Get the Latest Guidance
COVID-19 cases can result in serious illness, hospitalizations and deaths. Treatments are available to treat or prevent COVID-19 infection for individuals at risk for severe disease progression. Please use this page to get the latest guidance on COVID-19 Therapeutics in Virginia. Therapeutics administration is best practice, these medications are available in ample supply and should be prescribed for patients who are eligible.
- November 18, 2022 the FDA has updated the EVUSHELD Fact Sheet. The new FDA EVUSHELD Fact Sheet includes updated information on SARS-CoV-2 variants.The FDA EVUSHELD Fact Sheet update only encompasses section 12.4, Microbiology, table 6. There is no change to important safety information nor dosage and administration. Additionally, the usage guidance from the FDA remains unchanged.
- November 4, 2022 the Bebtelovimab Fact Sheet was updated to reflect pseudovirus data that shows the BQ.1 and BQ.1.1 subvariants have a large reduction in susceptibility (> 672 fold) to the drug. According to the FDA update, "This information shows that Bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1." However, it is important to note that FDA states clearly that Bebtelovimab remains authorized in all US regions until further notice.
- November 2, 2022, Transitioning of COVID mAb Therapeutic Reporting from Teletracking to HPOP:
- Recent HHS guidance for hospital data reporting has changed the therapeutic reporting process as reporting is being moved from Teletracking to the Healthcare Provider Ordering Portal (HPOP) system. The implementation date is November 2, 2022 and will consolidate therapeutic reporting for all products and ordering into one system. Reporting for legacy mAb has shifted to once a week on Thursdays by 11:59 pm to coincide with regular therapeutic reporting in HPOP. Data remains important to the federal response and is needed for tracking purposes and strategic decision making to provide more accurate and rapid support to the Regions.
- October 26, 2022, Shelf-Life Extension Bebtelovimab:
- A shelf-life extension for Bebtelovimab was issued, extending it from 18 months to 24 months. Please continue to check HHS: ASPR’s Website for the updated information.
- October 21, 2022,The FDA granted an extension of shelf-life for Molnupiravire (Lagevrio) from 24 months to 30 months.
- October 3, 2022, Evusheld Factsheet for Providers was updated.
- In the Warnings and Precautions Section 5.3, language has been added to address variants not neutralized by Evusheld: Certain SARS-CoV-2 viral variants may not be neutralized by monoclonal antibodies such as tixagevimab and cilgavimab, the components of EVUSHELD. EVUSHELD may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants.
- A table can be found within the factsheet detailing variants and neutralization data.
- October 3, 2022 HPoP Minimum Ordering Quantaties (MOQ) for Lagevrio and Evusheld:
- The United States Government (USG) allocation for Lagevrio (molnupiravir) was reduced for Virginia and the MOQ reduced from 24 doses to 15 doses to offer smaller volume ordering to HPoP providers. Additionally, the MOQ for Evusheld was lowered from 24 doses to 12 doses. The new MOQ of 12 doses equals 6 patient courses. Please note that this change does not impact small volume ordering which still allows for providers NOT in HPoP to order 1 to 3 patient courses.
- September 23, 2022, Bebtelovimab Product Replacement Initiative:
- HHS launched the Bebtelovimab Product Replacement Initiative in HPoP. The goal of this initiative is to assist with equitable access to commercial Bebtelovimab for under and uninsured patients. In order to participate you must: 1) Have used all USG supply acquired through the HHS distribution Program, 2) Have already purchased commercial Bebtelovimab and attests to using a purchased dose for an under or uninsured patient, and 3) Charge a reasonable administration fee for Bebtelovimab for the patient. Providers should consider waiving or reducing the administration fees to amount similar to the CMS payment rates of $350.50 onsite/$550.50 for at home visit when treating a patient who is under or uninsured.
- Requests for replacements can be made in HPoP. The replacement dose is only for commercially purchased product and will be replaced with commercial Bebtelovimab shipped directly from the supplier. Replacement comes from the commercial supply and can be used for any patient, regardless of insurance status.
- August 15th, Bebtelovimab is Available for Purchase Commercially
- As of August 15, 2022, Bebtelovimab has become commercially available for purchase. Orders can be placed directly through AmerisourceBergen.
- USG will allocate the remaining supply of Bebtelovimab to jurisdictions based on populations on September 6, 2022. Providers should not bill patients or insurance for any USG-procured product.
- VDH places a high priority on equitable availability of product. If a facility does not serve the under and/or uninsured, VDH encourages these locations to utilize the redistribution process to reallocate USG product for this vulnerable population.
- August 5th, EUA Updates
- Paxlovid - Additional post-authorization requirements for Pfizer to conduct
- A clinical trial in patients with “COVID-19 rebound” to evaluate a subsequent 5-day treatment in patients with rebound
- A clinical trial evaluating different durations of treatment in immunocompromised patients with mild-to-moderate COVID-19 to evaluate safety and efficacy for either 5, 10, or 15 days of treatment
- Lagevrio - Microbiology (Section 12.4)
- Addition of viral RNA rebound
- Approximately 1% of both LAGEVRIO and placebo recipients had evidence of recurrent COVID-19 symptoms coinciding with a rebound in viral RNA levels in nasopharyngeal samples
- Post-treatment viral RNA rebound was not associated with the primary clinical outcome of hospitalization or death
- Paxlovid - Additional post-authorization requirements for Pfizer to conduct
Oral AntiviralsThe Centers for Medicare & Medicaid Services has issued guidance to inform Part D sponsors of permissible flexibilities during the COVID-19 public health emergency related to oral antiviral drug(s). The guidance may be accessed here.
Monoclonal AntibodiesThe Centers for Medicare & Medicaid Services has issued guidance to inform coverage and reimbursement of monoclonal antibodies. Please see the linked flyer and CMS website for reimbursement information below:
- VDH Open Forum Guidance Document
- COVID-19 USG Bebtelovimab Product Replacement Initiative
- COVID-19 Therapeutics Antivirals
- COVID-19 Therapeutics Monoclonal Antibodies
- COVID-19 Therapeutics Operational and Logistical Aspects
- COVID-19 Therapeutics Direct Order Request (DOR) Process & Redistribution
- COVID-19 Therapuetics Pharmacists Prescribing Paxlovid Informational Webinar
- COVID-19 Therapeutics Reporting in HPoP
EVUSHELD ACCESS PROGRAM
- The Virginia Department of Health developed the EVUSHELD Access Program to support Skilled Nursing Facilities with COVID-19 infection prevention by increasing access to EVUSHELD, a monoclonal antibody for COVID-19 pre-exposure prophylaxis. The program provides access to EVUSHELD via a mobile unit and VDH staff are available to support interested facilities in coordinating a site-visit. The program is free of charge for facilities and eligible nursing home patients and staff.
- Learn more about the EVUSHELD Access Program
- EVUSHELD Access Program FAQs for Skilled Nursing Facilities
VDH: Total Allocations to Therapeutic Administration Sites for October 2022
*Oral Antiviral numbers presented do not include those allocated to Community Pharmacy Enhanced Services Network. These Oral Antiviral courses were bulk ordered and distribution to individual site locations is managed by respective Federal Retail Pharmacy Therapeutic Program (FRPTP) partners, VDH does not have visibility of course distribution to each region.
*Bebtelovimab allocations and administrations is only for USG-supply and not for commercially purchased Bebtelovimab.
*Please reference the Outpatient Therapeutic Portfolio- Jurisdiction Allocations for more detail.
- VDH: COVID-19 General FAQs - See Treatment for COVID-19 located under the COVID-19 Basics and Healthcare Providers sections.
- VDH: COVID-19 Therapeutics FAQs for Providers
- COVID-19 Outpatient Therapeutic Treatment Algorithm
- VDH: Bebtelovimab Commercialization FAQ Sheet
- FDA: Paxlovid Prescribing Checklist
- VDH: Paxlovid Prescribing Checklist
- VDH: Paxlovid Prescribing Checklist-Pharmacists
- Liverpool Interaction Checker
- VDH: Lagevrio (Molnupiravir) Prescribing Checklist
- VDH: Guidance on Expiring & Expired Therapeutics
- VDH: Healthcare & LTC Facility Therapeutics Handout (Español)
- VDH: "Are You at High Risk for COVID-19?" Handout (Español)
- HHS: ASPR Test to Treat Fact Sheet
- CDC: Clinical Care Guidance for Healthcare Professionals about Coronavirus
- CDC: Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19
- COVID-19 Therapeutics Resource Document for UniteUs
- VDH: Treatments Webpage
- VDH: COVID-19 Therapeutics Info Sheet [Spanish]
- COVID-19 Therapeutics Patient Presentation
- VDH: Monoclonal Antibody Therapy for COVID-19 Handout
- VDH: EVUSHELD Treatment Fact Sheet [English] [Spanish] [Amharic] [Arabic] [Chinese] [Dari] [Korean] [Pashto] [Tagalog]
- VDH: Paxlovid Treatment Fact Sheet [English] [Spanish] [Amharic] [Arabic] [Chinese] [Dari] [Korean] [Pashto] [Tagalog]
- VDH: Lagevrio (Molnupiravir) Treatment Fact Sheet [English] [Spanish] [Amharic] [Arabic] [Chinese] [Dari] [Korean] [Pashto] [Tagalog]
- CDC: Treatments Your Healthcare Provider Might Recommend if You Are Sick
- Medicare: Coronavirus Disease 2019 (COVID-19) Monoclonal Antibody Treatments
- HHS: Monoclonal Antibodies for High-Risk COVID-19 Positive Patients
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