest therapeutics locations: 

How can I become a provider who administers monoclonal antibody therapeutics?

Administration of monoclonal antibody therapeutics can occur across a wide variety of providers, including:

  • Hospitals (hospital-based infusion centers)
  • Ambulatory centers (Infusion centers, independent clinics)
  • Nursing Homes (SNF/LTCF)
  • Home Health Providers

Providers interested in becoming an administration site should complete this provider enrollment form to enroll.  Sites may also email therapeutics@odh.ohio.gov for additional information.

Additional information

 

 

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