On March 1, President Joe Biden made a big promise to Americans. In his State of the Union speech, he proudly announced he was launching a program that would allow people who test positive for COVID-19 to immediately have access to recently authorized pills to treat the viral infection.
“We’re launching the “Test to Treat” initiative so people can get tested at a pharmacy and, if they prove positive, receive the antiviral pills on the spot at no cost,” he said. Biden pledged that supplies of the medications would be increased at pharmacies across the nation, beginning in mid-March, to realize a vision of on-the-spot care for COVID-19.
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Those drugs have started to reach states, but the next step of getting them to people who might benefit from them the most is proving more challenging.
A regulatory change made in September 2021 allows pharmacists to write prescriptions for COVID-19 therapies and to administer the COVID-19 vaccine. But the U.S. Food and Drug Administration (FDA) emergency use authorizations (EUAs) for Paxlovid (Pfizer’s antiviral treatment) and molnupiravir (made by Merck and Ridgeback Therapeutics) specified that they could only be prescribed by physicians, advanced practice nurses, and physician assistants licensed to dispense antivirals. Only a fraction of retail pharmacy chains have such licensed providers on site who can write a prescription for a COVID-19 therapy.
In other words, while the Test to Treat program is well-intentioned, it’s not really addressing the true barriers to treatment for many of those who need it the most: those who don’t have a primary care physician or aren’t getting regular checkups at clinics or hospitals and who rely on pharmacies for treating everything from flu to strep throat to, now, COVID-19. If people test positive at a pharmacy that doesn’t have a prescriber on staff, then they still have to either make an appointment with a primary care physician, or go to an urgent care center or clinic to be evaluated. And because the pills need to be taken within a few days of symptoms or diagnosis to be most effective, that delay could make the treatment useless.
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Of Walgreens’ 1,300 locations that currently stock COVID-19 antiviral medications, for example, only 250 have health providers on site who can prescribe them. Walgreens partners with VillageMD, a nationwide network of primary care physicians, which co-locates many of its clinics adjacent to the pharmacy. In such cases, people who test positive and might need a COVID-19 antiviral prescription “wouldn’t have to physically leave the location,” says Dr. Clive Fields, chief medical officer of VillageMD. “They would go to the pharmacist, get tested, then walk 15 steps to the comprehensive primary care office, get evaluated, and if the antiviral is appropriate, get a prescription and literally pick it up without walking out of the location.”
That’s the ideal scenario that Biden laid out in the State of the Union, but it’s not possible in most of the nation’s pharmacies. While nine out of 10 Americans live within five miles of a pharmacy, if they can’t be seen by a medical provider and receive a prescription for an antiviral on site, then the Test to Treat program loses much of its disease-curbing power. “The idea of somebody coming into a pharmacy to get tested, then calling a doctor to see if they can make an appointment in three or four days doesn’t make sense,” says Fields. “It’s bad for the patient, bad for the community and bad for everybody the patient comes in contact with.”
Some experts say that the program does have the potential, however, to achieve what Biden hopes, and more—if it is linked to the at-home tests that the government is providing to every American household. It’s a matter of using the tools we have to fight the virus in a more coordinated and intentional way.
With the COVID-19 pandemic showing signs of waning, but not disappearing as new variants and subvariants of the virus are inevitable, protecting people from getting sick is still the highest public health priority. That means continuing to administer vaccines and booster shots—but these aren’t foolproof, so a certain percentage of vaccinated people will still get infected, and some of those will get seriously ill. For them, drug treatments could mean the difference between days battling flu-like symptoms at home, and weeks in the hospital—potentially in the Intensive Care Unit.
In October 2020, the FDA approved the first drug treatment for COVID-19, remdesivir, an antiviral that makes it difficult for the SARS-CoV-2 virus to make more copies of itself and infect other healthy cells. However, it is only available in IV form, so patients have to visit an infusion clinic or hospital for the therapy. Studies also show that it’s only moderately effective, reducing serious adverse events associated with COVID-19 by about 30% among those taking it within days of symptoms appearing compared to those who don’t.
It was over a year later, in December 2021, before the FDA issued an EUA for the first COVID-19 antiviral pills, Paxlovid, which also works by blocking SARS-CoV-2 from replicating. The agency authorized the drug based on studies from its maker, Pfizer,that showed the pills can lower risk of hospitalization by more than 90% among those most vulnerable to disease. Just a day after issuing that EUA, the agency authorized molnupiravir, another antiviral that prevents SARS-CoV-2 from making more copies of itself. After encouraging early data, researchers found that molnupiravir wasn’t as effective as they had hoped, lowering the risk of hospitalization and death by only about 30% among those at highest risk of disease.
All of these antiviral treatments are, for now, only approved or authorized for those at higher risk of getting severely ill with disease and who are more likely to need hospitalization. They are not meant to prevent infection in the first place, and are only meant to be taken within a few days of when symptoms first appear—the short window when the virus is busy pumping out copies of itself, before it builds up and enters the lungs and other organs.
There are, however, other COVID-19 therapies that the FDA authorized to both treat and, in some cases prevent infection. But unlike antiviral treatments,, monoclonal antibodies come in IV, and not pill form, so they aren’t available at pharmacies but only at infusion centers or hospitals. The monoclonal antibodies neutralize any virus floating around by soaking them up so the virus can’t attach to and infect healthy cells. The FDA has so far authorized four such treatments, but they have an Achilles heel: SARS-CoV-2 can easily mutate to get around antibodies. The National Institutes of Health currently advises doctors not to prescribe two of them because they aren’t effective against Omicron. Only Evushield, from AstraZeneca, and GlaxoSmithKline’s Xevudy, (which, interestingly, was developed from the immune cells of an early COVID-19 patient), continues to block Omicron.
The U.S. government has purchased drug treatments in bulk and is now distributing them through both the existing Federal Pharmacy Program, in which retail pharmacies can apply for and receive the drugs directly, and the new Test to Treat Program. Under both programs, people who need the drugs will receive them without charge or get reimbursed through their insurers.
For now, the Department of Health and Human Services (HHS) has coordinated the bulk of the hundreds of thousands of doses of COVID-19 treatments that have been distributed so far, through its HHS Coordination Operations and Response Element (HCORE). In some cases, HCORE advises states where the supply should go. Indiana, for example, says the government has selected and is now sending drugs directly to certain CVS and Walgreens locations with clinics where health care providers can prescribe them for people who test positive. In other cases, facilities can apply for the drugs: In Minnesota, pharmacies and long-term care facilities that want to dispense the drugs and have relationships with providers who can prescribe them can ask for them directly from the federal government.
Read more: Why the U.S. Fumbled Its Early Vaccine Rollout
Right now, access is spotty and inequitable, says Dr. Michael Ganio, senior director of pharmacy practice and quality for the American Society of Health System Pharmacists. “A lot of these clinics [to which the government is sending doses] are scattered around metro areas, and don’t include a lot of medically underserved communities or rural areas,” he says, where such one-stop-shopping for testing and treatments could be most powerful.
The supply is increasing, but only at a trickle. In Jan., Pfizer said the government was adding to its original order of 10 million doses of its therapy, expected to be filled by June, with another 10 million doses to be delivered by Sept. Last Nov., Merck and Ridgeback, which makes molnupiravir, agreed to provide the US government with more than 3 million courses of its medication. Doctors also expect that as their experience with prescribing the treatments to the most vulnerable people increases, then more otherwise healthy people will also become eligible for them in order to reduce the risk that anyone infected with COVID-19 becomes seriously ill.
Still, getting doses to individual pharmacies remains a slow process. And increasing supply still doesn’t allow pharmacists to prescribe the medications. “Supply is not the issue compared to two months ago,” says Rina Shah, group vice president of pharmacy operations and services at Walgreens. “I would say we have dispensed about 10% of the antivirals available to us.”
Biden’s Test to Treat program didn’t address the restrictive prescribing requirements in the EUA for COVID-19 antivirals. While the law passed last fall allows pharmacists to administer COVID-19 medications, and expedites people’s access to them, the FDA specifically limited prescribing of Paxlovid and molnupiravir to licensed health care providers because of concerns about drug-drug interactions and side effects. Paxlovid, for example, may cause kidney problems so those with kidney disease need to be monitored closely for changes in kidney function, while pregnant women should not use molnupiravir because of the risk of harm to the developing fetus. The FDA decided that physicians and other licensed providers should be the ones to evaluate people for these risks before prescribing the drugs. But pharmacists argue that evaluating patients for potential drug interactions and side effects is something they are also trained to do.
“Assessing and dispensing antivirals are in our wheelhouse,” says Shah. “In every pharmacy, this is what we do every day. We feel there is a really big opportunity in front of us to make a shift in the EUA language to impact hospitalization because we have the technology, talent, and expertise, and the ability to get into every community across the country to increase access to care that much more quickly.”
In fact, some public health experts say, the Test to Treat program, combined with the now widely available at-home rapid tests, could become a foundation for shifting the trajectory of COVID-19 by making it possible to treat individual cases without risking spread of the virus in a community. It should theoretically be possible, in fact, to cut out in-person visits entirely.
Ideally, people could test themselves at home, then connect via telehealth with a provider who verifies the test result, and can then evaluate that person for whether they need an antiviral by asking about their medical history and current medication use. If the person qualifies, then that provider can write a digital prescription, send it to a pharmacy, and that pharmacy can deliver the antiviral directly to the patient’s home, all without the infectious patient visiting a pharmacy or a health center where they might spread the virus to others.
“All of a sudden, you can massively decrease barriers to people getting treated for COVID-19,” says Dr. Michael Mina, formerly of Harvard School of Public Health and now chief science officer at eMed, a health software company that sells at-home rapid COVID-19 tests and provides telehealth experts to help people validate and interpret those results. “We’ve put tests into everyone’s homes. Now let’s link those tests to telemedicine and treatment so people can get a home test, get a lab report based on that home test, and then send that lab result to a physician who can prescribe a treatment,” he says. “Technically the whole process should be that you wake up with symptoms, get tested, and have a prescription delivered to you from your pharmacy all in under an hour.”
That, Mina says, should be the ultimate goal of Test to Treat. There’s no reason people who are potentially infectious should have to physically go into a pharmacy to get tested, and then sit around waiting for their prescription to be filled if there is an on-site provider who can prescribe them drugs available—or worse, be sent away if there isn’t. Mina, who contributed to the White House’s National COVID-19 Preparedness Plan released in March 2022, sees the federal government shifting its public health priorities from those oriented towards society as a whole to those that help individual people protect themselves from infection. That makes sense; as the urgent nature of containing a fast-moving virus wanes, it becomes more important to ensure that more people who are infected are treated quickly. That way, there will be fewer people who can spread the virus—to their friends, family, communities, and health care workers.
“The more that people get tested because they might want treatment, then that will keep them out of the hospital,” says Mina. “If we can do it right, all of a sudden, COVID-19 becomes a smaller issue for society.”
