States call for more monoclonal antibodies to treat COVID-19

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After months of urging providers to increase the use of monoclonal antibody treatments that could prevent some people with COVID-19 from end up in the hospitalThe Biden administration said that a “substantial” increase in demand from a handful of states had forced authorities to place new limits on drug orders.

Seven states – Alabama, Florida, Texas, Mississippi, Tennessee, Georgia and Louisiana – accounted for 70% of monoclonal antibody orders in recent weeks, according to the spokesperson for the Department of Health and Human Services, which manages the supply. treatments. purchased by the federal government. Overall, drug orders since mid-July have increased 20-fold.

Of those states, only Florida has fully vaccinated more than half of its total population, according to the Centers for Disease Control and Prevention. The rest rank in the bottom 10 states for immunizations nationwide. All seven rank among the top half of states with the highest rates of daily hospitalizations for COVID-19 in recent weeks.

“Given this reality, we must work to ensure that our supply of these life-saving therapies remains available to all states and territories, not just some,” the spokesperson said. Instead of vendors ordering drugs directly from the federal government vendor, AmeriSourceBergen, doses of monoclonal antibodies are now allocated by HHS to state health departments, “based on COVID-19 workload” and demand for drugs.

States will be responsible for deciding how to distribute the doses of REGEN-VOC from Regeneron and the combination bamlanavimab and etesevimab from Eli Lilly to doctors, clinics and pharmacies within their borders.

But some states say they have been caught off guard by the change in administration and say the new allowances will leave some providers empty-handed in the face of a wave of cases fueled by the highly contagious virus. Delta variant.

“We are responsible not only for supplying our sites, which we are happy to do, but any IV center, any supplier, any hospital will have to go through the state,” Florida Governor Ron DeSantis said at the time. of a press conference on Thursday.

“To start this from next week, we’re going to have to do it. There is going to be a huge disruption and the patients are going to suffer, ”the governor said.

DeSantis spokeswoman Christina Pushaw cited emails from federal health officials at the state health department in recent weeks that she said “provided no indication of an upcoming limitation of supply “. Pushaw said the state is now forecasting a shortfall of 41,050 doses of monoclonal antibody treatments next week, as part of new federal government allocations.

In Texas, state health officials said the Biden administration warned them that “the domestic supply has declined dramatically.” The state is now working to put in place a system to process drug orders “as quickly as possible.”

“We just don’t know what the supply will be in the long term and can’t predict what the effect will be,” said Douglas Loveday, spokesperson for health services for the State Department of Texas.

Administration spokesman Biden dismissed accusations that the move was a surprise, citing calls last week with state health officials to explain the change.

“It wasn’t like we flipped the switch and all of a sudden it happened. This is not how it works. It never worked that way, ”the spokesperson said.

The new order caps also come as the United States struck more deals to increase supplies of antibody treatments, after demand initially fell amid falling cases earlier this year.

Eli Lilly announced Wednesday that the US government has purchased an additional 388,000 doses of part of his combination antibody therapy. Regeneron said on Tuesday that the federal government had purchased an additional 1.4 million doses of their treatment.

The Food and Drug Administration also proposed Thursday to change its emergency use authorization for Eli Lilly’s drug, allowing it to be used as “post-exposure prophylaxis” in certain adults and children at high risk of COVID. -19 severe – meaning it could be given as a preventative measure after a person has been exposed to the virus, even if they have not tested positive. Regeneron’s monoclonal antibody had already been approved for this use in August.

Federal health officials said they had so far not seen widespread storage or misuse of the drugs. The FDA and HHS have urged providers to ensure the drugs are not used as a “vaccine substitute.”

However, before returning to the current allocation process – similar to a system the federal government used to ration monoclonal antibodies to states earlier in the pandemic – the Biden administration first said earlier this month that she would “review all orders to align with use.”

But the move has also frustrated providers, several state health officials have said, delaying shipments and creating uncertainty for health systems trying to schedule patients in the short window where drugs can be used before they can be used. ‘they don’t need to be hospitalized.

“On Monday morning, one of our hospitals serving as an infusion center alerted us that last week they had only received 25% of what they ordered and that their order for that week was still in progress. ‘review,’ said Shareese DeLeaver-Churchill, spokesperson for Maryland Gov. Larry Hogan.

Hogan said Tuesday he raised the issue during the White House’s weekly call with governors, decrying it as “another example of confused and contradictory directives coming from the federal government.”

“The immediate concern is that while we have over 30 facilities across the state that offer these treatments, some serve as the sole hub in their area, so these changes can dramatically affect access to care,” DeLeaver-Churchill said.



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