With COVID-19 cases spiking again across Texas, public health officials are urging physicians to acquaint themselves with the criteria for patients who can receive monoclonal antibody therapy.
“We’re hearing from our regions and local health departments that some pediatricians are referring young children, for example, but they are not eligible,” Texas Department of State Health Services (DSHS) spokesperson Chris Van Deusen told Texas Medicine Today in an email interview.
Three monoclonal antibody products have emergency use authorizations from the Food and Drug Administration (FDA) and are used in an outpatient setting to decrease the risk of hospitalization: REGEN-COV (a combination of casirivimab plus imdevimab), bamlanivimab plus etesevimab, and sotrovimab.
Patients who are eligible for these medications must:
- Have a positive COVID-19 test;
- Be within 10 days of symptom onset;
- Be age 12 or older; and
- Weigh a minimum of 88 pounds (40 kilograms).
The therapy is not authorized for patients who:
- Have been hospitalized due to COVID-19;
- Require oxygen therapy due to COVID-19; or
- Require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity.
To take pressure off hospitals and clinics, Gov. Greg Abbott has directed DSHS and the Texas Department of Emergency Management (TDEM) to open additional COVID-19 antibody infusion centers throughout the state, the governor’s office said in a press release.
These infusion centers treat COVID-19 patients who do not need hospitalization with monoclonal antibody medications that can prevent their condition from worsening and requiring hospital care. Texas used similar centers in early 2021 before vaccines became widespread.
For the physicians treating COVID-19 patients, the U.S. Department of Health and Human Services (HHS) recommends they use only REGEN-COV and sotrovimab until further notice, DSHS says. Bamlanivimab plus etesevimab is not as affective against the beta and gamma variants of COVID-19, and federal authorities have paused distribution of that combination. However, it has been shown to be effective against the delta variant and may be recommended in the future.
The U.S. government purchased large quantities of REGEN-COV, and it is available at no cost through the distributor, AmerisourceBergen, DSHS says. Sotrovimab was not purchased by the U.S. government, so there is a charge for it. The federal government also purchased bamlanivimab and etesevimab, and they likely will be free if that pause is lifted, DSHS says.
Physicians can check for the availability of monoclonal antibody treatments in their area and contact the facility directly to find out about availability. Administration of these medications requires a physician’s order.
Physicians must also report monoclonal antibody use to the TDEM portal, DSHS says. These monoclonal antibody therapies may be administered only in settings where there is immediate access to medications to treat a severe infusion reaction – such as anaphylaxis – and access to emergency medical services if necessary, the Centers for Medicare & Medicaid Services (CMS) says. Facilities also must report all medication errors and severe adverse reactions to FDA MedWatch.
Here are additional physician resources for monoclonal antibody treatments: