New COIVD-19 Therapeutics Announcements

Overview of COVID-19 Therapeutics and Prophylaxis for Non-Hospitalized Patients

The resources below provide:
  1. Interim guidance on outpatient treatment decisions for patients at risk of developing severe COVID-19.
  2. Comparison table of treatment options.
  3. How providers may obtain these treatments or prophylaxis for their patients.
  4. Where providers can refer their patients for infusion therapies.
  5. Reporting requirements.

Treatment Guidelines:
NIH Therapeutic Management of Nonhospitalized Adults

The FDA has suspended distribution of sotrovimab due to the omicron BA.2 subvariant, which now accounts for more than half of COVID-19 infections. Bebtilovimab is now the preferred monoclonal antibody therapy.

Clinical Decision Aid for patients 12+ from https://aspr.hhs.gov/COVID-19/Therapeutics/Documents/COVID-Therapeutics-Decision-Aid.pdf
Clinical Decision Aid for Pediatric Patients from https://aspr.hhs.gov/COVID-19/Therapeutics/Documents/COVID-Therapeutics-Decision-Aid.pdf

Treatment

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*Adapted from COCA call 1/22/22
Clinicians should refer to the EUA healthcare provider fact sheets for further details on Paxlovid, bebtelovimab, remdesivir, and molnupiravir. For the FDA-approved remdesivir (Veklury) for 12 yrs and older weight at least 40kg, refer to the full prescribing information.

Prophylaxis

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Evusheld
Description
  • Evusheld is a monoclonal antibody combination approved for use as a Pre-exposure Prophylaxis for those who are unable to receive or are not expected to mount an immune response with vaccines.
  • Distribution should be prioritized to hospitals that offer special services such as oncology and rheumatology, etc. Providers who care for such patients should refer to these centers for access to this product.
Patient Profiles
  • Active treatment for solid tumor and hematologic malignancies
  • Receipt of solid-organ transplant and taking immunosuppressive therapy
  • Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within two years of transplantation or taking immunosuppression therapy)
  • Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
  • Active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents).

Become a Provider

HHS currently distributes an allocation of Bebtelovimab, Paxlovid, Molnupiravir, and Evusheld to each state. All medications must be ordered through the Health Partners Order Portal (HPOP).
  1. Sign up with HPOP here.
  2. If you need help getting set up, email DPH.MABTherapy@illinois.gov

Locate Therapeutics and Prophylaxis In The City

  • Infusion Providers Accepting External Referrals:
Provider
Contact Information:
AMITA Health Saints Mary and Elizabeth Medical Center Tel: 312-770-8534
Fax: 312-770-3182
John H Stroger Jr Hospital of Cook County covidtherapeutics@cookcountyhhs.org
Provident Hospital of Chicago covidtherapeutics@cookcountyhhs.org
Saint Anthony Hospital ttruesdell@sahchicago.org
Swedish Covenant Hospital Tel: 773-907-7700
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  • Test to Treat in Chicago
  • Providers who don’t want to receive allocations can use the ASPR COVID-19 Therapeutics Locator to find providers, pharmacies and infusion centers with doses on hand.
  • For providers looking for immediate access to COVID-19 Therapeutics, available doses may be found on the IDPH Matchmaker Site. If you are a provider and have extra doses in between distribution cycles, please use this site so others have access.

State and Federal Reporting Requirements

Reporting into Health Partner Ordering Portal (HPOP)
  • Report utilization and doses on hand of bebtelovimab, Evusheld, Paxlovid, and Legevrio twice per week by 11:59pm every Monday and Thursday.
  • When reporting utilization of each product, report the quantity used since the last report. Do not report the cumulative amount over time.
  • For any issues related to ordering or reporting of HPOP therapeutics, reach out to cars_helpdesk@cdc.gov or 833-748-1979
  • Click here (https://aspr.hhs.gov/COVID-19/Therapeutics/Distribution/Pages/process-for-ordering.aspx) for more information on HPOP reporting.

Reporting into HHS Teletracking - All therapeutics that require reporting into this portal are currently paused.
  • Report utilization and doses on hand of bam/ete, sotrovimab, REGEN-COV weekly by 11:59pm every Wednesday

Reporting into NHSN for Long Term Care Facilities

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Provider Resource Library and Other Useful Links

Shelf life Extensions

Shelf-Life Extension infomation. Click the links to view the affected lot numbers.
 

CHI COVID rX

Pursuant to Health Order No. 2020-4  sites administering USG-Purchased COVID-19 therapeutics in the City of Chicago must report individual-level utilization data. 

Click here  to visit the portal and share your data with us. 

For questions about reporting or data requirements, please the view the FAQ or contact Frances Frances Lendacki Frances Lendacki at Frances Lendacki @cityofchicago..org or questions related to medication allocations andaccess, please contact Illinois Department of Public Health at (DPH.MABTherapy@illinois.gov) 

Sites interested in providing USG-purchased COVID-19 therapeutics, sign up for the Heath Partners Ordering Portal here.