Learn about the latest guidance for the use of monoclonal antibody therapy during the COVID-19 pandemic. This post is updated regularly. Last updated: March 1, 2022.
As of January 2022, FDA has paused two monoclonal antibody infusion therapies (casirivimab plus imdevimab / etesevimab plus bamlanivimab) that do not work against the dominant Omicron variant. In addition, some states have advised providers to stop prescribing monoclonal antibodies that do not work against Omicron.
There are also guidelines for some states on prescribing sotrovimab due to supply issues.
For many of us, it may seem like COVID-19 has been with us for ages. So you might be asking, after all this time, if there is any effective treatment for those who do get sick.
It is important to remember that the virus is still relatively new. It was first identified in December of 2019 in Wuhan, China. It was declared a global pandemic in March of 2020. With new diseases it takes time for scientists to study them and develop treatments.
The good news is that there are some promising treatments being used to combat the virus. One of them is monoclonal antibody infusion therapy.
NOTE: Monoclonal antibody therapies are free of charge, though there may be a fee from the healthcare provider for administering the dose.
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.
Research suggests these antibodies lower the amount of virus — the “viral load” — in a person’s body. People with lower viral loads have more mild symptoms. Reducing the viral load may help prevent hospitalization and death.
What monoclonal antibody therapies for COVID-19 are available?
The Food and Drug Administration (FDA) has approved emergency use authorization for four antibody infusion therapies:
- A combination of tixagevimab and cilgavimab
Sotrovimab and Bebtelovimab are outpatient treatments for mild to moderate COVID-19 in adults and children 12 years of older and weighing at least 88 pounds. These patients are at high risk for severe COVID-19, including hospitalization and death.
Tocilizumab is an in-patient treatment for hospitalized adults and children 2 years of age and older who are receiving systemic corticosteroids and require supplemental oxygen or ventilation.
The combination tixagevimab and cilgavimab (called EVUSHELD) is for prevention of COVID-19 in certain adults and children 12 years of age or older and weighing at least 88 pounds. These patients may be immunocompromised due to a medical condition or due to taking immunosuppressive medications or treatments; or cannot take the COVID-19 vaccine due to a history of severe allergic reactions to components of the vaccine.
In January 2022, FDA removed emergency use authorization for the combinations of casirivimab plus imdevimab and etesevimab plus bamlanivimab. Studies showed these monoclonal antibody therapies were not effective in treating the Omicron variant.
Find public locations where COVID-19 monoclonal antibody treatments are available.
Visit the COVID-19 Therapeutics Locator.
|Outpatient Treatment||Hospital Treatment||Post Exposure & High Risk||Prevention and High Risk||Effective Against Omicron BA.1||Effective Against Omicron BA.2|
|Tixagevimab and cilgavimab (Evusheld)||X||Yes||Yes|
Looking at this chart on a mobile phone? Scroll with your finger to see all the treatment options.
Is monoclonal antibody therapy effective against the Omicron variant?
Medical researchers have identified subvariants of the Omicron variant. Omicron BA.1 was the dominant COVID-19 variant in late 2021. Omicron BA.2 emerged in early 2022.
Some monoclonal antibody treatments are effective against one subvariant, while others are effective against both.
The monoclonal antibody treatment Sotrovimab is effective against Omicron BA.1 but not Omicron BA.2.
Bebtelovimab is the only monoclonal antibody treatment effective against both Omicron subvariants.
In addition, the combination of rixagevimab and cilgavimab (Evusheld) is effective against both subvariants of Omicron, but it is authorized only for prevention and not treatment.
The new COVID pills that recently received emergency use authorization are also effective in treating the Omicron variant.
Who should get monoclonal antibody therapy?
Monoclonal antibody treatment is now available for three specific uses:
➤ As an outpatient treatment at home who have symptoms of COVID-19 and who are at high risk for severe illness.
➤ As an outpatient preventive treatment at home to those at high risk for severe illness who have been exposed to COVID-19 but show no symptoms.
➤ As an outpatient preventive treatment at home for those at risk for severe illness to prevent developing COVID. This is known as pre-exposure prophylaxis.
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:
- People 65 years of age or older
- People 55 years or older with 1 or more of the following:>
- Heart disease
- High blood pressure
- Chronic respiratory disease, including moderate to severe asthma
- People 12 years of age or older with 1 or more of the following:
- A weakened immune system
- Taking medicine that weakens your immune system.
- Diabetes (type 1 or type 2)
- Chronic kidney disease.
- Children and adolescents 12-17 years of age and weighing more than 88 pounds with 1 or more of the following:
- Asthma/chronic respiratory problems requiring daily medication
- Often uses medical technology such as a ventilator or feeding tube
- Has a developmental condition like cerebral palsy
- Sickle cell disease
- Congenital or acquired heart disease.
Outpatient Treatment at Home
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:
- get rest
- stay hydrated
- take fever-reducing medicine, if needed
In addition, there are now two treatments available for those who have been diagnosed with COVID-19:
- Monoclonal antibodies
- COVID-19 pills
These are both currently available to people considered at high risk for severe COVID-19 as outpatient treatment. Talk with your doctor about treatment whether monoclonal antibody therapy or COVID pills are right for you. There is evidence it is effective in preventing severe illness.
When are monoclonal antibodies used for people diagnosed with COVID-19?
Monoclonal antibodies are used for people with a positive COVID-19 test and symptoms for 10 days or less. The therapy for COVID-19 works best when given early in the COVID-19 illness. This is only recommended for those considered high risk for severe illness. It is important to seek treatment early as you can only receive monoclonal antibodies if you have symptoms for less than 10 days.
How can I get monoclonal antibody infusion therapy if I have COVID-19?
Monoclonal antibodies are prescribed by a healthcare professional. Monoclonal antibodies to treat COVID-19 are given by IV infusion at an infusion center. For those at high risk or already diagnosed with COVID-19, discuss treatment options with your doctor.
How is monoclonal antibody infusion therapy given?
Monoclonal antibodies are administered by at an infusion center, some pharmacies, or even administered at home.
After the treatment is complete, the staff will monitor you for an hour. This is to watch for any signs of an allergic reaction. The whole process takes about 2-3 hours.
Where can I get monoclonal antibody treatment?
To locate monoclonal antibody treatments, you can check these websites:
Are people still contagious receiving treatment with monoclonal antibodies?
Antibody infusion therapy does not “cure” COVID-19. Even after receiving treatment, a person is still considered contagious. It is important to continue self-isolation until:
- 10 or more days have passed since you developed symptoms of COVID-19.
- You are fever-free for 24 hours without the use of fever-reducing medicine such as ibuprofen.
- Your COVID-19 symptoms are improving.
Outpatient Home Preventive Treatment
When are monoclonal antibodies used for people exposed to COVID-19 to prevent getting COVID?
Some people who are at high risk for severe illness may also be eligible for monoclonal antibody therapy if they are exposed to COVID-19. This is called post-exposure prophylaxis (PEP). Antibody therapy is given by an injection or IV when it is used to prevent COVID-19. People eligible to receive antibody therapy to prevent COVID-19 include those who:
- are not fully vaccinated;
- are at high risk of exposure to an infected individual if they live in places such as nursing homes or prisons;
- have medical conditions that may not give them full protection from the COVID-19 vaccine. This includes people who are:
- on chemotherapy or kidney dialysis
- have organ transplants
- on certain medications
For those at risk of ongoing exposure to COVID-19 or whose immune systems don’t respond to the vaccine, the therapy can be given every four weeks.
If you or a loved one meet any of these criteria, discuss with your doctor if the treatment is right for you.
When are monoclonal antibodies used to prevent COVID-19?
There is some exciting news about preventing COVID-19 infection in certain high-risk groups. AstraZeneca’s monoclonal antibody therapy, EVUSHELD (combination of tixagevimab and cilgavimab) is the only authorized therapy for prevention of COVID-19. This is sometimes also referred to as pre-exposure prophylaxis (PrEP). EVUSHELD also appears to provide protection from the Omicron variant. Evushield is given by an injection when it is used to prevent COVID-19.
Who may benefit from monoclonal antibody therapy for COVID-19 prevention?
COVID-19 vaccines have been a game changer for preventing infection and/or serious illness. However, certain groups of people don’t develop an immune response to vaccines. This includes certain cancer patients, people on dialysis, and people on immunosuppressant medications post-transplant. These patients do not develop an adequate immune response and are at high risk for serious illness. There are also certain groups of people for whom vaccination is contraindicated. So EVUSHELD is welcome news for these groups of people.
EVUSHELD has been found to be 83% effective in preventing symptomatic COVID-19. It may provide up to 6 months of protection.
What are the side effects of monoclonal antibody therapy?
People who receive monoclonal antibody treatment may experience pain at the injection or infusion site, including:
- Skin bruising
- Possible infection
More serious side effects include:
- Interferes with your body’s ability to fight off a future COVID-19 infection
- Reduces your body’s immune response to a COVID-19 vaccine
After undergoing infusion therapy, you must wait 90 days before getting a COVID-19 vaccine.
What are signs of an allergic reaction to monoclonal antibody therapy?
People can have an allergic reaction to monoclonal antibody infusion therapy. Therefore, you must be monitored by staff after treatment.
Signs of an allergic reaction to report to a healthcare professional:
- Nausea or vomiting
- Shortness of breath
- Low blood pressure
- Swelling of your lips, face, or throat
- Rash, including hives.
- Muscle aches
What treatments can be used for COVID-19 in hospitalized patients?
Doctors have developed effective treatments for hospitalized patients but none of these are monoclonal antibody treatments.
- Dexamethasone (Decadron) is a corticosteroid (like prednisone). In patients who need extra oxygen or are on a ventilator, dexamethasone can reduce risk of death.
- Remdesivir is an antiviral drug. It can be used in people over the age of 12 weighing 88 pounds or more. It can help speed up the recovery time for people with COVID-19.
- Baricitinib in combination with remdesivir is available for use in patients over the age of 2 who need respiratory support.
- Blood thinners in low doses are frequently used to prevent blood clots. Many people with COVID-19 develop them. Doctors may prescribe higher doses of blood thinners in people who are at high risk for developing blood clots.
Scientists continue to study COVID-19. They update guidance on treatments as new evidenced-based research becomes available.
Purvi Parikh, MD, FACAAI is an adult and pediatric allergist and immunologist at Allergy and Asthma Associates of Murray Hill in New York City. She is on faculty as Clinical Assistant Professor in both departments of Medicine and Pediatrics at New York University School of Medicine.
I’ve tested positive for Covid-19, now what?
There’s no way to know how you or anyone else will react to a SARS-CoV-2 infection or the COVID-19 disease. People at high risk for developing severe symptoms of COVID-19 include older adults and people with underlying conditions such as cancer, heart and lung conditions, high blood pressure, type 2 diabetes, kidney disease, obesity, sickle cell, or compromised (weakened) immune systems.
Recovering from COVID-19 can take time and patience. In one study, more than half of the patients surveyed were still feeling fatigued (very tired) 60 days after their first COVID-19 symptoms appeared, four in 10 patients still had labored breathing, and more than a quarter still had joint pain.
For full information on what to do now that you have a Covid-19 positive result, see I have Covid-19 by Combat Covid.
What are the available Covid-19 treatment options?
If you or a loved one test positive for COVID-19, you may now have treatment options. COVID-19 treatment options are available for patients with mild to moderate symptoms and for hospitalized patients. Mild symptoms may include fever, cough, sore throat, malaise (feeling unwell), headache, muscle pain, nausea, vomiting, diarrhea, and loss of taste and smell. Moderate symptoms may also include shortness of breath.
The U.S. Food and Drug Administration (FDA) has authorized treatments for emergency use. See Combat Covid for more in depth information on Covid-19 treatment options.
Monoclonal antibodies for high-risk Covid-19 positive patients
If you’ve tested positive for COVID-19, one of the first questions you may have is, What can I do to reduce the risk of getting sicker? The good news is, there are treatments that may reduce that risk. Depending on your age, health history, and how long you’ve had symptoms of COVID-19, you may qualify for a promising form of treatment for the disease. It’s called monoclonal antibody (mAb) treatment.
How do I know if I’m high risk, and what do I do next?
You or your loved one may be eligible for mAb treatment if you meet the following criteria:
- Are an adult or pediatric (≥ 12 years of age and weighing at least ≤ 40 kg) patient
- Have tested positive for COVID-19
- Are experiencing mild or moderate symptoms of COVID-19
- Experienced your first symptoms of COVID-19 in the last 10 days
- Are at high risk for having more serious symptoms of COVID-19 and/or going into the hospital
The information on How Do I Know if I’m High Risk by Combat Covid can help you decide if you or a loved one may qualify for monoclonal antibody (mAb) treatment and, if you do qualify, how you can get mAb treatment.
FAQs about monoclonal antibodies for consumers
Combat Covid answers to questions like, what are monoclonal Antibodies (mAbs), how soon does a person need to get treatment, are the treatments safe, what is being offered, and other vital information on monoclonal antibodies can be found on Combat Covid’s FAQ page.
What do I do if my loved one tests positive for Covid-19
If your loved one has tested positive for COVID-19, it can be an anxious and uncertain time for them and for you. You’ll probably have many questions. One of them may be, Are there any options to treat the disease?
The answer is yes. Depending on your loved one’s health history, how long they’ve had symptoms of COVID-19, and whether or not they’ve been hospitalized with the disease, they may be eligible for a variety of treatment options.
Frequently Asked Patient Questions About COVID-19 Monoclonal Antibody Treatments
What is monoclonal antibody treatment for COVID-19?
What is the difference between a monoclonal antibody treatment and a vaccine?
Why is monoclonal antibody treatment being recommended for me?
What is the benefit of taking monoclonal antibody treatment?
How is a monoclonal antibody treatment given?
What do I need to do after I receive monoclonal antibody treatment?
What are the possible side effects of a monoclonal antibody treatment?
Should I get monoclonal antibody treatment as soon as possible? Or should I wait to see if my symptoms get worse?
1. DHHS. Combat COVID. Accessed May 5, 2021. https://combatcovid.hhs.gov/.
2. Taylor PC, et al. Nat Rev Immunol. 2021. doi:10.1038/s41577-021-00542-x. Online ahead of print.
3. Marcotte H et al. Passive immunization. In: Mestecky J et al, eds. Mucosal Immunity. 4th ed. Vol 2. 2015:1403-1434.
4. CDC. COVID-19. Accessed January 27, 2021. https://www.cdc.gov/coronavirus/2019-nCoV/index.html.
5. National Institute of Health (NIH). Coronavirus disease 2019 (COVID- 19) treatment guidelines. Accessed May 7, 2021. https://www.covid19treatmentguidelines.nih.gov/.
6. Weinreich DM et al. N Engl J Med. 2020. doi:10.1056/NEJMoa2035002.
7. Copin R, et al. bioRxiv. 2021. [preprint] doi: https://doi.org/10.1101/2021.03.10.434834.
Coverage of Monoclonal Antibody Products to Treat COVID-19
Monoclonal antibody products to treat Coronavirus disease 2019 (COVID-19) help the body fight the virus or slow the virus’s growth. Medicare beneficiaries have coverage without beneficiary cost sharing for these products when used as authorized or approved by the Food and Drug Administration (FDA).
Expected Payment to Providers: Key Facts
Medicare payment for monoclonal antibody products to treat COVID-19 is similar across sites of care, with some small differences.
Medicare pays for the administration of monoclonal antibody products to treat COVID-19. For example, Medicare will pay a national average of approximately $310 for the administration of certain monoclonal antibody products.4
CMS will exercise enforcement discretion to allow Medicare-enrolled immunizers working within their scope of practice and subject to applicable state law to bill directly and receive direct reimbursement from the Medicare program for administering monoclonal antibody treatments to Medicare Part A Skilled Nursing Facility residents.
Medicare will pay the provider for these monoclonal antibody products when they are purchased by the provider. Medicare won’t pay if the product is given to the provider for free by, for example, a government entity.
When purchased by the provider, Medicare payment is typically at reasonable cost or at 95% of the Average Wholesale Price (an amount determined by the manufacturer). These payment amounts vary depending on which type of provider is supplying the product. Original Medicare will pay for these products for beneficiaries enrolled in Medicare Advantage.
For more specific information about Medicare payments to providers for these monoclonal antibody products, please see these Frequently Asked Questions.
2. Under the Hospital Without Walls initiative, hospitals can provide hospital services in other healthcare facilities and sites that would not otherwise be considered to be part of a healthcare facility; or can set up temporary expansion sites to help address the urgent need to increase capacity to care for patients.
3. Cost-sharing may apply to Medicare beneficiaries when they receive care from a provider that doesn’t participate in Medicare.
4. Certain monoclonal antibody products to treat COVID-19 have been authorized under Food and Drug Administration Emergency Use Authorizations since November 10, 2020. More information including the level II HCPCS codes for the administration/ infusion and post administration monitoring of these products can be found online in the Program Instruction.
Medicaid / CHIP
State Plan Amendment (SPA) Required: Potentially, depending on what services the state currently covers. Additionally, payment SPAs may be required if the state wants to pay a different rate for administration than they pay for other types of drug administration. States should seek technical assistance from CMS regarding SPAs that might be necessary.
1. Under section 6008 of the Families First Coronavirus Response Act (FFCRA), state and territorial Medicaid programs may receive a temporary 6.2 percentage point increase in the Federal Medical Assistance Percentage (FMAP). This temporary FMAP increase is available through the end of the quarter in which the COVID-19 PHE ends, if the state claims the increase in that quarter. To receive the temporary FMAP increase, a state or territory must cover COVID-19 testing services and treatments, including vaccines and their administration, specialized equipment, and therapies for most Medicaid enrollees without cost sharing. This includes therapeutics approved under Food and Drug Administration Emergency Use Authorizations and their administration.
CHIP Coverage: Therapeutics will generally be covered under an existing benefit (drugs and biologicals or other therapeutic benefits as determined under the State Plan).
SPA Required: No, if covered under an existing benefit
Plans subject to ACA market reforms
Coverage for COVID-19 therapeutics varies among plans subject to ACA market reforms.
Most individual and small group market insurance must cover essential health benefits. Essential health benefits generally include coverage for items and services related to the diagnosis and treatment of COVID-19.
The exact coverage details for individual services may vary by plan, and some plans may require prior authorization or other medical management before these services are covered. Cost sharing amounts, such as a deductible, coinsurance, or copay, for individual services may also vary by plan.
If a plan does not provide coverage of a specific prescription drug on its formulary, individuals may request coverage through the plan’s drug exceptions process.
If a plan denies coverage for a COVID-19 therapeutic, for example, for being experimental, an individual can appeal the decision.
Some state laws require issuers to waive cost sharing for certain COVID-19 treatment. Other issuers have voluntarily opted to do so.
Some plans are not required to offer essential health benefits.
General Public Resources:
- Infusion site locators to help people find sites of care
- US Department of Health and Human Services Monoclonal Antibody Therapeutics Distribution Location
- National Infusion Centers Association Infusion Site Locator
- U.S. Department of Health And Human Assistant Secretary for Preparedness and Response Monoclonal Antibodies for High-Risk COVID-19 Positive Patients Infographic, “Therapeutics Coverage Infographic”
- U. S. Department of Health and Human Services COMBATCOVID
- National Institutes of Health COVID-19 Treatment Guidelines
- Healthcare Ready | Strengthen. Safeguard. Respond.
Clinical Provider Resources developed by Regeneron:
- Is my Patient at High Risk for Progressing to Severe COVID-19 — English and Spanish Infographic
- How Antibodies & Vaccines Compare Infographic
- Advantage of Dual Monoclonal Antibody Infographic
Patient Resource developed by Regeneron:
- Exposed to COVID-19? What you do next is critical.
- Information About COVID-19: A Treatment Option (Patients-English)
- Information About COVID-19: A Treatment Option (Patients-Spanish)
- Frequently Asked Patient Questions about COVID-19 Antibody Treatments
- Two Ways to Fight COVID-19 Vaccines and Monoclonal Antibodies
- The Complementary Roles of Vaccines and Monoclonal Antibodies in Combatting the COVID-19 Pandemic