Information about outpatient COVID-19 therapeutics for health care providers

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COVID-19 therapeutics, including monoclonal antibody therapy and antivirals, can help prevent severe illness for some people who get infected with COVID-19 and are not yet hospitalized. The FDA has authorized these treatments for emergency use. Colorado’s supply of several therapeutics, including monoclonal antibody treatments and antivirals, is determined at the federal level. At this time, Colorado receives distributions of sotrovimab, bebtelovimab, Evusheld, Paxlovid, and molnupiravir. 

Providers who are interested in ordering COVID-19 therapeutics can request an account using this form. Once enrolled, there are utilization reporting requirements at the state and federal levels. For questions about the COVID-19 therapeutics program, please contact: cdphe_dcphr_covidtherapeutics@state.co.us

Providers should follow the patient prioritization recommendations in the NIH COVID-19 Treatment Guidelines: Therapeutic Management of Nonhospitalized Adults with COVID-19 when supplies of therapeutics are limited or other resources (clinic space, staffing, etc.) limit the ability to treat all patients. When there are no limitations of therapeutics or other constraints, any patient eligible under the EUAs should be offered treatment for COVID-19 after a discussion of risks and benefits.

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Pharmacies dispensing oral antivirals

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The tables on this page are only intended to provide information on the current distribution of therapeutics to health care providers in the state. Patients should contact a health care provider first to make sure they are eligible for COVID-19 therapeutics.

Data provided on this page are accurate as of 3 p.m. MST the prior day.

Facility Types

The “facility type” column indicates what population the listed provider serves. The general public may not be able to access therapeutics from certain providers depending on the population the facility serves. Where LTCF, DOC, or IHS is denoted, these facilities serve only those specific populations.

Specialized Facility Type Definitions (key)

  • LTCF | Long-term care facility
  • DOC | Department of Corrections 
  • IHS | Indian Health Service

Monoclonal antibody therapy 

  • Omicron variant is the most prevalent variant statewide.

  • Early studies suggest that sotrovimab and bebtelovimab monoclonal antibody therapies are likely to be effective in treating COVID-19 caused by the omicron variant.

  • Bamlanivimab/etesevimab and REGEN-COV are two other monoclonal antibodies that were previously distributed by CDPHE but are not currently authorized for use anywhere in the United States due to data showing they are highly unlikely to be active against the Omicron variant.

  • Evusheld is a long-acting monoclonal antibody authorized for pre-exposure prophylaxis (prevention) of COVID-19 in individuals who are moderately to severely immunocompromised or who are unable to be vaccinated. Evusheld is expected to retain neutralizing activity against omicron variant.

There are two ways to get monoclonal antibody treatment. Here are a few options: 

 

  1. Refer the patient to a treatment site through the CDPHE Monoclonal Antibody Connector Tool. The Monoclonal Antibody Connector Tool shows sites that have requested to be listed. It is not a comprehensive list of all sites offering monoclonal antibody therapy in Colorado. Submitting a referral is not a guarantee that treatment is available. After submitting a referral in the Monoclonal Antibody Connector Tool, provide the patient with the contact information for the site so that the patient can call the site to schedule an appointment.

  2. Refer the patient to a health care provider who is offering treatment in Colorado. You can find places to get treatment at The National Infusion Center Association or the HHS Protect Locator.

  • Sotrovimab and bebtelovimab are offered at certain facilities that are able to perform IV infusions.

  • Evusheld is being distributed to facilities such as specialty clinics (oncology, HIV, transplant, etc), hospitals, healthcare systems, and long-term care facilities.

  • Bamlanivimab/etesevimab and REGEN-COV are unlikely to be effective against omicron and are not currently being distributed.

Sotrovimab and bebtelovimab are the only monoclonal antibodies currently authorized for treatment of mild to moderate COVID-19 that are expected to be effective against the Omicron variant.

Sotrovimab is available for adults and pediatric patients (12 years of age and older weighing at least 40 kg) who:

  • Have tested positive for COVID-19.

  • Are at high risk for progression to severe COVID-19, including hospitalization or death.

  • Are within seven days of symptom onset.

Sotrovimab is not authorized for use in patients who:

  • Are hospitalized due to COVID-19, or

  • Require oxygen therapy due to COVID-19, or

  • 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).

People at risk of getting very sick from COVID-19 include:

  • People who are 65 years old or older.

  • People who are obese or overweight. This includes adults with a BMI of 25 or more. It also includes children under age 18 years old whose providers determine they meet the criteria.

  • Pregnant people.

  • People with certain underlying medical conditions.

Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID‑19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID‑19 requiring high flow oxygen or mechanical ventilation.

Bebtelovimab is only available for adults and pediatric patients (12 years of age and older weighing at least 40 kg) who:

  • Have tested positive for COVID-19.
  • Have had symptoms for seven days or less.
  • Are at high risk for progression to severe COVID-19, including hospitalization or death.
  • For whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.

Bebtelovimab is not authorized for use in patients who:

  • Are hospitalized due to COVID-19, OR
  • Require oxygen therapy and/or respiratory support due to COVID-19, OR
  • Require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity).

Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19.
Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
 

More information is available in the Emergency Use Authorizations (EUAs):

Some people who are at high risk for severe illness may qualify for monoclonal antibody therapy before they test positive if they:

  • Are not fully vaccinated or don’t have enough protection from the vaccine, and

  • Have been in close contact with someone who has COVID-19.

  • Are at high risk of becoming seriously ill.

This is called post-exposure prophylaxis. There are not currently any products available for post-exposure prophylaxis.

Monoclonal antibody therapy is not a substitute for vaccination against COVID-19. Getting vaccinated is the best way to keep from getting sick with COVID-19. 

People at risk of getting very sick from COVID-19 include:

  • People who are 65 years old or older.

  • Babies who are younger than 1 year old.

  • People who are obese or overweight. This includes adults with a BMI of 25 or more. It also includes children under age 18 years old whose providers determine they meet the criteria.

  • Pregnant people.

  • People with certain underlying medical conditions.

On February 24, 2022, the EUA for Evusheld (tixagevimab/cilgavimab) was revised to increase the dose to offer better protection against omicron subvariants. People who already received a dose of Evusheld prior to this change should receive an additional dose as soon as possible to have adequate protection.

Evusheld is only available for individuals who are:

  • Not currently infected with SARS-CoV-2 and have no known recent close contact with someone who is infected with SARS-CoV-2 and 

    • Who have moderate to severe immune compromise due to a medical condition or have received immunosuppressive medicines or treatments and may not mount an adequate immune response to COVID-19 vaccination or 

    • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction (such as severe allergic reaction) to a COVID-19 vaccine(s) or COVID-19 vaccine ingredient(s). 

Evusheld is not used as a treatment of COVID-19 for individuals who are already infected with the virus. It is also not for post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2.

More information is available in the Emergency Use Authorization for Evusheld: https://www.fda.gov/media/154701/download

  • Monoclonal antibody therapy gives you extra antibodies to help fight COVID-19. 

  • Your body naturally makes antibodies to fight infection. However, it takes time for your body to make enough antibodies to fight a new virus like COVID-19. 

  • Monoclonal antibodies, or mAbs, are made in a laboratory to fight a particular infection—in this case, COVID-19. They are given to patients directly with an infusion or injection to help fight the infection faster than your body could do on its own. 

  • Antibody treatments may have side effects. 

  • Allergic reactions can happen during and after an antibody infusion. 

  • Patients must be monitored for infusion reactions for at least one hour after receiving monoclonal antibody therapy. Symptoms of hypersensitivity, including anaphylaxis, and infusion-related reactions can include: fever; chills; nausea; headache; shortness of breath; low blood pressure; wheezing; swelling of your lips, face, or throat; rash, including hives; itching; muscle aches; and/or dizziness. 

  • An infusion or injection of any medicine may cause brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

Antivirals

The ASPR/HHS Test to Treat program allows sites to enroll as "full-service" therapeutics providers: from patient COVID-19 testing and symptom screening, to prescribing, to dispensing the oral antivirals. Given that oral antivirals are most effective when started within five days of symptom onset, this program seeks to simplify the oral antivirals access process for higher risk populations, especially in underserved communities.

This program is likely to expand the facility types enrolling, but this first wave focus is on long-term care facilities, combined clinics/pharmacies, and FQHCs. These providers will now be able to order oral antivirals (Paxlovid and molnupiravir) directly through the federal government, rather than relying on state and tribal allocation cycles. For more information on the federal Test to Treat program, visit the fact sheet here.

Test  to Treat Provider Enrollment Criteria
HHS requires potential Test to Treat sites to meet the following criteria:

  • Sites must be able to provide comprehensive end-to-end testing and treatment services to support a seamless patient experience.

    • COVID-19 testing onsite (or evaluation of at-home testing).

    • Clinical evaluation by licensed health care provider after a positive COVID-19 test to provide prescriptions when appropriate.

    • Co-located or affiliated pharmacy able to readily dispense medications to eligible patients.

  • Provide these services to all individuals, regardless of insurance status.

  • Accept new patients for priority same-day or next-day visits for COVID-19 services.

If you think your facility is a good fit for this program, contact cdphe_dcphr_covidtherapeutics@state.co.us to be referred to the ASPR Regional Coordinator for enrollment instructions.

A physician referral is not required for a patient to be seen at a Test to Treat location. While Test to Treat sites can see patients regardless of insurance status, there may be provider evaluation or pharmacy dispensing fees. Insurance may or may not cover all or some of these fees. A list of locations offering Test to Treat can be found at here.

As of now, there are two oral and one intravenous antivirals the FDA has authorized under EUA (remdesivir, or Veklury, is approved for inpatient use as well as outpatient use for adults or children who are at least 12 years old and weigh at least 40 kg; it is under EUA for children <12 years old who weigh at least 3.5 kg and children 12 years and older who weigh at least 3.5 kg but less than 40 kg). 

  1. Paxlovid

    • For treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients 12 years of age and older weighing at least 40 kilograms or about 88 pounds.

    • For patients who have positive results of direct SARS-CoV-2 testing AND who are at high risk for progression to severe COVID-19, including hospitalization or death.

    • Available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

    • Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19. Patients who start Paxlovid and are subsequently admitted to the hospital may finish the prescription at the discretion of their treating provider.

    • Special attention should be given to Paxlovid contraindications which can be found in the FDA EUA “Fact Sheet For Healthcare Providers: Emergency Use Authorization For Paxlovid,” particularly interactions with other medications.

  2. Molnupiravir

    • For the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults age 18 years or older.

    • For patients who have positive results of direct SARS-CoV-2 viral testing, AND who are at high risk for progression to severe COVID-19, including hospitalization or death, AND for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.

    • Available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

    • Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth.

    • It is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19 because benefit of treatment has not been observed in people when treatment started after hospitalization due to COVID-19.

    • Special attention should be given to molnupiravir in special populations (such as pregnant individuals or people of childbearing age) which can be found in the FDA’s Fact Sheet For Healthcare Providers: Emergency Use Authorization For Molnupiravir.

    • Molnlupiravir is not recommended in pregnancy.

  3. Remdesivir

    • For treatment of COVID-19 in adults and pediatric patients weighing at least 3.5kg.

    • For patients who are hospitalized OR are not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

    • Given as an intravenous (IV) infusion once a day for three days in a row and should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made and within seven days of symptom onset.

    • It is not authorized or approved for the pre-exposure or post-exposure prevention of COVID-19.

    • Remdesivir (Veklury) must be ordered directly from the manufacturer.

  • Providers can give patients a prescription for Paxlovid or molnupiravir and direct them to the pharmacies listed in the table above.

  • Pharmacies that want to stock oral antivirals can request an account at this link: https://forms.gle/UbXSX742pTMj1Q9C6 

As of now, oral antivirals (Paxlovid and molnupiravir) for COVID-19 are authorized for:

  • People age 12 years and older for Paxlovid or age 18 years and older for molnupiravir who: 

  • Have tested positive for COVID-19, and

  • Weigh at least 40 kilograms or about 88 pounds (Paxlovid only), and

  • Have had symptoms for less than 5 days, and

  • Are at high risk of becoming seriously ill. People at high risk of becoming seriously ill from COVID-19 include:

    • People who are 65 years old or older.

    • People who are obese or overweight. This includes adults with a BMI of 25 or more. It also includes children under age 18 years old whose providers determine they meet the criteria.

    • Pregnant people 

      • Note that molnupiravir has a warning for embryo-fetal toxicity; Paxlovid has no available human data on the use of nirmatrelvir during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Published studies with ritonavir are insufficient to identify a drug-associated risk of miscarriage.

    • People with certain underlying medical conditions.

As of now, the intravenous antiviral, remdesivir (Veklury), is authorized or approved for:

  • People of all ages (including pediatric patients who: 

  • Have tested positive for COVID-19, and

  • Weigh at least 3.5 kilograms, and

  • Have had symptoms for less than 7 days, and

  • Are at high risk of becoming seriously ill. People at high risk of becoming seriously ill from COVID-19 include:

    • People who are 65 years old or older.

    • Infants under 1 year old.

    • People who are obese or overweight. This includes adults with a BMI of 25 or more. It also includes children under age 18 years old whose providers determine they meet the criteria.

    • Pregnant people 

    • People with certain underlying medical conditions.

More information is available in the Emergency Use Authorization (EUA) for each product:

Antivirals to treat COVID-19 are not a substitute for vaccination against COVID-19. Getting vaccinated is the best way to keep from getting sick with COVID-19.

  • Paxlovid:

    • Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations. 

    • Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets.

  • Molnupiravir:

    • Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating.

    • Molnupiravir is administered as four capsules taken orally every 12 hours for five days, for a total of 40 capsules.

  • Remdesivir:

    • Remdesivir inhibits a SARS-CoV-2 protein to stop the virus from replicating.

    • Remdesivir is administered as an intravenous infusion once daily for three days.

Both oral antivirals are authorized for use no longer than five consecutive days. Remdesivir is approved/authorized for use no longer than three consecutive days.

  • Paxlovid:

    • Possible side effects of Paxlovid include impaired sense of taste, diarrhea, high blood pressure, and muscle aches.

    • Using Paxlovid in people with uncontrolled or undiagnosed HIV-1 infection may lead to HIV-1 drug resistance.

    • Ritonavir may cause liver damage, so caution should be exercised when giving Paxlovid to patients with preexisting liver diseases, liver enzyme abnormalities, or liver inflammation.

    • Using Paxlovid at the same time as certain other drugs may result in potentially significant drug interactions

    • There is no experience treating pregnant women or breastfeeding mothers with Paxlovid. For a mother and unborn baby, the benefit of taking Paxlovid may be greater than the risk from the treatment.

  • Molnupiravir:

    • Side effects observed in clinical trials included diarrhea, nausea, and dizziness.

    • Molnupiravir is not recommended for use during pregnancy. Molnupiravir is only authorized to be prescribed to a pregnant individual after the prescribing healthcare provider has determined that the benefits of being treated with molnupiravir outweigh the risks for that individual patient and after the prescribing health care provider has communicated the known and potential benefits and the potential risks of using molnupiravir during pregnancy to the pregnant individual.

    • If the decision is made to use molnupiravir during pregnancy, the prescriber must document that the known and potential benefits and the potential risks of molnupiravir use during pregnancy, as outlined in the Fact Sheet for Patients and Caregivers, were discussed with the patient. The patient should be enrolled in the Merck Pregnancy Surveillance Program as well. 

    • Females of childbearing potential are advised to use a reliable method of birth control correctly and consistently during treatment with molnupiravir and for four days after the final dose.

    • Males of reproductive potential who are sexually active with females of childbearing potential are advised to use a reliable method of birth control correctly and consistently during treatment with molnupiravir and for at least three months after the final dose.

  • Remdesivir:

    • Possible side effects of remdesivir include nausea, increased ALT, and increased AST.

    • Using remdesivir at the same time as chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data demonstrating a potential antagonistic effect.