Again, Americans are facing the problem of medical rationing.
First it was personal protective equipment, then ventilators, then vaccines, and now antibodies and antiviral therapeutics. Federal, state, and hospital officials are having to decide who gets first access to potentially lifesaving drugs like Pfizer’s Paxlovid. Unlike in March 2020, they have faced almost two years of managing scarcity. What can they learn from earlier shortages about how to fairly and effectively allocate these therapies?
Public attention focuses on tragic allocation dilemmas of which patient gets the last ventilator or pill. But much more is at stake in determining where doses go. The federal government should, as the saying goes, pour the water where the fire is burning. That is, scarce drugs should be distributed to states and cities where hospitals are at greater risk of being overwhelmed.
This is different than what the Trump administration did by sending vaccines to states based not on health need but based purely on population. Sending the same quantity of antivirals and antibody therapies to a city or state facing fewer infections and hospitalizations is unethical. More treatments should go where COVID outbreaks are severe, which will help reduce hospital pressure from the patients most at risk.
To achieve this goal, the federal government should depart from population-based distribution and prioritize a portion of available doses for high-risk sites, as they are currently doing for federally qualified health centers. States similarly should distribute more doses to particularly vulnerable cities and regions. And different drugs should be prioritized for different high-risk populations.
Importantly, direct federal distribution of some doses of antiviral therapeutics to places facing the greatest hospital stress and groups most in need would ensure a more just allocation. It would prevent unethical shenanigans by states that favor “first-come, first-served” distribution sites that really apply “first-come — among those with the biggest wallets and best connections.”
For instance, Merck’s molnupiravir reduces hospitalizations and improves survival by 30 percent. But it is contraindicated for children and requires special care in adults of childbearing age. An effective approach might be to guarantee a third of molnupiravir for Medicare and long-term-care patients, few of whom are of childbearing age and many of whom would gain substantial protection in absolute terms from a 30 percent risk reduction.
Pfizer’s Paxlovid reduces hospitalizations by 90 percent but is in the shortest supply and is probably best allocated directly to hospitals to treat severely immunocompromised patients who test positive, and to federally qualified health centers that serve low-income seniors and other vulnerable populations. These centers were effective at distributing vaccines and are likelier to be serving patient populations who are open to receiving therapies rather than ideologically committed to refusing both vaccines and therapies.
Finally, sotrovimab is a monoclonal that is effective against Omicron. Monoclonal antibody therapies have a long history of safe use during pregnancy. A portion of sotrovimab should go to hospitals and centers serving pregnant women. These women were unfairly excluded from vaccine trials, leading to vaccine hesitancy, and helping them will help their babies as well.
Passively waiting for patients to sign up for vaccines online unjustly and counterproductively exacerbated disparities. It favored people who were more Internet-savvy and meant many eligibility rules, like priority for immune-compromised people, could only be enforced based on the honor system.
Instead, public health departments and hospitals need to adopt an active outreach approach. Every positive test in a high-risk patient should prompt an outgoing phone call, text message, and e-mail to offer the patient the opportunity to receive therapies. Other health systems, like Britain’s National Health Service, can do this easily by connecting COVID tests to records. But even in the United States, whose health IT infrastructure lags behind, some large health systems can do it. And some cities also distributed vaccines using active outreach. Given the waning efficacy of contact tracing, cities’ contact tracing capacity could be repurposed to offer therapies.
Even if unable to match positive tests immediately to high-risk patients, the United States can still do more. Immunocompromised patients and pregnant women should be called and told to contact a hotline immediately if they test positive. Rapid tests should come with a hotline to call to receive antivirals or antibodies if people who are immunocompromised, older, or in some other high-risk group test positive.
Of course, we still have to distribute the last antiviral pill. And here, the National Institutes of Health guidelines for this have serious problems. First, they prioritize all doses rigidly by tier. The first tier has about 2 million people — unvaccinated people over 75, plus a similar number over 65 with one high-risk condition, plus immunocompromised adults. Tier 2 is made up solely of the unvaccinated — adults over 65 or anyone with a high-risk condition. Both are supposed to go before the vaccinated adults without immunocompromise in Tiers 3 or 4. Given the scarcity of these antiviral medications, having 2 million people in the first tier of patients is totally unhelpful.
Second, the NIH guidelines excessively favor the unvaccinated. An unvaccinated 18-year-old with obesity is in Tier 2, while an 80-year-old who received one dose of the Johnson & Johnson vaccine goes in Tier 3 and a pregnant woman with one vaccine dose goes in Tier 4. This is both medically unjustifiable and penalizes people at high risk who followed recommendations and got vaccinated despite the possibility that vaccines might not fully protect them.
The NIH guidelines also ignore the public health dimensions of distribution. The NIH does not prioritize health workers for therapies. Yet, the public strongly endorsed this approach for vaccines, and treating a health care worker during a surge helps not only the worker but all of us, since they can care for other patients who might otherwise go untreated. Similarly, the NIH guidelines ignore the option of prioritizing people from more socially vulnerable areas, an option hospitals have used and that the public endorsed for vaccine distribution.
Instead of using rigid tiers, the allocation guidelines should use a categorized priority system, which prioritizes portions of the therapy supply for specific groups. For instance, hospitals and pharmacies could prioritize 25 percent of doses for people who will save others if we save them — scarce health workers and pregnant women. Another 25 percent could be prioritized for the most disadvantaged 25 percent of geographic areas, who are less likely to comprise committed therapy refusers but more likely to be unboosted because of confusing messaging. Within each group, immunocompromised people should go to the top rather than being lumped with unvaccinated adults in Tier 1.
Right now, we are not getting these therapies to the right people. Reported recent recipients, like a 48-year-old man with diabetes who is fully vaccinated and boosted, or a 26-year-old vaccinated man who is overweight, are at far lower risk of hospitalization and death than immunocompromised people or even unboosted 60-year-olds with those same conditions.
Claims that therapies are “unlikely to change the course of the pandemic” are too pessimistic. We still have limited doses of Pfizer’s Paxlovid and of sotrovimab. But only about 2,200 people are dying of COVID daily. We should have enough to help many of them.
The Centers for Disease Control and Prevention and states should be tracking two sets of outcomes: therapies offered — or not — to people who died or needed intensive care and therapy recipients predicted to be at high risk of severe illness if infected. More therapies should go to the people most likely to die or become seriously ill, not people at lower risk who are better at refreshing their browser or have more time to call pharmacies. With the Omicron surge overwhelming hospitals, keeping these high-risk patients safe from hospitalization keeps the rest of us safe as well.
Dr. Ezekiel J. Emanuel is vice provost for Global Initiatives and codirector of the Healthcare Transformation Institute Perelman School of Medicine and the Wharton School at the University of Pennsylvania. Govind Persad is assistant professor of law at the Sturm Law School at University of Denver.