COVID-19 Monoclonal Antibody Treatment

Monoclonal antibody treatment has been authorized by the FDA for patients age 12 or older who are at high risk for severe complications and/or hospitalization. Children must weigh at least 40 kilograms or 88 pounds.

Eligible patients include those who:

• Have the COVID-19 virus
• Are within 10 days of beginning mild to moderate symptoms and
• Meet at least one risk factor identified by the FDA

The FDA defined high risk as patients who meet at least one of these criteria:

• Body mass index (BMI) of 35 or more
• Chronic kidney disease (consider hemodialysis patients)
• Diabetes
• Immunosuppressive disease
• Currently receiving immunosuppressive treatment (e.g. rheumatology patients, patients with IBD on Humira or other immunosuppressive therapy)
• Age 65 or older
• Age 55 or older and have:
  • cardiovascular disease OR
  • hypertension OR
  • chronic obstructive pulmonary disease/other chronic respiratory disease
  • Ages 12 -17 and have:
    • BMI in 85^th percentile or higher for age and gender based on CDC growth chart OR
    • Sickle cell disease OR
    • Congenital or acquired heart disease OR
    • Neurodevelopmental disorders (e.g. cerebral palsy) OR
    • Medical-related technological dependence not related to COVID-19 (e.g. tracheostomy, gastrostomy, or positive pressure ventilation) OR
    • Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control

Monoclonal antibodies are lab-made proteins that help the body protect itself against viruses. Bamlanivimab and etesevimab are made specifically to act against the COVID-19 virus.

Essentia Health offers the outpatient therapy these locations:

• Duluth: Essentia Health-St. Mary’s Medical Center, 407 E. Third St.
• Fargo: Essentia Health-32nd Avenue Clinic, 3000 32nd Ave. S.
• Brainerd: Essentia Health-St. Joseph’s Medical Center, 523 N. Third St.
• Ada: Essentia Health-Ada, 201 Ninth St. W.
• Deer River: Essentia Health-Deer River, 115 10th Ave. N.E.
• Detroit Lakes: Essentia Health-St. Mary’s Hospital, 1027 Washington Ave.
• Fosston: Essentia Health-Fosston, 900 Hilligoss Blvd. S.E.
• Graceville: Essentia Health-Holy Trinity Hospital, 115 W. Second St.
• Virginia: Essentia Health Urgent Care, 901 Ninth St. N.

Like the COVID-19 vaccines, bamlanivimab and etesevimab is an investigational drug. That means they are not yet approved by the FDA for any conditions and are still being tested in research studies. They have, however, been authorized by the FDA for certain patients who have COVID-19.

The FDA has determined that it is reasonable to believe that bamlanivimab and etesevimab may be effective in treatment of patients during the COVID-19 pandemic. In one trial study, it was found to lower the possibility patients needing an emergency room or hospital visit.

A patient has an intravenous infusion followed by at least one hour of monitoring. You are required to have a physical examination by a provider before starting the infusion.

Due to the limited supply of the drugs, eligible patients are randomly chosen by a computer for treatment. Those patients are contacted by a registered nurse from Essentia Health and then scheduled for an exam and an infusion. Randomized selection is an ethical method for choosing who gets access to the treatment.

People who have a positive COVID-19 test at any Essentia Health site are automatically screened for the FDA’s criteria and placed in the eligibility pool for randomization. Those who were tested at other sites can call a toll-free hotline at 1-833-769-1524 to be screened and added to the eligibility pool. Hotline hours are 8:30 a.m. to 5 p.m. Monday-Friday.

Essentia Health is using a randomized selection of patients to ensure fair and equitable access to all patients who meet the criteria set by the federal Food and Drug Administration (FDA).

Patients who meet the criteria are put in an eligibility pool and randomly chosen by computer. Chosen patients are then contacted by a registered nurse from Essentia Health and asked if they’d like to receive monoclonal antibody. If you agree, you are scheduled for an exam and an infusion.

Patients who have a positive COVID-19 test at any Essentia Health site are automatically screened for the FDA’s criteria and placed in the eligibility pool for randomization. Those who were tested at other sites can call a toll-free hotline at 1-833-769-1524 to be screened and added to the eligibility pool. Hotline hours are 8:30 a.m. to 5 p.m. Monday-Friday.

Patients who are placed in the eligibility pool remain there and may receive a call offering treatment up to the ninth day after the onset of their symptoms. The number of patients called depends on the number of infusion appointments available and the limited supply of the drugs.

Known side effects include anaphylaxis and infusion-related reactions, nausea, diarrhea, dizziness, headache, itching, and vomiting. These are not all the possible side effects of bamlanivimab. Bamlanivimab is still being studied so it is possible that all risks are not known at this time. These are not all the possible side effects. These drugs are still being studied so it is possible that all risks are not known at this time.

There is no cost the drugs, however, there is a charge for the administration of the infusion and provider visit. These fees are approximately $650. Health insurance may cover this based on a patient’s current benefit plan. Essentia Health does not want financial concerns to be a barrier to patients’ care. Essentia offers many forms of financial assistance and encourages patients to use them.

The COVID-10 pandemic and related government actions have caused confusion about what health care costs are being covered by insurance plans. Patients should contact their health insurance company’s customer service department to determine what patients may pay as a deductible, co-payment or coinsurance. Uninsured patients may qualify for assistance or reduced-cost care through one of Essentia Health’s many forms of Financial Assistance.