'Test to treat': Biden launches new Covid pill initiative amid outstanding questions on access
First unveiled at the State of the Union, the Biden administration on Tuesday officially launched its “Test to Treat” initiative that aims to make more free Covid-19 pills from Pfizer and Merck readily available across the country.
Participating pharmacy chains (although Biden stopped short of allowing pharmacists to prescribe the pills) can test someone (or people can test elsewhere), and if positive for Covid-19, the site can simultaneously provide one of the two antivirals in the same visit.
Locations participating in the Test to Treat initiative, which will initially include hundreds of federally-qualified health centers, pharmacy-based clinics at the top chains, and long-term care facilities across the country will receive the oral antiviral drugs, Pfizer’s Paxlovid and Merck’s molnupiravir, through a direct federal ordering process.
But this allocation will be in addition to the current supply of nearly 100,000 Paxlovid courses and almost 400,000 molnupiravir courses that states and jurisdictions are already receiving from the federal government every two weeks (click here to see the current sites nationwide receiving these supplies).
It’s unclear how long this initiative might last, or how many may gain access to the pills who otherwise wouldn’t have.
More than 2 million of the total 3 million Merck pills that the government purchased have already been distributed to states. For Paxlovid, although the US has purchased a total of 10 million courses, only about 690,000 courses have already been distributed because of difficulties in making the pill, and only about 100,000 more courses have been procured to date, according to a report from Stat News.
As HHS has effectively run out of Covid-19 funding, and Dems continue fighting for what looks like about $15 billion in more funds, according to the Washington Post, the timeline for the procurement of more Paxlovid is unknown. And given the difficulties in manufacturing Paxlovid, Pfizer said it only expects to have 6 million courses ready for the global market this month, and 24 million courses globally by June.
Experts think the initiative will be hampered by the relatively limited supplies (particularly for the more effective Paxlovid, as there have also been accounts of US pharmacies running out of storage space for molnupiravir), the limits around only allowing sites with medical doctors, and unknowns on whether the antivirals work for the vaccinated or those who have already had Covid-19 may severely hamper this initiative.
Michael Ganio, senior director at the American Society of Health-System Pharmacists, explained to Endpoints News how the Test to Treat initiative could be optimized by having the FDA get out of the way, and leveraging the help of pharmacists in ensuring the appropriate patients are accessing the pills. He also noted that while the decline in Omicron cases means supply concerns should be alleviated, another wave of cases from a new variant could create new supply issues.
If Test to Treat is limited to only those pharmacies and locations that have medical doctors and similar providers, then a major Test to Treat program is a bit of an illusion bc it’s what we already have today. Low access and difficulty for people to figure out where to go.
— Michael Mina (@michaelmina_lab) March 3, 2022
But the American Medical Association raised concerns about the safety of the initiative, particularly given all the negative interactions with Paxlovid, and as molnupiravir should not be given to pregnant women or children under 18. AMA president Gerald Harmon said in a statement last week:
While the administration laid out promising plans earlier this week to combat COVID-19 and put measures in place to prevent future pandemics, the pharmacy-based clinic component of the test-to-treat plan flaunts patient safety and risks significant negative health outcomes. This approach, though well intentioned in that it attempted to increase access to care for patients without a primary care physician, oversimplifies challenging prescribing decisions by omitting knowledge of a patient’s medical history, the complexity of drug interactions, and managing possible negative reactions.
Michael Lin, associate professor of neurobiology and bioengineering at Stanford University, also explained to Endpoints that he’s worried about the overuse of these Merck and Pfizer pills now, especially as this initiative from Biden is not being advertised as only for unvaccinated people, but the only data that’s available on the pills’ efficacy is in those who are unvaccinated.
“In the public mind, it’s ordering the priorities incorrectly,” Lin said. “At this stage, antivirals are important for those who need them,” but he noted that vaccinations and public masking will be far more effective at stopping the next wave of cases.