COVID Pre-exposure prophylaxis (PrEP) Overview
On December 08, 2021, the Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older and weighing at least 40 kilograms.) This product is only authorized for use among individuals who are not currently infected with SARS-CoV-2 virus and have not recently been exposed to an individual infected with SARS-CoV-2. The EUA requires that individuals either have:
- Moderate to severely compromised immune system 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
- A history of severe adverse reactions to a COVID-19 vaccine and/or component(s) where administration of the vaccine is not recommended.
Evusheld is not authorized for individuals for the treatment of COVID-19 or for post-exposure prevention of COVID-19. Pre-exposure prophylaxis with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended, including those with moderate to severe immunocompromising conditions. For individuals who have received a COVID-19 vaccine, Evusheld should be administered at least two weeks after vaccination. For additional information see: FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR EVUSHELD™ (tixagevimab co-packaged with cilgavimab) (fda.gov)
Frequently Asked Questions
Please read the Frequently Asked Questions (FAQ) so you can help protect yourself, your family, your friends, and your community.
I am interested in providing COVID PrEP at my clinic. How do I become a COVID PrEP provider?
The COVID PrEP provider network is limited to the following specialists: HIV/AIDS care, transplant services, oncology, hematology, rheumatology, neurology, gastroenterology, and allergy/immunology.
If you are a qualifying specialist, contact the state at COVID.Therapeutics@state.nm.us to receive registration information.
What patient screening is recommended for COVID PrEP?
Due to limited supply, screening of patients is recommended to facilitate appropriate use.
RECOMMENDED SCREENING FOR IMMUNOCOMPROMISED PATIENTS
Negative IgG SARS-CoV-2 antibody assay following a full course of vaccination
Despite reduced SARS-CoV-2 vaccine response rates in in some immunocompromised patients, vaccination is recommended for all immunocompromised patients regardless of the underlying cause of the immunodeficiency.
While COVID PrEP remain severely limited, restricting prescribing to fully vaccinated, immunocompromised patients who lack an antibody response to SARS-CoV-2 spike or to the receptor binding domain is likely to provide access to treatment to those at the highest risk of acquiring severe or fatal COVID-19. If a laboratory offers multiple tests for COVID-19 antibodies, testing should be performed using the test for IgG spike or RBD antibodies rather than for nucleocapsid antibodies, since vaccines do not contain nucleocapsid antibody.
Negative IgG SARS-CoV-2 antibody screening is not required. This is a recommendation to assist providers in prioritizing patients and for the stewardship of scarce a resource.
The appropriate test include: TriCore test number COVIGG, Labcorp test number 164055 and Quest test number 34499.
RECOMMENDED SCREENING FOR PATIENT WITH A CONTRAINDICATION TO VACCINE
Clear documentation that vaccination is contraindicated
The CDC considers a history of the following to be a contraindication to vaccination with COVID-19 vaccines:
1. Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine
a. A patient with an allergic reaction to a mRNA vaccine may be able to receive Janssen COVID-19 vaccine and vice versa.
2. Known diagnosed allergy to a component of the COVID-19 vaccine.
Please refer to the CDC clinical considerations for guidance regarding contraindications and precautions. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html#Contraindications
Can I give Evusheld as post-exposure prophylaxis?
No, this product is only authorized for use among individuals who are not currently infected with SARS-CoV-2 virus and have not recently been exposed to an individual infected with SARS-CoV-2.
I am not a COVID PrEP provider. Where may I refer my patient for treatment?
Primary care providers treating an immunocompromised patient or patient with vaccine contraindication shall refer the patient to a COVID PrEP provider for assessment and treatment. A list of COVID PrEP providers can be obtained by emailing COVID.Therapeutics@state.nm.us.
I am a primary care physician. My patient is unable to be referred to a COVID PrEP provider. What options are available to my patient?
In rare cases when an immunocompromised patient is unable to be referred to a COVID PrEP provider due to extenuating circumstances, the primary care physician may fill out a waiver form to receive a dose of COVID PrEP. The waiver is subject to review and approval by the Department of Health COVID therapeutics team. The waiver form may be obtained by emailing COVID.Therapeutics@state.nm.us.
What is the efficacy of Evusheld against the Omicron variant?
Preliminary data for the neutralizing activities of Tixagevimab/Cilgavimab against the Omicron (B.1.1.529) variant of concern are available. In vitro testing of Tixagevimab/Cilgavimab for neutralization of a pseudovirus expressing the spike protein representative of the predominant lineage of the SARS-CoV-2 Omicron variant has demonstrated a 132 to 183-fold reduction of potency (IC50) compared with its activity against the D614G variant. A 12 to 30-fold reduction in potency was demonstrated using authentic Omicron virus.
The clinical significance of the reduced in vitro potency of Tixagevimab/Cilgavimab against the Omicron variant is unknown at this time.
COVID PrEP Required Reporting
Reporting of Evusheld Inventory and Utilization
- All sites are required to report their inventory and utilization on HPOP. The data impacts the states allocation from the federal government. The data is also used to ensure equitable allocation between facilities.
Reporting Adverse Events
- Reporting of serious adverse events and medication errors is required by the FDA.
- Report serious adverse events to FDA MedWatch: https://www.fda.gov/media/76299/download
COVID PrEP Distribution
Evusheld, is currently under allocation. The state is currently receiving a very limited number of doses. The federal government allocates a portion of the available supply to each state on a bi-weekly cycle. https://www.phe.gov/emergency/events/COVID19/therapeutics/distribution/Pages/data-tables.aspx
New Mexico Department of Health allocates product to participating facilities. Shipments are received by facilities once every two weeks.
- 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/
- EVUSHELD EUA Letter https://den8dhaj6zs0e.cloudfront.net/50fd68b9-106b-4550-b5d0-12b045f8b184/6d1d5fea-2532-46e9-a1d4-1504f6dd41b2/6d1d5fea-2532-46e9-a1d4-1504f6dd41b2_pi_ifu_rendition__c.pdf
- EVUSHELD Fact Sheet for Healthcare Providers https://www.fda.gov/media/154701/download
- Directory of COVID PrEP Providers – The federal government is creating a Therapeutics Finder. In the meantime, you may email COVID.Therapeutics@state.nm.us for a list of COVID PrEP providers.
COVID PrEP Billing
- Products purchased by the federal government may only be billed for administration fees. For billing codes and claims allowances please visit:
- Uninsured and underinsured patients may have their administration fees billed through the HRSA COVID-19 Cares Program or the HRSA COVID-19 Coverage Assistance Fund. For more information, please visit www.hrsa.gov/coviduninsuredclaim
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)
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