Florida sent Evusheld to a private clinic before hospitals

Florida shipped a scarce new COVID-19 monoclonal antibody drug to treat the most vulnerable of patients — those with cancer or organ transplants whose immune systems don’t respond well to a vaccine — to a private clinic in Broward County before sending the therapeutic to Miami’s Jackson Memorial Hospital, which runs the largest solid organ transplant center in the Southeastern United States and provides follow-up care to thousands of immuno-compromised patients.

In December, Florida’s health department shipped 264 doses of a drug called Evusheld to a limited liability company that was incorporated in March 2020 and advertises house calls and COVID-19 testing, vaccination and therapy on its website. But the state did not send a shipment to Jackson Memorial until January, when the hospital received a total of 192 doses, according to federal data.

The private clinic, iCare Mobile Medicine, received more Evusheld in the state’s first shipment than any other hospital or medical provider in Florida.

Dr. Nicholas Suite, a neurologist and medical director of iCare Mobile Medicine, did not respond to phone calls and an email from the Herald requesting an interview on Monday. But Suite told STAT News, which first reported on iCare’s shipment of Evusheld, that the therapeutics arrived at his office on Dec. 24, and that since announcing its availability the phone has not stopped ringing with requests.

Florida refuses to explain its COVID drug distribution plan

Florida’s health department has refused the Herald’s requests to explain the state’s prioritization plan for distributing Evusheld and other COVID-19 therapeutics received from the federal government.

Monoclonal antibodies are used to treat mild or moderate COVID-19 within 10 days of the person’s first symptom, to prevent severe illness, hospitalization and death.  Miami

South Florida hospitals have more patients in need of monoclonal antibodies to treat COVID-19 than they have supplies of the scarce drugs, forcing some medical centers to prioritize one of the most vulnerable groups for treatment — individuals whose immune system does not respond well to a vaccine.

For these patients, Evusheld can provide up to six months of protection against COVID-19, according to the Food and Drug Administration, which authorized the treatment for emergency use on Dec. 8.

But Evusheld is scarce, and the supply is controlled by the federal government, which has shipped more than 6,300 doses to Florida, whose health department decides where to send the therapeutic and how many of the requested doses each medical provider will receive.

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. Miami-Dade and Broward counties have recorded the state’s highest number of new COVID cases, per capita, during the omicron surge.

No South Florida hospital other than Jackson received shipment by Jan. 6

No South Florida hospital other than Jackson Memorial has received a shipment of Evusheld as of Jan. 6, the federal data shows. However, the federal government has yet to report where Florida has distributed more than 4,700 doses of Evusheld shipped to the state since Dec. 27.

Jackson Health System, Miami-Dade’s public hospital network, which runs the Miami Transplant Institute in partnership with the University of Miami Health System, declined an interview request from the Herald regarding Evusheld and the significance of the new therapeutic for its patients.

The Miami Transplant Institute is one of the busiest solid organ transplant hospitals in the nation, performing more than 400 transplants during the year that ended June 30, 2021, according to federal data.

Doctors at the center also provide follow-up care for many more organ transplant recipients — more than 2,660 in 2020-2021 — all of whom are prescribed immunosuppressant drugs to prevent their bodies from rejecting the donor organ. Many patients who take immunosuppressant drugs do not build adequate immunity to the coronavirus after vaccination.

Chicago doctor has patients who were treated at Broward clinic

Dr. Michael G. Ison, a specialist in infectious disease and organ transplant surgery at Northwestern University’s Feinberg School of Medicine in Chicago, said transplant centers are ideally suited to distribute Evusheld, a drug for which there are many more patients who would benefit than there is of the medication itself.

“It’s the providers that are caring for those patients that can help better understand which of those patients probably should be prioritized above others for getting the drug,” Ison said.

“In fact, most transplant centers and expert groups have recommended a tiered structure where certain higher risk individuals get access to the drug first,” he said, “and that is best accomplished through the centers that are caring for these patients because, A) they’ve given them the drugs that put them in the situation they’re in needing this therapy, and B) they have the best set of data to understand which patients will receive the best benefit and therefore should be prioritized.”

Ison said he worried that patients who truly need Evusheld may not be able to access the drug if it’s put in the hands of a small medical practice that doesn’t have access to a broad range of patients with immunocompromised conditions.

“They will allow it to be given to anyone including people that may not be residents of the state, thereby kind of offering the drug to patients that are lower risk before those that are higher risk have a chance to get them,” he said.

Evusheld, manufactured by AstraZeneca Pharmaceuticals, is administered as two separate and consecutive intramuscular injections. It is free to patients, though providers may bill a patient’s health insurance for administering the drug.

STAT News reported that Suite said he follows the FDA and the manufacturer’s criteria for administering Evusheld and that he does not provide the drug to permanent residents of other states.

But Ison said he learned about iCare providing Evusheld from his patients in Chicago who traveled to South Florida to receive the drug from the private clinic. Northwestern Memorial Hospital in Chicago will get its first doses this week, he said.

“The real question is in the state of Florida how did that site get the drug but the largest transplant center didn’t? Clearly someone made a decision,” Ison said.

Florida Gov. Ron DeSantis speaks during a press conference in Fort Lauderdale on Jan. 3, 2022, urging the federal government to send between 30,000 and 40,000 more doses of monoclonal antibody treatments to Florida. One of those treatments, used for cancer and transplant patients, was shipped by Florida health officials to a small clinic in Broward over Jackson Memorial Hospital, which operates the largest solid organ transplant center in the Southeastern United States. Jose A Iglesias [email protected]

Broward Health has not received COVID treatment

At Broward Health, the public hospital system for North Broward, doctors have not received a shipment of Evusheld although the hospital could use the drug for patients who receive liver and kidney transplants.

Dr. Joshua Lenchus, Broward Health’s chief medical officer, said physicians have started to prioritize certain high risk patients with underlying medical conditions and who test positive for COVID-19 for monoclonal antibody treatments.

But the hospital has only received Regeneron’s monoclonal antibodies, a product called REGEN-COV, Lenchus said, and not Evusheld or another monoclonal antibody that is known to be most effective against the omicron variant, a drug called sotrovimab.

Lenchus said REGEN-COV is indicated for people who may have been exposed to someone who is infectious, and who are at high risk of developing severe disease due to an underlying medical condition. But the hospital stopped using the Regeneron product for post exposure cases in order to preserve the drug for those who have been diagnosed with COVID-19.

“What we’ve really been doing, because the supply is pretty scarce, is we’ve really been earmarking those other monoclonal antibodies, REGEN-COV and sotrovimab, if we get it, for those people who actually test positive.”

In the same way that hospitals must allocate scarce medical treatments, Florida’s health department is responsible for developing and communicating an equitable system for distributing a potentially life-saving drug during a pandemic, said Kenneth Goodman, who founded and directs the University of Miami Miller School of Medicine’s Institute for Bioethics and Health Policy.

‘Lack of transparency’ in Florida’s COVID decisions, Miami doctor says

“All of this potentially useful therapeutics and an environment of scarcity is occurring under a complete lack of transparency,” said Goodman, who also is director of the Florida Bioethics Network, which has published guidelines for managing shortages of COVID-19 therapeutics in hospitals.

“Any decision about how to allocate a scarce resource is one that we’ve been working on for more than two years now, as have the ethics communities in 49 other states,” Goodman said. “In some states they actually listen. In some states, including Florida, they don’t.”

Goodman said there are different ways to figure out a fair distribution system for a scarce resource, but that the guidelines are pretty straightforward. He emphasized that transparency is key.

“Overall,” he said, “it’s reasonable to say how much have you got, where are you sending it and why, and how did you decide.“

This story was originally published January 10, 2022 7:18 PM.

Daniel Chang covers health care for the Miami Herald, where he works to untangle the often irrational world of health insurance, hospitals and health policy for readers.