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. 

Please note supply will be extremely limited the first several months. Phased eligibility criteria will be in place in order to prioritize patients at highest risk.

COVID-19 Oral Treatment Tools

Frequently Asked Questions

General Questions

What options are currently available for COVID-19 treatment?

Monoclonal Antibody Treatment

  1. REGEN-COV (casirivimab and imdevimab, administered together)
  2. Bamlanivimab and etesevimab, administered together
  3. Sotrovimab 

Oral Antiviral Treatment

  1. Paxlovid
  2. Molnupiravir 

It is recommended that eligible individuals receive monoclonal antibody treatment when possible. Due to limited supply, oral antiviral treatments are currently reserved for those who are unable to access monoclonal antibody treatment. 

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

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

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.
  • Uninsured or underinsured patients can have providers bill treatment costs to the HHS COVID-19 Uninsured Program or Coverage Assistance Fund.

Questions About Phase Criteria

Why are phased criteria for oral treatments necessary?

Due to high case rates (6,912 cases in the previous week) and limited initial oral therapeutic supply (approximately 940 doses available weekly statewide), a phased approach is necessary to prioritize those at greatest risk of severe disease. Prescribing will initially be restricted to patients who are at high risk of severe disease and hospitalization. The state will utilize an oral antiviral and monoclonal antibody screening score (OMASS) to prioritize patients at the highest risk of severe disease. In addition, access to oral therapeutics will be limited initially to counties without monoclonal antibody infusion sites and areas with limited access to monoclonal antibody infusions. New Mexicans in these communities have more difficulty accessing medical care. Prioritizing patients in these communities will help to increase access to COVID-19 treatment and reduce hospitalizations. As supply becomes more readily available, criteria will expand to include all counties and all eligible patients under the EUA. 

Despite prioritization efforts, it is still likely that paxlovid supply will be insufficient to meet demand during the first several months. 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?

Due to limited supply, the state is utilizing a phased release of COVID-19 oral treatments. The state is currently in Phase 1-A.

Who is in Phase 1?

 

Paxlovid Patient Criteria:

  • Treatment can be started within 5 days or less from symptom onset AND
  • Positive COVID-19 test AND
  • Must reside in an eligible county AND
  • OMASS score of 6 or greater OR
  • 12-17 years of age and OMASS score of 3 or greater

Molnupiravir Patient Criteria:

  • Treatment can be started within 5 days or less from symptom onset AND
  • Positive COVID-19 test AND
  • Must reside in an eligible county AND
  • OMASS score 3 or greater

Oral Antiviral & Monoclonal Antibody Screening Score (OMAS)
adapted from Mayo Clinic’s published Monoclonal Antibody Screening Score (MASS

RISK FACTOR POINTS
Age 65 years and older 2
BMI 35 kg/m2 and higher 2
Diabetes mellitus 2
Chronic kidney disease 3
Cardiovascular disease in a patient 55 years and older 2
Chronic respiratory disease in a patient 55 years and older 3
Hypertension in a patient 55 years and older 1
Immunosuppressed and unlikely to have responded to vaccines (eg: CD20 inhibitors, BTK inhibitors, campath, recent CAR-T, organ transplant) 3
Pregnancy* 4
BIPOC (Black, Indigenous, People of Color) status 1

* Molnupiravir is not recommended for use in pregnancy.

Eligible Counties:

1-A

1-B

1-C

1-D

Bernalillo

Hidalgo

San Juan

1-A counties &

1-B counties &

1-C counties &

Catron

Lincoln

Santa Fe

Colfax

Eddy

Chaves

Cibola

McKinley

Sierra

Curry

Lea

Guadalupe

De Baca

Mora

Socorro

Los Alamos

Luna

Roosevelt

Doña Ana

Rio Arriba

Taos

Otero

Quay

 

Grant

San Miguel

Torrance

 

Union

 

Harding

Sandoval

Valencia

 

 

 

Who is in Phase 2?

 

Paxlovid Patient Criteria:

  • Treatment can be started within 5 days or less from symptom onset AND
  • Positive COVID-19 test AND
  • OMASS score of 4 or greater OR
  • 12-17 years of age and OMASS score of 3 or greater

Molnupiravir Patient Criteria:

  • Treatment can be started within 5 days or less from symptom onset AND
  • Positive COVID-19 test AND
  • OMASS score 3 or greater

Oral Antiviral & Monoclonal Antibody Screening Score (OMAS)
adapted from Mayo Clinic’s published Monoclonal Antibody Screening Score (MASS

RISK FACTOR POINTS
Age 65 years and older 2
BMI 35 kg/m2 and higher 2
Diabetes mellitus 2
Chronic kidney disease 3
Cardiovascular disease in a patient 55 years and older 2
Chronic respiratory disease in a patient 55 years and older 3
Hypertension in a patient 55 years and older 1
Immunosuppressed and unlikely to have responded to vaccines (eg: CD20 inhibitors, BTK inhibitors, campath, recent CAR-T, organ transplant) 3
Pregnancy* 4
BIPOC (Black, Indigenous, People of Color) status 1

* Molnupiravir is not recommended for use in pregnancy.

Eligible Counties: All Counties

Who is in Phase 3?

Paxlovid & Molnupiravir Patient Criteria:

  • Treatment can be started within 5 days or less from symptom onset AND
  • Positive COVID-19 test AND
  • OMASS score of 3 or greater

Oral Antiviral & Monoclonal Antibody Screening Score (OMAS)
adapted from Mayo Clinic’s published Monoclonal Antibody Screening Score (MASS

RISK FACTOR POINTS
Age 65 years and older 2
BMI 35 kg/m2 and higher 2
Diabetes mellitus 2
Chronic kidney disease 3
Cardiovascular disease in a patient 55 years and older 2
Chronic respiratory disease in a patient 55 years and older 3
Hypertension in a patient 55 years and older 1
Immunosuppressed and unlikely to have responded to vaccines (eg: CD20 inhibitors, BTK inhibitors, campath, recent CAR-T, organ transplant) 3
Pregnancy* 4
BIPOC (Black, Indigenous, People of Color) status 1

* Molnupiravir is not recommended for use in pregnancy.

Eligible Counties: All Counties

Who is in Phase 4?

Any patient eligible based on EUA criteria.

Eligible Counties: All Counties 

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

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.

During initial central distribution, please allow 24-48 hours for medication processing and shipment. It is recommended to send prescriptions for patients within 72 hours of symptom onset until supply is sufficient to decentralize distribution.

Questions about Prescribing Oral Therapeutics

Who is authorized to prescribe oral therapeutics?

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 therapeutics?

    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.

          For a listing of locations please visit https://cv.nmhealth.org/providers/covid-19-oral-therapeutics-information-for-providers/ 

          Do not send prescriptions to alternative pharmacies or Walgreens not listed above. They do not have medication in stock. 

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

          Due to limited supply, the network of pharmacies will be limited to a few partners. Initially, the state will partner with a single pharmacy partner, Walgreens. As medication supply increases, pharmacy locations across the state will receive oral therapeutics for onsite prescription processing and dispensation. As additional supply becomes available, the pharmacy network will 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
          933 San Mateo Blvd NE Suite 501, Albuquerque, NM 87108
          Phone: 505-313-8080
          Fax: 505-313-8082 

          Prescriptions will be sent via overnight mail directly to the patient’s home or an approved alternate pick up location.

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

          Paxlovid supplies are very limited. Consider referral to a monoclonal antibody site or treatment with molnupiravir.

          Contact your local hospital regarding regarding monoclonal antibody treatment referral or use the COVID-19 Infusion Site Locator: https://covid.infusioncenter.org to find the closest location.

          Refer to the NIH COVID-19 treatment guidelines for additional guidance on medication selection.

          https://files.covid19treatmentguidelines.nih.gov/guidelines/covid19treatmentguidelines.pdf

          Prescription Processing Notes

          • The dispensing pharmacy is responsible for verifying that the patient resides within an eligible county.
          • 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.
          • During the initial central distribution, 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 therapeutic 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 therapeutic 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 Therapeutics Billing

          Weekly HHS Office Hours

          New information regarding these therapeutics, 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.

          The Biweekly calls take place on Tuesdays (2:00 – 3:00PM ET) and Thursdays (2:00 – 3:00PM ET)

          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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