COVID-19 monoclonal antibodies are neutralizing antibody treatments available to people who have tested positive for COVID-19, exhibit mild to moderate symptoms of the disease, and who are at high risk of developing severe COVID-19.
Monoclonal antibody treatments involve the administration of a combination of monoclonal antibody products, either bamlanivimab in combination with etesevimab or casirivimab in combination with imdevimab. Bamlanivimab is no longer recommended as monotherapy in Colorado.
Monoclonal antibody treatments have been authorized for those individuals with an onset of symptoms within 10 days, who are not hospitalized, but are at high risk of developing severe COVID-19 because they have one of the following conditions as listed in the emergency use authorization:
- A body mass index (BMI) of 35 or more; chronic kidney disease; diabetes, immunosuppressive disease; are currently receiving immunosuppressive treatment; are 65 years of age or older; are 55 years of age or older AND have cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease/other chronic respiratory disease.
- Are 12 – 17 years of age AND have a BMI in or above the 85th percentile for their age and gender based on CDC growth charts (https://www.cdc.gov/growthcharts/clinical_charts.htm), OR have one of the following conditions: sickle cell disease; congenital or acquired heart disease; neurodevelopmental disorders (cerebral palsy); a medical-related technological dependence (tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19); asthma, reactive airway, or other chronic respiratory disease that requires daily medication for control.
Monoclonal antibody treatments are not indicated for use on those who are hospitalized or on oxygen for COVID-19 treatment.
If you have tested positive for COVID-19 and you are an individual at high risk of developing severe COVID-19 due to your age or one of the medical conditions listed above, contact your provider to see if you are eligible for monoclonal antibody treatment. These are outpatient treatments, administered intravenously at hospitals, outpatient infusion centers and clinics. Each treatment requires one infusion, administered over an hour or less, followed by one hour of post-infusion monitoring. The medications are free, and administration fees are paid for through Medicaid, Medicare, and many health insurance plans.
Extending all Coloradans access to COVID-19 monoclonal antibody treatment is a goal and priority. Therefore, we have reached out to hospitals, infusion centers, and clinics statewide to identify their interest and capacity to administer these treatments.
To ensure equitable access, if the demand for monoclonal antibody treatment was to exceed the available supply, the Department has built an online software tool that can be adjusted to help fairly allocate treatment if needed. Currently, all eligible patients entered into the tool are selected for treatment.
The Department is building communication tools so Coloradans with mild to moderate COVID-19 can learn if these therapies are right for them. The Department is continuing to explore ways to provide outreach to the general public.
Check to see if you are eligible for COVID-19 monoclonal antibody treatment based on your COVID-19 test, your onset of symptoms, and your medical condition. If you are eligible, contact your healthcare provider who can assess your symptoms, discuss the benefits and risks of monoclonal antibody treatment, and determine your eligibility to receive it. If you agree to receive the treatment, your healthcare provider will write a prescription for you.
Your healthcare provider (physician, advance practice nurse with prescriptive authority, and physician assistants) may then enter the prescription into the Department online software tool and you will be contacted by the hospital, infusion site or clinic to schedule the treatment. Or, your healthcare provider may provide you with a prescription for monoclonal antibody treatment and you will select and contact an infusion site to administer the treatment.
All infusion sites seeking a supply of COVID-19 monoclonal antibody products must order the products directly from AmerisourceBergen Corporation (ABC), the sole distributor of these products.
The products are free of charge to requesting sites.
Determine that your patient meets the eligibility criteria to receive the product. Eligible patients are those who are:
- Symptomatic with less than 10 days since symptom onset AND
- At high-risk. High-risk is defined as
- Have a body mass index (BMI) ≥35
- Have chronic kidney disease
- Have diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Are 65 or older
- Are 55 or older AND have cardiovascular disease, OR hypertension, OR chronic obstructive pulmonary disease/other chronic respiratory disease.
- Are 12-17 years of age AND have a BMI in or above the 85th percentile for their age and gender based on CDC growth charts, OR have one of the following conditions: sickle cell disease; congenital or acquired heart disease; neurodevelopmental disorders (cerebral palsy); a medical-related technological dependence (tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19); asthma, reactive airway, or other chronic respiratory disease that requires daily medication for control.
- Have a positive Sars-CoV-2 PCR OR any antigen test that detects specific proteins from the virus
This treatment is not authorized for use in patients who:
- Are hospitalized.
- Require oxygen therapy.
- Require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
Decide which process you would like to follow in order for your patient to receive treatment. There are two processes available.
- Complete the COVID-19 Medication Random Allocation Process tool
- The final page of the random allocation tool includes a list and map of current infusion sites registered with the state. You and your patient can select the patient’s closest or preferred location to receive treatment. The infusion site will be notified of the selection and will contact the patient to schedule treatment.
- If the site selected is unable to accommodate your patient, you will be notified by the infusion site to select another location. When you have done so, you must notify the original infusion site in order for the patient’s record to be transferred to the new treatment location.
- Provide your patient with a prescription for monoclonal antibody treatment and inform the patient of the location of potential infusion sites the patient may contact to receive treatment.
There is insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. These medications should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus and should be discussed with the referring provider. More information can be found in the Emergency Use Authorization fact sheets for bamlanivimab and etesevimab and casirivimab and imdevimab.
Monoclonal antibody treatments are approved for use in children who are 12-17 years old AND have a BMI in or above the 85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm OR if they have one of the following:
Sickle cell disease.
Congenital or acquired heart disease.
Neurodevelopmental disorders (cerebral palsy).
A medical-related technological dependence (tracheostomy, gastrostomy, or positive pressure ventilation not related to COVID-19).
Asthma, reactive airway, or other chronic respiratory disease that requires daily medication for control.