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In mid-November, Kevin Billingsley, MD, MBA, chief medical officer at Yale Cancer Center in New Haven, Connecticut, was keeping a close eye on the new COVID variant sweeping across South Africa. Six weeks later, the Omicron variant had become the dominant strain in the US — and the Yale health system was no exception.
"As we entered January, we had a breathtaking rate of infection in our hospital," said Billingsley, who also leads clinical care at the Smilow Cancer Hospital. "Some of the newly authorized COVID agents were available, but not widely enough to make a clinically meaningful impact to protect all high-risk individuals during this surge."
That left the team at Yale with difficult decisions about who would receive these treatments and who wouldn't.
The health system convened a COVID-19 immunocompromised working group to identify which patients should get priority access to one of the promising drugs authorized to treat the infection — the monoclonal antibody sotrovimab and antiviral pills Paxlovid and molnupiravir — or the sole available option to prevent it, Evusheld.
"Although clinically sound, none of these decisions have been easy," Billingsley told Medscape Medical News. "We have done a lot of case-by-case reviewing and a lot of handwringing. Omicron has been a wild ride for us all, and we have been doing the best we can with limited resources."
'We're Seeing Incredible Variability'
The team at Yale is not alone. The restricted supply of COVID-19 treatments has led many oncologists and other experts across the US to create carefully curated lists of their most vulnerable patients.
In late December, the National Institutes of Health (NIH) published broad criteria to help clinicians prioritize patients most likely to benefit from these therapies. A handful of state health departments, including those in Michigan and Minnesota, established their own standards. Patients with cancer — specifically those with hematologic malignancies and receiving oncology therapies that compromise the immune system — appeared at the top of everyone's list.
But ultimately individual decisions about who receives these drugs and how they're allocated fell to institutions.
"Overall, what we're seeing is incredible variability across the country because there's no uniform agreement on what comprises best practices on allocating scarce resources," said Matthew Wynia, MD, MPH, professor of medicine and director of the Center for Bioethics and Humanities at the University of Colorado in Aurora. "There are so many people at the top of most lists, and the drugs are in such short supply, that there's no guarantee even those in the top tier will get it."
Medscape Medical News spoke to experts across the country about their experiences accessing these treatments during the Omicron surge and their strategies prioritizing patients with cancer.
Dealing With Limited Supply
Overall, the limited supply of COVID-19 drugs means not every patient who's eligible to receive a treatment will get one.
A snapshot of the past 2 weeks, for instance, shows that the count of new infections hit almost 4.3 million, while distribution of the two antiviral pills Paxlovid and molnupiravir and the monoclonal antibody sotrovimab reached just over 600,000 courses.
Since receiving emergency use authorization in early December, almost 500,000 courses of the pre-exposure prophylactic agent Evusheld — which offers about 6 months of protection for immunocompromised individuals — have been distributed; however, about 7 million adults in the US could potentially benefit from it.
In addition, the distribution of drugs is uneven. The federal government manages the overall distribution to states, but states then decide how to divvy up these allocations to hospitals, pharmacies, and medical centers. In Ohio, for instance, the antivirals go to providers who already receive monoclonal antibodies, while in Tennessee, the supply of antiviral agents only goes to Walmart pharmacies.
This strategy, Wynia explained, can leave clinicians at the mercy of where and how much states decide to allocate to each location. "I've heard of some hospitals and health systems in Colorado that aren't using all they've got, but most don't have nearly enough," Wynia said. However, he noted, "some of that is inevitable. We will never get a perfect distribution of these drugs when there is such variable need and demand."
And, according to Nicolette Louissaint, PhD, MBA, senior vice president of policy and strategic planning at the Healthcare Distribution Alliance in Arlington, Virginia, "we can take some comfort that the federal government is actively looking at cases from week to week and working with state and local health departments to see who needs these products, which means the process is constantly being reviewed and adjusted."
Plus, not every positive COVID-19 case, even among immunocompromised individuals, necessarily warrants treatment. "If, for instance, an individual with cancer has a mild case of COVID-19, their provider may not deem it necessary for them to receive treatment," Louissaint noted.
Still, given the limited and unpredictable supply, "we have had to be thoughtful about who gets these drugs," said Derek Raghavan, MD, PhD, president of the Levine Cancer Institute, part of the 40-hospital Atrium Health system in Charlotte, North Carolina.
Raghavan said the highest priority goes to patients with hematologic malignancies, those receiving or coming off chemotherapy or experiencing myelosuppression and immune paresis, as well as those who have undergone organ transplants. Age and other comorbidities, such as diabetes or obesity, play into the lineup as well.
To further hone their priority list, the Levine Cancer Institute has implemented a cancer-centered Hospital at Home initiative. The program includes 40 oncology nurse navigators who routinely screen and score all cancer patients who test positive for COVID-19 by their symptoms and risk factors. For a time-sensitive treatment like Paxlovid, this close monitoring allows patients with COVID to access the pills within 5 days of symptom onset.
Ultimately, "the decision regarding who gets these drugs is [made] by a team to overcome any risk of personal bias, and some of it just comes down to the interface between clinical judgment and available data," Raghavan told Medscape Medical News. "Although we'd like to have more COVID drugs available and fewer patients with COVID, we have been able to get adequate supplies for our most at-risk patients."
Like Raghavan, Karen Bloch, MD, MPH, the medical director for the COVID Infusion Clinic at Vanderbilt University Medical Center (VUMC), said the clinic has had to be highly selective about which patients would benefit most from the COVID monoclonal antibodies. For patients with cancer, her team prioritizes individuals who would be least able to develop antibodies through vaccination or natural infection — which includes patients with B cell malignancies, acute myeloid leukemia, or multiple myeloma receiving active treatment, as well as those who recently received an allogeneic or autologous stem cell transplant.
"Since our criteria for treatment with therapies such as sotrovimab and Evusheld are pretty stringent, we have had sufficient supply to treat those who meet our internal 'category 1' predetermined criteria," said Bloch, professor of medicine and associate division director for clinical affairs at VUMC in Nashville. "More recently, as the supply chain has begun to open up, we've been able to loosen our criteria for sotrovimab, though not for Evusheld yet."
The Yale team described a similar evolution. "Initially, only a small subset of oncology patients could get these drugs," said Osama (Sam) Abdelghany, PharmD, MHA, associate director of Oncology Pharmacy Services at Smilow Cancer Hospital. But as the caseload has diminished, Abdelghany noted, "we have been able to reach many more patients with COVID-19."
An Equitable System?
Wynia, who has written many reports on crisis standards of care, has spent thousands of hours delving into the ethics of allocating scarce resources during a disaster.
A core problem arises when there are too many people who need a scarce resource and no way of differentiating among them.
In response to the limited supply of COVID-19 treatments, some institutions, such as the University of Pittsburgh Medical Center and Massachusetts General Hospital, have created a lottery system. Others, such as Johns Hopkins Medicine, have opted for first come, first served. Each strategy comes with caveats.
"First come, first served prioritization may be quicker, but it gives more well-resourced people an advantage, and lends itself to people abusing the system or exacerbating existing disparities," Wynia said.
While a lottery system may be more equitable, this strategy often comes at the price of efficiency. "The practicality of doing a lottery when you have to make a decision about whether or not to treat the patient sitting in front of you comes with its own challenges," Wynia said.
At the University of Colorado, he explained, the health center constantly scans medical records for patients who have been diagnosed with COVID and fall into a high-risk group. That way clinicians can call or email those most likely to benefit from these drugs.
"It ends up being a bit of a first come, first served strategy," Wynia said. "But we also do not have a huge supply coming in each week so reaching out to the most eligible people when we have the drugs in hand means more privileged patients are less likely to game the system."
To manage the supply of Evusheld, Timothy Kubal, MD, MBA, and colleagues also reach out to patients most likely to benefit — specifically, those who can't mount an adequate antibody response after vaccination.
"We screen all of our patients who have been receiving anti-CD20 agents and other chemotherapy agents known to suppress antibody response," Kubal, a medical oncologist/hematologist at the Moffitt Institute in Tampa, Florida, told Medscape Medical News. "We then test those patients for antibodies and deliver Evusheld if they have no evidence of antibodies."
Fortunately, in the coming months, distribution of these drugs should improve significantly. Pfizer says it expects to deliver 10 million courses of Paxlovid by the end of June, and another 10 million by the end of September. More than 1 million courses of sotrovimab should be distributed by GlaxoSmithKline through the end of March. And, recently, the Biden administration announced it purchased 1.2 million courses of Evusheld from AstraZeneca.
"Every few weeks because the COVID picture changes, the demand changes," said Louissaint. "With vaccination rates going up and cases going down, fewer patients will need these products."
Still, the constant barrage of supply shortages over the past 2 years — from COVID tests, ventilators, and personal protective equipment early on to COVID vaccines a year later and more recently healthcare staff and COVID tests once again — has taken its toll.
"We have faced supply challenge after challenge, and have had to be creative in each situation," said Lisa Barbarotta, MSN, APRN, program director of Oncology Education and Clinical Practice at Smilow Cancer Hospital. "Nothing has been easy about this."
And, Bloch cautioned, even with broader access to COVID-19 drugs on the horizon, there is still no substitute for vaccination. "Getting vaccinated is the best and first line of defense for most people," she said.
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Cite this: Victoria Stern. Can Cancer Patients Get Approved COVID Therapies? - Medscape - Feb 14, 2022.