'Test to Treat' gets COVID pills to at-risk patients fast but its reach is limited

Starting this week, high-risk patients with COVID symptoms will be able to walk into hundreds of pharmacy-based clinics for a free test – and walk out with a free course of COVID treatment pills.

It's the start of a new initiative from the Biden administration, and it's a key feature of the President's national COVID preparedness plan. "I've ordered more pills than anyone in the world has," Biden said in his State of the Union address March 1, "And now, 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."

The program aims to speed up the process of getting COVID drugs for high-risk patients who need to start the treatment quickly for it to work. But it is limited by the requirement to have a prescriber on-site — which most pharmacies don't have — and will initially only reach only hundreds among the tens of thousands of retail pharmacies nationwide.

Americans can already get the COVID pills prescribed by their doctors, but Test to Treat is an additional pipeline for COVID pills that intends to streamline the process. Currently, getting the pills can be time-consuming and complicated, says Dr. Cameron Webb, senior policy adviser for equity on the White House COVID-19 response team.

"[A high-risk person with COVID-19 would] have to identify that they have symptoms. They have to get a test, get a test result, contact a provider who can prescribe the medication, get that prescription sent over, and then go pick up that prescription. That's six different steps," Webb says.

Test to Treat will "compress that timeline," he adds, by identifying pharmacy-based clinics and community health centers where patients can get a test, get assessed and prescribed an appropriate drug course, and leave with the pills in one visit.

Two COVID treatment pill options are currently authorized by the FDA – Paxlovid from Pfizer and molnupiravir from Merck and Ridgeback Pharmaceuticals. For both, "It's really important to start treatment within three to five days or so of the onset of infection if you really want to have the impact of that treatment," says Dr. Celine Gounder, an infectious disease specialist and a senior fellow and editor at Kaiser Health News.

The pills are antivirals, which means they stop the virus from making copies of itself in the body. In addition to helping an individual recover, "the treatment should also reduce their infectious period, and reduce the risk of onward transmission to others," Gounder says.

The test-to-treat program will help make treatments more accessible to some, but the initial rollout to pharmacies will be mostly restricted to some large chain stores with on-site healthcare services, such as CVS Minute Clinics.

"I think it's a step in the right direction in trying to make the process more seamless for patients," says Michael Ganio, a senior director at the American Society of Health-System Pharmacists

The program is starting with several hundred sites this week and will grow from there, but there's a limited number of pharmacies that can participate, says Natalie Quillian, deputy coordinator for the White House COVID response.

"Right now these pills must be prescribed by a prescribing authority," Quillian says, such as nurse practitioners, doctors, and physicians' assistants that are licensed to prescribe drugs.

Most pharmacies don't have them on-site. CVS, the nation's largest pharmacy chain, has almost 10,000 locations across the country – and just 10% of them contain Minute Clinics, with on-site prescribers, that would qualify them to become test-to-treat sites, a CVS spokesperson confirmed in an email to NPR.

"I don't think we'll get to the tens of thousands of locations – we're targeting those clinics and locations [like] pharmacy clinics, community health centers, Veterans Affairs clinics, where you have a prescribing authority that can actually prescribe the pills," Quillian says.

There is a way that Test to Treat could become available almost everywhere: Pharmacists say if they were allowed to prescribe the pills themselves, they could help make the program ubiquitous.

In South Carolina, "the people that I need to get access to Paxlovid and molnupiravir don't necessarily have access to a pharmacy with an on-site clinic," says Julie Ann Justo, a pharmacy professor at the University of South Carolina College of Pharmacy and a practicing clinical pharmacist.

The COVID pills come with prescribing challenges –which pharmacists say they are well-qualified to handle. Pfizer's Paxlovid is considered highly effective, reducing the risks of hospitalization by nearly 90%, but it can interfere with many commonly prescribed drugs and cause health problems, if the drug dosages aren't adjusted. Merck's molnupiravir is less effective – cutting the risks of severe COVID by around 30%, according to data reviewed by the FDA – and it comes with reproductive risks.

"Pharmacists are medication experts," says Susan Davis, pharmacy professor at Wayne State University in Michigan, and past president of the Society of Infectious Disease Pharmacists, "We have been managing drug interactions and dose adjustments routinely for decades. We could handle this."

Last fall, the Biden administration amended the PREP Act, a law that applies during public health emergencies, to theoretically allow pharmacists to prescribe some COVID treatments. But pharmacists can't prescribe COVID pills specifically, because of regulations in some states and from the FDA, which specified in the pills' authorization letters that these drugs could only be prescribed by "physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs."

The suggestion is also controversial. The American Medical Association, which represents physicians, issued a statement saying that the pills should be prescribed by a doctor who knows a person's full medical history.

As it stands, health experts say the test-to-treat program needs good communications, public buy-in, and funding from Congress to succeed. Patients need to know about the program, and to know which pharmacies in their neighborhood are enrolled, in order to use it – and those pharmacies will need to have a consistent supply of those medications, Ganio says.

Biden administration officials say they'll be launching a "one-stop shop" website later this month, where people will be able to find test-to-treat locations, along with sites where they can get free masks, tests and vaccines.

The test to treat program comes at a time when coronavirus cases are falling steeply in the U.S., and the supply of Pfizer's Paxlovid pill is ramping up. These are good trends, but it's not a time to be complacent, says Dr. James Hildreth, president and CEO of Meharry Medical College: "The virus is not done with us yet, right? And, if we do have another surge, having a system like this in place could have a huge impact on controlling it."

Hildreth says the program holds a lot of promise — so long as it expands its outreach to rural communities, indigenous groups, and other marginalized high-risk people that need it the most. [Copyright 2022 NPR]