New federal rules reduce Alabama monoclonal antibody treatments for COVID by 18%

A week after federal authorities shifted distribution avenues for an effective COVID-19 treatment, Alabama saw its allotment throttled by more than 1,000 doses, concerning state doctors who have used monoclonal antibody therapy since November to prevent serious COVID-19 illnesses. 

Alabama was allotted 6,576 "patient courses," an 18% reduction from the previous week's allotment of 8,030, the Alabama Department of Public Health confirmed Wednesday. 

Under new federal regulations, the U.S. Department of Health and Human Services will allocate antibody shipments for states, using a universal formula to determine how many doses each state receive. Medical providers could previously order the drugs directly, and 70% of the nation's supply was funneling into Southern states because of high case rates and early adoption of the treatment last winter. Federal authorities said they moved to regulate shipment of the drugs to preserve limited quality amid the high demand in the South. 

Some doctors in Alabama say the state’s decrease this week may be tied in a drop of new COVID-19 cases from record highs this summer, but public health officials in recent days expressed concern at the reduction of antibody treatments while hospital capacity is still stretched very thin. 

"We kept people out of the hospitals, we decreased the death rate dramatically by using these aggressively and early on," said Dr. David Thrasher, one of the earliest proponents of monoclonal antibodies last year. "The real trick is getting people early, and we did. We had facilities in Montgomery going seven days a week. We were really happy, in the midst of being out of ICU beds, because it was critical to treat these people to keep them out of the system."

Monoclonal antibodies, produced by cloning immune cells that have been effective at fighting off severe COVID-19 illnesses, were first administered via IV infusion late last year. Thrasher and other doctors stress the antibody treatment is not a substitute for vaccination — which is safe, effective and significantly cheaper than monoclonals — but it has been a valuable tool in keeping high-risk individuals out of state hospitals. 

HHS in early September told states it would cap shipments of the drugs after to preserve supply amid a rise in demand. A second change last week took states by surprise, with HHS requiring providers request allotments through state health departments. Providers previously ordered the treatment directly from the supplier. 

State Health Officer Dr. Scott Harris on Friday said this presented a huge logistical challenge for Alabama, which had to work around the clock to set up a system to handle provider requests. With the allotment reduction and change in ordering process, people who could have received the monoclonal treatment likely slipped through the cracks.

“We know the clock is ticking for those folks,” Harris said. “We generally try to give those drugs within 10 days of the onset of illness. And yet this has really disrupted the supply. So, we are really sorry to say there are probably going to be some patients who aren’t able to access that drug who thought they were going to have that available to them."

Thrasher said it was reasonable Alabama was using a high number of the drugs, as it  has higher case rates, lower vaccination rates and was an early adopter of monoclonal treatments, with more than 100 providers using the drugs by the end of 2020. The state quickly began ramping up providers of the treatment, which doctors say is proven to prevent serious COVID-19 illness in infected patients.

Alabama ramped up antibody treatment centers through the winter, before the safe and effective vaccine became widely available. A downturn in new COVID cases through the spring and early summer effectively “mothballed” many treatment centers, Thrasher said. He counted four treatments in the entire month of June alone in Montgomery. But in July, treatments in Montgomery jumped to 100. Last month, as a deadly COVID-19 wave swelled in the state, at least 2,000 people sought the treatment in Montgomery. 

"We had a system that was doing well, everyone was working really hard, and then the federal government stepped in,” Thrasher said. 

At Troy Regional Medical Center, CEO Rick Smith said the hospital administered 650 doses in the last 60 days, a feat for a more rural health system. 

“In our clinical perspective, that's 650 people that didn't have to be admitted, that didn't end up on a ventilator,” Smith said. “It's absolutely effective. One of the best defenses against this COVID-19 virus that we have.”

In the Gadsden area, Dr. Jason Junkins was ramping up his first monoclonal treatment program for three area urgent and primary care clinics when the HHS changes came down. At the height of the COVID wave several weeks ago, Junkins said his practice could have given monoclonals to 30 to 40 patients per day. 

“So far, we got 48 (allotted) our first week, our second week we got 90-something,” Junkins said. “We’re in a decent situation right now.”

UAB, one of Alabama’s largest health care providers, said Wednesday they are not currently concerned about monoclonal supply. 

“If that changes, we'll be making noise about that because we know that's an effective tool to keep COVID positive patients from getting clinically ill,” Dr. Sarah Nafziger said. 

Tennessee this week recommended providers preserve the supply of monoclonal by limiting access for vaccinated people, reserving it for unvaccinated people who are most likely to suffer severe complications from a coronavirus infection. 

More:Tennessee recommends vaccinated residents lose access to monoclonal antibody treatment

Alabama says it has no plans to do the same. Assistant State Health Officer Dr. Karen Landers said Wednesday the state has offered guidance on the high-risk conditions that would make someone eligible for the therapy.

“Obviously, we want people to be vaccinated, first of all,” Assistant State Health Officer Dr. Karen Landers said. 

"We want people to get vaccinated so we don't get to this point,” said Thrasher.  “You can't punish people for not being vaccinated. That's really wrong. And people who get vaccinated, who try to do the right thing, in my mind, also have breakthrough infections — why punish them? We don't. If you get sick, I'm going to treat you, period, if I have the product. My philosophy is if you're sick, and I have a product that will keep you out of the hospital, you're going to get it. I will not keep it on the shelf and say, 'Well, an unvaccinated patient may come in this afternoon.'”

Contact Montgomery Advertiser reporter Melissa Brown at 334-240-0132 or mabrown@gannett.com.