Jennifer Padgett has spent 2 1/2 years terrified for her immunocompromised daughter, Hannah. Hannah catches pneumonia like mosquito bites; what could Covid wreak? Their whole family locked down in the early days, rushed to get vaccines when they became available and kept masking and avoiding indoor dining in their small southern town even after the Centers for Disease Control and Prevention loosened restrictions.
So Padgett was shocked last month when, during a Google search on new variants, she learned there was a drug available to protect patients like her daughter, a 23-year-old childhood cancer survivor whose immune system can’t make enough antibodies. Even more startling: It had been available since December. How had she never heard of it?
Her confusion only grew when she set up a doctor’s appointment with Hannah to request it. The doctor initially thought she was asking about Paxlovid, a pill for treating Covid, and then a different therapy. Finally, the physician pulled out her laptop, googled it, and realized that she had been in the dark.
“I’ve never heard of this,” she said, staring at a webpage.
Padgett and her doctor weren’t the only ones in the dark. For many immunocompromised patients, Evusheld was supposed to offer salvation, a way of protecting people who couldn’t respond to vaccines because their T cells and B cells were impaired — perhaps by cancer, a genetic condition, or drugs taken for organ transplants. Many saw it as their path back to a pre-Covid life, or at least to seeing family and friends again after a two-year hermitage.
Yet eight months after the Food and Drug Administration first authorized the treatment, only a tiny fraction of the roughly 7 million patients who might be eligible have received it. Hundreds of thousands of doses sit on shelves in hospitals and infusion centers across the country, even as a new coronavirus variant rips through the population.
“I think it’s clear throughout the pandemic that lip service has been paid for protecting immunocompromised Americans, but actual policy delivery has failed time and time again,” said Matthew Cortland, a senior fellow at Data for Progress who has been tracking Evusheld distribution.
Transplant and cancer patients who have heard of the therapy sometimes see doctors who don’t know what it is and won’t prescribe it. Doctors who treat transplant and cancer patients say they see patients who don’t know it’s an option.
“It’s been really disappointing that we’ve had such a limited rollout,” said Camille Kotton, an infectious disease specialist at Mass General.
The rollout can have life or death stakes. Although vaccines and prior infections have reduced the risk for most Americans, the picture is more muddled for people with weakened immune systems. A CDC analysis of 10 states published this month found that immunocompromised people accounted for 12.2% of all Covid-related hospitalizations, despite being only 3% of the U.S. population.
Vaccination still significantly lowers their odds of being hospitalized with Covid, but, unlike with the immunocompetent, it didn’t significantly lower their odds of dying once there. (The CDC, however, did not track whether immunocompromised patients had received the full 3 to 5 doses they are eligible for, and experts stress that everyone should get vaccinated, even if they are likely to get less protection than others.)
Evusheld — along with more widespread use of boosters — could provide supplemental protection. It consists of two antibodies that are injected into a patient and stay in the blood for about six months, smothering the virus in the event of exposure or infection.
The Federal government is aware the tool is being underused. On a recent call with providers and patient advocacy groups, Health and Human Services therapeutics director Meghan Pennini acknowledged that only around 165,000 people had received the drug, according to a transcript obtained by STAT.
“There are many more out there who could use the medication,” she said.
Plans to solve the shortfall, though, have been slow to materialize. When President Biden announced new measures to combat BA.5, a variant that may now be infecting nearly a million Americans each day, he said they would include plans to make “Evusheld more widely available through enhanced distribution to clinicians’ offices and clinics” and “in the coming weeks” set up a hotline to help people access the medication.
Infectious disease physicians said they welcomed the moves but await actual details.
Reached for comment, an HHS spokesperson said the new efforts included “targeted social media content, decision aids and other resources for providers, direct engagement with immunocompromised advocacy groups, webinars for clinicians and advocacy groups with the U.S. Surgeon General” and “planned outreach” to information officers at local health departments.
The current landscape offers an eerie, funhouse mirror reflection of the chaos that unfolded over the winter, when the drug was first authorized. A small minority of immunocompromised patients had followed its development for months and scrambled to find doses, while many major medical centers, anticipating a shortage, reserved precious vials for the most vulnerable of the most vulnerable: People less than 6 months out of lung or bone marrow transplant, for example, or cancer patients on therapies that decimated their B cells.
The government didn’t institute a national system, though, and some small practices and concierge clinics received numerous doses that they doled out far more leniently. A nationwide, “Hunger Games”-like scramble ensued.
Now, a strange apothecarial silence has settled. In theory, doses are abundantly available. According to HHS, 400,000 two-shot packages — one dose is two shots, and two doses make up a course — have been distributed to local medical centers but not yet administered to patients, and the government has contracted with AstraZeneca, the drug’s developer, for nearly a million more. Some major centers have relaxed their criteria, allowing anyone with any immunosuppressive condition or on immunosuppressive drugs to receive it. Yet the number of patients with Evusheld antibodies in their blood has barely budged.
“Why are there so many doses sitting on shelves?” said Priya Nori, an infectious disease physician at Albert Einstein School of Medicine.
Kee Conti, director of an infusion center in East Oakland, said she sees only five or six Evusheld patients per week, even though basic epidemiological math shows her community has thousands of eligible patients. Ryan Roux, director of pharmacy at MD Anderson Medical Center in Houston, said the hospital had started receiving shipments from community hospitals that can’t give out the doses they have. CDR Health in Tallahassee has received 2,600 doses for use in Florida’s long-term care facilities; CEO Tina Vidal-Duart said they’ve given out only 252, despite email, text and call campaigns.
“For at least the last 4 weeks, I have declined shipments because we don’t have any place to store it,” Conti said, adding that she has about 80 doses in the fridge. “I should be utilizing every dose that we have and begging for more, but that is not what happens.”
The list of potential culprits is long. Conti blamed reimbursement in part: Medicare pays only $150.50 nationally and slightly more in places with higher costs of living. For some centers, she said, that’s not enough to justify the 90 minutes it takes to inject a patient and monitor for side effects.
Until recently, the government had not invested in national education efforts. But AstraZeneca, the drug’s developer, is also limited in how widely it can market a drug under emergency use authorization, leaving a promotional vacuum, especially among primary care doctors.
A rheumatoid arthritis patient in Louisville, Ky., who requested anonymity for fear she could be dropped by the doctor, shared screenshots of her request, via MyChart, for a prescription. In February, the doctor said she was unfamiliar with the drug but that fortunately there were new treatment options if she got sick. In March, she said she was hesitant to prescribe a drug she knew so little about. Declining altogether, the doctor assured her that the virus was becoming less severe.
“Thankfully, we do see that each variant becomes less deadly and more contagious which is what we saw with prior pandemics,” the doctor said, pointing to, among other viruses, SARS and MERS, neither of which became less deadly after their emergence.
In part because of built-up immunity, Covid infections are indeed on average less risky, but “the risk is still substantially higher than for a non-immunocompromised person,” said Deepali Kumar, an infectious disease doctor who sees transplant patients at the University of Toronto. “Prevention is always better than treatment.”
Evusheld’s own turbulent history has also contributed to the slow uptake. Some physicians may be under the mistaken belief that Evusheld isn’t effective because it had reduced potency against the first Omicron variant.
The FDA doubled the recommended dose to compensate, though, and the drug actually performs better against new variants, including BA.5, even if it’s still not as effective as it was against the original virus.
“The virus has sort of swung back toward Evusheld,” said James Crowe, the Vanderbilt immunologist who first isolated the antibodies back in 2020.
Other physicians are still operating as if doses are scarce, Cortland said, and only giving it out to the highest-risk groups..
Some patients have found the drug as difficult to get as it was last winter. Karen Medved, whose husband, Thomas, has leukemia, told STAT that their doctor in Western Pennsylvania had never heard of it when they asked. They eventually got a prescription but couldn’t get an appointment for another three weeks.
Hannah Padgett’s doctor was happy to write a prescription and help find a place to fill it, but her mother quickly ran into a wall. She reached out to five different medical centers near their home in the South who either didn’t respond to her, told her they had doses but no system for distributing them, or, in one case, said they only distributed it to their patients.
“I was going to reach out to her oncology team in Ohio that she used to see,” she said. “I was willing to drive up there.”
The result is that access to Evusheld has remained deeply unequal: Primarily patients who are highly educated and most active in their care have been able to get the drug. Others have largely not.
Conti said state officials have allocated her doses in part because her clinic is in a largely Black, Hispanic and low-income Asian neighborhood particularly hard-hit by Covid. But in fact, mostly white and wealthier individuals have traveled to receive infusions. She said she has brought up the concerns to local public officials, to no avail.
“We talk about this disparity,” she said. “But there’s no plan to change it.”
A spokesperson for AstraZeneca said it did not track demographic data, referring questions to HHS, which did not respond.
Evusheld lasts only around 6 months, and possibly less against the new variants. The first group of patients who received it are now coming back in for their new shots. This raises new questions of equity — how many people will actually get the refill? — but also offers an opportunity to reach out to old and new recipients alike, Kotton said.
Those efforts will include a direct-to-consumer ad campaign that AstraZeneca launched last month — the first such campaign for any Covid therapy — after working closely with the FDA to stay within the bounds of their emergency authorization.
“It is the right thing for the company to do to build awareness and education given what we know regarding utilization, lack of awareness, and lack of activation,” a spokesperson said.
Padgett is hopeful access will soon become easier, but she thinks they finally have an end to their own endeavor. After STAT reached out for comment, one medical center agreed to give Hannah the drug, saying there was simply a mixup. She is filing paperwork and hopes to have an appointment this week.
“For the next patient it’ll be better,” Padgett said. “But still, it shouldn’t be this hard for anyone.”