Photo of Doctor wearing visor as safety precaution in the course of consultation of senior man. Physician practitioner is discussing monoclonal antibodies infusion therapy with  patient in a private modern clinic appointment during coronavirus pandemic.

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 then 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 for those who get sick with the virus. One of them is monoclonal antibody infusion therapy. Monoclonal antibodies are given intravenously as infusion therapy before patients need hospitalization. There are also treatments available for people who are hospitalized with COVID-19. They may also be given to certain people exposed to COVID-19 as protection against the virus, including those undergoing chemotherapy or organ transplants.

NOTE: Monoclonal antibody therapy doses containing the combination of casirivimab and imdevimab are free of charge.

The U.S. government signed an agreement with Regeneron, the maker of casirivimab and imdevimab, so patients that need it would not be charged. Some patients, depending on their insurance coverage, may have to pay a fee to their healthcare provider for administering the dose.

What COVID-19 treatment is there for people outside the hospital? 

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:

  • self-isolate
  • get rest
  • stay hydrated
  • take fever-reducing medicine, if needed

Talk with your doctor about monoclonal antibody infusion therapy. There is evidence it is effective in preventing severe illness.

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 infusion therapy work?

Monoclonal antibodies are given by IV to people diagnosed with COVID-19. This therapy uses COVID-19 antibodies to help a person’s body fight off the infection. 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.

Who should get antibody infusion therapy?

People with COVID-19 with symptoms less than 10 days and who are at risk for severe illness

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.

People exposed to COVID-19 who are at risk for severe illness

Some people who are at high risk for severe illness can also be eligible for monoclonal antibody therapy if they are exposed to COVID-19. Antibody therapy is given by a shot 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 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.

 

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 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.
    • Obesity
    • 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:
    • Obesity
    • 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.

What monoclonal antibody infusion 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 casirivimab and imdevimab
  • A combination of etesevimab and bamlanivimab (distribution paused by FDA in June 2021)
  • Sotrovimab
  • Tocilizumab

 

 

How can I get monoclonal antibody infusion therapy if I have COVID-19?

Monoclonal antibodies are prescribed by a healthcare professional. 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 IV at an infusion center. Upon arrival, you will have an IV started. Then you will have the antibody infusion about an hour later.

After the infusion is complete, the staff will monitor you for another 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 infusion therapy?

Since monoclonal antibodies are administered by IV, they are currently only available in infusion centers. To locate an infusion center near you, visit:

Are people still contagious after monoclonal antibody infusion therapy?

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.

What are the side effects of monoclonal antibody infusion therapy?

People who receive monoclonal antibody treatment may experience pain at the infusion site, including:

  • Skin bruising
  • Soreness
  • Swelling
  • 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 infusion therapy?

People can have an allergic reaction to monoclonal antibody infusion therapy. This is why you must be monitored at the infusion clinic for one hour after your infusion.

Signs of an allergic reaction to report to a healthcare professional:

  • Fever
  • Chills
  • Nausea or vomiting
  • Headache
  • Shortness of breath
  • Low blood pressure
  • Wheezing
  • Swelling of your lips, face, or throat
  • Rash, including hives.
  • Itching
  • Muscle aches
  • Dizziness

What treatments can be used for COVID-19 in hospitalized patients?

Doctors have developed effective treatments for hospitalized patients.

  • 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.

The following information is courtesy of Combat Covid

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.

The following information is courtesy of Regeneron

Frequently Asked Patient Questions About COVID-19 Monoclonal Antibody Treatments

What is monoclonal antibody treatment for COVID-19?
After exposure to a new virus like SARS-CoV-2, your body needs time to naturally make antibodies that fight against the infection. There may be cases where your body is unable to respond and make antibodies against SARS-CoV-2. Or, it is too early in the course of infection for your body to have made enough antibodies to fight the infection. Monoclonal antibodies are man-made antibodies that act like your own antibodies in the immune system to help you fight this infection.1,2
What is the difference between a monoclonal antibody treatment and a vaccine?
If you are healthy, vaccines can help your own body protect you from the virus that causes COVID- 19, but it takes time for this protection to build up. Some people cannot be vaccinated or the vaccine does not work well for them. Unlike a vaccine, monoclonal antibody treatment immediately helps you fight the virus if you get sick with COVID-19. Because monoclonal antibody treatment comes from an outside source, they can help those who still get sick after receiving the vaccine.1,3,4
Why is monoclonal antibody treatment being recommended for me?
Some people who become sick with COVID-19 are at high risk for more severe illness, including needing to be hospitalized and possibly dying. Factors that may make you higher risk include being overweight, having certain heart or lung diseases, being diabetic, belonging to certain racial and ethnic groups, and/or certain existing medical conditions. Older age can also be a factor. Your doctor will explain the specific reason they are recommending monoclonal antibody treatment for you.1
What is the benefit of taking monoclonal antibody treatment?
Large studies have shown that monoclonal antibody treatment lowers the risk of needing to go to the hospital or dying from COVID-19. These studies have also shown that monoclonal antibody treatment can help people feel better faster and have fewer days with COVID-19 symptoms.5
How is a monoclonal antibody treatment given?
Monoclonal antibody treatments can be administered by infusion into a vein or by injection under the skin depending on particular therapy. You will receive the treatment at a site that is able to administer the medication like an infusion center. When you arrive, you will go through a screening process before you receive the infusion. The whole appointment could take 2 to 3 hours but the infusion can take as little as 20 minutes. After the infusion is complete, the staff will watch you for about an hour to make sure you do not have an allergic reaction or other side effects. You will then be able to return home.1
What do I need to do after I receive monoclonal antibody treatment?
You should continue to isolate, even at home, because even though you may feel better, you can still spread the virus. Your doctor will tell you when you can stop isolating. You may experience new or worsening symptoms after infusion, including fever, difficulty breathing, rapid or slow heart rate, tiredness, weakness or confusion. If these occur, contact your healthcare provider or seek immediate medical attention as some of these events have required hospitalization.1
What are the possible side effects of a monoclonal antibody treatment?
Similar to other medications given by an infusion into the vein, you may experience brief pain, bleeding, bruising, soreness, swelling, or possible infection at the site of infusion. Some people had allergic reactions. Some patients may experience worsening symptoms after infusion, including fever, difficulty breathing, rapid or slow heat rate, tiredness, weakness or confusion. If these occur contact your health provider or seek immediate medical attention as some of these events require hospitalization. Please talk to your doctor if you have any questions or concerns about possible side effects.1
Should I get monoclonal antibody treatment as soon as possible? Or should I wait to see if my symptoms get worse?
Monoclonal antibody treatment must be given within 10 days of your first COVID-19 symptoms. Receiving the treatment sooner will allow it to start working to help prevent progression of COVID-19.1,2,6
Are monoclonal antibody treatments effective against viral variants?
Studies have shown that some monoclonal antibodies are effective against the known viral variants. Mutations of viruses may continue to occur. If you have any questions about viral variants, please ask your doctor.7
COVID-19, coronavirus disease 2019; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

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

icon of an 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).

Medicare

Disclaimer: The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law.
Infographic of Coverage of Monoclonal Antibody Products to Treat COVID-19

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.

1. Services must be furnished within the scope of the product’s FDA authorization or approval and within the provider’s scope of practice.

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

Medicaid Coverage Required: Yes, in states subject to section 6008(b)(4) of the Families First Coronavirus Response Act.1

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:

Clinical Provider Resources developed by Regeneron:

Patient Resource developed by Regeneron:

Casirivimab and Imdevimab Regeneron Resources:

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