MIAMI — A scarce monoclonal antibody for people who cannot build immunity from COVID-19 vaccines will be prioritized for distribution to Florida hospitals with large numbers of organ transplant and cancer patients, the Florida Department of Health said on Tuesday, signaling a change in strategy more than three weeks after the state passed over large medical centers and delivered the first shipment of the drug to a small clinic in Broward County.
Florida’s health department said that as of Jan. 14 “every registered provider that requested Evusheld received an allocation” and that the agency had identified 11 hospitals in the state with transplant and cancer patients and prioritized them to receive the drug, called Evusheld, which is manufactured by AstraZeneca.
“Evusheld is an important tool for providers to help protect these very high-risk patients,” Weesam Khoury, a health department spokeswoman, said in an email. “To efficiently distribute this vital therapy, the Department prioritizes and ensures that transplant and oncology centers receive allocations of AstraZeneca for their patients.”
The health department did not name the hospitals. Khoury added that the health department was working with transplant and oncology centers to inform medical providers about the benefits and availability of Evusheld, collect data on patient services and “streamline a direct allocation model” for hospitals with high-risk patients to register their facilities and order the drug through the state.
Prior to establishing online registration and ordering, the health department said it was calling hospitals and other providers to gauge their interest in and ability to provide Evusheld.
Jackson Memorial Hospital, which houses the Miami Transplant Institute, the busiest organ transplant center in the Southeastern United States, received its first shipment — 840 courses of Evusheld — on Thursday, a spokeswoman confirmed.
But other South Florida medical centers, representing thousands of patients who would likely benefit from the scarce drug, were still awaiting shipment on Friday, according to distribution data from the federal Department of Health and Human Services.
The University of Miami Health System’s Sylvester Comprehensive Cancer Center, the only National Cancer Institute-designed facility in South Florida, has yet to receive its allotment of 648 doses, HHS data shows.
UHealth would not confirm whether Sylvester has received Evusheld, and a Jackson Memorial spokeswoman declined the Herald’s interview request about the hospital’s need for Evusheld and how it would prioritize the drug for patients
Broward County’s public hospital networks, Memorial Healthcare System and Broward Health, are not listed on the HHS data as institutions that will receive Evusheld though both medical centers provide organ transplant and cancer care.
A Memorial Healthcare spokeswoman, Yanet Obarrio Sanchez, said the public hospital for South Broward “has requested to be added to the list, and it is our understanding that two of our hospitals will be added to the list shortly.”
Jennifer Smith, a spokeswoman for Broward Health, the public hospital for North Broward, said, “We have been working with the state to be added to the Evusheld allocation list.”
Evusheld, a monoclonal antibody authorized for emergency use by the Food and Drug Administration on Dec. 8, can reduce the risk of severe illness and death from COVID-19 in immuno-compromised persons. The federal government has purchased all 700,000 doses of Evusheld manufactured by AstraZeneca and last week the United States ordered an additional 500,000 courses of the drug.
Florida’s health department has sole discretion for determining where in the state to send Evusheld and how much. An agency spokesman said last week that the department’s distribution strategy prioritized access to the drug, with treatment available within a two-hour drive of any resident.
The first medical provider in Florida to receive Evusheld was iCare Mobile Medicine, a concierge medical service in Cooper City incorporated in March 2020 and that advertises house calls and COVID-19 tests, vaccines and therapies on its website. The clinic also has a site in Miami-Dade, near Miami International Airport.
A health department spokesperson said the agency shipped the drug first to iCare because of the clinic’s “proven track record” of quickly receiving and administering other COVID-19 therapeutics to patients.
The medical director of iCare, Dr. Nicholas Suite, a neurologist who also teaches pre-med at American Heritage Schools, a private school with campuses in Broward and Palm Beach counties, said he prioritizes patients for Evusheld based on their medical condition and eligibility for the drug.
Evusheld requires a doctor’s prescription and is indicated for people with weakened immune systems or allergic reactions to the vaccines. Unlike other monoclonal antibodies, Evusheld is administered prior to exposure to the virus that causes COVID-19 and not after exposure or infection.
“We at iCare have been treating cancer patients, organ transplant patients, and those in immunosuppressive therapy — all which would be in extreme risk from COVID,” Suite said in a text message. “Some of the patients have been referred specifically by infectious disease doctors, oncologists and transplant centers who wished to selflessly give their immunocompromised patients the best opportunity to survive this global pandemic.”
Suite said patients found iCare using the state health department’s website listing providers of monoclonal antibody treatments, including Evusheld. However, the state website did not list iCare as an Evusheld provider on Tuesday.
While South Florida’s largest hospitals waited for a shipment of Evusheld, Suite said iCare filled the needs of patients. He suggested that hospitals had not been responsive to the state’s queries about the drug.
“The ethical considerations should properly focus on encouraging those excellent institutions who control large numbers of these immunocompromised patients to be more immediately responsive and accommodating to both the FDOH [Florida Department of Health] and all of their patients regarding this important treatment for COVID-19,” he said in a text message.
Florida has not released a list of providers who requested and received Evusheld from the state, but there is clearly more demand for the drug than there is supply.
Experts say that eventually there will be enough Evusheld for everyone who needs it, but that until then the scarce drug should be allocated to those eligible patients who are at greatest risk of severe illness and death from COVID-19.
The National Institutes of Health’s COVID-19 Treatment Guidelines Panel recommends that providers prioritize certain immunocompromised patients for Evusheld when there’s a shortage, including all lung transplant recipients, patients within one year of receiving any organ transplant and those taking certain immunosuppresant drugs or with untreated HIV.
At some Florida hospitals, administrators have already begun to prioritize which of their patients will receive the drug first.
Dr. Mark Parkulo, a specialist in internal medicine at the Mayo Clinic in Jacksonville, said the hospital received 120 doses of Evusheld as of Jan. 12 and was scheduled to receive an additional 700 courses.
“We’re happy that the state is giving us the supply,” Parkulo said. “We’re in a position to deliver the drug.”
Parkulo said Mayo Clinic will ration Evusheld much in the same way that institutions managed the COVID-19 vaccines when they were first approved in December 2020.
“It’s clear that, especially early on, there’s going to be more patients who qualify for the medication than actually we have doses to give,” he said. “My guess is that will still be the case for several weeks and maybe months.”
The Mayo Clinic, which provides organ transplants and cancer care, used its electronic medical records to identify those patients most likely to need Evusheld and then divided them into tiers, with those most likely to need the drug listed at the top.
“We searched certain pieces of information: transplant status, medication status, those kinds of things that would qualify them for the medication,” he said.
In the top category were patients with lung and bone marrow transplants, and those undergoing active chemotherapy for cancer.
“We’ve identified here at Mayo Clinic ,2,000 of those Category 1 patients,” Parkulo said. ”Those aren’t necessarily all the patients who qualify but those are the highest-risk patients. There are probably even more than that.”
Parkulo said Evusheld is administered in two consecutive injections into a muscle, which takes five minutes, and that the patient must be monitored for at least one hour afterward for a potential adverse reaction.
Because Evusheld is given prior to infection, patients who qualify for the drug must be isolated from any area of the hospital where COVID-positive patients are housed. That means Evusheld cannot be given in the same area the hospital uses to provide other monoclonal antibody treatments, which are administered after exposure or infection.
Administering monoclonal antibodies also requires nurses and other health care workers, Parkulo said, noting that many hospitals are struggling with “logistical issues” created by workplace absences due to the latest surge in COVID-19 infections fueled by the highly contagious omicron variant.
Mayo Clinic chose to use its COVID-19 vaccine center to deliver Evusheld. But finding space and staff to administer the drug is possibly the least of a hospital’s challenges.
With Evusheld and other COVID-19 therapeutics authorized for emergency use, physicians have many more tools now to fight the pandemic. But the complexity of the virus and knowing which treatments work against what variants and the best times to apply them makes a doctor’s job more complex, Parkulo said.
“The question really is going to come up: What scheme are you using to treat patients who are infected? Do they get monoclonal antibodies? Do they get Paxlovid (antiviral pill)?” he said. “The complexity keeps going up in trying to manage all the different treatments and modalities that are coming out.”
Most physicians know that one monoclonal antibody, called Sotrovimab, is shown to neutralize the omicron variant while two others are not as effective against the mutated virus. With Evusheld, some doctors have reported breakthrough COVID-19 infections in their patients, though it’s not clear how those cases occurred.
Dr. Michael G. Ison, a specialist in infectious disease and organ transplant surgery at Northwestern University’s Feinberg School of Medicine in Chicago, posted a comment to the social media website, Twitter, on Monday stating that the hospital had its first COVID-19 breakthrough in a patient taking Evusheld.
But Ison, one of the first to question Florida’s distribution of Evusheld after his patients had traveled to South Florida to receive treatments from the Broward clinic because Northwestern had not yet received its shipment, said more research is needed to understand what happened in breakthrough cases.
“It is too early to understand the efficacy of Evusheld,” he said in an email. “There have been a few reports of breakthrough infections but (we) will need longer follow-up and more data collected to understand the efficacy of the therapy in the setting of omicron.”
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