NEW: Variants and Evusheld Resistance Updates
On Friday, January 6th, FDA released important information about risk of COVID-19 due to certain variants not neutralized by Evusheld
- FDA is closely monitoring the emergence of the XBB.1.5 subvariant, a SARS-CoV-2 Omicron variant that is currently estimated to account for 28% [as of Jan. 6, 2023] of circulating variants in the U.S.[Total resistance including XBB.1.5 is estimated at ~92%].
- Because of its similarity to variants that are not neutralized by Evusheld(e.g., XBB), FDA does not anticipate that Evusheld will neutralize XBB.1.5.
- This means that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5. However, FDA is awaiting additional data to verify that Evusheld is not active against XBB.1.5.
- Further updates will be provided as new information becomes available.
- Health care providers should inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 variants not neutralized by Evusheld.
On Tuesday, January 10th, NIH updated their statement regarding Evusheld here: Statement on Evusheld | COVID-19 Treatment Guidelines (nih.gov).
- In the US, the prevalence of subvariants likely to be resistant to tixagevimab plus cilgavimab (Evusheld) is more than 91%. Although tixagevimab plus cilgavimab is still authorized by the FDA for COVID 19 pre-exposure prophylaxis (PrEP), it is unlikely to be effective at preventing COVID 19 in the vast majority of individuals. However, no alternative options for PrEP are available, and clinicians could still administer tixagevimab plus cilgavimab after considering an individual patient’s risks and the regional prevalence of the resistant subvariants.
The Evusheld Fact Sheet has been updated to reflect in-vitro neutralizing data for several Omicron subvariants.
Refer to FDA releases important information about risk of COVID-19 due to certain variants not neutralized by EVUSHELD.
NEW: Therapeutics Information Sheets
New Lagevrio Information Sheet
- Quick reference document for health care providers.
- Highlights patient eligibility and effectiveness information.
Updated as of January 2023: Paxlovid Information Sheet
- Quick reference document for health care providers.
- Highlights patient eligibility and effectiveness information.
Coming soon: Outpatient Veklury Information Sheet
- Quick reference document for health care providers.
- Highlights patient eligibility and effectiveness information.
NEW: Walgreens Expands Home Delivery to include Lagevrio
On Dec. 27, 2022, Walgreens expanded the oral antiviral free prescription delivery service to include Lagevrio which delivers COVID-19 medications directly to the doorsteps of Americans. Previously, this program was only for Paxlovid.
Patients with a prescription for Lagevrio or Paxlovid that is filled at Walgreens in a socially vulnerable community, based on the Centers for Disease Control and Prevention (CDC) Social Vulnerability Index, will be able to have their Lagevrio or Paxlovid prescription delivered to their home at no cost via Walgreens.com and the Walgreens app.
New and Updated Resources: Lagevrio Information Sheet, Digital Toolkit, and CDC Webpages
ASPR has added a new Lagevrio Information Sheet and updated their Digital Toolkit with Test to Treat social media content.
CDC has also updated the Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19 for Healthcare Professionals. This update highlights Age being the strongest risk factor for severe COVID-19 outcomes.
NEW: Legislative Provision to Allow Part D payment of EUA oral antivirals if commercialized while under EUA
H.R. 2617 enacted to include EUA oral antivirals as covered Part D drugs. HR2617 Bill has the following impact:
- NO CHANGE to the current payment structure.
- Allows coverage of COVID-19 oral antivirals (Paxlovid, Lagevrio) by Medicare Part D plans if a product is commercialized while under EUA (prior to change, a product available only under EUA would not have met statutory definition of a covered Part D drug).
- COVID-19 oral antivirals continue to be provided by HHS free of charge; no payment can be sought for USG procured medications.
- CMS is already able to cover fully approved oral antivirals under Part D.
- There remains ample supply of USG procured product to facilitate continued distribution of free product.
New and Updated Resources: Lagevrio Information Sheet, Digital Toolkit, and CDC Webpages
ASPR has added a new Lagevrio Information Sheet and updated their Digital Toolkit with Test to Treat social media content.
CDC has also updated the Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19 for Healthcare Professionals. This update highlights Age being the strongest risk factor for severe COVID-19 outcomes.
Reminder: Shelf-Life Extensions
ALL COVID-19 therapeutics have received extensions for some or all lots. Please check with the manufacturer before removing any products from the proper storage conditions.
Additional Shelf-Life Extension for Paxlovid
On December 21st , FDA authorized an additional extension to the shelf life from 18 months to 24 months for certain lots of Paxlovid. FDA is working on updating webpages to reflect extended dates.
For up to date information on expiration dates, please visit: Important Updates | HHS/ASPR and Expiration Dating Extension | FDA.
Maintain all monoclonal antibodies under proper refrigerated temperatures, even if they are not currently authorized for use. It is possible that monoclonal antibodies will be authorized again in the future for use against new strains of SARS-COV2.
Update: No additional shelf-life extension is possible for etesevimab
- Refer to online resources to determine true expiration date for etesevimab and bamlanivimab vials.
- Product can be returned for destruction as a bam/ete patient course using expired ete with matching bam vial of earliest expiration date (patient course = 2 vials ete, 1 vial bam).
NOTE: ASPR continues to work with product manufacturers to maximize shelf-life. We will provide any updates for upcoming expiration dates as soon as we receive.
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