Information about outpatient COVID-19 therapeutics for health care providers

Last updated on September 1, 2022.

Available languages: Español

#FFFFFF
Photo of doctor and patient talking
#FFFFFF

COVID-19 treatments, including monoclonal antibody therapy and antivirals, can help prevent severe illness for some people who get infected with COVID-19 and are not hospitalized, but have one or more risk factors for progression to severe disease. Risk factors include certain medical conditions, including being overweight or obese, and older age. Additionally, risk factors can include social and environmental conditions called social determinants of health; these are not the result of individual choices, but historical barriers like systemic racism and discrimination. Providers should evaluate all people who test positive for COVID-19 for treatment.

 

Essential information for therapeutics providers

Colorado’s supply of therapeutics, including monoclonal antibody treatments and antivirals, is determined in part at the federal level. At this time, Colorado receives federal distributions of Evusheld, Paxlovid (including dose packs for patients with moderate renal impairment), and Lagevrio (molnupiravir).  Providers may also order the intravenous antiviral remdesivir directly from the manufacturer.

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.

Requests for therapeutics are due weekly on Monday by midnight MT.

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

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.

In order to meet the guidelines from HHS and help the state of Colorado fulfill our mission, reporting therapeutics use and inventory is required. Accurate reporting will allow the state to ensure equitable distribution of treatments across Colorado.

PROVIDERS THAT DO NOT REPORT AT LEAST WEEKLY IN HPOP RISK FUTURE ORDERS NOT BEING APPROVED.

Weekly reporting: 
To meet these guidelines from HHS and help the state of Colorado fulfill our mission, twice weekly reporting is required on the following:

  • Evusheld

  • Paxlovid

  • Molnupiravir

Reports are due Monday before midnight ET.

Although the following products are no longer authorized for use by the FDA, or recommended for use by CDPHE, weekly reporting of inventory is required for:

  • Bebtelovimab (for USG supply only)

  • Sotrovimab

  • REGEN-COV and bam/ete

These products should not be disposed of due to their possible efficacy against potential future COVID-19 variants. 

If you are having difficulty with navigating HPoP, please refer to the following:

Get started with Oracle HPoP Provider Portal

HPOP Therapeutics Partner Quick Start User Guide_v1.pdf (cdc.gov)

Clinical educational resources on therapeutics, including training are available for providers. Email cdphe_covid_med_guidance@state.co.us to request these resources.


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)

DOC | Department of Corrections 
FRPP | Federal Retail Pharmacy Partners
LTCF | Long-term care facility
IHS | Indian Health Service

#FFFFFF

Provider table

#FFFFFF
Open Embed
#FFFFFF

Pharmacies dispensing oral antivirals

#FFFFFF
Open Embed
#FFFFFF

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
#FFFFFF

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 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.

For more information on the federal Test to Treat program, visit ASPR's fact sheet.

 

Dispensing oral antivirals

Some providers have asked if they are able to dispense oral antivirals directly from their practice without sending a prescription to be filled at a pharmacy.

Section 12-280-120(6)(a), C.R.S., states: "A practitioner may personally compound and dispense for any patient under the practitioner's care any drug that the practitioner is authorized to prescribe and that the practitioner deems desirable or necessary in the treatment of any condition being treated by the practitioner, and the practitioner is exempt from all provisions of this article 280 except section 12-280-129."

Providers who are able to directly dispense oral antivirals are strongly encouraged to enroll in the federal Test to Treat program. Please review the provider requirements below and email Megan Ramsey Kolli at megan.ramseykolli@state.co.us for questions and enrollment information.

 

Test  to Treat provider requirements

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

    • COVID-19 testing on-site or via telehealth (or evaluation of at-home testing).

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

    • Ability to readily dispense medications within the practice or via a co-located, affiliated, or partner outpatient pharmacy.

  • Sites must be able to provide these services, regardless of the patient’s insurance status, same-day or next day.

  • Sites may partner with another provider or pharmacy to offer these services.

  • Sites must report their therapeutic inventory and administration twice weekly on Monday and Thursday.

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. Find a list of locations offering Test to Treat.

Types of antivirals

As of now, there are two oral antivirals the FDA has authorized under EUA. One intravenous antiviral, remdesivir (branded asr Veklury), is FDA-approved for inpatient use as well as outpatient use for adults or children who are at least 28 days old weighing at least 3 kilograms

  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 have one or more risk factors 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.

    • Renal Paxlovid is a lighter dosage formulation that is more appropriate for those who would qualify for Paxlovid, but have moderate renal impairment that would contraindicate them for the full dosage.  Review the “Important Dispensing Information” for health care providers.

  2. Lagevrio (Molnupiravir):

    • For the treatment of mild-to-moderate 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.

    • Lagevrio is not authorized for use in patients younger than 18 years of age because it 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 Lagevrio 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 (Veklury):

    • For treatment of COVID-19 in adults and pediatric patients 28 days or older weighing at least 3 kilograms.

    • 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 that are not part of the Test to Treat program can give patients a prescription for Paxlovid or Lagevrio (molnupiravir) and direct them to a pharmacy listed in the table above.

  • Pharmacies that want to stock oral antivirals can request an account.

  • Providers can order remdesivir (Veklury) directly from the manufacturer.

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 approved for:

  • People of ages  28 days or older who: 

  • Have tested positive for COVID-19, and

  • Weigh at least 3 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.

      • Renal Paxlovid is administered as 2 tablets (one each of nirmatrelvir and ritonavir) taken together orally twice daily for five days, for a total of 20 tablets.

  • Lagevrio (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 (Velkury):

    • 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 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 or breastfeeding people with Paxlovid. For pregnant people and their babies, the benefit of taking Paxlovid may be greater than the risk from the treatment.

  • Lagevrio (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 (Velkury):

    • 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.

#FFFFFF

Monoclonal antibody therapy 

  • As of November 22, 2022, CDPHE no longer recommends bebtelovimab for use, as it is not expected to be effective against the BQ.1 and BQ. 1.1 subvariants of COVID-19, which CDC now estimates to be the most common variants circulating in the state.

  • Bamlanivimab/etesevimab, REGEN-COV, and sotrovimab are other monoclonal antibodies that were previously distributed by CDPHE, but are not currently authorized for use anywhere in the United States. Data shows they are highly unlikely to be active against omicron and its subvariants.

  • 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.

Refer the patient to a health care provider who is offering treatment in Colorado. You can find providers with treatment using the ASPR Therapeutics Locator.

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

  • Sotrovimab, bamlanivimab/etesevimab, REGEN-COV, and bebtelovimab are unlikely to be effective against the current subvariants of omicron and are not currently being distributed.

 

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

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 for adequate protection.

On June 29, 2022, the FDA updated the Fact Sheet for Healthcare Providers for Evusheld (tixagevimab/cilgavimab) to specify that all patients who receive Evusheld should receive a repeat dose every six months. This update contained information about repeat dosing for patients who received either the original dosing of 150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab or the higher dose of 300 mg/3 mL of tixagevimab and 300 mg/3 mL of cilgavimab. 

  • Patients who initially received 150 mg of tixagevimab and 150 mg cilgavimab should receive an additional dose if they have not yet done so.
    • If the initial dose was ≤3 months prior, patients should receive 150 mg tixagevimab and 150 mg cilgavimab.
    • If the initial dose was >3 months prior, patients should receive 300 mg tixagevimab and 300 mg cilgavimab.
  • Once they have received an initial dose of 300 mg tixagevimab and 300 mg cilgavimab (or an initial dose of 150 mg of tixagevimab and 150 mg cilgavimab followed by an additional dose as above), all patients who received Evusheld should receive a repeat dose every six months. Repeat dosing should be timed from the date of the most recent Evusheld dose.

Find the updated Fact Sheet for Healthcare Providers

Additionally, the shelf life for Evusheld has been extended from 18 to 24 months for specific lots when stored in accordance with manufacturer directions.

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.