Kaiser Health News 
Modern Healthcare Illustration / Getty Images
For months, Joelle Ruppert was among the millions of Americans who are COVID vaccine holdouts. Her reluctance, she said, was not so much that she opposed the new vaccines but that she never felt “compelled” by the evidence supporting their experimental use.
Nonetheless, after she fell ill with COVID last month, Ruppert, a Florida preschool teacher, found herself desperate to try an experimental product that promised to ease her symptoms: infusion with a potent laboratory-produced treatment known as monoclonal antibody therapy.
“I was in bed; I was feeling so badly, like the longest flu I ever had in my life,” said Ruppert, 54, of Gainesville. “I was, like, whatever, give me whatever.”
Ruppert and her husband, Michael, 61, who also contracted COVID-19, are among thousands of people in the U.S. who in recent weeks have rushed to receive infusions of the powerful antibody cocktails shown to reduce hospitalizations by 70% when given promptly to high-risk patients.
The rush has been fueled in no small part by governors in Southern states, where vaccinations lag and hospitalizations are soaring with delta-variant infections. Republican Govs. Ron DeSantis of Florida and Greg Abbott of Texas are among leaders touting the antibody treatments even as they downplay vaccination and other measures that health officials say can prevent illness in the first place.
Together, they have opened dozens of state-sponsored sites where monoclonal antibody therapy is offered, holding regular news conferences to endorse the potentially lifesaving benefits, while continuing to resist wider public health measures such as mask mandates and vaccine passports.
“Anyone that has a better-than-average risk with COVID, if you do get infected, this is something you can do early and potentially really make a difference,” DeSantis said Saturday at the opening of a monoclonal antibody infusion site in Manatee County.
Since mid-July, delivery of the antibody cocktail made by Regeneron Pharmaceuticals has soared from 25,000 doses to 125,000 doses per week, with about half shipped to four states: Florida, Texas, Mississippi and Alabama, said Alexandra Bowie, a company spokesperson. The treatments use laboratory-produced molecules to replace, enhance or mimic the body’s natural antibodies that fight infection.
The sudden spotlight on the antibody treatments has whipsawed some public health experts, who have struggled for months to create and sustain sites capable of offering the therapy. The treatment is delivered primarily through a one-dose intravenous infusion that takes about 25 minutes, followed by an hour of observation for reactions.
Antibody cocktails, which must be given within 10 days of COVID infection or exposure, are effective for many patients, but “this is not a substitute for vaccine, by any means,” said Dr. Christian Ramers, chief of population health and an infectious disease specialist at Family Health Centers of San Diego.
“It’s a backwards strategy,” said Ramers. “It’s so much better to prevent a disease than to use an expensive, cumbersome and difficult-to-use therapy. It does not make any medical sense to lean into monoclonals to the detriment of vaccines. It’s like playing defense with no offense.”
The cost of Regeneron infusions: about $1,250 a dose. For now, the federal government is covering the cost.
The federal government is also covering the costs of COVID vaccination, at about $20 a dose.
Hospitals and infusion centers also charge for the time- and resource-intensive administration of monoclonal antibody treatment. Medicare has agreed to pay providers between $310 and $450 for performing it in healthcare settings — and $750 for treatment in a patient’s home.
Some patients who receive the treatment may be charged similar amounts for copays and administration fees, depending on what a hospital charges and what their insurance covers. DeSantis has emphasized that the treatment is provided at no cost to patients at Florida’s state-run sites.
The Food and Drug Administration authorized two monoclonal antibody treatments for emergency use for COVID in November, weeks after President Donald Trump credited Regeneron’s product for curing his infection. Since then, use of a cocktail made by Eli Lilly has been halted because it wasn’t effective against some COVID variants. In May, sotrovimab, a monoclonal antibody made by the pharmaceutical firm GlaxoSmithKline, also received emergency authorization.
The treatment is authorized for people newly infected with COVID at high risk of hospitalization and for high-risk patients who have been exposed to the virus. Those eligible include a wide swath of the American public: people who are overweight or obese; those who have diabetes, heart disease or other illnesses; and those with compromised immune systems.
The COVID vaccines also were authorized under emergency-use protocol. This week, the Pfizer-BioNTech vaccine was granted full approval for use in people 16 and older.
Christina Pushaw, a DeSantis spokesperson, said criticism of efforts to promote monoclonal antibody therapy amounts to “a false choice.”
“Prevention and treatment are not mutually exclusive,” she said in an email. “Both monoclonals and vaccines save lives. The difference is that vaccines are preventative and cannot help someone who is already infected with COVID-19.”
Some health officials welcomed the attention to monoclonal antibody therapy generated by DeSantis and others, saying the treatment has been undervalued and underused. The federal government has shipped more than 1.3 million doses of monoclonal products to nearly 6,300 sites, according to the HHS. So, far, about 637,000 doses — or fewer than half — have been used.
“It’s not about vaccination. It’s about a treatment for COVID that can keep patients out of the hospital,” said Connie Sullivan, president and chief executive of the trade group National Home Infusion Association. “This isn’t about politics. This is about patients at risk.”
Still, some unvaccinated people appear to view the antibody treatments as a backup plan if they get sick, several health officials said.
At Memorial Hospital Pembroke in South Florida, Chief Nursing Officer David Starnes has overseen treatment of more than 2,000 patients with antibody cocktails since December. At least 90% of the patients have been unvaccinated — and the numbers keep climbing.
“What’s amazing to me is that a vaccine we’ve been working on for 10 years, they are deathly afraid of,” Starnes said. “But this highly experimental cocktail? They’re willing to run in there the minute that they’re sick to get this infused into their bodies.”
Even those confounded by the emphasis on monoclonals over vaccination in some states say this new attention to the treatment has helped counter a basic public relations problem: Until recently, awareness of monoclonal treatments, often called mAbs, was low, leaving patients in danger of missing the 10-day window for treatment.
Utah, where fewer than half of residents are vaccinated, is among the states hosting an intensive, coordinated effort to reach people in time. Officials at the Intermountain Healthcare system, based in Utah, pulled together a team of volunteer medical professionals, dubbed “the mAb squad,” who scan lists of newly positive COVID patients and call those who meet eligibility criteria to connect them with the treatment.
Dr. Curt Andersen, a family medicine physician and an associate medical director with Intermountain Healthcare, said he’s seeing lists of 70 to 80 patients every day because of the delta surge. “I talked to this one gentleman who got treated. Then his wife got treated. Then his mother, who was at very high risk,” Andersen said. “On the phone, he broke down in tears because we had this resource and he was so grateful.”
Ruppert, the Gainesville preschool teacher, said she, too, was grateful. She and her husband both felt better within days of being treated at UF Health Shands Hospital. The experience has caused her to rethink how to protect herself and her family from COVID.
“Now that I’ve been there, I have a completely different perspective on this,” said Ruppert, who will be eligible for vaccination in mid-October, 90 days after the antibody infusion. “I most likely will be vaccinated.”
Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
Related Article 
Florida launches antibody treatment effort to help hospitals 
HHS releases calculator tool to improve COVID-19 monoclonal antibody treatment capacity
Source link : https://www.modernhealthcare.com/supply-chain/hot-spots-where-covid-vaccination-lags-push-experimental-antibody-treatment
