Monoclonal Antibody Treatment Chart
| Outpatient Treatment | Hospital Treatment | Post Exposure & High Risk | Prevention and High Risk | |
| Sotrovimab | X | |||
| Tocilizumab | X | |||
| Tixagevimab and cilgavimab (Evusheld) | X | |||
| Bebtelovimab | X | X |
What are the dangers of monoclonal antibodies?
Monoclonal antibody infusion therapy is used to treat a person who has COVID-19. The medicine used during this treatment is called the Regeneron cocktail (a mix of two antibodies: casirivimab and imdevimab). The Regeneron cocktail is an “investigational” medicine. This means it is still being studied and not all of the risks are known at this time.
What to expect from monoclonal antibody treatment?
Aug 31, 2021 · Monoclonal antibody therapy needs to be given as soon as possible after symptoms start to work—ideally within 4 days and no longer than seven days. To find out if you are at high risk and eligible for COVID 19 Monoclonal Antibody infusion therapy, please call the UNC COVID Help Line at 888-850-2684, between 8 a.m. and 5 p.m., 7 days a week.
Are there side effects of monoclonal antibody treatment?
Feb 17, 2022 · Antibodies designed to attack COVID-19 have been developed, and in several studies have been shown to reduce the risk of progressing to severe COVID-19 and hospitalization when given early to people who test positive for COVID-19. This therapy is given as an infusion through an IV at one of the UNC Health infusion centers.
Do monoclonal antibodies interfere with natural immunity?
Monoclonal antibodies, or mAbs, are made in a laboratory to fight a particular infection (in this case, SARS-CoV-2) and are given to you directly in an infusion. So the mAb treatment may help if you are at high risk for serious symptoms or a hospital stay. The mAb treatment for COVID-19 is different from a COVID-19 vaccine.
What is a monoclonal antibody for COVID-19?
Monoclonal antibodies are laboratory-produced molecules that act as substitute antibodies that can restore, enhance or mimic the immune system's attack on cells. Monoclonal antibodies for COVID-19 may block the virus that causes COVID-19 from attaching to human cells, making it more difficult for the virus to reproduce and cause harm. Monoclonal antibodies may also neutralize a virus.Mar 31, 2022
Who could benefit from monoclonal antibody therapy to prevent COVID-19?
See full answerVaccines are the best way to protect against COVID-19. But some people with weakened immune systems do not produce enough antibodies after vaccination, and others are severely allergic to the vaccine. The FDA recently authorized Evusheld, a pre-exposure prophylaxis (PrEP) monoclonal antibody therapy developed by AstraZeneca, which should help prevent COVID-19 in these populations.To be eligible for Evusheld, individuals must be 12 years or older and have a moderately to severely weakened immune system, or have a history of severe adverse reactions to the COVID-19 vaccine or its components. In addition, the therapy cannot be given to someone with a current SARS-CoV-2 infection, or who has been recently exposed to someone who is infected. Evusheld is given as two consecutive shots, and evidence suggests it can help prevent symptomatic infection for at least six months.Apr 1, 2022
What is the difference between monoclonal antibodies and the COVID-19 vaccine?
COVID-19 vaccines help stimulate and prepare a person's immune system to respond if they are exposed to the virus. However, monoclonal antibodies boost the immune system only after a person is already sick, speeding up their immune response to prevent COVID-19 from getting worse.Nov 8, 2021
How many types of monoclonal antibody COVID-19 treatments are there in the US?
In the United States, there are three anti-SARS-CoV-2 monoclonal antibody treatments with FDA Emergency Use Authorization (EUA) for the treatment of COVID-19: bamlanivimab plus etesevimab, casirivimab plus imdevimab,, and sotrovimab.
Is there a monoclonal antibody therapy for post COVID-19 exposure?
FDA authorizes bamlanivimab and etesevimab monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19 | FDA.Sep 16, 2021
Are antibodies beneficial during the COVID-19 pandemic?
When reinfections or breakthrough infections happen, having antibodies plays an important role in helping prevent severe illness, hospitalization, and death. For many diseases, including COVID-19, antibodies are expected to decrease or “wane” over time.Nov 10, 2021
Can I get the COVID-19 vaccine if I was treated with monoclonal antibodies or convalescent plasma?
If you were treated for COVID-19 symptoms with monoclonal antibodies or convalescent plasma, you should wait 90 days before getting a COVID-19 vaccine.
What is a monoclonal antibody?
Monoclonal antibodies are laboratory-produced molecules that act as substitute antibodies that can restore, enhance or mimic the immune system's attack on cells.Mar 31, 2022
Do I need the COVID-19 vaccine if I still have antibodies?
Yes, the COVID-19 vaccines are recommended, even if you had COVID-19.Nov 23, 2021
Which drug is approved by FDA to treat COVID-19?
Veklury (Remdesivir) is an antiviral drug approved for use in adults and pediatric patients [12 years of age and older and weighing at least 40 kilograms (about 88 pounds)] for the treatment of COVID-19 requiring hospitalization.Mar 31, 2022
How many types of COVID-19 vaccines are available in the US?
Three COVID-19 vaccines are authorized or approved for use in the United States to prevent COVID-19. Pfizer-BioNTech or Moderna (COVID-19 mRNA vaccines) are preferred. You may get Johnson & Johnson's Janssen COVID-19 vaccine in some situations.
What is the first drug that was approved by the FDA to treat COVID-19?
Remdesivir is the first drug approved by the FDA for treatment of hospitalized COVID patients over the age of 12.Jan 25, 2022
What Are Monoclonal Antibodies?
Antibodies are part of our natural defense against viruses such as SARS-CoV-2, the virus that causes COVID-19. But they take time for the body to make.
Are You High Risk for Severe COVID-19 and Eligible?
The criteria for patients to be considered for Monoclonal Antibody infusion therapy are:
What Are Monoclonal Antibodies?
Antibodies are part of our natural defense against viruses such as SARS-CoV-2, the virus that causes COVID-19. But they take time for the body to make.
Are You High Risk for Severe COVID-19 and Eligible?
There are two situations in which you may be eligible to receive monoclonal antibodies:
WHAT IS A MONOCLONAL ANTIBODY?
Your body naturally makes antibodies to fight infection. However, your body may not have antibodies designed to recognize a novel (or new) virus like SARS-CoV-2, the virus that causes COVID-19.
How Can I Get Monoclonal Antibodies?
To receive a mAb you should be referred for treatment by your healthcare professional and directed to available infusion locations. If you do not have a healthcare provider, call the Combat COVID Monoclonal Antibodies Call Center at 1-877-332-6585 to find out who to talk with about your symptoms and treatment.
WHAT IF I DO NOT QUALIFY FOR MONOCLONAL ANTIBODY TREATMENT?
Your healthcare professional may decide you do not qualify for mAb treatment. There could be several reasons for this. You may not meet all eligibility criteria or you may have an underlying health condition that disqualifies you for mAb treatment.
WHAT CAN I EXPECT FROM TREATMENT (INFUSION)?
The mAb treatment is usually offered at an infusion center because the treatment is given through an intravenous (IV) infusion or shots. Depending on the mAb treatment you receive, the whole process takes about 1-3 hours, depending on the treatment..
CAN MONOCLONAL ANTIBODY TREATMENT MAKE ME SICK?
Antibody treatments do not contain any live SARS-CoV-2, so there is no risk you will get COVID-19 from mAb treatment. However, the antibody treatment may have side effects:
What antibody is used to block the virus?
Monoclonal antibodies against COVID-19 attach to the virus to block it from entering human cells. The monoclonal antibody protein also “marks” the virus to be broken down by the immune system and cleared from the body.
Can monoclonal antibodies cause nausea?
Most people tolerate monoclonal antibody infusions very well. Some people may experience infusion-related side effects, such as nausea and dizziness, that are short-lived and go away on their own. As with any medication, there is the potential for mild or more severe allergic reactions, which are uncommon.
What is the EUA for bamlanivimab?
On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy, bamlanivimab, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. Review the Fact Sheet for Health Care Providers EUA of Bamlanivimab regarding the limitations of authorized use.
Can you use bamlanivimab in emergency settings?
Bamlanivimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.
What are monoclonal antibodies?
Antibodies are naturally produced by your body to fight off infections. When your body is introduced to a new virus such as COVID-19, it does not have the antibodies to fight it off. That is where monoclonal antibodies come in. Monoclonal antibodies are created in a laboratory. They can target a particular virus or infection such as COVID-19.
How does monoclonal antibody therapy work?
Monoclonal antibodies are given by IV or a single-dose injection to people diagnosed with COVID-19. This therapy uses COVID-19 antibodies to help a person’s body fight off the infection. The injection is a lower dosage than the infusion therapy.
What monoclonal antibody therapies for COVID-19 are available?
The Food and Drug Administration (FDA) has approved emergency use authorization for five antibody infusion therapies:
Is monoclonal antibody therapy effective against the Omicron variant?
So far, it appears only one of the monoclonal antibody treatments – sotrovimab – is effective against the Omicron variant for outpatient treatment. Most of the other monoclonal antibody treatments have limited or no effectiveness against the Omicron variant .
Who should get monoclonal antibody therapy?
Monoclonal antibody treatment is now available for three specific uses:
Who is at high risk for severe illness from COVID-19?
While anybody can get very sick or even die from COVID-19, those most at risk include:
What COVID-19 treatment is available for people diagnosed with COVID-19?
If you are diagnosed with COVID-19 but aren’t sick enough to be hospitalized, you may think there isn’t much you can do. It is important to:
What are monoclonal antibodies?
Our bodies naturally make antibodies to fight infections. However, if you haven’t received the COVID-19 vaccine or had a previous COVID-19 infection, your body will not have antibodies designed to recognize a new virus like SARS-CoV-2.
How does monoclonal antibody therapy help?
Monoclonal antibody therapy is a way of treating COVID-19 for people who have tested positive, have had mild symptoms for seven days or less, and are at high risk for developing more serious symptoms.
Who is eligible for monoclonal antibody therapy?
Given that COVID-19 vaccination provides strong protection against severe disease and need for hospitalization, monoclonal antibody therapy is an option for certain high-risk patients with COVID-19.
Frequently Asked Questions
The following frequently asked questions will prepare providers for common questions about monoclonal antibody treatment cost and coverage in the outpatient setting. Other options are available for inpatient settings. 1
Additional Resources
Additional CMS guidance on coding, billing, payment allowances, and effective dates for COVID-19 Monoclonal Antibodies and their Administration During the Public Health Emergency:
