Question 1

What is a close-contact encounter?

Accepted Answer

The CDC defines a close-contact encounter as being within 6 feet of someone who is infected with COVID-19 for a total of 15 minutes or more, providing care at home to someone who is sick, having direct physical contact with the person, sharing eating or drinking utensils or being exposed to respiratory droplets.

Question 2

Who is eligible for treatment?

Accepted Answer

Bamlanivimab 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

Question 3

What are the risk factors identified by the FDA?

Accepted Answer

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

Older age (65 and older)
Obesity or overweight (BMI greater than 25 kg/m2 B, or if age 12-17, have BMI greater than or equal to 85th percentile for their age and gender based on CDC growth charts)
Pregnancy
Chronic kidney disease
Diabetes
Immunosuppressive disease or immunosuppressive treatment
Cardiovascular disease (including congenital heart disease) or hypertension
Chronic lung diseases (IE, chronic obstructive pulmonary disease, moderate to severe asthma, interstitial lung disease, cystic fibrosis and pulmonary hypertension)
Sickle cell disease
Neurodevelopmental disorders (IE, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
Having a medical-related technological dependence (IE, tracheostomy, gastrostomy or positive-pressure ventilation unrelated to COVID-19)

Other medical conditions or factors (IE, race or ethnicity) may also place individual patients at high risk for progressing to severe COVID-19 and authorization of REGEN-COV under the EUA is not limited to the medical conditions or factors listed above. See additional information from the CDC on medical conditions and factors associated with increased risk for progressing to severe COVID.

Health care providers should consider the benefit-risk for an individual patient with any of the following conditions, including but not limited to:

Cancer
Dementia
Down syndrome
Liver disease
Smoking (current or former)
Stroke or cerebrovascular disease
Substance-use disorder

Question 4

What are monoclonal antibodies?

Accepted Answer

Monoclonal antibodies are lab-made proteins that help the body protect itself against viruses. The Regeneron monoclonal antibodies casirivimab and imdevimab are made specifically to act against the COVID-19 virus.

Question 5

Where does Essentia Health offer this therapy?

Accepted Answer

Essentia Health offers the outpatient therapy at nine locations:

Duluth: Essentia Health-St. Mary’s Medical Center, 407 E. Third St.
Fargo: Essentia Health-32nd Avenue Clinic, 3000 32nd Ave. S.
Baxter: Essentia Health-Baxter Clinic Urgent Care, 13060 Isle Dr, Ste A
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.

Question 6

What is an investigational drug?

Accepted Answer

Like the COVID-19 vaccines, Regeneron (casirivimab + imdevimab) is investigational. That means it is not yet approved by the FDA for any conditions and is 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 Regeneron (casirivimab + imdevimab) may be effective in treatment of patients during the COVID-19 pandemic. In one research study, it was found to lower the possibility of patients needing an emergency room or hospital visit.

Question 7

What does this treatment require?

Accepted Answer

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.

Question 8

How does a patient ask for this treatment?

Accepted Answer

Due to the limited supply of the drug, 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.

Question 9

How does Essentia Health select patients for this treatment?

Accepted Answer

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 bamlanivimab treatment. 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 bamlanivimab.

Question 10

What are the possible side effects of bamlanivimab?

Accepted Answer

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.

Question 11

What does bamlanivimab treatment cost?

Accepted Answer

There is no cost for the monoclonal antibodies. However, there is a charge for the administration and provider visit. Essentia Health has a process in place to ensure that patients will not experience non-covered costs for the treatment.

Question 12

Is it covered by health insurance?

Accepted Answer

The COVID-19 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 they may pay as a deductible, co-payment or coinsurance. Essentia has a process in place to ensure that patients will not experience non-covered costs for the treatment.

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