Demand for monoclonal antibody treatments has surged in recent months, leading the Biden administration to take over distribution of the drugs in an attempt to mitigate shortages—a decision that has frustrated health officials in several states who say their supplies are now being limited.
Demand for monoclonal antibody treatments surges
According to the New York Times, demand for monoclonal antibody treatments has surged in recent months—with state orders increasing from 27,000 weekly doses in July to 168,000 doses in late August.
FDA in November authorized the use of two monoclonal antibody treatments made by Eli Lilly and Regeneron Pharmaceuticals. These treatments use lab-developed molecules to either replace, improve, or imitate the natural antibodies the body produces to fight infection. They are administered through infusions, which take around an hour and a half to complete.
Antibody treatments have been shown to be highly effective at reducing risk of hospitalization in patients with mild to moderate Covid-19 if the treatments are given within 7 to 10 days of symptom development. In particular, Regeneron's antibody treatment has been shown to reduce patients' risk of hospitalization by 70%, the Times reports.
Although monoclonal antibody treatments were not heavily used during the winter surge of coronavirus cases, many hospitals and health centers are now increasing their efforts to offer the treatments to patients as cases and hospitalizations continue to rise across the country.
For example, nurses at Houston Methodist Hospital administered almost 1,100 antibody treatments at eight different sites during the first week of September—more than twice as many treatments administered in any week last winter. In addition, the hospital has reduced the average time between orders and treatments from three days to two to give patients a better chance to fight off infection.
Currently, seven Southern states—Alabama, Florida, Georgia, Louisiana, Mississippi, Tennessee, and Texas—make up around 70% of all orders for monoclonal antibodies, a spokesperson for HHS said.
The federal government intervenes to prevent shortages
According to the Washington Post, the surge in the demand for monoclonal antibody treatments has led the Biden administration to impose new limits on states ordering the drug to prevent shortages in supply.
So far, 2.4 million monoclonal antibody doses have been shipped nationwide, and at least 1.1 million doses have been administered. While it is unclear how many doses are still available due to gaps in reporting, decreasing federal supplies and surging demand from Southern states have led to "large shortfalls in deliveries," according to the Times.
In response to the demand, HHS last week announced it would be reverting to a distribution method for the antibody treatments used from November 2020 to February 2021.
Instead of hospitals ordering the antibody drugs directly like they have been, HHS will now examine hospitalization data and case rates in each state and determine how many doses each state should receive. From there, state governments will decide the number of doses that individual sites will receive.
According to an HHS spokesperson, the new system will "help maintain equitable distribution, both geographically and temporally, across the country, providing states and territories with consistent, fairly distributed supply over the coming weeks."
In addition, the federal government has purchased 1.8 million additional doses of antibody treatments to bolster supplies through the rest of the year, the Times reports. Of the purchased doses, 1.4 million were from Regeneron, and around 400,000 were from Eli Lilly.
States express frustration over new supply limits
Several state health officials have expressed frustration over the new distribution plan, CBS News reports, citing delays in shipments and uncertainty among health systems as they try to schedule patients within the short window of time when the antibody treatments are most effective at preventing hospitalization.
Under the new plan, which went into effect on Sept. 13, several states have already said they are being allocated far fewer doses from the federal government than they initially requested. For example, in North Carolina, providers have requested 15,000 weekly doses—more than double than what HHS has allocated for the state—and Florida said its weekly allotment has left the state's clinics 41,000 doses short of their original request.
"We have providers struggling to get the necessary product," Kody Kinsley, who leads operations for North Carolina’s Covid-19 response, said. "I think what has happened is a classic logistics issue, where all of a sudden there’s much more demand."
Aruna Arora, president of Alabama's state medical association, said the state's hospitals are "full and under tremendous stress," which has caused physicians to be "very concerned about federal efforts that will end up limiting our supply and access to this effective treatment."
Separately, Diana Berrent, the founder of Survivor Corps, which has worked to help patients find monoclonal antibody treatments, agreed, saying, "You're layering in 50 new layers of bureaucracy." (Mueller, New York Times, 9/18; Bernstein, Washington Post, 9/14; Tin, CBS News, 9/17)