Monoclonal antibodies are currently only authorized as treatment and pre-exposure prophylaxis for people who have a medical condition or other factors that increase their risk for severe illness. There are currently no authorized monoclonal antibody products for post-exposure prophylaxis.

Specific Criteria for Treatment and Pre-Exposure Prophylaxis

For treatment, patients must meet all of these criteria:

• Be 12 years or older
• Weigh at least 88 pounds
• Be 65 or older or have a medical condition or other factor that increases their risk for severe COVID-19
  • Consider race and ethnicity when assessing individual risk. Longstanding systemic health and social inequities may contribute to an increased risk of getting sick and dying from COVID-19.
• Test positive for COVID-19 on a nucleic acid amplification test or antigen test
• Have mild to moderate COVID-19 symptoms
• Are able to start treatment within seven days of symptom onset
• Are not hospitalized or receiving oxygen therapy due to COVID-19

For pre-exposure prophylaxis, patients must meet all of these conditions:

• Be 12 years or older
• Weigh at least 88 pounds
• Are not currently infected with SARS-CoV-2
• Have no known recent exposure to an individual infected with COVID-19
• Have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination, or COVID-19 vaccination is not recommended due to a history of severe adverse reaction, such as severe allergic reaction, to a COVID-19 vaccine or any of its components.

For additional guidance, see the Evusheld Prescriber Checklist (PDF).

One product is currently authorized for emergency use for treatment in New York State. Sotrovimab is no longer authorized for use due to the prevalence of the BA.2 omicron subvariant and its reduced activity against this variant.

Bebtelovimab

Note: This product is expected to remain effective against the omicron BA.1 and BA.2 omicron variant sublineages (section 12.4, Fact Sheet for Providers).

• Indication: Treatment of patients for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
• Administration: IV injection over at least 30 seconds
• Authorized Patient Age: 12 years and older
• FDA Fact Sheets:
  • Bebtelovimab Fact Sheet for Providers (PDF)
  • Bebtelovimab Fact Sheet for Patients, Parents and Caregivers (PDF)

Tixagevimab with Cilgavimab (EVUSHELD)

Note: This product is expected to remain effective against the omicron variant (section 12.4, Fact Sheet for Providers).

• Indication: Pre-exposure prophylaxis
• Administration: IM injections
• Authorized Patient Age: 12 years and older
• FDA Fact Sheets:
  • EVUSHELD Fact Sheet for Providers (PDF)
  • EVUSHELD Fact Sheet for Patients, Parents and Caregivers (PDF)
  • Evusheld Prescriber Checklist (PDF)

To decide if monoclonal antibody is appropriate for a patient, refer to the COVID-19 Decision Support Tool (PDF, December 30, 2021).

Treatment is most effective when given as soon as possible after symptom onset and should be considered for eligible patients, regardless of vaccination status.

Due to limited clinical efficacy data, bebtelovimab is only authorized as a treatment for patients whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. However, based on the scientific evidence (Phase 2 trial and pharmacokinetic data), it is expected that bebtelovimab may be effective for the treatment of patients with mild-to-moderate COVID-19 to reduce the risk of progression to hospitalization or death (Section 14.4, bebtelovimab Fact Sheet For Providers).

For pre-exposure prophylaxis, long-term efficacy data indicate that EVUSHELD can be re-dosed every six months for people who continue to qualify for therapy. Due to limited supplies, EVUSHIELD is only available to select locations serving populations eligible for pre-exposure prophylaxis.

CDC guidelines no longer recommend delaying COVID-19 vaccination after receiving monoclonal antibody therapy.

Referring for Therapy

Here are some resources to help you find a referral site:

• NYC Health Map: COVID-19 Treatment
• Health Information Tool for Empowerment: Monoclonal Antibody Treatment Site Locator
• NYC Health + Hospitals: ExpressCare can prescribe oral antivirals or schedule monoclonal antibody infusions. For more information, call 212-COVID19 (212-268-4319).
• U.S. Department of Health and Human Services (HHS): EVUSHIELD Therapeutics Locator

Offering Therapy

The following website has information for providers interested in offering monoclonal antibody therapy:

• New York State: COVID-19 Monoclonal Antibody Therapeutics: Information for Providers

The following websites have information for monoclonal antibody treatment providers:

• HHS: Monoclonal Antibody Playbook for Outpatient Administration
• HHS: Combat COVID: Tools for Your Practice
• Centers of Medicare and Medicaid Services: Coverage for Monoclonal Antibody Treatments

Offering Evusheld

Two options are available in NYC for offering Evusheld to your patients:

1. To administer Evusheld in your practice, you can order from a pharmacy with Evusheld in stock by checking the COVID-19 Therapeutics Locator.
   • If you are a specialty pharmacy and want to receive Evusheld access, visit New York State COVID-19 Monoclonal Antibody (mAb) Therapeutics for step-by-step instructions on how to become a provider. If you have questions, email COVID19therapeutics@health.ny.gov.
   
   
2. Alternatively, providers can send a prescription to Alto Pharmacy, which will deliver Evusheld to the prescribing provider/clinic’s address at no cost. Prescriptions confirmed by 11 a.m. on weekdays will be delivered to the provider/clinic office on the same day during normal clinic business hours. Prescriptions confirmed after 11 a.m. will be delivered the following day.

When prescribing through Alto:

1. Specify the appropriate dose of each product in the prescription:
   • The initial dose is 300 mg of tixagevimab and 300 mg of cilgavimab.
   • For patients who received the previously recommended dose (150 mg of tixagevimab and 150 mg of cilgavimab), administer a second dose of 150 mg of tixagevimab and 150 mg of cilgavimab as soon as possible.


2. Send prescription through ePrescription. Search by:
   • Name: Alto Pharmacy
   • Address: 100 Park Avenue, Front E, New York, NY 10017
   • NPI: 1417578899
   • NCPDP: 5831866
   
   If you have trouble finding Alto Pharmacy, check search filters to remove mileage or radius limits and "favorites" or "recently viewed" filters.
   
   Alternatively, Alto Pharmacy accepts prescriptions by phone at 800-874-5881, or by fax at 415-484-7058.


3. Once the prescription is sent, Alto will coordinate directly with provider/clinic for delivery directly to provider/clinic office. Verify the clinic/practice’s phone number and address for delivery. If an alternative phone number or address should be used, include that information in the "Notes to Pharmacist" section.
   
   Advise patients that they may receive a call or text message from the pharmacy; however, no action is needed by the patient.
   
   If you have any questions, call Alto Pharmacy at 800-874-5881. More information is available at the Alto Pharmacy website.

For more information on prescribing Evusheld, see the Evusheld Prescriber Checklist (PDF). For information on billing and reimbursement for the administration of Evusheld, visit the CMS Monoclonal Antibodies webpage. For details on coding, refer to the Evusheld Coding Resource (PDF, AstraZeneca).

Referring Patients for Evusheld

Evusheld will be offered soon at NYC Health + Hospitals. Community providers interested in referring their patients for Evusheld will need to either complete an eFax form or call 212-COVID-19 (212-268-4319). For more information on how to refer, visit NYC Health + Hospitals Evusheld Treatment.

People at increased risk of severe COVID-19 and their caregivers should be advised:

• About the benefits of prompt monoclonal antibody therapy to reduce the risk of hospitalization and death.
• To get tested immediately if they develop COVID-19 symptoms or were recently exposed.
• To contact their provider right away if they test positive. People who do not have a provider can visit ExpressCare or call 212-COVID19 (212-268-4319) to speak with a doctor about treatment options.

Resources for Patients

• COVID-19: When You Are Sick
• Patient Handout: COVID-19 Treatments Are Available (PDF)
  Other Languages: Español | Русский | 繁體中文 | 简体中文 | Kreyòl ayisyen | 한국어 | বাংলা | Italiano | Polski | ײִדיש | العربية | Français | اردو
• Palm Card: Treatment for COVID-19 (PDF)
  Other Languages: Español | Русский | 繁體中文 | 简体中文 | Kreyòl ayisyen | 한국어 | বাংলা | Italiano | Polski | ײִדיש | العربية | Français | اردو
• NYC Health + Hospitals: Monoclonal Antibody Eligibility Screening Tool

Oral antivirals are authorized for people who have tested positive for SARS-CoV-2, regardless of their vaccination status.

Paxlovid is the preferred oral antiviral. Molnupiravir is approved for use in people ages 18 years and older for whom alternative FDA-authorized COVID-19 treatment options are not accessible or clinically appropriate.

Neither product should be used for longer than five consecutive days.

Oral antiviral therapy is authorized for people who meet all of the following conditions:

• Be age 12 years and older and weigh at least 88 pounds for Paxlovid; 18 years and older for molnupiravir
• Be age 65 or older or have a medical condition or other factor that increase their risk for severe COVID-19
  • Consider race and ethnicity when assessing individual risk. Longstanding systemic health and social inequities may contribute to an increased risk of getting sick and dying from COVID-19.
• Test positive for COVID-19 on a nucleic acid amplification test or antigen test. Results from an FDA-authorized home-test kit should be validated through video or photo but, if not possible, patient attestation is adequate.
• Have mild to moderate COVID-19 symptoms
• Are able to start treatment within five days of symptom onset
• Are not hospitalized due to severe or critical COVID-19 when treatment is initiated

For Paxlovid Only

Precautions

Co-administration of Paxlovid can alter the plasma concentrations of other drugs, and other drugs may alter the plasma concentrations of Paxlovid. Consider the potential for drug interactions prior to and during Paxlovid therapy and review concomitant medications during Paxlovid therapy.

The following resources are available to assess and manage potential drug-drug interactions:

• NIH Treatment Guidelines Statement on Potential Paxlovid Drug-Drug Interactions
• Paxlovid Fact Sheet for Health Care Providers (PDF)
• Paxlovid Checklist Tool for Prescribers (PDF)
• Liverpool Drug Interactions Tool, including downloadable phone app
• Infectious Diseases Society of America: Management of Drug Interactions with Nirmatrelvir/Ritonavir: Resource for Clinicians

Therapy is not recommended for patients with severe kidney (eGFR <30 mL/min) or liver (Child-Pugh Class C) impairment. Dosage adjustments are needed for patients with moderate renal impairment (eGFR ≥30 to <60 mL/min). Providers should discuss with patients who have kidney or liver problems whether Paxlovid is right for them.

Paxlovid may lead to a risk of HIV-1 developing resistance to HIV protease inhibitors in patients with uncontrolled or undiagnosed HIV-1 infection. Patients on ritonavir- or cobicistat-containing HIV or HCV regimens should continue their treatment as indicated.

For Molnupiravir Only

Molnupiravir should be prescribed for patients ages 18 years and older for whom alternative FDA-authorized COVID-19 treatment options are not accessible or clinically appropriate.

Precautions

Molnupiravir is not recommended during pregnancy. Prescribing providers should advise individuals of childbearing potential to use effective contraception correctly and consistently for the duration of treatment and for four days after the last dose of molnupiravir.

Breastfeeding is not recommended during treatment and for four days after the last dose of molnupiravir. A lactating individual may consider interrupting breastfeeding and pumping and discarding breast milk during this time.

Men of reproductive potential who are sexually active with women of childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least three months after the last dose.

For more information, see the Molnupiravir Fact Sheet for Providers (PDF) and the FDA Molnupiravir Checklist Tool for Prescribers (PDF).

Two products have received emergency use authorization.

Nirmatrelvir with Ritonavir (Paxlovid)

• Indication: Treatment
• Administration: Oral
• Authorized Patient Age: 12 years and older
• FDA Fact Sheets:
  • Paxlovid Fact Sheet for Providers (PDF)
  • Paxlovid Fact Sheet for Patients, Parents and Caregivers (PDF)
  • Paxlovid Checklist Tool for Prescribers (PDF)

Molnupiravir

• Indication: Treatment
• Administration: Oral
• Authorized Patient Age: 18 years and older
• FDA Fact Sheets:
  • Molnupiravir Fact Sheet for Providers (PDF)
  • Molnupiravir Fact Sheet for Patients, Parents and Caregivers (PDF)
  • Molnupiravir Checklist Tool for Prescribers (PDF)

Treatment must be administered within five days of symptom onset, but it is most effective when given as soon as possible after symptoms begin. High-risk patients who present within six to 10 days of symptoms onset should be referred for monoclonal antibody therapy. Treatment is appropriate for all eligible patients, regardless of vaccination status.

Prior to initiating treatment with molnupiravir, carefully consider the known and potential risks and benefits. See section on eligibility for information on prescribing precautions.

To decide if oral antiviral treatment is appropriate for a patient, providers can refer to the COVID-19 Decision Support Tool (PDF, December 30, 2021).

Paxlovid and molnupiravir are available in several pharmacies in NYC. To check their daily reported supplies on hand, visit the COVID-19 Therapeutics Locator. See below for instructions on how to send a prescription to Alto Pharmacy for free delivery to patients.

Oral antivirals can only be prescribed by a physician, advanced practice registered nurse or physician assistant. For more information on prescribing Paxlovid, see the Paxlovid Checklist Tool for Prescribers (PDF).

Prescriptions placed with Alto Pharmacy will be delivered to the patient’s preferred address at no cost. Once the prescription is placed, patients can schedule their delivery on the Alto mobile app, by text or by phone with Alto pharmacists.

Alto Pharmacy can offer direct support in English and Spanish and support in numerous other languages through language line.

Prescriptions confirmed by 5 p.m. on weekdays or 1 p.m. on weekends will be delivered the same day.

Complete the following steps to prescribe an oral antiviral medication for a patient:

1. Add Alto Pharmacy to your electronic health record (EHR) system for e-prescribing. To locate Alto Pharmacy in your ePrescribing platform or EHR, search by:
   • Name: Alto Pharmacy
   • Address: 100 Park Avenue, Front E, New York, NY 10017
   • NPI: 1417578899
   • NCPDP: 5831866
     
     If you are having trouble finding Alto Pharmacy, check search filters to remove mileage or radius limits and "favorites" or "recently viewed" filters.
     
     Alternatively, Alto Pharmacy accepts prescriptions by phone at 800-874-5881, or by fax at 415-484-7058.


2. Verify patient’s phone number and address for delivery.


3. Choose the oral antiviral you would like to prescribe.
   • If you would like to automatically have molnupiravir substituted when Paxlovid is unavailable, you must submit two prescriptions — one for each medicine. State in the notes section of the molnupiravir prescription: "To be used in case Paxlovid prescription cannot be filled because of supply limitation." Substituting with molnupiravir can only be done for patients meeting eligibility criteria and with no contraindications for either product.


4. In the note for pharmacist section, indicate the patient’s:
   • Race/ethnicity from the following options: Asian/Native Hawaiian or other Pacific Islander; Black; Hispanic/Latino; Native American/Alaska Native; and White
   • Date of symptom onset


5. Submit prescription to Alto Pharmacy.


6. Advise patient that they will receive a call or text message from the pharmacy (800-874-5881) and they must respond to schedule the delivery. More information is available at the Alto Pharmacy website.


7. Contact Alto Pharmacy at 800-874-5881 for questions on medicine interactions or other concerns.

People at increased risk of severe COVID-19 and their caregivers should be advised:

• About the benefits of prompt oral antiviral treatment to reduce the risk of hospitalization and death
• To immediately get tested if they develop COVID-19 symptoms or were recently exposed
• To contact their provider right away if they test positive

Patient Handout: COVID-19 Treatments Are Available (PDF)