Monoclonal antibody treatments are authorized under Emergency Use Authorization (EUA) for the treatment of mild-to-moderate COVID-19 in high-risk adult patients and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing.

Please find below resources and common FAQs regarding these treatment options, including patient criteria and how to find nearby infusion sites.

1. What are neutralizing monoclonal antibodies?

Neutralizing monoclonal antibodies are laboratory-made antibodies that are similar to the antibodies of patients who have recovered from COVID-19. Scientists think these antibodies may help limit the amount of virus in a patient’s body, giving his/her body more time to learn how to make its own antibodies. Monoclonal antibodies do not have any COVID-19 virus or viral RNA in them.

Individuals 12 or older may qualify for a monoclonal antibody treatment if they have certain age-based risk factors.

First, the patient must be able to check ALL of the boxes below.

Next, the patient must meet ONE of the criteria for his/her age group below.

While there are some similarities, there are three main ways in which antibodies differ from vaccines. First, when given to infected patients, these neutralizing monoclonal antibodies can transfer a type of immunity to the patient, which is referred to as passive immunity. This may help fight the infection before the immune system builds up a response to the virus, which is called adaptive immunity. Vaccines provide active immunity by helping the body make its own antibodies to protect itself. Neutralizing monoclonal antibodies also work more quickly than vaccines, but the immunity they convey is of a limited duration compared to that of vaccines. Third, scientists are able to develop antibody treatments faster than they are able to develop vaccines. For more information on treatments for COVID-19, including antibodies and vaccines, you can visit LillyAntibody.com or combatcovid.hhs.gov.

Doses can vary between individual neutralizing monoclonal antibodies, but are likely based on their potential clinical effect to reduce viral load and neutralize virus for a sufficient period of time.

If you are treating a patient who is high-risk and has begun experiencing symptoms of COVID-19, an antibody treatment could be an option, and may reduce patient symptoms and/or the risk of being hospitalized. In order to be eligible for this type of treatment, patients must have tested positive for SARS-CoV-2 and be within 10 days of symptom onset. If together you and your patient decide to pursue an antibody treatment, you can find infusion centers HERE.

Monoclonal antibody treatments should be administered within 10 days of symptom onset and before a patient has been hospitalized due to COVID-19. For more information, you can visit CombatCOVID.hhs.gov.

Monoclonal antibodies are administered through a single intravenous infusion (IV). The infusion duration will depend on the size of the prefilled IV bag that is used. Patients must be monitored for at least 60 minutes following the infusion.

You can click HERE to find an infusion site tracker by city and state.

Through the federally-run distribution program, antibody treatments are purchased by the federal government and offered at no cost to states, sites of care, or patients. Services and ancillary expenses necessary to administer the infusion are the responsibility of the individual site of care and can be billed according to published Centers for Medicare & Medicaid Services (CMS) guidance.

A patient who meets the criteria for an antibody treatment will need an order from a healthcare provider. The process includes the following steps:

Step 1: The healthcare provider must confirm that the patient meets the criteria to receive an antibody treatment.

Step 2: The healthcare provider should locate a nearby infusion center.

Step 3: The healthcare provider should discuss with staff at the infusion site regarding the preferred method for prescribing treatment. In some cases, the patient’s HCP will write the order. In other cases, an HCP at the infusion site will write the order.

Neutralizing monoclonal antibody treatments authorized for emergency use by the U.S. Food and Drug Administration (FDA) are still being studied. Therefore, serious and unexpected adverse events may occur that have not been previously reported with neutralizing monoclonal antibody use. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of neutralizing monoclonal antibodies. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy. For more information regarding side effects of monoclonal antibody treatments, please refer to combatcovid.hhs.gov.

CMS is updating the set of toolkits for providers, states and insurers to help the health care system swiftly administer monoclonal antibody treatment with these new Medicare payment rates on the Monoclonal Antibody COVID-19 Infusion webpage.

In addition, CMS is updating coding resources for providers on the COVID-19 Vaccines and Monoclonal Antibodies webpage.

Access the chart and learn more.

The “Pfizer Regional Hubs” are within specified local health departments. These local health departments maintain stock of Pfizer vaccine to support access for the eligible ages, and for the vaccine to be shared with other COVID-19 vaccine providers who need access to this vaccine and can manage it appropriately. If partners reach out to request Pfizer vaccine from a Pfizer Regional Hub, such requests should be directed to the key immunization staff at that hub, most importantly, the Immunization Action Plan (IAP) Coordinator. IAPs are key facilitators of this process, as they are able to oversee review of current supplies and requests, and follow through appropriately (www.Michigan.gov/LHDmap).

 

 

Requests should be made with consideration of minimizing waste but with an emphasis on maximizing access for patients. MDHHS’s focus for immunizing providers is to ensure that when vaccine is on-hand, there are no missed opportunities for vaccination when an eligible patient presents.

Regional hubs cannot assume responsibility for providing transport to/from a requesting site, nor can they guarantee having supply on-hand to meet all requests. It is the requestor’s responsibility to contact the regional hub to assess vaccine availability and to perform appropriate transport of vaccine for redistribution. The regional hub must have a Redistribution Agreement in place and can ONLY support sites that are currently enrolled as a Michigan COVID-19 Vaccination Provider. When transporting vaccine, this must be done appropriately with qualified vaccine transport methods and using a digital data logger. The requestor must ensure all storage, handling and documentation requirements are in place prior to seeking out a request.

 

 

COVID-19 Vaccine Providers are urged to utilize the public display option of VaccineFinder so that the public can easily locate COVID-19 vaccine nearby; this would also ensure the public can identify providers that have Pfizer vaccine in-stock if they need to obtain vaccine for age 12 – 18 years. Information on promoting public display of vaccine available can be found here.