COVID-19 treatments

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Overview
  • Bamlanivimab and the combination product casirivimab and imdevimab (Regeneron) are neutralizing antibody treatments for mild to moderate COVID-19 for people who are at risk of developing severe COVID-19. The FDA granted  an Emergency Use Authorization to bamlanivimab on November 10, 2020 and to casirivimab and imdevimab on November 21. These products are considered clinically equivalent treatments based on limited available data. The federal government has shipped weekly allotments of both treatments to states, including Colorado. 

  • Antibody treatments are for those with an onset of symptoms within 10 days, who have mild to moderate COVID-19 and are not hospitalized but who are at risk of developing severe COVID-19 because they have one of the following conditions:

    • 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.

    • These 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 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 a prescription of bamlanivimab or  casirivimab and imdevimab. 

  • These are outpatient treatments, administered intravenously at hospitals and outpatient infusion centers. Each treatment requires one infusion, administered over an hour, 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.  

  • The demand for antibody treatment at times may exceed supply. If this occurs, the state will allocate the limited allocation through a random allocation tool developed by CDPHE to ensure equal access to everyone in the state.

FAQ

We expect regular weekly shipments of bamlanivimab and casirivimab and imdevimab averaging around 1,000 doses of bamlanivimab and 250 doses of casirivimab/imdevimab doses.

  • Extending all Coloradans access to  the antibody therapy is a goal and priority. Therefore, we are reaching out to hospitals and infusion centers statewide to identify their interest and capacity to administer this treatment. 

  • In anticipation that the need for the antibody treatment will exceed the supply, the Department recognized the necessity of a fair, random allocation process. The Department built an online software allocation tool where healthcare prescribers input information about their patients who qualify for treatment and the tool will randomly determine whether the patients are selected for treatment. The odds of being selected will vary by supply of the therapeutic agent and the estimated weekly demand, defined by the expected number of eligible persons who would choose treatment for the given week.  

  • The Department is building communication tools, such as information websites, so Coloradans with mild to moderate COVID-19 can learn if these therapies are right for them. The Department is also exploring how to provide outreach to the general public.

  • Check to see if you are eligible for either bamlanivimab or  casinvirmab and imdevimab below. If so, contact your healthcare provider who can assess your symptoms, discuss the benefits and risks of the 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 request to receive the treatment will then be entered by your healthcare provider (physician, advance practice nurse with prescriptive authority, and physician assistants) into the random allocation tool. If you are selected to receive treatment, you will be contacted by the hospital or infusion site you and your provider identified when completing the random allocation tool to schedule treatment.

There are 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 casirivimab and imdevimab.
 

These 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. 

Eligibility Determination

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