Consumers will be able to walk into a clinic at a CVS or Walgreens, get tested for the coronavirus and, if the results come back positive, go home with a free course of antiviral medicine under a “test to treat” program announced by President Biden this week as part of his new pandemic road map.
The one-stop approach has been hailed as a potential breakthrough by some doctors, who say it will make it far easier for people at heightened risk of severe disease to get the lifesaving drugs quickly — especially for those who don’t have regular doctors. But the American Medical Association came out strongly critical of the plan Friday afternoon, saying prescribing decisions should be made “under the guidance and supervision of physicians with expertise to deal with complex medications.”
And many puzzle pieces — including having adequate supplies of antiviral drugs and rapid tests — must fall into place for the program to scale up quickly as envisioned in the president’s plan.
“The overall goal of the program is to increase access to lifesaving treatments that need to be given quickly to be effective,” said Tom Inglesby, senior adviser to the White House coronavirus response team.
The program aims to streamline the process for people with underlying conditions to obtain either Pfizer’s Paxlovid or Merck and Ridgeback Biotherapeutics’ molnupiravir. Both drugs significantly reduce the risk of hospitalization and death if they are taken within five days of the onset of symptoms. In clinical trials, Pfizer’s pill was shown to be nearly 90 percent effective at keeping high-risk patients from developing severe illness. Merck’s drug reduced the risk of hospitalization or death by 30 percent.
“I’m rooting for this,” said Eric Topol, a molecular medicine professor and executive vice president of Scripps Research, calling the program “the bold type of move we need. This is what we want to have in place to be ready for a surge.”
But he also had questions about the challenges ahead. “We need a much better supply of anti-COVID pills, accurate tests, and solid coordination with pharmacists to pull this off,” he tweeted earlier in the week after the announcement.
Administration officials said in interviews that they are confident they have sufficient supplies of both the pills and test kits to launch the program in hundreds of pharmacy locations, as well as in community health centers and long-term-care facilities, beginning next week. They say the antiviral drugs have already been bought by the federal government and will be provided free.
“At this point, we have enough Paxlovid and molnupiravir to provide the medications,” Inglesby said.
The debate over who is best-positioned to prescribe the drugs stems in part from concerns the medications are inappropriate for some people. Pfizer’s pill cannot be taken alongside several common medications, including some that treat heart conditions and control cholesterol. It is also not recommended for people with severe kidney or liver problems. Molnupiravir does not have known drug interactions, but it is not recommended during pregnancy or for those younger than 18 because it could affect bone and cartilage growth.
The AMA said in a statement Friday that the administration’s plan, “though well intentioned … oversimplifies challenging prescribing decisions by omitting knowledge of a patient’s medical history, the complexity of drug interactions, and managing possible negative reactions.”
But White House officials countered that the program is primarily focused on the quarter of Americans who do not have a primary care provider.
People who can meet with a family physician shortly after testing positive should do so, said Cameron Webb, senior adviser for equity on the White House coronavirus task force and a physician. But the test to treat locations will boost access to the lifesaving treatments for those who do not have such doctors. “Now they have a path,” he said.
Other officials noted that the health-care providers in pharmacies, usually advanced practice registered nurses and physician assistant, are equipped to screen patients for possible contraindications, just as primary care physicians would, before prescribing the pills.
Such pharmacies also have access to automated systems that screen for drug interactions, allowing them to prescribe the pills safely, said Céline Gounder, an infectious-disease specialist and senior fellow and editor-at-large for Kaiser Health News, who supports the plan.
Several experts said the biggest challenge facing the proposal is the still-limited supply of antiviral pills.
After the Food and Drug Administration authorized the drugs in late December, both Pfizer and Merck began ramping up production but struggled to meet demand during the peak of the omicron wave in January. Since then, doctors say the pills have become more widely available but can still be tough to obtain because of pharmacy staffing shortages and weekend closures.
Administration officials noted that production of the pills is ramping up: Last week, the federal government distributed 148,980 courses of Paxlovid and 349,776 courses of molnupiravir to the states, and hundreds of thousands of doses remain available, according to data published by the Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.
This month, Inglesby said, 1 million additional courses of Paxlovid will be sent to pharmacies, including those that will be participating in the test-to-treat program. In April, an additional 2.5 million courses of Pfizer’s drug will be shipped out. In addition, Pfizer has indicated it can deliver 10 million treatment courses of Paxlovid by June.
Even as the supply of the antivirals has been increasing, the number of new daily cases in the United States has plummeted as the omicron surge wanes. Over the past week, an average of 54,609 new cases were reported each day, and only a fraction of those people would likely be eligible for the drugs.
Topol worried that if a new variant emerged suddenly, the supply might be outstripped by demand.
“A lot of the success of this depends on the level of circulating virus,” he said. “If it is really low, then a million blister packs may be enough. But if we head into a variant or another surge, it won’t cut it.”
Meanwhile, the availability of rapid coronavirus tests, in short supply as recently as January, has also increased in pharmacies and other stores as cases have declined. The number of tests now on the market should be sufficient to meet the needs of the test-to-treat program, said Wilbur Lam, a physician and biomedical engineer at Emory University who runs the lab tasked by the National Institutes of Health with evaluating the rapid tests.
“The supplies of existing tests on the market are steadily increasing and … there’ll be even more authorized tests on the market in the near future,” Lam said.
While details on the participating providers are still being worked out, two large pharmacy chains, CVS and Walgreens, say they are preparing to sign on, although they do not yet have firm start dates or locations.
“Our pharmacists and pharmacies … stand ready to further support in the timely and accessible delivery of covid-19 treatments to patients,” said Karen May, a Walgreens spokeswoman.
Many large pharmacy locations have walk-in clinics staffed by nurse practitioners and physician assistants — a setup “uniquely positioned” for the test to treat model, said CVS Pharmacy spokesman Matthew Blanchette. “We look forward to helping provide expanded access as additional inventory [of antiviral pills] becomes available,” he added.