We've said this before and will say it again: It does not matter how effective a medication is if it cannot reach the patients who need it most.
For individuals allergic to or unable to generate a response to vaccination, AstraZeneca's Covid-19 antibody treatment, known as Evusheld, can help fill the void of protection. However, roughly 80% of available doses are currently sitting unused in warehouses, pharmacies, and hospitals.
This story is another striking yet unsurprising example of how a disjointed health care system can affect the most vulnerable patients, with disproportionate impacts on Black, Asian and Hispanic populations. For some immunocompromised patients, research has shown that vaccines may not protect them—rendering it reasonable to consider Evusheld a potential alternative to vaccination for this population.
FDA authorized AstraZeneca's Evusheld antibody cocktail for emergency use in December 2021 as two consecutive injections. It is intended to be used as a preventive treatment against coronavirus infection for individuals ages 12 and older who are moderately to severely immunocompromised and may not generate a strong response to vaccination. It can also be used by those who are allergic to components of the Covid-19 vaccines.
In August, AstraZeneca reported that Evusheld reduced the risk of symptomatic Covid-19 infection by 77% in a late-stage clinical trial of 5,197 participants, more than 75% of whom had comorbidities that could render vaccines less effective.
This preventive treatment can "give [immunocompromised individuals] the antibodies that they essentially need in order to avoid getting admitted to the hospital" for Covid-19, said Krist Azizian, chief pharmacy officer for Keck Medicine of USC. "This could truly be lifesaving."
In February, FDA revised Evusheld's emergency use authorization to increase its initial dosing regimen from 150 mg to 300 mg.
According to FDA, this change in dosing was made based on data suggesting a higher dose might be needed to prevent infection from two omicron subvariants. In addition, the agency said the treatment interval, which was initially set at once every six months, may need to be shortened to around three months in the future.
As local and state governments across the country continue to ease the masking requirements that have helped protect the immunocompromised, the Biden administration has insisted it will continue protecting the more than 7 million Americans who have weakened immune systems and remain vulnerable to Covid-19—and Evusheld has become a key piece of the administration's strategy, the New York Times reports.
However, many advocates for immunocompromised individuals have noted that limited awareness and a complicated process for allocating the limited supply of the drug have hindered the distribution of Evusheld.
In fact, around 80% of the available doses are currently sitting unused in warehouses or on pharmacy and hospital shelves because there is so much confusion surrounding the drug, the Times reports.
Currently, the drug is being distributed to states by the federal government. According to a senior federal health official, the Biden administration has purchased 1.7 million doses—enough to fully treat 850,000 individuals—and had almost 650,000 doses ready for distribution as of last week. However, states have ordered only around 370,000 doses, and less than 25% of those have been used.
"There's so many other people who are scrapping and driving for hours to get Evusheld, when in Mississippi it's sitting on the shelves," said Kimberly Cooley, a liver transplant recipient in Duck Hill, Miss., who got Evusheld from her transplant team at the University of Mississippi Medical Center.
According to the Times, interviews with doctors, patients, and government officials suggest that the drug is underutilized for a variety of reasons. Unfortunately, some patients and doctors "don't even know that [Evusheld] exists," said Janet Handal, president and co-founder of the Transplant Recipients and Immunocompromised Patient Advocacy Group.
Sasha Mallett, an immunocompromised physician in Portland, Ore., spent weeks cold-calling hospitals, pharmacies, and health organizations to find the drug. But many of the heath workers she spoke to had never heard of Evusheld—even if their workplaces had the drug in stock.
Notably, some providers have said they do not know how to use the drug and are hesitant to prescribe it, the Times reports.
At the same time, government guidance and communication about the drug has been minimal and confusing. Government data sets about Evusheld’s availability were so complex and confusing that Rob Relyea, a software developer in the Seattle area, developed his own mapping tool to track which providers have the drug for his wife.
"People should know where to go to get in line," he said.
In addition, the government has limited guidelines on which individuals should be prioritized for the drug. In some hospitals and medical centers, doses are being reserved for the highest-risk patients, including recent transplant recipients and cancer patients. However, doses in other areas of the country are being distributed through a lottery or on a first-come, first-served basis.
Dorry Segev, a transplant surgeon at NYU Langone Health, said, "The biggest problem is that there is absolutely no guidance or prioritization or any rollout in place at all, and it's been a mess. Without formal guidelines, you really can't do anything."
According to the Times, the Biden administration is attempting to address the confusion by raising awareness and discussing guidance.
"It is overwhelming and it's all new," said Mitchell Grayson, chief of the allergy and immunology division at Nationwide Children's Hospital. "Providers are definitely trying to keep up, it's just—I don't know how well everyone's doing with that."
As someone who reads and writes about health care news every day, I am feeling some stark déjà vu, as I am reminded of Covid-19 antivirals. Let me explain.
Just a few months ago, we saw similar headlines about the open-ended questions surrounding antivirals, along with frustrations about limited supply and difficult access for patients. Then, Covid-19 antivirals rose up in priority and popularity—from being lauded by only a few public health experts to getting the spotlight in the President's State of the Union (SOTU) address. This was followed by a large (like, billions of dollars large) funding proposal to support the new 'test to treat' program. So how did Covid-19 antivirals go from the unknown potential gamechangers to the spotlight of President Biden's SOTU address? And are there lessons learned from that experience that may be applied to other impactful treatments like Evusheld?
Biden's new funding proposal does include support for ordering more Evusheld. However, available supply does not equal adequate understanding and uptake. There is a clear lack of awareness about this drug and its use (hence the nearly 80% of doses sitting in warehouses or hospital shelves going unused). I believe this can change. The recent flood of news about the Evusheld predicament is a very good thing. It brings this preventive treatment into the spotlight, and it can have a butterfly effect on how much effort is put into distilling out concise, clear, and consistent guidance about Evusheld's use. This is what happened with Covid-19 antivirals. What started out as a few news clips and discussions snowballed into wide-scale coverage and billions of dollars in funding. It's nowhere near perfect, but we are in a much better place to get antivirals to the patients who need them. The same can happen for Evusheld and immunocompromised patients, but there needs to be collective advocacy, outreach, and demands.
Many of the challenges in uptake and distribution stem from unclear guidance from the federal government. While they work to increase awareness and clarity, here's what you can do.
No one player will be responsible for progress here. It will take everyone, including health care leaders, medical providers, community partners, health care media organizations, and patients, among others.
If you are a health care leader, here is a starter list of tangible steps to take:
And yes, some of these steps will simply be too hard to accomplish right now. But there is power in understanding what it will take to ensure patients get the treatments they need.
Because of the way our health care system works, the burden will at least partly fall on patients—but it shouldn't mean driving ten hours to receive this treatment or having to develop an Evusheld inventory tracking tool. (But you should check out the mapping tool. It's great.)
It's easy to feel like we are up against an insurmountable barrier with stories like this one. And while much of the barriers to understanding, access, supply, and distribution may be out of our immediate control, there are tangible steps health care leaders can take. If we hope to improve access to medications like Evusheld for vulnerable patients, namely the 7 million immunocompromised patients in the United States, we can't stop in in the face of structural barriers. Keep raising awareness and advocating for clear guidelines. It makes a difference.
With the fall of mask-mandates and the re-opening of cities, it is crucial we do all we can to help the most vulnerable patients. It won't be easy, but we already knew that. Easy or not, it is necessary.
For assistance on relaying constantly evolving information and regulatory guidance with patients and important stakeholders, you can review our communication strategy audit. (Reyes, Los Angeles Times, 3/6; Morris/Stolberg, New York Times, 3/6)
Advisory Board's Alyssa Nystrom, Olivia Koscso, and Pamela Divack helped contribute to this article.
What Aaron Caroll highlights in this piece is what we have been saying at Advisory Board for months. It doesn't matter how effective a medication is if it can't reach the people who need it most.
This is the unfortunate reality of a disjointed health care system—much of the burden is placed on patients. If patients can't access the necessary therapies, then the medications will not be the "game changers" we once hailed them to be. And while that sounds harsh, it is the reality that Caroll dissects.
So what can we do?
Right now, oral antivirals and other Covid-19 treatments are slowly increasing in supply and availability. However, much of the issue in getting these treatments to patients is systemic in our health care infrastructure and the lack of coordination across the industry. But it's not too late: there are still tactics we can employ to make the most out of these highly effective Covid-19 treatments.
To ensure antivirals live up to be 'game changers', I've written about nine critical considerations that all health care leaders should be thinking about as they manage Covid-19 antivirals, many of which draw upon lessons learned from Covid-19 vaccine rollout. These considerations require heightened collaboration from leaders across the health care ecosystem. I detail tactics on treatment distributions, the critical role of access, patient support and navigation, and communication and public health messaging. You can review a deep dive into these considerations here.
The most important questions to consider
The burden shouldn't be on patients to access Covid-19 treatments, but consistent public health messaging and guidance, coupled with resources dedicated to patient navigation and support, will be essential to helping patients get treatments in time to have an impact. As we observed with Covid-19 vaccine uptake, it is essential that patients understand that the authorized treatments are safe and effective, can identify whether they are eligible to receive such treatments, and know when and how to access them. Health care leaders must also be prepared to respond to any mis or dis-information that may arise. Consider the following questions for your Covid-19 treatment communication strategy, and check out our Covid-19 communication strategy audit for more guidance:
Andrew Mohama contributed to this article.
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