Of the dozens of patients Dr. Jim Yates has treated for covid-19 at his long-term care center in rural Alabama, this one made him especially nervous.
The 60-year-old man, who had been fully vaccinated, was diagnosed with a breakthrough infection in late September. Almost immediately, he required supplemental oxygen, and lung exams showed ominous signs of worsening disease. Yates, who is medical director of Jacksonville Health and Rehabilitation, a skilled nursing facility 75 miles northeast of Birmingham, knew his patient needed more powerful interventions 鈥 and fast.
At the first sign of the man鈥檚 symptoms, Yates had placed an order with the Alabama Department of Public Health for monoclonal antibodies, the lab-made proteins that mimic the body鈥檚 ability to fight the virus. But six days passed before the vials arrived, nearly missing the window in which the therapy works best to prevent hospitalization and death.
鈥淲e鈥檝e been pushing the limits because of the time frame you have to go through,鈥 Yates said. 鈥淔ortunately, once we got it, he responded.鈥
Across the country, medical directors of skilled nursing and long-term care sites say they鈥檝e been scrambling to obtain doses of the potent antibody therapies following a change in federal policy that critics say limits supplies for the vulnerable population of frail and elder residents who remain at highest risk of covid infection even after vaccination.
鈥淭here are people dying in nursing homes right now, and we don鈥檛 know whether or not they could have been saved, but they didn鈥檛 have access to the product,鈥 said Chad Worz, CEO of the American Society of Consultant Pharmacists, which represents 1,500 pharmacies that serve long-term care sites.
Before mid-September, doctors and other providers could order the antibody treatments directly through drug wholesaler AmerisourceBergen and receive the doses within 24 to 48 hours. While early versions of the authorized treatments required hourlong infusions administered at specialty centers or by trained staff members, a more recent approach allows doses to be administered via injections, which have been rapidly adopted by drive-thru clinics and nursing homes.
Prompt access to the antibody therapies is essential because they work by rapidly reducing the amount of the virus in a person鈥檚 system, lowering the chances of serious disease. The therapies are authorized for infected people who鈥檝e had symptoms for no more than 10 days, but many doctors say they鈥檝e had best results treating patients by Day 5 and no later than Day 7.
After a slow rollout earlier in the year, use of monoclonal antibody treatments exploded this summer as the delta variant surged, particularly in Southern states with low covid vaccination rates whose leaders were looking for alternative 鈥 albeit costlier 鈥 remedies.
By early September, orders from seven states 鈥 Alabama, Florida, Georgia, Louisiana, Mississippi, Tennessee and Texas 鈥 accounted for 70% of total shipments of monoclonals.
Those Southern states, plus three others 鈥 Arkansas, Kentucky and North Carolina 鈥 ordered new courses of treatment even faster than they used their supplies. From July 28 to Sept. 8, they collectively increased their antibody stockpiles by 134%, according to a KHN analysis of federal data.
Concerned the pattern was both uncontrolled and unsustainable given limited national supplies, officials with the Department of Health and Human Services stepped in to equalize distribution. HHS barred individual sites from placing direct orders for the monoclonals. Instead, they took over distribution, basing allocation on case rates and hospitalizations and centralizing the process through state health departments.
鈥淚t was absolutely necessary to make this change to ensure a consistent product for all areas of the country,鈥 Dr. Meredith Chuk, who is leading the allocation, distribution and administration team at HHS, said during a conference call.
But states have been sending most doses of the monoclonal antibody treatments, known as mAbs, to hospitals and acute care centers, sidestepping the pharmacies that serve long-term care sites and depleting supplies for the most vulnerable patients, said Christopher Laxton, executive director of AMDA, the Society for Post-Acute and Long-Term Care Medicine.
While vaccination might provide 90% protection or higher against serious covid in younger, healthier people, that鈥檚 not the case for the elders who typically live in nursing homes.
鈥淵ou have to think of the spectrum of immunity,鈥 Laxton said. 鈥淔or our residents, it鈥檚 closer to 60%. You know that 4 out of 10 are going to have breakthrough infections.鈥
The mAb treatments have for use in high-risk patients exposed to the virus, and experts in elder care say that is key to best practices in preventing outbreaks in senior facilities. That could include, for example, treating the elderly roommate of an infected nursing home patient. But because of newly limited supplies, many long-term care sites have started to restrict use to only those who are infected.
Still, some states have worked to ensure access to mAbs in long-term care sites. Minnesota health officials that prioritizes residents of skilled nursing facilities for the antibody therapies through a weighted lottery. In Michigan, state Medical Director Dr. William Fales directed emergency medical technicians and paramedics to the Ascension Borgess Hospital system in Kalamazoo to help administer doses during recent outbreaks at two centers.
鈥淭he monoclonal antibodies made a huge difference,鈥 said Renee Birchmeier, a nurse practitioner who cares for patients in nine of the system鈥檚 sites. 鈥淓ven the patients in the assisted living with COPD, they鈥檙e doing OK,鈥 she said, referring to chronic obstructive pulmonary disease. 鈥淭hey鈥檙e not advancing, but they鈥檙e doing OK. And they鈥檙e alive.鈥
Long-term care sites have accounted for a fraction of the orders for the monoclonal treatments, first authorized in November 2020. About 3.2 million doses have been distributed to date, with about 52% already used, according to HHS. Only about 13,500 doses have gone to nursing homes this year, according to . That doesn鈥檛 include other long-term care sites such as assisted living centers.
The use is low in part because the treatments were originally delivered only through IV infusions. But in June, the Regeneron monoclonal antibody treatment was authorized for use via subcutaneous injections 鈥 four separate shots, given in the same sitting 鈥 and demand surged.
Use in nursing homes rose to more than 3,200 doses in August and nearly 6,700 in September, federal data shows. But weekly usage dropped sharply from mid-September through early October after the HHS policy change.
Nursing homes and other long-term care sites were seemingly left behind in the new allocation system, said Cristina Crawford, a spokesperson for the American Health Care Association, a nonprofit trade group representing long-term care operators. 鈥淲e need federal and state public health officials to readjust their priorities and focus on our seniors,鈥 she said.
In an to White House policy adviser Amy Chang, advocates for long-term care pharmacists and providers called for a coordinated federal approach to ensure access to the treatments. Such a plan might reserve use of a certain type or formulation of the product for direct order and use in long-term care settings, said Worz, of the pharmacy group.
So far, neither the HHS nor the White House has responded to the letter, Worz said. Cicely Waters, a spokesperson for HHS, said the agency continues to work with state health departments and other organizations 鈥渢o help get covid-19 monoclonal antibody products to the areas that need it most.鈥 But she didn鈥檛 address whether HHS is considering a specific solution for long-term care sites.
Demand for monoclonal antibody treatments has eased as cases of covid have declined across the U.S. For the week ending Oct. 27, an average of nearly 72,000 daily cases were reported, a decline of about 20% from two weeks prior. Still, there were 2,669 confirmed cases among nursing home residents the week ending Oct. 24, and 392 deaths, according to the .
At least some of those deaths might have been prevented with timely monoclonal antibody therapy, Worz said.
Resolving the access issue will be key to managing outbreaks as the nation wades into another holiday season, said Dr. Rayvelle Stallings, corporate medical officer at PruittHealth, which serves 24,000 patients in 180 locations in the Southeast.
PruittHealth pharmacies have a dozen to two dozen doses of monoclonal antibody treatments in stock, just enough to handle expected breakthrough cases, she said.
鈥淏ut it鈥檚 definitely not enough if we were to have a significant outbreak this winter,鈥 she said. 鈥淲e would need 40 to 50 doses. If we saw the same or similar surge as we saw in August and September? We would not have enough.鈥
Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.
