On The Cover
Johanna Taylor Katroscik, PharmD
During President Biden’s state of the union address in early March 2022, he announced the launch of the “Test to Treat” initiative as a way for patients to get tested for COVID-19 and, if the result is positive, receive prompt treatment. What followed has been a whirlwind of debate about the initiative and whether or not it actually improves access to the people who need it most.
What is the Test to Treat initiative?
The Test to Treat initiative is intended to create easy access to COVID-19 tests and oral therapeutic options at pharmacy-based clinics. Currently, the initiative is being coordinated through the Office of the Assistant Secretary for Preparedness & Response. In theory, it would prevent patients from having to make multiple trips or stops to get tested and treated for COVID-19. Although the initial rollout of the initiative has expanded these services to some patients, many still do not have access to qualifying pharmacies.
Pharmacies that qualify must have a licensed prescriber onsite who has the authority to prescribe the oral antivirals. According to the emergency use authorization (EUA) fact sheets for health professionals, both Paxlovid (nirmatrelvir tablets, ritonavir tablets) and Lagevrio (molnupiravir capsules) may only be prescribed by “physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs” in the therapeutic classes that encompass both Paxlovid and Lagevrio. While some pharmacies do have practitioners onsite who have this prescribing ability, the majority of pharmacies do not.
Additionally, pharmacists are not listed as qualifying prescribers for these two medications. One of the things that makes this particularly frustrating, and confusing, is that pharmacists were granted the authority to order and administer certain COVID-19 therapeutics last year under one of the Public Readiness and Emergency Preparedness (PREP) Act declarations. Then, in September of 2021, Secretary Becerra authorized pharmacists to be able to order oral COVID-19 therapeutics. However, because of the language in the current EUAs for Paxlovid and Lagevrio, pharmacists cannot actually order them.
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The two therapeutics covered under the Test to Treat initiative
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Variable
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Paxlovid (nirmatrelvir tablets, ritonavir tablets)
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Lagevrio (molnupiravir capsules)
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Drug class
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Nirmatrelvir is a SARS-CoV-2 main protease inhibitor, ritonavir is an HIV-1 protease inhibitor and CYP3A inhibitor.
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Molnupiravir is a nucleoside analog that inhibits SARS-CoV-2 replication.
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EUA
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Paxlovid has received an EUA for use in patients who have received a positive diagnosis for COVID-19 via viral testing, are at least 12 years old and weigh at least 40 kg, have mild to moderate symptoms, and are at risk for developing severe COVID-19.
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Lagevrio has EUA for use in patients who have received a positive diagnosis for COVID-19 via viral testing, are at least 18 years old, have mild to moderate symptoms, and are at risk for developing severe COVID-19.
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Limitations of authorized use
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Paxlovid is not authorized for use as pre- or postexposure prophylaxis or for use in patients who must be hospitalized, and it should not be used for more than 5 days in a row. Additionally, because Paxlovid has not received full FDA approval its use is only authorized under the public health state of emergency and could be withdrawn at any time.
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Lagevrio is not authorized for use as pre- or postexposure prophylaxis or for use in patients who must be hospitalized, and it should not be used for more than 5 days in a row.
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Recommended dosing and administration
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Paxlovid includes two separate medications, nirmatrelvir (150 mg tablets) and ritonavir (100 mg tablets). The recommended dose is nirmatrelvir 300 mg (2 tablets) with ritonavir 100 mg (1 tablet) and should be taken by mouth twice daily for 5 days. The doses can be taken with or without food and should be started as soon as possible after a positive COVID-19 diagnosis.
If eGFR is ≥ 30 and < 60 mL/min, the dose of nirmatrelvir should be reduced to 150 mg (1 tablet) twice daily. The nirmatrelvir should still be coadministered with ritonavir 100 mg (1 tablet).
If patient has severe renal impairment (eGFR is < 30 mL/min) or severe hepatic impairment (Child-Pugh Class C), use of Paxlovid is not recommended.
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Lagevrio is supplied as 200 mg molnupiravir capsules. The recommended dose is 800 mg (4 capsules) to be taken by mouth every 12 hours for 5 days. The doses can be taken with or without food and should be started as soon as possible after COVID-19 diagnosis (within 5 days of symptom onset).
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Common adverse effects
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Altered sense of taste, diarrhea, hypertension, muscle pain or aches.
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Diarrhea, nausea, dizziness.
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Warnings and precautions
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Paxlovid is a CYP3A inhibitor—there are numerous potentially significant drug–drug interactions with medications that are either metabolized via CYP3A enzymes or drugs that induce CYP3A enzymes. Full fact sheet should be consulted when considering concomitant drug therapy.
Risk of liver toxicity (i.e., elevations in transaminase levels, hepatitis, and jaundice).
Risk of HIV-1 drug resistance in patients with undiagnosed or uncontrolled HIV-1 infection.
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Risk of embryo-fetal toxicity; use is not recommended for pregnant people.
May affect bone and/or cartilage growth; should not be used if patient is younger than 18 years old.
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Note: At the time of publication, neither Paxlovid nor Lagevrio has received FDA approval, they are still only authorized for use under EUA. The information in this table was adapted from the fact sheets for health care providers.
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How many Test to Treat sites are there?
At the time of publication, there were approximately 2,200 Test to Treat sites where patients could receive these services. Pharmacy-based clinics, Health Resources Services Administration (HRSA)–supported federally qualified health centers, and long-term care facilities were the initial sites that qualified as Test to Treat centers. Initial distribution of antivirals to Test to Treat clinics began in early March 2022 and allowed these clinics to receive oral antiviral pills at no cost, directly from HHS. The capability of facilities to order directly from HHS will also expand to long-term care pharmacies as well as to the Department of Veterans Affairs.
Then, in April 2022, the Biden Administration published a press release discussing their plan to continue to improve patient access to oral antivirals and Test to Treat locations. The press release gives a brief overview of the next steps the administration plans to take to help increase patient access to these medications. The administration hopes to double the number of places that patients can receive oral antiviral treatment by allowing all pharmacies who are part of the federal antiviral pharmacy program to be able to order the oral antiviral medications directly from the government at no cost to the pharmacy.
Unfortunately, the press release does not give specifics about which pharmacies are part of the federal antiviral pharmacy program or how pharmacies who are not part of the program can enroll in it. The administration is also planning on working with state and local governments to increase the number of Test to Treat sites. According to the statement, new Test to Treat sites will be launched in “select communities” in the upcoming weeks and are intended to meet the needs of people who need these services the most. Once again, there was no in-depth information about where these sites would be located or how many sites would be funded.
What’s the scoop with the AMA statement about Test to Treat?
To add to an already complicated matter, the American Medical Association (AMA) published a press release on March 4, 2022, opposing the Biden Administration’s Test to Treat initiative. Part of their statement reads “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.” and goes on to say, “The AMA is pleased the administration is ramping up supply of antivirals so in the near future they will be broadly available. But, in the meantime, establishing pharmacy-based clinics as one stop shopping for COVID-19 testing and treatments is extremely risky.”
Pharmacy organizations, on the other hand, have also made statements about the Test to Treat initiative. Many of these statements note that the while initiative was “well-intentioned,” it omits many pharmacies and pharmacists from being able to provide the high level of care entitled to patients who do not have access to a primary care physician or a clinic. On March 9, 2022, fourteen pharmacy associations and organizations sent a letter to President Biden sharing their perspective on the new initiative. The letter underscores the high level of training and expertise that pharmacists have, stating, “Pharmacists are clinically trained medication experts and are the primary health care professionals responsible for ensuring safe medication use, including identifying and mitigating drug interactions associated with oral antiviral medications for COVID-19.” It also discusses the problematic wording in the EUAs for both Paxlovid and Lagevrio in specifying who is able to prescribe or order these medications. Even though Secretary Becerra authorized pharmacists to order oral antivirals, the wording in the EUAs prevents this. Additionally, the letter brings to light that the individuals who would benefit most from Test to Treat sites, such as rural and underserved communities, will likely not have access to them. Ultimately, the letter calls for the removal of the EUA limitation placed on who can prescribe or order these potentially life-saving medications.
It’s also important to note that even though AMA has made public statements about Test to Treat and pharmacists’ roles, pharmacists have many physician allies and should continue to build and foster relationships with them.
Federal financial support for uninsured patients runs out
Yet another issue that has been surfacing regarding COVID-19 vaccinations, therapeutics, and testing has been the recent news that the HRSA COVID-19 Uninsured Program has stopped accepting claims for patients without insurance. According to the HRSA website, any claims made for testing or treatment after March 22, 2022, will not be processed nor will any claims for vaccine administration that were made after April 5, 2022. This program was nested under the HRSA Provider Relief fund and provided reimbursement to providers giving care to patients without insurance. Without this program, many pharmacies are struggling to figure out how to provide these services to their uninsured patients.
However, there are 15 states that offer Medicaid coverage for uninsured patients. In these states, patients may still be eligible for testing, treatment, and vaccine administration. These states are covered by federal funding under the Families First Coronavirus Response Act (FFCRA) and will continue to receive federal funding that is independent of the HRSA COVID-19 Uninsured Program. Funding through this program will continue until the end of the public health emergency. So, while these funds are still available, they may not be for much longer.
Other federal programs that provide vaccines to uninsured children and adults
- Vaccines for Children (VCF) Program is a program meant to help children receive Advisory Committee on Immunization Practices–recommended vaccines at no cost. For more information on the program, see the CDC Vaccines for Children Program website.
- Section 317 of the Public Health Service Act is a program that allows for federal funds to be used to purchase vaccines for patients who are qualified. Currently, qualified patients include children who are not eligible to participate in the VCF program and uninsured adults. For more information, see the CDC vaccine webpage with information on the 317 vaccine program.
While these programs will not provide testing or treatment for COVID-19, they may be good resources for pharmacies to utilize to ensure that patients can receive vaccines which offer the best protection from COVID-19.
What does all of this mean for pharmacies and pharmacists?
As of publication, pharmacists are not yet able to order oral COVID-19 antivirals and many pharmacies can no longer receive reimbursements for providing testing, treatments, or vaccines to uninsured patients. Additionally, the only pharmacies that are eligible to be Test to Treat sites must have a qualified prescriber onsite who can prescribe the oral antivirals. However, patients can still see their primary care providers or receive oral COVID-19 antiviral prescriptions from an urgent care facility and fill them at any pharmacy that has the medication in stock.
As pharmacies, pharmacists, and pharmacy technicians continue to navigate the twists and turns of the COVID-19 pandemic, one thing is certain; pharmacists and technicians are incredibly resilient and flexible. The pandemic has been challenging but has also shown the value of pharmacy-based care. Pharmacies continue to be one of the most accessible health care touchpoints that patients have. As the pandemic slowly treads on, pharmacists and technicians will continue to rise to the occasion. Hopefully legislators continue to recognize this and expand access in more meaningful ways in the future. ■
Full statements
- APhA statement on Test to Treat (apha.us/APhATestTreatStatement)
- AMA statement on Test to Treat (apha.us/AMATestTreat)
- Pharmacy organization letter to remove limits on prescribing COVID-19 treatments (apha.us/RemoveLimitsLetter)
- Test to Treat website (apha.us/HHSTestTreat)