Q&A: Regulations may limit use of COVID-19 test-to-treat initiative

Select pharmacies will soon be able to provide antivirals to patients who test positive for SARS-CoV-2 on the spot at no cost through the recently announced test-to-treat initiative.

The American Society of Health-System Pharmacists (ASHP) applauded the initiative but also expressed concern that access will be limited unless the FDA removes language in the emergency use authorizations (EUAs) that prevents pharmacists from ordering Paxlovid (Pfizer) and molnupiravir (Merck).

ASHP and 13 other pharmacy organizations in the U.S. have sent a letter to President Joe Biden, urging his administration to remove this barrier. Otherwise, the test-to-treat locations will be restricted to pharmacies with walk-in clinics, where a nurse practitioner or physician assistant can order antivirals.

“For the most part, these are located in metropolitan areas,” Michael Ganio, PharmD, MS, BCPS, FASHP, senior director of pharmacy practice and quality at ASHP, said in an interview. “This creates a problem with equitable access in rural or medically underserved communities.”

Healio asked Ganio to further discuss the barriers to widespread use of the test-to-treat initiative and what efforts are needed to expand access.

Healio: What obstacles will pharmacists face in implementing the test-to-treat initiative?

Ganio: The obstacles are more about patient access to the antivirals. The rollout of this initiative to pharmacy-based clinics is great as a start, but it’s a small percentage of the overall number of pharmacies. So, for patients and providers to have a place to go for testing and treatment, they have to locate one of these specific pharmacies that has a walk-in type of clinic. The obstacle we see is that it’s not leveraging the network of America’s most accessible health care practitioners, and that’s the pharmacist. By including pharmacists in the list of prescribers who can order the medication, you basically expand this whole idea of a one-stop shop to include tens of thousands of locations across the country.

There is a COVID-19 declaration in the PREP Act. The ninth amendment to that declaration actually authorized pharmacists to order therapeutics for COVID-19, including anything that’s given orally, which these antivirals are, or given under the skin as a subcutaneous injection, or given into the muscle. The problem that we’re faced with is that when the FDA authorized these antivirals, they inserted specific language that limits the prescribing to just physicians, nurse practitioners and physician assistants. So, despite the language in the PREP Act that [HHS] Secretary [Xavier] Becerra had authorized back in September, pharmacists still are not able to prescribe these medications.

Healio: Is there any indication that the FDA will make changes to the antivirals’ EUAs?

Ganio: We've been in communication with them. We, as a coalition of different pharmacy groups, have met with them to have that limitation removed. The coalition also released a letter to the president, asking the administration to address this limitation within the EUA language. The president is interested in expanding access. HHS Secretary Becerra already did that expansion back in September. The FDA’s EUA is really preventing us from taking full advantage of that workforce.

Healio: The antivirals are reserved for patients at high risk for disease progression. Will prioritization be an issue?

Ganio: The CDC has curated a list of chronic health conditions and other patient demographics like age, for example, that would signify that a person is at risk of severe COVID-19. So, that piece of it is a little more clear cut. The other part that’s not so black and white is how vaccination fits into prioritizing who would get treatment. As the supply increases, that becomes less of an issue. So, hopefully as the omicron surge declines and the supply of these medications continues to increase, we’ll have less concern over trying to reserve the antivirals for the most vulnerable.

Healio: Should pharmacies communicate with patients’ PCPs when they receive antivirals through the test-to-treat initiative?

Ganio: Patients’ health care needs should be centrally coordinated to a primary care provider. The treatment window for the oral antivirals is within 5 days of symptom onset, so it’s not always possible to get in touch with your primary care provider and track down a prescription for one of these medications in that time frame. The antivirals may require communication, and not just with a primary care provider. If you look at some of the drug interactions for Paxlovid, for example, some of the more critical ones are cardiovascular medications and transplant medications, and so there might be a need to communicate with multiple providers on the team.

Healio: Do you have anything else to add?

Ganio: Yes, two things. A lot of primary care providers are probably familiar with pharmacy-run clinics to manage drug therapy. The most common are anticoagulation clinics. So, managing a patient’s warfarin. There are also diabetes clinics, smoking cessation clinics and HIV clinics, where pharmacists are managing patients’ medications. All of that is done under collaborative practice agreements that are authorized at the state level.

There are some examples where pharmacists are working in primary care clinics and might see a patient or follow up on a patient’s [COVID-19] positive test. Probably one of the more common examples would be a pharmacist working in a hospital emergency department and looking at urine cultures from the previous day and, once they know which antimicrobial is the most appropriate, they may call the patient and pharmacy and switch therapy. They can do that through these collaborative practice agreements.

The problem with the language in the EUA is that it not only stops that PREP Act declaration amendment from being implemented, but that wording is also blocking any collaborative practice agreements.

The second part I would like to add is the drum we’ve been beating for a long time. Pharmacists are one of the few health care professionals not included under Social Security for reimbursement under Medicare. Even though we provide these services and some primary and specialty care in clinic-type settings, there’s no recognition or reimbursement for that. The reimbursement for prescriptions is fraught with problems with pharmacy benefit managers (PBMs) and dispensing fees, particularly for the antivirals that are very low. Our whole profession is tied to dispensing these products. It’s not a service-based reimbursement. And so, we have issues that those reimbursements decline or there are DIR fees and things that the PBMs do to reduce the amount that pharmacies get in that margin. This puts more of a pinch on the workforce. So, pharmacists are doing the evaluation and looking at the patient's history and determining which COVID-19 therapy is appropriate, but there's no reimbursement for that service, whereas if you went into Minute Clinics, you would see a physician’s assistant or nurse practitioner and they would have the ability to bill your insurance.

References:

ASHP applauds administration's focus on COVID test to treat, opioid treatment in State of the Union. https://www.ashp.org/news/2022/03/07/ashp-applauds-administrations-focus-on-covid-test-to-treat-opioid-treatment-in-state-of-the-union. Accessed March 10, 2022.

Pharmacist groups call on Biden administration to remove limits on prescribing COVID treatments. https://www.ashp.org/news/2022/03/09/pharmacist-groups-call-on-biden-administration-to-remove-limits-on-prescribing-covid-treatments. Accessed March 10, 2022.