Evusheld Updates
FDA has updated the Evusheld Fact Sheets and released important information about risk of COVID-19 due to certain variants not neutralized by Evusheld. Evusheld is still recommended for use at this time.
Evusheld:
Key Points from the FDA
- EVUSHELD may be less effective at preventing COVID-19 because it does not neutralize all circulating variants. However:
- EVUSHELD has neutralizing activity against the most prevalent current SARS-CoV-2 viral variant/subvariant (Omicron BA.5)
- EVUSHELD has a long half-life (85 days) and is intended to protect against both current and future variants, and it is unknown what variants will be circulating in the future.
- EVUSHELD is currently the only authorized or approved product in the U.S. for pre-exposure prophylaxis of COVID-19 for individuals who may not mount an adequate immune response to COVID-19 vaccines or for whom vaccination is not recommended.
- FDA continues to recommend EVUSHELD as an appropriate COVID-19 prevention option, in combination with other preventative measures as appropriate (such as getting vaccinated and boosted)
Paxlovid Updates:
Recent updates to the NIH Clinical guidelines for Paxlovid include:
- Additional drug-drug interactions
- Information on viral rebound that may occur after Paxlovid other treatments or in patients with no treatment
- Updated data about variant susceptibility
On September 30, 2002, the FDA updated the Paxlovid Fact Sheet for Providers to include:
Bebtelovimab Replacement Program
On September 23rd, the bebtelovimab product replacement program went live in HPOP. A provider who has commercial supply and treats an under or uninsured patient with a purchased dose can request a replacement dose, at no charge, from a designated United States Government supply.
Provider site:
- Must have used all their USG supply acquired through the HHS distribution program
- Must have purchased commercial bebtelovimab
- Must attest to using a purchased dose for an under or uninsured patient
- May charge a reasonable administration fee - not to exceed the CMS-established administration fees - for bebtelovimab for that patient
- Please consider waiving or reducing the administration fee to be reasonable for the patient being treated
- May not charge the underinsured or uninsured patient for the cost of the bebtelovimab medication
Process:
- Make the request for the replacement in your HPOP account
- Complete the attestation
- Enter the lot number and expiration date of the purchased dose
- Replacement doses will be batched and processed once per week by the distributor
 To sign up for an HPOP account, please contact Therapeutics@dshs.texas.gov.
For additional questions about the replacement program, please visit Bebtelovimab (ASPR - scroll to bottom) or contact COVID19Therapeutics@HHS.gov
Evusheld and Lagevrio Minimum Order Quantity Change in HPOP
Beginning October 3rd, the minimum order quantity will decrease for Evusheld and Lagevrio.
-
12 cartons of Evusheld (equal to six patient courses)
- 15 patient courses of Lagevrio.
Reminder: HPOP Reporting Required
Reporting for all products, both administered (even if it is zero) and on-hand count, is required in HPOP. If a facility has inventory, reporting is required on Mondays and Thursdays.
When reporting, please enter:
- patient courses administered/dispensed and
- patient courses on-hand
Enter the courses administered/dispensed since last entry AND on hand. DO NOT enter cumulative totals that have already been reported.
If your site would like additional training on reporting, please contact HPOP-Therapeutics@hhs.gov.
Do NOT report commercially purchased bebtelovimab in HPOP.
Reminder: Shelf-Life Extensions
Several products have initial expiration dates approaching, but many COVID-19 therapeutics have received extensions. Please check with the manufacturer before removing any products from the proper storage conditions.
See links below for detailed expiry information:
Please find an addition listing of expiration extensions from the FDA here.
Maintain all monoclonal antibodies under proper refrigerated temperatures, even if they are not currently authorized for use. It is expected that will be authorized again in the future for use against new strains of SARS-COV2.
Existing USG Bebtelovimab
The United States Government (USG) requests that providers reserve the USG-purchased bebtelovimab for uninsured and underinsured patients.
Facilities must continue to report transfers, wastage, and administration and on-hand inventory of all USG-purchased bebtelovimab in HPOP on Mondays and Thursdays until this supply has been depleted.
Providers MAY NOT seek reimbursement for bebtelovimab that was distributed at no cost from the USG and should keep this stock separated from any product that is purchased. The batch numbers for bebtelovimab will be different for commercial bebtelovimab than the USG supply. Do not report commercially purchased bebtelovimab in HPOP.
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