Federal rules force Texas officials to ration COVID-19 immunotherapy drugs

TEMPLE, Texas — While there are few treatments are available to patients who have already contracted COVID-19, doctors can use immunotherapy drugs like Regeneron, Bamlanivimab and Etesevimab to improve their patients condition. 

Available under Emergency Use Authorization (EUA) from the FDA, the drugs contain monoclonal antibodies that target a spike protein on SARS-CoV-2. Patients must be observed for several hours afterwards due to the possibility of a severe allergic reaction.

Still, local Texas doctors were allowed to directly order it, and Express ER Medical Director Dr. Daniel Akers said it has proven to be effective in some cases. 

“It has been proven in many studies to help and the earlier you give it, the better,” Akers said.

Then, late Sept. 13, the U.S. Department of Health and Human Services announced that doctors would not be able to order the drugs directly and they would be allocated by state officials instead.

The Texas Department of State Health Services (DSHS) told 6 News Wednesday the federal government made the decision due to a high demand and short supply of the drug across the nation. 

DSHS said any pending drug orders from a current source, AmerisourceBergen, are being closed.

A DSHS email stated their department is now tasked with developing “a state system for allocations as quickly as possible.”

DSHS has already stood up seven Regional Infusion Centers around the state and the Texas Division of Emergency Management has been operating another eight RICs. DSHS said more than 100 private health care providers (mostly hospitals) in Texas were also offering this treatment.

Now, it is not clear how much of the drug will be available to all those providers.

DSHS said via email, “right now, demand exceeds supply, so the federal government and manufacturers are ramping up their efforts to increase production and distribution.”

DSHS said the treatment is ideal for those suffering mild to moderate symptoms but are at risk for a more severe case or hospitalization.

Those eligible for monoclonal antibody therapy must have a positive COVID-19 test, be within 10 days of onset of first symptoms, be at least 12 years of age and at least 88 lbs. If a patient has already been hospitalized, or if they are currently on oxygen therapy, they are ineligible. 

“Anecdotal reports include some patients feeling relief from symptoms later the same day of their treatment,” the email said.

Written by Andrew Moore

Categories: Health

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