āUpdates as of April 19, 2022:
- Bebtelovimab received EUA from the FDA on February 11, 2022
- On February 24, 2022, the FDA revised the EUA for tixagevimab/cilgavimab (Evusheld) to change the initial dose.
- Beginning on March 7, 2022, the U.S. Department of Health and Human Services (HHS) began distributing the oral antiviral treatments, Paxlovid and molnupiravir, directly to federally-qualified health centers (FQHCs), pharmacy-based clinics, and long-term health facilities as part of the new federal Test to Treat program.
- With recent data showing that sotrovimab is not fully effective against the Omicron BA.2 subvariant, the FDA updated the EUA for sotrovimab so that it is no longer authorized in any U.S. state or territory at this time. HHS has paused distribution of sotrovimab to these regions as well).
- On April 1, the NIH updated the guidelines on the preferred and alternative therapies for non-hospitalized patients.
- The allocation strategy for oral antiviral products has been updated to include federal pharmacy partners and counties.
Introduction
Currently available anti-SARS-CoV-2 therapeutics that have received Emergency Use Authorization (EUA) or approval from the Food and Drug Administration (FDA) include:
Anti-SARS-CoV-2 Monoclonal Antibodies
Bamlanivimab/etesevimab, cairivimab/imdevimab (REGEN-COV), and sotrovimab are NOT effective against the Omicron variant and/or the Omicron BA.2 subvariant and are not authorized for use anywhere in the United States. As such, HHS and CDPH are not distributing these monoclonal antibody products at this time.
Antivirals
Remdesivir has been added as one of the recommended treatments for acute COVID-19 in high-risk outpatients in the NIH treatment guidelines and granted approval for adult and pediatric outpatients. Additionally, it has received an EUA authorizing (PDF) use in the non-hospitalized pediatric patients under the age of 12 years as well.
Distribution for Products Under EUAs
The U.S. Department of Health and Human Services (HHS) currently manages a state/territory-coordinated distribution system for most COVID-19 therapeutic products under EUA. This means that facilities cannot directly order these products (with the exception of the federally approved Test to Treat pharmacies as referenced below).
Remdesivir, which is approved for outpatient treatment of adults and children 12 years and older and EUA authorized for use in pediatric patients under the age of 12, is not part of the federal state/territory-coordinated distribution system. Gilead will work with distributors directly to make Remdesivir available in qualified outpatient facilities.
HHS publishes distribution amounts of each COVID-19 therapeutic, including specific allocations made to California. With the loss of federal funding for COVID-19 in March 2022, distribution amounts will be reduced in an effort to preserve the supply of therapeutic products.
The California Department of Public Health (CDPH) is allocating COVID-19 therapeutics active against Omicron included in the HHS state/territory-coordinated distribution system using the below strategies:
Bebtelovimab Anti-SARS-CoV-2 monoclonal antibodies
| Treatment of mild to moderately ill outpatients with positive SARS-CoV-2 viral test
| Facilities able to provide infusion services and monitor patients; number of courses for each site determined by Medical Health Operational Area Coordinators (MHOACs) at county level | Allocated to counties Based on new cases (7-day average) and new COVID-19 hospitalizations (7-day average). Weighted 25% to cases; 75% to hospitalizations. |
Paxlovid Oral protease inhibitor & Molnupiravir Oral nucleoside analogue | Treatment of mild to moderately ill outpatients with positive SARS-CoV-2 viral test | Allocated to federal pharmacy partners and counties. Federal partners may request courses up to a capped amount by the state. Remaining courses are allocated to counties. | Allocated to federal pharmacy partners and counties. After capped amount reached by the state, remaining courses re allocated to counties based on new COVID-19 cases (7-day average) and Healthy Places Index (HPI); with 50% weighted to cases and 50% weighted to HPI. Within the 50% allocated by HPI, 40% to Q1 (most disadvantaged); 30% to Q2; 20% to Q3; 10% to Q4 (most advantaged). |
Evusheld Anti-SARS-CoV-2 monoclonal antibody | Pre-exposure prophylaxis
| Facilities able to provide infusion services and monitor patients; number of courses for each site determined by Medical Health Operational Area Coordinators (MHOACs) | Allocated to counties Based on share of the population in different HPI equity quartiles; 40% of state allocation to Q1 (most disadvantaged); 30% to Q2; 20% to Q3; 10% to Q4 (most advantaged). |
Additionally, the new Test to Treat initiative that was launched on March 7, 2022 ensures that individuals can receive rapid testing, assessment, and treatment all in one location. The HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) distributes the oral antiviral products (Paxlovid and molnupiravir) directly to Test to Treat pharmacy-based clinics, health centers, and long-term care facilities. This program does not impact current state and territory allocations that are going to other sites. For more information, please refer to ASPR's Test to Treat fact sheet (PDF). Please refer the ASPR Test to Treat map for a list of all federally supported Test to Treat sites. For a list of Test to Treat locations in California, please refer to the CDPH Test to Treat webpage.
Ordering COVID-19 Therapeutics
Facilities that are able to operationalize COVID-19 therapeutics and would like to be considered for product allocations should contact their Medical and Health Operational Area Coordinator (MHOAC).
Remdesivir is not being allocated by the federal government and can be purchased (PDF) directly from the distributor.
Identifying Locations with COVID-19 Therapeutics
Sites receiving therapeutic products and estimated availability can be found at the HHS Therapeutics Locator. The Therapeutics Locator is based on shipments and reported utilization and is not a guarantee of availability. These therapies require a prescription by a licensed and authorized provider. Patients should coordinate with their healthcare provider prior to contacting a location to receive these therapies.
For a list of Test to Treat locations, please refer the HHS Test to Treat site locator.
Originally published on January 19, 2022