Of the dozens of patients Dr. Jim Yates treated for COVID-19 at his long-term care facility in rural Alabama, this one made him particularly nervous.
The 60-year-old man, who had been fully vaccinated, was diagnosed with a breakthrough infection in late September. Almost immediately, he needed extra oxygen, and lung tests showed worrying 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 – and faster – interventions.
At the first sign of the man’s symptoms, Yates had placed an order with the Alabama Department of Public Health for monoclonal antibodies, the lab-made proteins that mimic the body’s ability to fight the virus. But six days passed before the vials arrived, nearly missing the window in which therapy works best to avoid hospitalization and death.
âWe’ve pushed the boundaries because of the time frame you have to stick with,â Yates said. “Luckily once we got him he responded.”
Across the country, medical directors at skilled nursing and long-term care sites say they have been pushing hard to get doses of potent antibody therapies following a change in federal policy that it says critics, are limiting supplies for the vulnerable population of frail and elderly residents who remain most at risk of COVID-19 infection even after vaccination.
âThere are people currently dying in nursing homes, and we don’t know if they could have been saved or not, but they didn’t have access to the product,â said Chad Worz, CEO of American Society of Consultant Pharmacists. , which represents 1,500 pharmacies serving long-term care facilities.
Before mid-September, doctors and other providers could order antibody treatments directly from the drug wholesaler AmerisourceBergen and receive the doses within 24 to 48 hours. While the earliest versions of licensed treatments required hour-long infusions administered at specialist centers or by trained staff, a newer approach allows for the delivery of doses via injections, which were quickly adopted by clinics. driving and nursing homes.
Quick access to antibody therapies is essential because they work by quickly reducing the amount of virus in a person’s system, thereby reducing the risk of serious illness. Therapies are allowed for those infected who have had symptoms for no more than 10 days, but many doctors say they have had the best results by treating patients on day 5 and no later than day 7.
After a slow rollout earlier in the year, the use of monoclonal antibody treatments exploded this summer as the delta variant increased, especially in southern states with low COVID-19 vaccination rates which executives sought alternative remedies – although more expensive.
By early September, orders from seven states – Alabama, Florida, Georgia, Louisiana, Mississippi, Tennessee and Texas – accounted for 70% of total monoclonal shipments.
Those southern states, along with three others – Arkansas, Kentucky, and North Carolina – ordered new treatments even faster than they used up their supplies. From July 28 to September 8, they collectively increased their antibody stocks by 134%, according to a KHN analysis of federal data.
Fearing the model was both out of control and unsustainable given limited national supplies, officials from the Department of Health and Human Services stepped in to equalize the distribution. HHS has banned individual sites from placing direct orders for monoclonal drugs. Instead, they took care of the distribution, basing the allocation on case rates and hospitalizations and centralizing the process through state health services.
“It was absolutely necessary to make this change to ensure a consistent product for all regions of the country,” said Dr Meredith Chuk, who heads the allocation, distribution and administration team at HHS, during ‘a conference call.
But states have sent most doses of monoclonal antibody treatments, known as mAbs, to hospitals and acute care facilities, bypassing 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 Medicine and Long-Term Care.
While vaccination may offer 90% or more protection against severe COVID-19 in younger, healthier people, this is not the case for older people who typically live in nursing homes.
âYou have to think about the spectrum of immunity,â Laxton said. âFor our residents, it’s closer to 60%. You know that 4 in 10 are going to get breakthrough infections. “
MAb treatments have been cleared for use in high-risk patients exposed to the virus, and elderly care experts say it is key to best practice in preventing outbreaks in facilities for the elderly. This could include, for example, treating the elderly roommate of an infected nursing home patient. But due to the newly limited supply, many long-term care sites have started restricting use to only those infected.
Yet some states have made efforts to ensure access to mAbs in long-term care sites. Minnesota health officials are relying on a policy that prioritizes residents of qualified nursing homes for antibody therapy 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 .
âMonoclonal antibodies have made a huge difference,â said Renee Birchmeier, a nurse practitioner who cares for patients at nine of the system’s sites. âEven assisted living patients with COPD are doing well,â she said, referring to chronic obstructive pulmonary disease. âThey are not moving forward, but they are doing well. And they are alive.
Long-term care sites accounted for a fraction of orders for monoclonal treatments, first authorized in November 2020. About 3.2 million doses have been distributed to date, of which about 52% have already been used, according to the HHS . Only about 13,500 doses have gone to nursing homes this year, according to federal data. This does not include other long term care sites such as assisted living centers.
Use is low in part because treatments were originally only delivered by IV infusions. But in June, Regeneron monoclonal antibody treatment was cleared for use by subcutaneous injections – four separate injections, given in the same session – and demand has increased.
Use in nursing homes reached more than 3,200 doses in August and nearly 6,700 in September, according to federal data. But weekly usage fell sharply from mid-September to early October after the HHS policy change.
Nursing homes and other long-term care sites have apparently been left behind in the new allowance system, said Cristina Crawford, spokesperson for the American Health Care Association, a nonprofit business group. representing long-term care operators. âWe need federal and state public health officials to readjust their priorities and focus on our seniors,â she said.
In an October 20 letter to White House Policy Advisor Amy Chang, advocates for pharmacists and long-term care providers called for a coordinated federal approach to ensure access to treatment. Such a plan could reserve the use of a certain type or formulation of the product for direct ordering and use in long-term care facilities, said Worz, of the pharmacy group.
So far, neither the HHS nor the White House have responded to the letter, Worz said. HHS spokesperson Cicely Waters said the agency continues to work with state health departments and other organizations “to help get COVID-19 monoclonal antibody products to areas that need it most “. But she did not ask if the HHS was considering a specific solution for long-term care sites.
Demand for monoclonal antibody treatments has eased as COVID-19 cases have declined in the United States. Still, there were 2,669 confirmed cases among nursing home residents during the week ending Oct. 24 and 392 deaths, according to the Centers for Disease Control and Prevention.
At least some of those deaths could have been prevented with timely monoclonal antibody therapy, Worz said.
Addressing the access problem will be key to managing epidemics as the country prepares to enter another holiday season, said Dr Rayvelle Stallings, medical officer at PruittHealth, which serves 24,000 patients at 180 locations across the country. the South-East.
PruittHealth pharmacies stock a dozen to two dozen doses of monoclonal antibody treatments, just enough to treat the expected breakthrough cases, she said.
âBut it’s certainly not enough if we were to have a major epidemic this winter,â she said. âWe would need 40 to 50 doses. What if we see the same increase or a similar increase that we saw in August and September? We wouldn’t have enough.
JoNel Aleccia, Kaiser Health News. Phillip Reese, assistant professor of journalism at California State University-Sacramento, contributed to this report. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with policy analysis and surveys, KHN is one of the three main operational programs of the KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization that provides information on health issues to the nation.