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Here’s how Florida distributes scarce COVID-19 therapy

There are many more patients who will need Evusheld than there is of the drug available.
A worker looks out the doorway of one of the buildings providing monoclonal antibody treatment at Camping World Stadium in Orlando, Tuesday, Aug. 17, 2021.
A worker looks out the doorway of one of the buildings providing monoclonal antibody treatment at Camping World Stadium in Orlando, Tuesday, Aug. 17, 2021.
Published Jan. 12

To manage a scarce COVID-19 therapy in sharp demand among people with weakened immune systems, Florida’s health department said on Tuesday that the state distributes the drug, called Evusheld, to medical providers who request supply — based on the population density of their service area and in a way that ensures the treatment is no more than a two-hour drive from any resident who needs it.

A spokesperson for the health department, responding to the Miami Herald’s reporting on Monday that Florida had delivered more Evusheld in December to a small Broward County clinic than the state sent to the region’s public hospitals, said the agency chose that provider based on a track record of quickly administering other COVID-19 therapies to patients.

“Realistically, the main goal behind this whole thing was to get it within two hours of everybody and to providers who can get treatments in arms as efficiently as possible,” said Jeremy Redfern, press secretary for the Florida Department of Health.

Redfern added that the state also uses COVID-19 case surveillance data and the Centers for Disease Control and Prevention’s Social Vulnerability Index — a ranking of a community’s social factors, such as poverty and lack of housing — when determining where to send Evusheld and how much.

In a written statement, Redfern said that the health department has not declined any provider’s requests for Evusheld, a monoclonal antibody cocktail that received emergency use authorization on Dec. 8, and that the arrival of the drugs depends on logistical factors, such as the amount ordered and the delivery location.

“By utilizing providers that have a proven track record of administering a high volume of monoclonals, the Department ensured readiness to deploy the first Evusheld tranche as it was delivered from the federal government,” Redfern said. “The goal is to expand access to this life-saving therapy, and in some cases private providers were ready and able to help as soon as the doses were available. Correlating shipment arrivals does not relate to prioritization.”

Related: Florida sent scarce COVID-19 therapy to a small private clinic before some big hospitals

Access vs. need

But though the state aims to ensure access to Evusheld through adequate geographic distribution — and by steering patients to providers with the drug via the health department’s online locator for monoclonal antibodies — medical professionals said they still question how the state is ensuring that the scarce therapy reaches those who need it most.

Kenneth Goodman, founder and director of the University of Miami Miller School of Medicine’s Institute for Bioethics and Health Policy, reviewed the health department’s email describing its distribution criteria for Evusheld and said the statement did not provide enough transparency.

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“It’s still legitimate to say, ‘Where are the doses, and where are you deciding to send them?’” Goodman said. “Ensuring access is a great phrase but it’s nugatory unless we know how many doses there are and the allocation plan for them.”

Goodman also questioned the state’s criteria for determining the “proven track record” of providers whom the health department prioritizes to receive the drug.

“How does the state assess that track record? Who in the state has that track record?” he added. “Who determined the track record was adequate to the task? Those should be uncontroversial questions.”

‘Hellish bureaucracy’

Florida’s priority for distributing the scarce drug came into question after the state delivered Evusheld to iCare Mobile Medicine, a medical concierge group that incorporated in March 2020 and advertises house calls and COVID-19 testing and therapies on its website, before the drug reached South Florida’s organ transplant centers and cancer institutes.

Nicholas Suite, the medical director for iCare, said in an email that the health department approached the medical concierge group about Evusheld, in part because of the private clinic’s track record but also because the practice was open and operating during the Christmas and New Year’s holidays.

“At iCare Mobile Medicine we’ve built a record of distributing COVID treatments including vaccines and monoclonal antibody treatments quickly and efficiently. When DOH called, we were ready to do our part to begin administering this treatment to the community to protect highly immunocompromised patients, especially given the Omicron surge,” Suite said in the email.

Suite, who is a board-certified neurologist, added that many of iCare’s patients meet the Food and Drug Administration’s criteria for eligibility to receive Evusheld, which requires a doctor’s prescription and is only authorized for individuals who have compromised immune systems due to a medical condition or a medication. The drug is also indicated for people who have a history of adverse reactions to ingredients in the vaccines.

“The patients we are helping are highly immunocompromised — such as transplant patients or people going through chemotherapy — who in many cases haven’t been able to live normal lives since the pandemic began, even after receiving the vaccine, because they aren’t able to build sufficient antibodies on their own,” Suite said. “We’re extremely proud to be able to help these patients access this life-saving treatment, which we administer at no cost to the patient.”

Redfern said that the health department has reached out to some hospitals that declined Evusheld while others have not responded to the agency’s queries and still more are in the process of acquiring internal approvals for a shipment. He said iCare received one of the state’s first shipments of Evusheld because of the clinic’s track record.

“When we’re dealing with a lot of these big hospitals, they have a lot more bureaucracy,” he said. “We start calling hospitals and they’re, ‘Hey we’ll take this.’ Then we have to go through paperwork to get them the medication and they have to go through their bureaucracy to get approval. When we call iCare, they’re small. … You don’t have the hellish bureaucracy of waiting for different approvals through different hospitals.”

Questioning why Jackson didn’t receive first drug batch

Michael G. Ison, a specialist in infectious disease and organ transplant surgery at Northwestern University’s Feinberg School of Medicine in Chicago, said hospital transplant centers and cancer institutes can leverage extensive patient relationships and data to determine who will benefit most from Evusheld.

The challenge, he said, is that there are many more patients who will need Evusheld than there is of the drug available. So even after the state allocates the drug, hospitals will have to do the same with their patient populations.

Ison reviewed Redfern’s email describing the state’s plan for distributing Evusheld.

“I think this is a fair plan but doesn’t answer the question,” Ison said in an email response. “Why no drug to the largest transplant center?”

Jackson Memorial Hospital, Miami-Dade’s public hospital system, runs the largest solid organ transplant center in the Southeastern United States and provides follow-up care to thousands of immunocompromised transplant patients and had not received a shipment of Evusheld as of Tuesday afternoon.

Because Evusheld is the only monoclonal antibody indicated as a pre-exposure protection against COVID-19, Ison noted that the pressure to get early treatment doesn’t exist — undercutting the department’s desire to prioritize access over need.

Transplant centers and cancer institutes, he said, could easily leverage the patient relationships they’ve established to get Evusheld to those who need it most.

“If you look at many of the transplant centers around the country, they’re very efficient at getting the patients in and dosed when they receive the drug,” Ison said. “So down the road, having this kind of broader access would make sense. But early on, at least having access to all the doctors that are providing the care for these types of patients seems to take priority over the access.”

The supply chain

The federal Department of Health and Human Services controls the supply of Evusheld and other COVID-19 therapeutics with FDA emergency use authorization, including other monoclonal antibodies and antiviral pills.

As of Tuesday, the federal government has allocated 225,432 courses of Evusheld — which is administered in two consecutive intramuscular injections — to all states and territories. Florida has an allocation of 10,992 through Jan. 16, according to the federal government’s distribution data.

But not all of those Evusheld courses are ordered and ready to be delivered to Florida providers, Redfern said. That’s just the maximum amount that Florida can order from the government, and before the state submits its order to HHS, he added, the health department first must contact all of the state’s providers, gauge their need and confirm their interest in receiving an order.

“Once they agree to take it, we have to order it from HHS, then they send it to us and we send it to the providers,” Redfern said.

According to the federal Department of Health and Human Services’ online locator for COVID-19 therapeutics, Florida’s first shipments of Evusheld skipped all South Florida hospitals, though medical centers in Ocala, Tampa and Gainesville also were among the first to receive the drug.

No hospitals in Miami-Dade and Broward counties, which have recorded the state’s highest number of new COVID cases per capita during the omicron surge, received a shipment of Evusheld in December.

Jackson Memorial Hospital is allocated 840 courses of Evusheld, according to the federal data. But a Jackson Memorial spokesperson said Tuesday that the hospital had not yet received the shipment.

In Broward, the only provider listed on the HHS online locator as having Evusheld is iCare, even though the county’s two public hospital systems — Broward Health and Memorial Healthcare System — both have organ transplant centers and cancer institutes.

Patients in need

In the email to the Herald explaining the state’s distribution plan for Evusheld, Redfern included a testimonial and a photograph of a Broward County resident who has cancer and said the health department helped her find the drug after vaccination did not produce a sufficient immune response.

Diane Barron, who did not accept the Herald’s interview request, explained how Evusheld has helped her regain her life after three years of missing family social gatherings and avoiding public places. She did not describe her cancer.

“I now have hope that I hadn’t had for the last three years since my cancer diagnosis,” Barron said in the statement. “I have the opportunity to re-enter the world without fear that anyone, vaccinated or not, could put me at risk of serious illness or death. The Broward County Department of Health has been a conduit of information and made a real difference in my life.”

The health department did not say where Barron received Evusheld, but iCare is the only Broward provider that has received a shipment.

For other Florida residents seeking Evusheld, the search continues in frustration.

Jean Winters, a Palm Beach County resident, said she has been searching for a provider who can administer Evusheld to a family member who has chronic lymphocytic leukemia and takes targeted therapy for the cancer as well as immunosuppressant drugs for an autoimmune illness.

Winters said she asked her loved one’s oncologist, her internist and the state health department, none of whom could provide her with information about how to get Evusheld for her loved one, she said.

“How in the hell are we citizens supposed to find out what providers have this,” Winters said in an email. “How would we have known whom to contact? I’ve never heard of iCare Mobile before, and would not assume that this company would have it.”

• • •

How to get tested

Tampa Bay: The Times can help you find the free, public COVID-19 testing sites in Citrus, Hernando, Hillsborough, Manatee, Pasco, Pinellas, Polk and Sarasota counties.

Florida: The Department of Health has a website that lists testing sites in the state. Some information may be out of date.

The U.S.: The Department of Health and Human Services has a website that can help you find a testing site.

• • •

How to get vaccinated

The COVID-19 vaccine for ages 5 and up and booster shots for eligible recipients are being administered at doctors’ offices, clinics, pharmacies, grocery stores and public vaccination sites. Many allow appointments to be booked online. Here’s how to find a site near you:

Find a site: Visit vaccines.gov to find vaccination sites in your ZIP code.

More help: Call the National COVID-19 Vaccination Assistance Hotline.

Phone: 800-232-0233. Help is available in English, Spanish and other languages.

TTY: 888-720-7489

Disability Information and Access Line: Call 888-677-1199 or email DIAL@n4a.org.

• • •

More coronavirus coverage

KIDS AND VACCINES: Got questions about vaccinating your kid? Here are some answers.

BOOSTER SHOTS: Confused about which COVID booster to get? This guide will help.

BOOSTER QUESTIONS: Are there side effects? Why do I need it? Here’s the answers to your questions.

PROTECTING SENIORS: Here’s how seniors can stay safe from the virus.

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