VDH COVID-19 Monoclonal Antibody and Therapeutics Bi-Weekly Updates

Reporting Requirements for Therapeutics Usage & Inventory

• Sites that are not currently compliant with reporting will begin to receive a notification on the need to report and may not have their orders fulfilled until they report.
• Reporting for Sotrovimab is due every Wednesday by 11:59PM ET in the in the U.S. Healthcare COVID-19 Portal (i.e., TeleTracking/NHSN)
• VDH has published a job aid for reporting into the U.S. Healthcare COVID-19 Portal, which can be accessed here
• Reporting courses administered and daily on-hand for Paxlovid, Molnupiravir, Evusheld and Bebtelovimab are due daily by 11:59pm EDT in the HHS Health Partner Order Portal (HPoP).
• VDH has published a job aid for reporting into the HHS Health Partner Order Portal (HPoP) here
• If you are having challenges with reporting or have questions, please contact COVID19Therapeutics@vdh.virginia.gov for assistance.

Therapeutics Ordering Process for Federal Retail Pharmacy Therapeutic Program (FRPTP) Partners

Continuing our efforts to increase access of therapeutic treatments, Virginia Department of Health (VDH) is rolling out a new oral antiviral ordering process for Federal Retail Pharmacy Therapeutic Program (FRPTP) partners. FRPTP partners will have the option to allow their individual locations to manage their own oral antivirals requests through VaxMaX OR our FRPTP partners can opt to request oral antivirals in bulk for their respective chains by completing a REDCap Bulk Order Survey. For those who are NOT a PRPTP partner, this does not change or impact your ordering process.

• Location Managed / Grant External Access
• Enroll all participating locations with HHS via HPoP as an FRPTP partner
• FRPTP partner must grant external rights to VDH for each pharmacy location opting in
• Have each location opting in complete the VDH Therapeutics enrollment survey, found here
• Ensure each location reports therapeutics on-hand and administrations daily via HPoP and confirms receipt of orders
• Chain-Managed / Bulk Request
• Enroll all participating locations with HHS via HPoP as an FRPTP Partner
• Coordinate internally with your participating locations
• Submit an FRPTP Bulk Therapeutics Request through the REDCap Survey, found here
• Report therapeutics on-hand and administrations daily via HPoP and confirm receipt of orders
• For additional questions, contact covid19therapeutics@vdh.virginia.gov

FDA: Update to Evusheld Dosage

• On February 24^ththe FDA announced changes to the dosing of EVUSHELD (Tixagevimab/cilgavimab). Please see updates from the FDA below:
• Tixagevimab 300mg IM and cilgavimab 300mg IM administered as separate, consecutive injections
• Patients who already received the previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab) should receive an additional dose of 150 mg of tixagevimab and 150 mg of cilgavimab as soon as possible
• Administer at least 2 weeks after COVID-19 vaccination
• PROVENT trial - indicates effectiveness for 6 months, may repeat 
• For further information, please view the full updated EUA factsheet from the FDA here

FDA: Update to Sotrovimab Administration

• On February 23^rd, the FDA announced a change to the administration of Sotrovimab:
• Sotrovimab now must be administered within 7 days of symptom onset
• This is a change from the previous guidance of providing treatment within 10 days of symptom onset
• For further information, please view the full updated EUA factsheet from the FDA here

Federal Initiatives for Oral Antivirals

• Test to Treat Program
• The federal government is working with 9 Federal Retail Pharmacy Partners to develop a “Test to Treat” model, serving as a one-stop shop for patients to be assessed, diagnosed, prescribed treatment and receive treatment all in one stop.
• Pharmacies participating in this program in Virginia include CVS, Walmart, Walgreens, Kroger
• These pharmacies will have the ability to directly order oral antivirals from the federal government for pharmacies that have a clinic located inside the pharmacy building.
• Ordering will go live for these pharmacies on March 7^th.
• Long-term Care Pharmacy Partner Program
• The federal government is working with 5 LTCF pharmacy partners to allow LTCF pharmacies to order oral antivirals directly from the government.
• Ordering will go live for these LTCF pharmacies on March 7^th.
• For further information, please view the full updated EUA factsheet from the FDA here

New VDH Webpage

• Please note that the VDH Therapeutics webpage has been redesigned
• You can find the new webpage here

Updates to the VDH COVID-19 Treatment Locator Tool Reminder

• Please find the locator tool here: COVID-19 Treatment Locator
• If you are not listed on the Locator Tool and provide appointments to the public, please email covid19therapeutics@vdh.virginia.gov

COVID-19 Therapeutics Webinar

• VDH will facilitate March webinars. Registration is required:
• 03/09/2022
• 03/23/2022

COVID-19 Therapeutics Open Forum Calls

• VDH will facilitate open forum calls every other week in March
• 03/16/2022
• 03/30/2022