Lagevrio Order Quantity Change in HPOP
Starting November 7th, Lagevrio orders greater than 15 will no longer need to be in multiples of 15.
- The minimum is still 15 patient courses
- You may order any number of courses above 15 (such as 16 or 40)
Transitioning All COVID Monoclonal Antibodies Therapeutic Reporting to HPOP
The TeleTracking system has been the tool for reporting COVID-19 therapeutics inventory and utilization data for COVID-19 older therapeutics (casirivimab/imdevimab, bamlanivimab/etesevimab, and sotrovimab) since March 2020. As of November 2, 2022 report all COVID-19 therapeutics in HPOP portal. You will no longer report therapeutics in TeleTracking or TDEM portal. If you do not have monoclonal antibodies selected as an option for your facility and need to report these older products, please email Therapeutics@dshs.texas.gov.
This change will consolidate therapeutic reporting for all products and ordering in one system. Therapeutic 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 across the country.
HHS hospital data reporting guidance here: COVID-19 Hospital Data Reporting Guidance Update
- If your facility has an HPOP account: no further action needed
- If your facility does NOT have an HPOP account, contact CARS Helpdesk
- To report legacy mAb inventory on-hand: access the "Courses Administered and Available" tab
- User guides for HPOP are posted in HPOP in the Partner and Provider Portals
- Contact the CARS Helpdesk: cars_helpdesk@cdc.gov or 833-748-1979 to:
- Find out if your facility has an HPOP account
- Setup an account
- For general inventory reporting questions: contact therapeutics@hhs.gov
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.
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.
Therapeutics Activity Against Emerging Variants
All products retain activity against most prevalent variant,BA.5 and there are currently no changes in authorization for use for any of the products.
*UPDATED* Bebtelovimab:
FDA updated the Health Care Provider Fact Sheet for bebtelovimab with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.
Currently, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Prescribers should monitor CDC regional variant frequency data and refer to the Antiviral Resistance information in the Healthcare Provider Fact Sheet for details regarding specific variants and resistance against SARS-CoV-2 variants in your area, particularly Omicron subvariants BQ.1 and BQ.1.1.
- Retains activity against BA.4.6, BA.2.75 and BA.4 (confirmed) & likely against BF.7 and BA.2.75.2 (preliminary); activity potentially impacted against BQ subvariants (preliminary)
- FDA Updates on Bebtelovimab | FDA
Evusheld:
- Loses neutralization potency against BA.4.6 (confirmed)& potentially also against BF.7, BA.2.75.2 & BQ subvariants (preliminary); retains activity against BA.2.75*and BA.4
- Breakthrough infections are possible, advise patients to have a treatment plan in place and to seek timely medical attention if symptoms occur
- Evusheld Fact Sheet for Healthcare Providers
Paxlovid, Lagevrio, and Veklury:
- Expected to retain activity against all circulating variants based on preliminary data & sequence analysis
- Additional data pending
Testing against emerging variants is ongoing for monoclonal antibodies currently not authorized for use (Regen-COV, bam/ete, sotrovimab).
Full statement from NIH here: Statement on Omicron Subvariants | COVID-19 Treatment Guidelines (nih.gov)
View prevalence of COVID-19 variants nationally here: CDC COVID Data Tracker: Variant Proportions
Additional findings:
Veklury (remdesivir) - Outpatient Use
FDA approved expanded use of Veklury (remdesivir) to certain non-hospitalized adults and pediatric patients for treatment of mild-to-moderate COVID-19 disease (Jan 21, 2022), including:
- Adults and pediatric patients 28 days of age and older and weighing at least 3 kgwithpositive results of direct SARS-CoV-2 viral testing, AND
- Who are not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death
Veklury is the only COVID-19 therapeutic treatment available for patients under 12 years of age.The treatment course of Veklury (remdesivir) should be initiated as soon as possible after diagnosis of symptomatic COVID-19 has been made and must be within 7 days of symptom onset.The recommended total duration of treatment for non-hospitalized patients is 3 days.
Procurement/Ordering:
Commercially available through Gilead Pharmaceuticals: https://www.gilead.com/remdesivir
Veklury is available through multiple distributors. For additional information regarding purchasing or how to access Veklury (remdesivir), email remdesivir@amerisourcebergen.com, call 1-800-746-6273 or reach out directly to your AmerisourceBergen, Cardinal, or McKesson representative.
More on Velkury here: Velkury(remdesivir) HCP Website
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