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For Health Care Providers
How can providers prescribe COVID-19 therapeutics to patients?
Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. When prescribing COVID-19 treatments, health care providers can use the following tools:
For an overview of mild to moderate COVID-19 outpatient therapies:
- COVID-19 Outpatient Therapeutics Decision Tree
- Health Care Provider COVID-19 Outpatient Therapy Toolkit
- COVID-19 Outpatient Therapy Guidance
- COVID-19 Therapeutics Education Session for Clinicians
For the management of Paxlovid drug-drug-interactions:
- Paxlovid Drug-Drug-Interactions list by University of Michigan
- COVID-19 Drug interactions by University of Liverpool
- Paxlovid Patient Eligibility Screening Checklist Tool for Prescribers
For COVID-19 oral antiviral medications standard prescriptions:
To see what locations currently have COVID-19 therapeutics.
What is Test to Treat?
The Test to Treat program is a nationwide initiative launched by the federal government to ensure rapid access to no-cost COVID-19 oral medications for individuals who have tested positive for COVID–19, who are experiencing mild to moderate symptoms, and who are at high risk for severe disease including hospitalization and/or death. Test to Treat sites will provide COVID-19 tests, determine eligibility of COVID-19 patients to receive COVID-19 therapy, and prescribe medication that patients can fill on-site or at affiliated pharmacies.
What Is Antiviral Medication?
Antiviral medication is a treatment that kills a virus or suppresses its ability to replicate and, hence, inhibits its capability to multiply and reproduce. Vaccinations remain the best way to protect a person from COVID, and are a preventative measure to reduce severity of illness and risk of hospitalization or, even, death. Antivirals are prescribed after a person has tested positive for COVID-19 and within 5 days of symptom onset. Talk to a provider about your eligibility for antiviral treatment.
What Are Monoclonal Antibody Therapies?
Monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system's attack on cells. Monoclonal antibodies are designed to block viral attachment and entry into human cells, thus neutralizing the virus. It is designed to limit viral replication and may be effective for the treatment of COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.
Monoclonal antibody treatment is for people who have tested positive for COVID-19 and have mild to moderate symptoms. When administered to non-hospitalized patients as soon as possible after positive viral testing for SARS-CoV-2 and within 7 days of symptom onset, monoclonal antibodies may reduce viral load, symptoms, and risk of hospitalizations and emergency room visits associated with COVID-19. Information reported by the manufacturers to the food and drug administration indicates that among high-risk symptomatic individuals, there is a 70% reduction in hospitalizations and deaths.
Bebtelovimab is currently the only authorized monoclonal antibody therapy given the prevalence of the Omicron BA.2 sub-variant.
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Evusheld (Tixagevimab + Cilgavimab)
On 12/08/2021, the FDA issued an Emergency Use Authorization (EUA) for the medication Evusheld (tixagevimab/cilgavimab).
Evusheld is a monoclonal antibody administered for pre-exposure prophylaxis to those who are either immunocompromised and unable to receive the COVID-19 vaccine or who are not expected to mount a response to the COVID-19 vaccination.Designed to block viral attachment and entry into the cells, Evusheld is a long-acting monoclonal antibody (mAb) therapy used for pre-exposure prophylaxis (PrEP) of COVID-19 in adults and children >12 years and weighing at least 40kg. Only individuals who have immunocompromise due to a medical treatment or condition are eligible to receive this medication and the very few who are determined to be ineligible for additional vaccination because of a severe reaction to an earlier vaccination. Individuals who have received the COVID-19 vaccine must wait at least 2 weeks before receiving Evusheld.
Unlike other mAb medications used for COVID-19, Evusheld is not a treatment for COVID-19, it is only for PrEP (prevention). Evusheld is NOT a substitute for vaccination. Evusheld is not for those who have been exposed to COVID-19, and is not meant as a treatment for COVID-19.
Evusheld is only available by prescription and is administered via IM injection. The SARS-CoV-2 variants that will be circulating in the U.S. when Evusheld may need to be redosed are not known at this time and therefore repeat dosing recommendations cannot be made; the Fact Sheets will be revised with repeat dosing recommendations in the future when more data are available.
- Prioritization and Distribution of Evusheld
- Evusheld Letter of Emergency Use Authorization (EUA)
- Evusheld Healthcare Providers Fact Sheet
- Evusheld Patient Fact Sheet
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Bebtelovimab (Lilly)
An emergency use authorization (EUA) was issued from the U.S. Food and Drug Administration (FDA) on Feb. 11, 2022, for the COVID-19 monoclonal antibody therapeutic bebtelovimab. The EUA allows healthcare providers to administer bebtelovimab for outpatient treatment of mild to moderate COVID-19 in adults and children age 12 years and older, who are at high risk for progressing to severe COVID-19 and/or hospitalization and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
HHS will allocate patient courses of bebtelovimab on a recurring basis as product becomes available from the manufacturer. The initial 50,000 patient courses will be made available on Monday Feb. 14 to state and territorial health departments.
Bebtelovimab is used for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg):
- with 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 approved or authorized by FDA are not accessible or clinically appropriate
Dosage and Administration
- The dosage in adults (18 years and older) and pediatric patients (≥12 years of age and weighing at least 40 kg) is bebtelovimab 175 mg.
- Administer bebtelovimab as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset.
- Bebtelovimab must be administered as a single intravenous injection over at least 30 seconds.
Contraindications
- No contraindications have been identified based on the limited available data for the emergency use of bebtelovimab authorized under this EUA.
Drug Interactions
- Bebtelovimab is not renally excreted or metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are renally excreted or that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.
Pregnancy and Lactation
- There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.
- There are no available data on the presence of bebtelovimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk.
Pediatric Use
- Bebtelovimab is not authorized for use in pediatric individuals under 12 years of age or weighing less than 40 kg. The safety and effectiveness of bebtelovimab have not been assessed in pediatric patients.
- The recommended dosing regimen in patients 12 years to less than 18 years of age, weighing at least 40 kg, is expected to result in comparable serum exposures of bebtelovimab as those observed in adults.
Patient Counseling Information
- As a healthcare practitioner, you must communicate to the patient and/or caregiver information consistent with the "FACT SHEET FOR PATIENTS, PARENTS AND CAREGIVERS" and provide them with a copy of this Fact Sheet prior to administration of bebtelovimab.
- However, if providing this information will delay the administration of bebtelovimab to a degree that would endanger the life of a patient, the information must be provided to the parent and/or caregiver as soon as feasible after bebtelovimab administration.
- Remind patients treated with bebtelovimab that they should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect "high touch" surfaces, and frequent handwashing) according to CDC guidelines.
Additional information can be found at https://www.fda.gov/media/156152/download.
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Billing and Coding
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Resources
General
- COVID-19 Monoclonal Antibody Therapeutics Toolkit
- NICA COVID-19 Antibody Treatment Resource Center
- Project ECHO
- Duke Margolis Center For Health Policy: COVID-19 Monoclonal Antibody Treatments: Recommendations and Promising Practices for Providers
- HHS ASPR TRACIE (Mini-Webinar): Monoclonal Antibody Therapy Experiences in Michigan
Research Articles
- Original Article (Bamlanivimab): SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19
- Original Article (Casarivimab and Imdevimab): REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19
- Original Article (Bamlanivimab and Etesevimab): Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19A - Randomized Clinical Trial
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Additional resources for long term care facilities
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Communication Resources
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Ethical Considerations
During times of limited availability of therapeutic mediations, it is essential that all prescribers apply ethical principles in determining eligibility of these medications. Medications should only be prescribed in bonified clinician-patient relationships. Additional information on ethical principles during scarce resource allocations can be obtained through MDHHS.