Groups Concerned About ‘Test to Treat’ Plan

With one sentence tucked into the March 1 State of the Union address, President Biden kicked off a new effort to combat COVID-19: “We are launching the ‘Test to Treat’ initiative so people can get tested at a pharmacy and, if they prove positive [for SARS-CoV-2], receive the antiviral pills on the spot at no cost,” he stated.

But the idea that pharmacy-based testing sites could independently provide antivirals, such as Pfizer’s nirmatrelvir-ritonavir (Paxlovid) and Merck’s molnupiravir was met with concerns from both the American Medical Association (AMA) and pharmacy groups.

‘Pretty Limiting’

HHS confirmed in an FAQ that the program would be limited to the “nation’s largest pharmacy chains” with onsite clinics, such as CVS MinuteClinics, along with long-term care centers, community health centers, and veterans’ health centers.

CVS confirmed to MedPage Today via email that it would participate in the program, while the Walgreens Boots Alliance and Walmart confirmed to MarketWatch that they would take part. CVS told MedPage Today on Tuesday that all of its clinics (>1,200 nationwide) would participate and the program may start as early as next week.

But the National Community Pharmacists Association (NCPA) maintains that list is too restrictive: Pharmacies that do not have onsite prescribers (physician assistants, nurse practitioners) would not be eligible for the program. NCPA CEO B. Douglas Hoey, RPh, MBA, told MedPage Today that the program is “pretty limiting to mostly big chains, and even then within the big-chain ranks.” In other words, not even all of the big-chain pharmacies have in-house clinics, so expanding the program to independent pharmacies would broaden its reach.

Theresa Tolle, president-elect of the American Pharmacists Association (APhA) and owner of the Bay Street Pharmacy in Sebastian, Florida, said that many rural communities don’t even have eligible pharmacy-based clinics.

‘Prescribing Decisions This Complex’

The AMA argued that the program bypasses the expertise of primary care physicians (PCP). “Leaving prescribing decisions this complex in the hands of people without knowledge of a patient’s medical history is dangerous in practice and precedent,” they wrote in a statement. “We urge patients who test positive for COVID-19 to contact their physician to discuss treatment options.”

But 28 million people in the U.S. did not have health insurance in 2020, while a quarter of Americans do not have PCPs. They stand to benefit the most from a program like “Test to Treat,” Cameron Webb, MD, JD, a senior policy advisor for equity, White House COVID-19 Response Team, told the Washington Post. He added that people who have easy access to a primary care provider should consult them about treatment, which “reassured” the AMA, according to an association statement.

The NIH’s COVID treatment guidelines recommend nirmatrelvir-ritonavir, sotrovimab, and remdesivir (Veklury) as preferred therapies for outpatients with mild-to-moderate COVID-19. Molnupir is listed as an alternative therapy, along with bebtelovimab.

Nonetheless, Hoey stressed that the timing of antivirals is important. “One thing about these drugs is that time is of the essence,” he stated. “So they need to be started within just a few days of the first symptom for them to really maximize their effectiveness.”

NCPA President Michele Belcher, RPh, owner of Grant’s Pass Pharmacy in Grant’s Pass, Oregon, noted that, “We do have a certain population in our communities that may not have a [primary care] provider, and at that point those patients are having to go to either an urgent care or an emergency room,” she said.

Pharmacies “may be the only healthcare provider that many communities have access to,” she added.

Some Pharmacists Left Out

The NCPA and APhA would like to see “Test to Treat” let pharmacists prescribe COVID-19 antivirals. Hoey stressed that the FDA left pharmacists off the list of prescribers for nirmatrelvir-ritonavir and molnupiravir under the Emergency Use Authorizations.

As for the AMA’s concerns that pharmacy-based clinic providers won’t necessarily have the “knowledge … of the complexity of drug interactions, and [how to manage] possible negative reactions,” Hoey said pharmacists may be even better equipped than other healthcare providers.

“Honestly, if you’re going to have drug interactions, there’s no one better than a pharmacist, who actually is the expert in medication, to be checking the drug interactions.” However, he added that “there are some complexities to it, and it does take a little bit more time.”

Belcher pointed out that pharmacists already acted as prescribers during the pandemic when, under the HHS PREP Act declaration, those who met certain criteria were authorized to order and administer COVID treatments, including the monoclonal antibody injection casirivimab/imdevimab (REGEN-COV).

Belcher’s own pharmacy saw COVID patients before or after pharmacy hours, in their vehicles, or in a dedicated room set up for immunization and assessment, she said.

She explained that many of the patients who came for treatment were not vaccinated, which gave her staff the opportunity to discuss their vaccine hesitancy, and provide education. “So it was a very moving and fulfilling time in our career, to have expanded duties, licensure, and then to have such a positive response,” Belcher said.

She also agreed that when it came to the complexities of prescribing antivirals, pharmacists have it covered. She noted that pharmacists use software that identify drug interactions, and will even call prescribers to flag a potentially overlooked interaction. She stated that “these are things that pharmacists are doing every single day, hundreds of times across the country.”

Tolle suggested that the “Test to Treat” rollout should focus on pharmacies in areas where COVID case-numbers are still high, and where access to treatment has been difficult. “To provide greater access, and decrease barriers, for patients’ utilization of pharmacies who are already providing testing would be ideal,” she said.

Belcher said NCPA has written to the FDA about expanding “Test to Treat” to include pharmacists. “With the appropriate guardrails in place, I think that we could certainly get to a place where the FDA, the AMA, feel comfortable with a similar type of ability for pharmacists to be able to test and treat,” she said.