COVID-19 Oral Treatments - Information for Providers

Treatment for COVID-19 is recommended for some people who have tested positive for COVID-19. When possible, an individual should receive a monoclonal antibody infusion. For patients who do not have access to monoclonal antibody infusion and who are at high risk of severe COVID-19 disease, there are currently two available oral treatments:

  1. Paxlovid
  2. Molnupiravir

These treatments are authorized by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) while clinical studies continue to look at their usefulness and safety.

Treatments must be given within 5 days of developing symptoms. 

COVID-19 Oral Treatment Tools

Frequently Asked Questions

General Questions

What outpatient options are currently available for COVID-19 treatment?

Monoclonal Antibody Treatment

  1. Bebtolovimab

    The CDC and New Mexico Department of Health routinely review the regional and state antiviral resistance data. Only monoclonal antibody treatments that are considered effective will be available for administration.

    For more information on monoclonal antibody treatment, click COVID-19 Monoclonal Antibody Treatment Information for Providers.

    Remdesivir Outpatient Treatment

    Remdesivir Outpatient Treatment

    1. Remdesivir

    Oral Antiviral Treatment

    1. Paxlovid
    2. Molnupiravir

    For more information on monoclonal antibody treatment, click COVID-19 Monoclonal Antibody Treatment Information for Providers.

    Are the COVID oral treatments FDA approved?
    • No, these medications have been granted an emergency use authorization (EUA).
    • This is the Food and Drug Administration (FDA) authorization of an unapproved product or unapproved uses of an approved product for emergency use.
    • EUA is NOT the same as FDA approval.
    • EUA medications are considered investigational.
    What should individuals of childbearing potential know about oral treatments?

    Paxlovid

    There are maternal and fetal risks associated with untreated COVID-19 in pregnancy. Benefit of Paxlovid may outweigh risk. The Society of Maternal Fetal Medicine has issued a statement supporting the use of Paxlovid in pregnant patients who meet the clinical qualifications. Talk to your health care provider regarding the risks and benefits of this medication if you are pregnant.

    Tell your healthcare provider if you are taking combined hormonal contraceptive. Paxlovid may affect how your birth control pills work. It is recommended that you use effective barrier contraception or do not have sexual activity while taking Paxlovid and for four days following treatment. 

    Molnupiravir

    For individuals who are able to become pregnant:

    • You should use a reliable method of birth control (contraception) consistently and correctly during treatment with molnupiravir and for 4 days after the last dose of molnupiravir. Talk to your healthcare provider about reliable birth control methods.
    • Before starting treatment with molnupiravir your healthcare provider may do a pregnancy test to see if you are pregnant before starting treatment with molnupiravir.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with molnupiravir.

    For individuals who are sexually active with partners who are able to become pregnant:

    • It is not known if molnupiravir can affect sperm. While the risk is regarded as low, animal studies to fully assess the potential for molnupiravir to affect the babies of males treated with molnupiravir have not been completed. The risk to sperm beyond 3 months is not known. Studies to understand the risk to sperm beyond 3 months are ongoing.
    • A reliable method of birth control (contraception) should be used consistently and correctly during treatment with molnupiravir and for at least 3 months after the last dose.
    • Talk to your healthcare provider about reliable birth control methods. Talk to your healthcare provider if you have questions or concerns about how molnupiravir may affect sperm.
    Are oral treatments effective against Omicron?

    Both Molnupiravir and Paxlovid have been tested in a laboratory setting against the Omicron variant. They are expected to remain effective against Omicron based on the initial data. Their efficacy against COVID variants will continue to be studied.

    Is there a cost for this treatment?
    • There may be some costs associated with the treatment. Patients should talk to their provider regarding the cost of treatment and available coverage options.
    • There is no cost to the patient for the medication itself.
    • Costs associated with patient assessment may be billed to the patient’s insurance or to Medicare/Medicaid.

    *As of March 22, 2022, the Uninsured Program will no longer process or pay for claims submitted for COVID treatments.  

    Questions About Phase Criteria

    Why are phased criteria for oral treatments necessary?

    Effective 2/14/2022, the Oral Antiviral and Monoclonal Antibody Screening Score (OMASS) tool will no longer be utilized in New Mexico. The tool is being phased out as current COVID-19 therapeutics inventory has exceeded demand.

    Providers should determine patient eligibility by reviewing each medication’s individual FDA Emergency Use Authorization. The documents can be found on the FDA’s Emergency Use Authorization Drugs and Non-Vaccine Biological Products webpage.

    Despite prioritization efforts, it is still likely that Paxlovid supply can become insufficient to meet demand when cases increase and demand is greater than supply.   Prescribers should have an alternative treatment plan in the case that the prescription cannot be filled by the pharmacy.

    Who is eligible to receive oral treatments?

    Paxlovid Patient Criteria:

      • Treatment can be started within 5 days or less from symptom onset AND
      • Positive COVID-19 test

    Molnupiravir Patient Criteria:

      • Treatment can be started within 5 days or less from symptom onset AND
      • Positive COVID-19 tes

    Providers should determine patient eligibility by reviewing each medication’s individual FDA Emergency Use Authorization. The documents can be found on the FDA’s Emergency Use Authorization Drugs and Non-Vaccine Biological Products webpage

    Eligible patients must have a positive COVID-19 test, be symptomatic, and treatment started within 5 days or less of symptom onset.

    Must my patient be symptomatic in order to prescribe oral treatments?

    COVID Oral therapeutics shall be reserved for symptomatic patients. Asymptomatic patients shall not be provided a prescription for oral therapeutics.

    Both molnupiravir and paxlovid must be started by the patient within 5 days of symptom onset for the therapy to be effective. Providers should ensure that the patient is able to receive medication within the treatment window.

    Prescribers should note the date of symptom onset on the prescription. This information is critical for pharmacists to ensure the patient receives their prescription within the treatment window.

     

    If a patient cannot fill a prescription in their community and requires their prescription be mailed to their home from Community Pharmacy, please allow 24-48 hours for medication processing and shipment. It is recommended to send prescriptions for patients within 72 hours of symptom onset.

    Questions about Prescribing Oral Treatments

    Who is authorized to prescribe oral treatments?

    Molnupiravir and Paxlovid may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which the medication belongs. Providers should review the FDA fact sheets for providers and carefully review contraindications and potential drug interactions prior to prescribing either of the new oral therapeutics. Providers should be aware that the pharmacy may not have access to medication lists for patients. Prescribers are responsible for assessing any potential drug interactions prior to prescribing an oral therapeutic.

      Which COVID-19 diagnostic tests are acceptable for the purpose of prescribing oral treatments?

      Please check https://cv.nmhealth.org/providers/covid-19-oral-therapeutics-information-for-providers/ for a list of other pharmacies in your community. 

      A positive COVID-19 result from any FDA approved COVID-19 diagnostic test including rapid antigen tests is acceptable. Confirmation with PCR is not necessary for the purpose of prescribing oral therapeutics.

      Providers should confirm any positive COVID-19 test result with the presence of symptoms that support the positive test result. Oral therapeutics should be provided only to symptomatic patients.

        What Information must I provide to my patients regarding these products?

        Providers should review the FDA fact sheets for providers and carefully review required consultation, contraindications, and potential drug interactions prior to prescribing either of the new oral therapeutics. Providers should be aware that the pharmacy may not have access to medication lists for patients. Prescribers are responsible for assessing any potential drug interactions prior to prescribing an oral therapeutic.

        Paxlovid Factsheet for Healthcare Providers

        https://www.fda.gov/media/155050/download

        Molnupiravir Factsheet for Healthcare Providers

        https://www.fda.gov/media/155054/download

        In addition, prescribing health care providers must provide the patient/caregiver with an electronic or hard copy of the “Fact Sheet for Patients and Caregivers” prior to the patient receiving molnupiravir or paxlovid and must document that the patient/caregiver has been given an electronic or hardcopy of the “Fact Sheet for Patients and Caregivers”

        Paxlovid Factsheet for Patients, Parents, and Caregivers

        https://www.fda.gov/media/155051/download

        https://www.fda.gov/media/155075/download

         

        Molnupiravir Factsheet for Patients, Parents, and Caregivers

        https://www.fda.gov/media/155055/download

        https://www.fda.gov/media/155115/download

          What needs to be included on the prescription for processing?

          In order for the pharmacy to process oral therapeutics prescriptions in a timely manner. The following information is essential:

          1. Date of symptom onset
            • It is important for the pharmacy team to know this information so that they can ensure patient receives medication within the therapeutic window.
          2. Patient address (if the patient does not have permanent housing please annotate as such)
            • Alternative shipping location if applicable
          3. Patient’s telephone or an alternate means of contact for the patient
          4. Pharmacy insurance information-if available
          5. Alternate Therapy– Supply remains limited. In order to ensure your patient receives timely treatment, please indicate the alternate therapy you would prefer your patient to receive if the medication is out of stock. For example, “If paxlovid is not available, please substitute molnupiravir OR If paxlovid is not available, please contact prescriber for monoclonal antibody referral.”
            Where can I send a prescription?

            All prescriptions shall be sent electronically when possible. Providers without the ability to send an E-Rx may send a fax or phoned prescription. Please include in the notes section the date of symptom onset. It is important for the pharmacy team to know this information so that they can ensure the patient receives their medication within the treatment window.

            The listing of pharmacy locations will expand as supply increases. Please continue to check https://cv.nmhealth.org/providers/covid-19-oral-therapeutics-information-for-providers/ for an up-to-date list of locations.

            Why aren’t oral treatments available at all pharmacies yet?

            Based upon availability of supply, the pharmacy network has and will continue to expand to include all interested pharmacies

            My patient does not live in a city with a location that has in-store supplies available. How will they get their prescription filled?

            Please send the prescription to Community, A Walgreens Pharmacy #16544. Prescriptions will be sent via overnight mail across the state directly to the patient’s home or an approved alternate pick up location.

            Community, A Walgreens Pharmacy #16544

            933 San Mateo Blvd NE Suite 501, Albuquerque, NM 87108

            Phone: 505-313-8080

            Fax: 505-313-8082

            Monday thru Friday from 8:30am to 4:00 pm
            Weekend Prescriptions Friday 4pm- Monday 8am need to be sent to a location with same day pick up. See the table below for the closest location.

            The pharmacy did not have the medication I prescribed in stock. What options are available to my patient?

            Please check https://cv.nmhealth.org/providers/covid-19-oral-therapeutics-information-for-providers/ for a list of other pharmacies in your community. 

            Please refer to the COVID THERAPEUTICS FOR OUTPATIENTS – QUICK REFERENCE GUIDE FOR PRESCRIBERS for additional treatment options.

            Prescription Processing Notes

            • The dispensing pharmacy shall obtain a list of the patient’s medications in order to check for potential drug interactions.
            • The dispensing pharmacy shall confirm that the patient will be able to receive and start the medication within 5 days of symptom onset.
            • If medications are shipped, prescriptions must be filled and shipped overnight within 24 hours of receipt.
            • If a prescription is unable to be filled within 24 hours, the prescription shall not be accepted by the pharmacy. The prescriber and patient shall be notified and referred for alternative COVID treatments such as a monoclonal antibody infusion.
            • If a prescription is not picked up within 5 days of symptom onset, the prescription shall be returned. The prescriber shall be notified to refer patient for alternative COVID treatments such as a monoclonal antibody infusion.

            Clinical Resources

            National Institutes of Health (NIH) COVID-19 Treatment guidelines

            https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/ 

            Paxlovid Factsheet for Healthcare Providers

            https://www.fda.gov/media/155050/download

            Molnupiravir Factsheet for Healthcare Providers

            https://www.fda.gov/media/155054/download

            COVID Oral Treatments Billing

            • There may be some costs associated with the treatment. Patients should talk to their provider regarding the cost of treatment and available coverage options.
            • There is no cost to the patient for the medication itself, but costs associated with patient assessment may be billed to the patient’s insurance or to Medicare/Medicaid.
            • As of March 22, 2022, the Uninsured Program stopped accepting claims for COVID testing and treatment due to a lack of sufficient funds.  

            Weekly HHS Office Hours

            New information regarding these treatments, administration and their distribution is provided weekly by the federal government. If you are interested in joining, please email COVID19Therapeutics@hhs.gov to request Zoom links.

            Additional Resources

            Health and Human Services (HHS) has numerous toolkits with information ranging from administration resources, clinical evidence summaries, patient education resources, COVID-19 variant proportion data, and frequently asked questions to payment resources. These tools are available through the HHS Public Health Emergency webpage:

             

            https://www.phe.gov/emergency/events/COVID19/therapeutics/Pages/default.aspx

            Additional Questions

            Providers may direct additional questions for New Mexico Department of Health to COVID.Therapeutics@state.nm.us

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