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Information and Resources for Healthcare Providers

Introduction

Lifesaving treatments are available for those individuals at highest risk for severe complications from COVID-19, including hospitalization or death. This includes people age 65 years and older, and people with certain medical conditions, including weakened immune systems. COVID-19 treatments including antiviral medications and monoclonal antibody therapies are highly effective and important tools for preventing severe illness, including hospitalization and death, for people who have tested positive for COVID-19 and are in the early stage of illness.

All COVID-19 therapeutics require a prescription order from a licensed healthcare provider. Ohioans who believe they might be eligible for one of these treatments should consult with a qualified provider to discuss medical history and current medications to check for possible drug-to-drug interactions, and to determine the best course of treatment.

Treatments including antiviral medications and monoclonal antibodies are currently available under U.S. Food and Drug Administration (FDA) emergency use authorization to treat COVID-19 for those who are at highest risk of severe illness from COVID-19 based on age, medical and health conditions, and vaccination status. In addition, a preventive treatment is available for people with weakened immune systems or people who have had severe reactions to the COVID-19 vaccines or their ingredients and therefore cannot receive the vaccine.

Eligibility and Prioritization Strategies

In addition to eligibility criteria for each therapeutic product, recipients should also be at high risk for developing severe illness from COVID-19. Risk factors for developing serious illness from COVID-19 include age, vaccination status, immune status, and medical conditions.

Age is the strongest risk factor for severe COVID-19 outcomes. People who are age 65 years and older, especially those who live in congregate settings, are at increased risk for serious illness, hospitalization, and death from COVID-19.

People with certain underlying medical conditions, which includes but is not limited to cancer, heart conditions, chronic kidney disease, chronic lung diseases, chronic liver diseases, diabetes, obesity, cerebral palsy, and solid organ or stem cell transplant. The risk of severe COVID-19 increases for people with more than one underlying medical condition.

People who are moderately to severely immunocompromised also are at increased risk for developing serious illness from COVID-19.

The risk of severe COVID-19 increases as the number of underlying medical conditions increases in a person.

In cases where supply of one or multiple COVID-19 treatments are limited, the U.S. Department of Health and Human Services offers guidance on how to prioritize treatments among these high risk groups.

Oral Antiviral Pills (Paxlovid and Molnupiravir)

Oral antiviral pills are an at-home COVID-19 treatment option for those who are high risk of severe illness. These prescribed pills work to keep the SARS-Cov-2 virus from replicating properly, thereby reducing viral load, which can help reduce symptom severity.

Currently available oral antivirals include: Paxlovid (Pfizer), including a version for people with severe renal impairment, and Molnupiravir (Lagevrio). These oral antiviral pills are available under FDA emergency use authorization to treat COVID-19. These pills work to keep the SARS-Cov-2 virus from replicating properly, thereby reducing viral load, which can help reduce symptom severity. For both types of antiviral pills, the treatment course must be initiated within five days of symptom onset.

The list of oral therapeutic options is subject to change as new research becomes available, and as the FDA provides EUAs for other therapeutics for the treatment of COVID-19. 

PAXLOVID

A prescription is required for Paxlovid for the treatment of mild-to-moderate COVID-19.

Eligibility: Eligible individuals must be age 12 or older who weigh at least 88 pounds (40 kg), test positive for COVID-19, and be at high risk for progression to severe illness from COVID-19.

Paxlovid is not recommended for those with severe kidney disease or who are on dialysis, or those with severe liver disease. Dose adjustments may be required for patients with mild to moderate kidney disease. Healthcare providers should also monitor for possible drug-to-drug interactions and prescribe alternative treatments as needed or make adjustments to other medications during COVID-19 treatment. Please review the Paxlovid FDA EUA Fact Sheet for a list of contraindications, warnings, and precautions.

Dosage: 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet), with all three tablets taken together twice daily for five days, for a total of 30 tablets. An additional dose pack presentation with appropriate dosing is available for those with mild to moderate kidney disease.

Timing of treatment: Paxlovid should be initiated as soon as possible after diagnosis of COVID-19 — no later than five days after symptom onset.

Full prescribing information: Fact Sheet for Healthcare Providers

More information about Paxlovid, including dosing instruction, potential side effects, drug interactions, warnings/precautions, contraindications, specific populations, and information about who is able to prescribe Paxlovid, is available in the FDA’s Fact Sheet for Healthcare Providers.

MOLNUPIRAVIR (Lagevrio)

A prescription is required for Molnupiravir for the treatment of mild-to-moderate COVID-19.

Eligibility: Eligible individuals must be age 18 or older, test positive for COVID-19, and be at high risk for progression to severe illness from COVID-19.

Molnupiravir is not recommended for individuals who are pregnant. Breastfeeding is not recommended during treatment and for four days after the last dose. Please review the Molnupiravir FDA EUA Fact Sheet for a list of contraindications, warnings, and precautions.

Dosage: 800 mg (four 200 mg capsules) taken orally every 12 hours for five days, for a total of 40 capsules.

Timing of treatment: Molnupiravir should be initiated as soon as possible after diagnosis of COVID-19 — no later than five days after symptom onset.

Full prescribing information: Fact Sheet for Healthcare Providers

More information about Molnupiravir, including dosing instructions, potential side effects, drug interactions, warnings/precautions, contraindications, specific populations, and information about who is able to prescribe Molnupiravir, is available in the FDA’s Fact Sheet for Healthcare Providers.

Antiviral IV Infusion

REMDESIVIR (VALKURY)

A prescription is required for Remdesivir for the treatment of mild-to-moderate COVID-19. The antiviral treatment administered through intravenous infusion is also available under full FDA approval for adult and pediatric through hospitals or outpatient treatment locations. Remdesivir was originally approved by the FDA for treating patients hospitalized with COVID-19 and its use was expanded this year for people who are not hospitalized, but are at high risk for disease progression. This is the only available treatment for children younger than age 12 who are at high risk for serious COVID-19 illness.

Eligibility: Eligible individuals must be 28 days of age and older and weighing at least 6.6 pounds, test positive for COVID-19, and be at high risk for progression to severe illness from COVID-19.

Dosage: Nonhospitalized patients receive a three-day course by IV. Hospitalized patients typically receive a five-day course by IV.

Timing of treatment: Remdesivir should be initiated in nonhospitalized patients within seven days of symptom onset.

Full prescribing information: National Institutes of Health COVID-19 Treatment Guidelines.

Monoclonal Antibodies

Monoclonal antibodies (mAbs) are molecules made in a laboratory to fight a specific infection. They can mimic the immune system's attack on cells, and give the body the antibodies it needs to protect itself. A mAb treatment could limit the amount of virus in a person’s body, which could mean milder symptoms and less likelihood to need hospital treatment. These treatments are given by intravenous infusion through a hospital or outpatient healthcare facility.

The availability and supply of certain COVID-19 therapies can change frequently based on effectiveness against particular variants or subvariants of COVID-19. Currently, one mAb is available for treatment of COVID-19 under emergency use authorization from the FDA, Bebtelovimab.

BEBTELOVIMAB

A prescription is required for Bebtelovimab for the treatment of mild-to-moderate COVID-19. This mAb is the only one effective against the Omicron subvariant BA.2, currently the dominant strain of the virus, for treatment of a positive COVID-19 patient.

Eligibility: Eligible individuals must be age 12 or older who weigh at least 88 pounds (40 kg), test positive for COVID-19, and be at high risk for progression to severe illness from COVID-19.

Dosage: 175 mg/2 mL (87.5 mg/mL) in a single-dose vial administered as a single intravenous injection lasting approximately 30 seconds.

Timing of treatment: Bebtelovimab should be initiated as soon as possible after diagnosis of COVID-19, and no later than seven days after symptom onset.

Full prescribing information: Fact Sheet for Healthcare Providers

More information about Bebtelovimab, including dosing instructions, potential side effects, drug interactions, warnings/precautions, contraindications, specific populations, and information about who is able to prescribe Bebtelovimab, is available in the FDA’s Fact Sheet for Healthcare Providers.

Preventive Medication

EVUSHELD

A prescription is required for Evusheld, a preventative treatment available under FDA emergency use authorization to protect vulnerable people with severely compromised immune systems before they are exposed to COVID-19. Evusheld, a pre-exposure prophylaxis, is given as an injection into the muscle and may be effective for up to six months. Evusheld is not a treatment for people who have tested positive or who have been exposed to COVID-19.

People who may not develop a sufficient immune response after COVID-19 vaccination because of a weakened immune system could benefit from Evusheld. People who are unable to receive a COVID-19 vaccination because of a severe reaction to the vaccine or its ingredients may also benefit.

Eligibility: Eligible individuals must be age 12 or older who weigh at least 88 pounds and have certain immunocompromised conditions that increase their risk for severe illness from COVID-19. Evusheld also can be used to help prevent COVID-19 illness in individuals who are unable to receive the COVID-19 vaccination series because of severe reactions to the vaccine or its ingredients. Evusheld should not be given to anyone currently infected with COVID-19 or exposed to someone with COVID-19.

Dosage: Evusheld consists of two monoclonal antibodies provided together to help prevent infection with the virus that causes COVID-19. It is administered during one visit with two separate intramuscular injections given one after the other.

Timing of treatment: Before exposure to SARS-CoV-2.

Full prescribing information: Fact Sheet for Healthcare Providers

People who believe they might be eligible for Evusheld should consult with a qualified provider to discuss medical history and determine the best ways to stay protected against COVID-19.

More information: Fact Sheet: Evusheld for COVID-19 Prevention

Prescription Orders Required for COVID-19 Treatments

In Ohio, a patient must have a prescription order to receive COVID-19 therapeutics.

These pills may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants. Providers are strongly encouraged to ensure compliance with requirements for oral antiviral ordering and administration under state law.   

Clinicians who wish to consider or recommend use of these therapies should review the COVID-19 Treatment Guidelines published by the National Institutes of Health (NIH) as well as the FDA EUA for each specific medication.   

These treatments are intended for outpatient dispensing; clinicians and health systems should provide medication in a location and manner in which patients with COVID-19 can be safely managed. 

Risk is generally based on age, specific comorbidities by age group (e.g., kidney disease, diabetes, cardiovascular disease, chronic respiratory disease, etc.) and/or a body mass index greater or equal to 25. Evaluating risk based upon these factors helps to ensure the treatments are being made available safely and to the Ohioans who need them the most.

The Centers for Disease Control and Prevention (CDC) website provides a list of risk factors for severe illness from COVID-19 on the webpage Underlying Medical Conditions Associated with High Risk for Severe COVID-19. The likelihood of developing severe COVID-19 increases when a person has multiple comorbidities.

Supplies of the treatments are limited. When demand exceeds supply, providers should follow guidance from the U.S. Department of Health and Human Services (HHS) to prioritize treatments for those at the very highest risk for severe outcomes.

Ohio COVID-19 Therapeutics Providers

Healthcare providers should first check with their associated health systems to determine availability of the treatments.

Healthcare providers seeking a therapeutics location to direct a patient for treatment are advised to use the Office of the Assistant Secretary for Preparedness & Response’s COVID-19 Therapeutics Locator, which is a searchable national map displaying public locations that have received shipments of the treatments. The website allows healthcare providers to easily locate the nearest therapeutics locations to help them connect their patients with the treatments. In addition, ODH offers an Ohio-focused COVID-19 Therapeutics Locator.

As a reminder, patients must have a prescription to access treatment and should not contact therapeutics distribution locations directly. When a patient has a prescription and has been connected to a location, calling ahead to confirm availability of the treatment and scheduling an appointment is recommended. Most locations will require an appointment.

Test to Treat Locations

There are now locations where patients can get tested, have a medical visit, and, if eligible, receive treatment. The national Test to Treat initiative includes sites across Ohio that have healthcare providers available to provide timely and thorough assessment and discuss relevant oral antiviral treatment options.

If a person tests positive at a different location or with an at-home test, that person can also go to these Test to Treat locations to receive a prescription from a qualified healthcare provider and access treatment on the spot if eligible.

Appointments are required at many of these locations, so those seeking care are advised to schedule an appointment online and to call ahead to ensure the treatment is still available. Some Test to Treat sites may have telehealth options available.

More information: Test to Treat program | Find a Test to Treat Location

How to be a Therapeutics Provider

Dispensing of therapeutics occurs across a broad group of providers, including:

  • Hospitals and health systems
  • Retail pharmacies
  • Federally Qualified Health Centers
  • Long-term Care Pharmacies

Due to a limited supply, oral antivirals are being distributed through certain types of providers. Providers interested in dispensing oral therapeutics should complete a provider enrollment form to enroll. Sites may also email therapeutics@odh.ohio.gov for additional information.

Resources for Healthcare Providers