COVID-19 Monoclonal Antibody Therapy
Do I qualify for monoclonal antibody therapy?
You qualify for monoclonal antibody treatment if you are 65 or older, you've tested positive for COVID-19, and it has been 10 days or less since your symptoms first started. You may also qualify if you are under 65, have tested positive for COVID-19, and it has been 10 days or less since your symptoms first started, and you have other health conditions that put you at higher risk. Monoclonal antibody treatment is most effective when given early and the sooner it is given the better.
Getting vaccinated is the best way to prevent COVID-19. Monoclonal antibody treatment should NOT be used to prevent COVID-19. People who might benefit the most from this treatment are those who are most likely to be hospitalized or die from COVID-19.
People who are older or have underlying medical conditions are the most likely to benefit from mAb. Talk to your doctor or use our risk score calculator to find out if you would qualify for mAb. The risk score calculator will tell you if you qualify for mAb treatment and how to schedule an appointment at an infusion site. You may also call the COVID-19 Hotline at 1-800-456-7707 to find an infusion site near you.
What is monoclonal antibody therapy (mAb)?
Our bodies naturally make antibodies to fight infection. Monoclonal antibodies are like the antibodies your body makes to fight other viruses, but they are made in a lab and are designed to target the coronavirus spike protein. When the antibodies bind to the spike protein, they block the virus from entering your body’s cells. This keeps the virus from spreading to more of your cells and can help those who are at higher-risk of being hospitalized with COVID-19.
Vaccines prevent illness by triggering your body’s natural immune response. Within a few weeks of getting a vaccine, your body creates enough antibodies to prevent infections. Monoclonal antibody therapy is different from a COVID-19 vaccine. If you already have the virus and are at higher-risk, mAb treatment can give you the antibodies your body needs to protect itself from severe illness — so you don’t end up in the hospital.
Monoclonal antibodies are given to people through an intravenous (IV) infusion. These infusions are usually given in an outpatient infusion center. You will be at the infusion center for about 2 hours for the treatment. It takes about an hour for you to get all of the medicine through the infusion and then a healthcare worker will need to monitor you for any side effects for another hour.
Learn more about monoclonal antibody treatment.
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Does monoclonal antibody therapy help everyone who has COVID-19?
No. Monoclonal antibody treatments is most effective for people 65 and older and people who have certain health conditions that put them at higher-risk of hospitalization or death from COVID-19. To quality for mAb therapy, you must:
- Test positive for SARS-CoV-2.
- Currently have symptoms of COVID-19.
- Be within the first 10 days of symptom onset.
- Be at high risk for severe illness from COVID-19 due to things like age and underlying medical conditions.
Getting COVID-19 during pregnancy can be very dangerous for both mother and baby. Symptoms often get worse and can turn severe very quickly. There is no evidence to suggest that mAb therapy will harm the mother or baby. The Utah Department of Health strongly recommends mAb therapy for women who are pregnant and test positive for COVID-19.
Studies show mAb treatments can lower the amount of virus (called a viral load) that causes COVID-19 in your body, which can help prevent severe symptoms and illness. In clinical trials, this treatment resulted in a 70% reduction in risk for hospitalization and death. Monoclonal antibody treatments are effective at keeping people out of the hospital, but don’t help people as much once they are sick enough with COVID-19 to be admitted into the hospital. It only works if you get treated within 10 days after first having symptoms of COVID-19 and testing positive.That’s why it’s so important to get tested for COVID-19 as soon as you can after your symptoms start.
Utah gets a limited supply of the medications used in mAb therapy, so it is reserved for those who would most likely benefit from treatment. In order to get mAb therapy, you need to meet certain criteria or have a referral from a doctor or medical provider.
Can children get monoclonal antibody therapy?
Children are less likely to benefit from mAb therapy than adults because they have a lower risk of being hospitalized for COVID-19.
The studies of COVID-19 mAb therapy did not include children. Since we don’t know the benefits to children and don’t have any safety information for this drug in children, mAb therapy should only be considered for children at highest risk of serious complications from COVID-19 and after careful medical review by a doctor or medical provider.
Right now, children younger than 12 are not able to get mAb treatment. Children between the ages of 12 and 17 may qualify depending on their medical history. Talk to your child’s medical provider or specialist (immunologist, oncologist, etc.) to see if mAb will be safe and effective for your child. Medical providers who have questions or who determine mAb would be beneficial for your child should send an email to Pediatric.MonoclonalAntibodies@imail.org to arrange treatment.
The best way to protect children from COVID-19 is to get vaccinated. Children 5 years and older are eligible to get vaccinated right now.
Where can I get monoclonal antibody therapy?
There are mAb treatment locations across the state of Utah. Many of these locations are at hospitals or outpatient clinics. The Utah Department of Health also has a free mAb infusion center in Murray and St. George, Utah.
You must qualify or have a doctor’s referral to get mAb treatment. DO NOT show up to a treatment location without an appointment. You will be turned away.
Talk to your doctor or use the risk score calculator to see if you qualify for mAb and to find a treatment center near you. You can also call the COVID-19 hotline at 1-800-456-7707 for more information.
Which antibody therapy should I get?
Monoclonal antibody therapies have different levels of effectiveness against the different strains, or variants, of COVID-19. The Utah Department of Health updates recommendations for which mAb treatments have been determined to be most effective based on CDC, FDA, and HHS recommendations as well as guidance from healthcare systems in Utah. Your doctor or the mAb treatment site will decide which medication to give you.
The FDA has given emergency use authorization (EUA) for three different mAb treatments:
Is monoclonal antibody therapy safe?
The FDA has granted emergency use authorization (EUA) for the use of mAb, which means it has been proven safe and effective for certain people. The FDA and CDC have recommendations for who should get mAb treatment. Researchers are still studying it for safety and effectiveness in other groups of people. More than 400,000 people have already been treated with monoclonal antibodies.
What are the side effects of monoclonal antibody therapy?
All medications and medical treatments have side effects. It’s important to talk to your doctor about the potential risks and benefits before starting any treatments or medications.
The most common side effects of mAb therapy are:
- Pain, bleeding, swelling, or bruising at the injection site (or place where the needle is put into your arm for the infusion)
- Infection at the injection site
- Feeling sick to your stomach (nausea)
- Vomiting
- Diarrhea
- Dizziness
- Headache
- Itchiness
- High blood sugar (called hyperglycemia)
- Pneumonia
Although it’s rare, there is a risk of anaphylaxis (a severe, potentially life-threatening allergic reaction) or other infusion-related reactions when you get mAb therapy. In clinical trials of bamlanivimab and casirivimab/imdevimab with nearly 3,000 people, two severe allergic reactions and five serious reactions related to the delivery of the treatment into the vein were reported. These reactions were treated and the patients recovered.
Talk to your doctor about potential side effects before getting mAb therapy.
Should I get monoclonal antibody therapy if I tested positive for COVID-19, but am not feeling sick yet?
Monoclonal antibody therapy is most effective in the first 10 days after your symptoms start. You need to be treated as early as possible after you become infected with the virus. So, the sooner the better — even if you're not feeling that bad yet.
COVID-19 is very dangerous to certain people because the disease often gets worse very quickly for those whose age, health conditions, or work or living environment (like those who live in a long-term care facility) put them at higher-risk.
As medical experts have studied mAb therapy, data shows that treatment keeps people who are at higher-risk from severe COVID-19 out of the hospital — in cases that normally may have ended up needing hospitalization. When those at higher-risk were treated early— before their symptoms were severe — the treatment was able to stop the disease from getting worse, and fewer patients needed to be hospitalized. Antibody treatment was not as effective if people waited until their symptoms were bad or getting worse.
How much does monoclonal antibody therapy cost?
The federal government is paying for the costs of mAb therapy. However, the treatment provider can still charge you a fee to administer the medication. Ask the treatment provider if there are any costs with getting mAb therapy before you go to your appointment.
If you have health insurance, these costs may be covered by the insurance company. Medicare and Medicaid both cover the cost for infusion administration.
If you don’t have health insurance, there are two free treatment locations in Murray and St. George operated by the Utah Department of Health.
Do I have to be a U.S. citizen to get treatment?
You don’t have to be a U.S. citizen to get mAb therapy. You may be asked to show a photo ID or other identification to make sure the right person gets the treatment. This information is not shared with immigration officials or used to determine who would benefit from this treatment.
How long do I need to wait after having monoclonal antibody therapy to get a COVID-19 vaccine?
The CDC recommends you wait at least 90 days after getting mAb therapy before getting a COVID-19 vaccine.
If you had a different type of antibody therapy that wasn’t for COVID-19 (such as intravenous immunoglobulin or RhoGAM), you don’t need to wait to get a COVID-19 vaccine.
Learn more at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html.
For medical providers
Getting vaccinated is the best way for your patients to prevent COVID-19. Encourage your patients to get vaccinated as soon as possible and to get a booster dose if it would be beneficial for them based on their age and underlying medical conditions. The Utah Department of Health has patient education materials, videos, graphics, and other materials to help you talk to your patients about the risks and benefits of COVID-19 vaccination. Learn more about COVID-19 vaccination.
Monoclonal antibody treatments are effective at keeping people out of the hospital, but don’t help people as much once they are sick enough with COVID-19 to be admitted into the hospital. It’s estimated to take about 16 infusions - or 16 people to be treated - to prevent 1 hospitalization.
Monoclonal antibody treatment should NOT be used to prevent COVID-19. It is not a therapy to help people just “feel better” but is intended to prevent severe outcomes among people who are most likely to be hospitalized or die from COVID-19. People who benefit the most from this treatment are typically older or have complex underlying medical conditions.
Letter to medical providers from Dr. Michelle Hofmann, deputy director at the Utah Department of Health, about the availability of mAb therapy in Utah.
Download PDF
Which patients are eligible to receive monoclonal antibody therapy?
The Utah Crisis Standards of Care Monoclonal Antibody Allocation Guidelines (updated 10/22/2021) provides the inclusion criteria for which patients qualify to receive mAb therapy at this time. These guidelines were developed by the Scarce Medications Allocation Subcommittee of the Utah Crisis Standards of Care Workgroup to ensure that mAb treatment is prescribed fairly and to patients who are most likely to benefit from it. This subcommittee consists of physicians trained in critical care, infectious disease, pediatrics, and internal medicine; hospital pharmacists, and experts in allocation frameworks and ethics.
Patients who qualify for mAb must:
- Test positive for SARS-CoV-2.
- Currently have symptoms of COVID-19.
- Be within the first 10 days of symptom onset.
- Be at high risk for severe illness from COVID-19 due to things like age and underlying medical conditions.
The Utah COVID-19 risk score calculator finds those most at risk for severe complications of COVID-19 and who would likely qualify for mAb therapy. More than 20,000 patient cases were used to make sure the risk calculator could accurately predict which patients would most likely be hospitalized or suffer severe outcomes from COVID-19 and benefit the most from this treatment.
Patients can take the risk score calculator online to determine if they would qualify for mAb treatment. After the survey, the patient is told whether they qualify and how to schedule an appointment at the nearest infusion site. Patients may also call the COVID-19 Hotline at 1-800-456-7707 if they need help finding an infusion site near them. Hotline operators are available 24 hours a day, 7 days a week.
Risk score calculator
Where can my patients get monoclonal antibody therapy?
Patients can receive treatment at the Utah Department of Health Monoclonal Antibody Infusion Centers in Murray and St. George, Utah or at one of more than 30 hospitals and outpatient clinics providing mAb infusions in Utah.
Patients must qualify or have a doctor’s referral to get mAb treatment. Patients should NOT show up to a treatment location without an appointment. Patients will be turned away if they don’t have an appointment.
Steps for referring patients to the Utah Department of Health mAb infusion centers in Murray or St. George, Utah:
- Screen your prospective patients 16 and older to make sure they meet the inclusion criteria. Inclusion criteria are based on current emergency use authorizations and the Utah COVID-19 risk score calculator. You can also encourage your patients to take the risk score calculator online themselves to see if they qualify for mAb and to find a treatment center near them.
- Explain the benefits and risks of treatment and confirm the patient’s desire to be treated.
- Email the patient's name and contact information to mabinfusions@utah.gov using an encrypted email.
- If you are contacted by a patient you think may be eligible for mAb treatment and are unable to complete a provider referral within the 10-day eligibility window, please direct the patient to https://coronavirus.utah.gov/noveltherapeutics. Patients who complete the risk score calculator survey and are eligible for treatment will be provided contact information for a 24/7 hotline that can help schedule the patient for mAb treatment at the UDOH infusion center.
- All requests for infusions in children aged 12-15 years should be emailed to Pediatric.MonoclonalAntibodies@imail.org.
- Once our mAb team at the Utah Department of Health receives your email referral, they will reach out to the patient to get the infusion scheduled and respond to your email with the outcome of the referral.
How much will this treatment cost my patients?
Medicare and Medicaid both cover the cost for infusion administration. For patients who don’t have insurance, HRSA provides an option to providers to be reimbursed for treatment services at the Medicare rate; all our major systems take advantage of the HRSA program for the uninsured.
For patients who are covered under commercial insurance plans, costs of infusion may vary, but many large insurers are waiving all costs. Some, though, are not, and there are even reports of some insurers not covering treatment at all. The insurance and health coverage landscape is complex. Commercial insurance covers about 22% of Utahns, other health coverage is provided through government plans, such as Medicare and Medicaid, and self-funded employer plans that are regulated at the federal level.
The Utah Department of Health infusion sites and the Mobile Infusion Strike Teams offer mAb at no cost to the patient. In the medical model at hospitals, patients who are commercially insured face potentially high deductibles or copays depending on their insurance plan.
Learn more about potential costs and coverage for mAb treatment.
Encourage your patients to ask the treatment provider if there are any costs with getting the treatment before they schedule their appointment so they know what to expect.