HHS takes over monoclonal distribution

Published 9:11 pm Tuesday, September 21, 2021

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How many, if any, monoclonal antibody treatments will be available locally is still a mystery.

Last week, the U.S. Department of Health and Human Services announced direct ordering for monoclonal treatments from manufacturers would be shifted to a state coordinated distribution system.

Troy Regional Medical Center Chief Executive Officer Rick Smith said TRMC received the notification last week, but he was unsure how many monoclonal treatments the hospital would receive in the future. Smith said instead of ordering directly from the manufacturer, HHS would determine how many treatments each state would be allotted and then, the Alabama Department of Public Health would determine how those treatments would be distributed across the state.

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“We had been getting about 100 doses per week, and we were burning through those doses,” Smith said. “We’ve placed our order, but we’re not sure how many doses we will get. The way I see it, is if we we’re giving 20 doses a day, that was 20 people that weren’t being hospitalized, that was 20 people that weren’t being put on ventilators and that was 20 people that may not die from COVID.”

According to the Alabama Department of Public Health, the surge in COVID cases brought on by the Delta Variant also cause a surge in the use of monoclonal treatments. According to the ADPH, monoclonal antibody treatment builds rapid immunity to the virus and helps prevent hospitalization, but they are not a replacement for COVID-19 vaccination and are intended to help those at high risk for serious COVID illness, individuals who have recently tested positive for the virus, or people who are close contacts of persons who have tested positive for COVID.

According to the ADPH, the U.S. Department of Health and Human Services transitioned to a distribution model in order to “help ensure the consistent availability of these critical products for current and future patients in all geographic areas of the country.”

“During this transition, our highest priority will be to ensure that the ordering process for monoclonal antibodies is in place, so Alabama healthcare providers can be sent needed products as soon as possible,” State Health Officer Dr. Scott Harris said.

The distribution process is as follows:

• HHS will determine each state’s weekly amount of monoclonal antibody products based on cases and use on a week-by-week basis. Healthcare providers must record their utilization of the products promptly in order to be eligible to receive additional shipments.

• The Alabama Department of Public Health will identify which sites in the state will receive the product and the amount each of the multiple sites receives. HHS will continue to monitor product utilization rates, COVID-19 case burden, and the overall availability of monoclonal antibodies to determine when a shift back to the normal direct ordering process may be possible.

• Providers are to prioritize patients based on their risk of progression to severe COVID disease. Treatment should be given as soon as possible (within 10 days) after a close contact to a positive case of COVID-19, to patients who tested positive, and to individuals who are at high risk for disease progression to severe COVID-19.