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Information about outpatient COVID-19 therapeutics for health care providers

Last updated on January 18, 2024.

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Outpatient COVID-19 treatments can help prevent severe illness for some people who get infected with COVID-19, are not hospitalized, and 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 (at least 50 years of age, but especially 65 and older). Additional risk factors are social and environmental conditions called social determinants of health. Health care providers should evaluate all people who have symptoms of COVID-19 for treatment.

Medication to treat COVID-19 is not a substitute for vaccination, although vaccinated people may still benefit from treatment. Getting vaccinated against COVID-19 and staying up to date is the best way to keep from getting sick with COVID-19. Encourage patients to get their COVID-19 vaccine as recommended.

Essential information for therapeutics providers

When prescribing outpatient antivirals for patients diagnosed with COVID-19 (either via testing or clinically*), consider:

  • Are they within five (nirmatrelvir/ritonavir and molnupiravir) or seven days of symptom onset (remdesivir)?
  • Do they have symptoms consistent with mild to moderate COVID-19?
  • Are they at risk for progression to severe COVID-19?
  • Are they currently not hospitalized?
  • Are they 12 years or older for nirmatrelvir/ritonavir or 18 years or older for molnupiravir? Is the patient at least 28 days old for remdesivir?
  • Is the patient at least 40 kg (88.18 lbs) (for nirmatrelvir/ritonavir)? Is the patient at least 3 kg (6.6 lbs) (for remdesivir)?

*FDA recognizes that, in rare instances, people with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. In such instances, their health care provider may determine if treatment is appropriate.

Providers should follow the guidelines in the NIH COVID-19 Treatment Guidelines: Therapeutic Management of Nonhospitalized Adults with COVID-19. Pediatric providers should follow the guidelines in the NIH COVID-19 Treatment Guidelines: Therapeutic Management for Nonhospitalized Children with COVID-19.

Medication specific information links

Medication
Dosing and prescribing guides
Fact sheet for providers
Nirmatrelvir/ritonavir (Paxlovid)

Paxlovid dosing and prescribing reference guide

Checklist for providers

Pharmacist dispensing guide for renal impairment

Fact sheet for healthcare providers: Emergency use authorization for Paxlovid
Molnupiravir (Lagevrio)Dosing and administration for Lagevrio (molnupiravir)Fact sheet for healthcare providers: Emergency use authorization for Lagevrio (molnupiravir)
Remdesivir (Veklury)Veklury dosing and administrationVeklury: Highlights of prescribing information

Providers should consider what medications a patient is taking and the presence of renal or hepatic disease. Providers can check for drug interactions using the Liverpool COVID-19 Drug Interactions Checker. Providers should consider the magnitude and significance of the potential drug-drug interaction when choosing a management strategy. Potential strategies include:

  • Increasing monitoring for potential adverse events to the concomitant medication. 
  • Adjusting the dose of the concomitant medication. 
  • Temporarily withholding the concomitant medication. 
  • Using an alternative to the concomitant medication. 
  • Using alternative COVID-19 therapies.

Consider consulting with an expert (e.g., a pharmacist or the patient’s specialist providers) when treating patients who are receiving highly specialized therapies or drugs that are prone to concentration-dependent toxicities, such as certain anticonvulsant, anticoagulant, immunosuppressant, antiarrhythmic, chemotherapeutic, and neuropsychiatric drugs.

†Pfizer has dosing recommendations and precautions for renal and hepatic impairment. Find warnings and precautions, including for risk of hepatotoxicity and risk of HIV-1 resistance development. Remdesivir has warnings and precautions, including monitoring for elevated transaminase levels.

 

COVID-19 therapeutics are now available on the commercial market and must be ordered directly from the manufacturers. 

Providers should order nirmatrelvir with ritonavir (Paxlovid) and molnupiravir (Lagevrio) through their usual medication ordering channels. Information is provided on how to order Veklury (remdesivir) in general and for outpatient providers.

To learn more about the commercialization of COVID-19 therapeutics, see the U.S. Department of Health & Human Services’ webpages Sunsetting the U.S. Government COVID-19 Therapeutics Distribution Program and COVID-19 Therapeutics Transition to Commercial Distribution: Frequently Asked Questions.

Assistance programs are available to help eligible patients get COVID-19 medicine at no cost.

Medication
Patient assistance program
Nirmatrelvir/ritonivir (Paxlovid)Paxcess patient support program 
Phone: 1-877-219-7225
Molnupiravir (Lagevrio)Merck Patient Assistance Program
Phone: 1-800-727-5400*
Merck requires the prescribing provider to call and make an “Urgent Need” request for the medication. Providers may need to provide additional information, such as the patient’s insurance coverage, medical conditions, date of symptom onset, and other medications. 
Remdesivir (Veklury)Gilead Advancing Access
Phone: 1-800-226-2056

CMS recently issued a memo about Medicare Beneficiary Coverage Pathways for Commercial Oral Antivirals for COVID-19.

Figure from CMS: 
medicare beneficiary coverage chart

For those who previously ordered COVID-19 therapeutics through federal/state channels: in order to meet HHS guidelines, reporting of U.S. Government (USG) inventory is expected until all delivered product is reconciled for the provider site/central awardee. Reporting is done by the facility that orders therapeutics, not the prescribing provider when a prescription is provided.

Federal reporting requirements can be found on the ASPR COVID-19 Therapeutics webpage, along with links to HPoP and HPoP user guides.

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

Email COVID19Therapeutics@hhs.gov with any further questions.

Voluntary reporting of therapeutics inventory to USG is a mechanism for providers to report commercial treatment location data that will be visible in an enhanced treatments locator tool. HPoP users can use their existing account for voluntary reporting. Non-HPoP users can access the HPoP Voluntary Reporting site.

The prescribing health care provider and/or designee must report all medication errors and serious adverse events potentially related to these medications to Medwatch: The FDA Safety Information and Adverse Event Reporting Program. Reports must be filed within seven calendar days from the health care provider's awareness of the event.

Information on FDA shelf life extensions and expirations can be found on FDA’s Expiration Dating Extension webpage, as well as the ASPR product expiration webpage. Email COVID19Therapeutics@hhs.gov with any questions.

In general, USG-distributed therapeutics are the property of USG and must be used in accordance with the FDA approval or FDA Emergency Use Authorization (EUA). USG-distributed therapeutics may not be donated or otherwise used outside the United States. Check expiration dates on ASPR’s website before disposing of therapeutics. ASPR provides guidance on inventory and disposal management.

Clinical educational resources on therapeutics may be found on CDC’s webpage Interim Clinical Considerations for COVID-19 Treatment in Outpatients. Email cdphe_covid_med_guidance@state.co.us with any questions.

The ASPR/HHS Test to Treat program is a community health program that offers free influenza and COVID-19 health services to eligible participants (Medicaid, Medicare, VA, IHS insured patients) nationwide. There is a Home Test to Treat program and an in-person Test to Treat program.

A physician referral is not required for a patient to be seen at a Test to Treat location. While Test to Treat sites are required to 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 locations offering Test to Treat.

The National Institutes of Health’s Home Test to Treat program offers free at-home rapid tests, free telehealth visits, and free treatment (for eligible patients) for COVID-19 and flu. Adults aged 18 years and older who are uninsured or underinsured, on Medicare or Medicaid, in the VA health care system, or who receive care from the Indian Health Services are eligible to participate in Home Test to Treat.