Last week during President Biden’s first State of the Union address, he announced a new Test-to-Treat initiative underway as we move into the next phase of living with COVID-19 in our midst for the foreseeable future. This Test-to-Treat program will enable selected pharmacy-based clinics and federally-qualified community health centers (FQHCs) to dispense Paxlovid or Molnupiravir to patients with confirmed mild-to-moderate COVID-19 who are at high risk of developing severe disease. While this next step is a good and practical move in the fight against COVID-19, major flaws in the program’s economics and logistics threaten to stymie these well-intentioned efforts and should be corrected quickly to ensure a smooth and timely rollout.

This is perhaps the biggest oversight of the whole program that requires immediate attention. Background:  For years, pharmacists in many states have had the ability to prescribe, either by leveraging collaborative agreements with other providers (MDs, DOs, ARNPs, etc.) or autonomously through statewide protocols. There are varying degrees of permissions pharmacists have that are state-specific, but recognizing that prescriptive authority is within a pharmacist’s scope of practice is by all means nothing new. When the FDA released the EUA (emergency use authorization) fact sheets for these two antivirals, many in my profession were shocked that pharmacists were not included as eligible prescribers. It just doesn’t make any sense, and it is in direct opposition with the PREP Act that grants pharmacists broad prescriptive authority for COVID diagnostics, vaccines, and monoclonal antibodies. And what adds insult to injury is for states where pharmacists otherwise enjoy broad prescriptive authority like the state I practice in (Washington), there is no allowance for even creating a workaround by leveraging collaborative agreements like we would for most other drugs. A case could be made for pharmacies writing and operating under a collaborative agreement with a local provider anyway and then asking for forgiveness later, especially in rural and geographically-isolated areas with limited access and options for healthcare. It appears part of what drove the FDA’s decision to exclude pharmacists from having prescriptive authority had to do with the novel antivirals’ side effect profiles, drug interactions, contraindications, and dosing adjustment requirements with certain pre-existing conditions – the very areas in which pharmacists have exceptional clinical training and subject matter expertise. It may be time to re-educate regulators on who we are as pharmacists and what value we bring to care teams since we have long been recognized as The Medication Experts. Fortunately, we have many local, state, and federal advocates as well as virtually all pharmacy professional associations working hard to convince the FDA to reconsider its position.

The relentless involvement of independent and community pharmacies to provide COVID-19 vaccines and testing over the past year and half have largely saved the US from a much more devastating and long-lasting pandemic. Community pharmacies have been the cornerstone of patient access to medication and general health and wellness information in countless American neighborhoods for more than a century, and pharmacists continue to rank atop lists of most trusted professionals. Much of this has to do with ethics and honesty, but pharmacists are unique in that they are also seen as very accessible and trustworthy. As such, it is imperative that patients in every community be afforded the ability to walk into their neighborhood pharmacy, receive COVID-19 testing and any necessary treatment in one fell swoop. Without enabling these community pharmacies to have the autonomy they need, the patient experience will go something like this:

1. Patient reports to community pharmacy for COVID testing
2. Patient tests positive and requires antiviral treatment
3. Patient is referred to primary care provider (it is estimated that approximately 25% of Americans report they do not have a PCP₁)
4. Patient makes appointment with PCP to either establish care and/or report COVID test results
5. Provider prescribes antiviral to patient’s preferred community pharmacy
6. Patient returns to community pharmacy to fill prescription for antiviral.

Meanwhile, with all of these extra hoops the system makes the patient jump through, time is ticking – the patient could be getting sicker and exposing others, which could lead to further community disease spread. And given the antiviral(s) must be initiated within 5 days of symptom onset, same day test and treat is really the only practical solution that prioritizes patient care and public health. Nationwide, reports of life-saving antivirals sitting on pharmacy shelves with pharmacists having no pathway to dispense them to patients in need due to fractures in our system are becoming far too commonplace. Identifying and partnering exclusively with America’s largest chain “big box” pharmacies severely restricts patient access, and the Administration should be inclusive of independent and community pharmacies willing to participate in order to broaden the footprint of this life-saving program.

Up until now, most states report that Molnupiravir supply has far outpaced Paxlovid availability. In WA, locations eligible to procure these antivirals were double for Molnupiravir compared to Paxlovid, with nearly 3 times more Molnupiravir doses having been ordered. We’ve gotten news that imbalance in allocations is actively being addressed as more partner sites are being approved and allocated additional Paxlovid doses. However, given the early reports that Paxlovid’s efficacy appears far and away greater than Molnupiravir’s, it will likely be deemed the more preferred of the two options in patients who meet all criteria for administration. Thus, the ramp up in production and distribution of Paxlovid is imperative and should coincide with a quickly-approaching expected uptick in community spread post COVID-19 mandates.

Even if the aforementioned hurdles are overcome, a big barrier for community pharmacies to expanding into this space is the costs associated with providing this care. Declining pharmacy reimbursement rates are multifactorial and a squeeze that our profession has been challenged with for many years; however, COVID antivirals are unique in that the reimbursement model will require plans to pay a dispensing fee only versus paying the ingredient cost plus dispensing fees since the federal government is supplying the pharmacies the antivirals free of charge. But given that it costs a pharmacy approximately $12.50 on average to dispense one prescription,₂  pharmacies must rely on drug markup and dispensing fees to keep their doors open and stay competitive. In this memo , the federal government (CMS) directed Part D pharmacy benefit managers (PBMs) to pay dispensing fees that are “sufficient to ensure eligible patients can readily access these drugs at available pharmacies” and that the fees “may be higher than a sponsor’s usual negotiated dispensing fees given the unique circumstances” of the pandemic.₃ But when left to the private sector without clear parameters and required minimums, neither directive can be truly achieved and instead is leading pharmacies to continue shouldering the costly care of COVID-19. Comparatively, the federal government’s dispensing fee for uninsured patients is $12, while many Medicaid programs are paying upwards of $10. Early reports indicate that commercial pharmacy benefit managers (PBMs) are paying in the $1 to $10 dispensing fee per prescription range. This doesn’t even begin to cover the costs associated with providing community access to these drugs. Further, given that these antivirals are new to the market, require in-depth medical history evaluation and drug-interaction review, and necessitate individualized patient consultation, these activities will likely take pharmacists away from performing other duties for upwards of 30-45 minutes per patient depending on the complexity. Many pharmacies are still operating leaner than they would like since increased workload from COVID hasn’t subsided, and burnout rates reported among pharmacy personnel are still concerningly high. None of these realities are factored into the losses these pharmacies will experience by continuing to serve patients in this capacity without a new payment methodology. Across the country, there are reports of many small, independent pharmacies making the decision to opt out of ordering or stocking these medications as they simply cannot afford to take the financial hit. This will disproportionately affect patients in underserved, rural communities and gum up overburdened hospitals and urgent care centers – running counter to the very intent of the test-to-treat program. Many pharmacists and professional advocacy groups are petitioning the government to instate a flat reimbursement fee of $40 (same as COVID vaccine rate), at least temporarily, to encourage community pharmacy participation without hamstringing their financial solvency and recognize the indispensable role they play in providing critical access to COVID antiviral distribution.

Beleaguered pharmacy care teams are finding ways to get patients what they need and providing high-quality care regardless of reimbursement or compensation because that’s who we are at our core. We would rather have the process for patients be functional even if we have to bear the brunt of the effort because other alternatives generate waste and contribute to delays in care and resultant patient harm. The implementation plan in its current form is simply unsustainable; since pharmacies serve as the primary intersection between care and cure, we need federal support and for our voices to matter

COVID restrictions are lifting everywhere in various stages as I write this, and what the past 2 years should have taught us all is that as we start to slowly return to pre-pandemic life, we will undoubtedly see an uptick of community COVID spread, the possible arrival of new variants, and an increased need for readily-available, streamlined antiviral access in addition to the mainstay of vaccinations. Timing is everything – it’s imperative we get this Test-to-Treat initiative right at the outset. I believe that with a little course correction, it holds the promise of brighter, healthier days ahead.

References:

1. Levine DM, Linder JA, Landon BE. Characteristics of Americans With Primary Care and Changes Over Time, 2002-2015. JAMA Intern Med. 2020;180(3):463–466. doi:10.1001/jamainternmed.2019.6282
2. National Community Pharmacists Association. (2020, March 2). Pharmacy Reimbursement Modernization Needed, Report Says. Https://Ncpa.Org. Retrieved March 8, 2022, from https://ncpa.org/newsroom/news-releases/2020/03/02/pharmacy-reimbursement-modernization-needed-report-says
3. Brooks-LaSure, Chiquita. “Permissible Flexibilities Related to Oral Antiviral Drugs for Treatment of COVID-19 That May Receive U.S. Food and Drug Administration Emergency Use Authorization and Are Procured by the U.S. Government.” Received by All Part D Sponsors, Cms.gov, 23 Nov. 2021, https://www.cms.gov/files/document/oralantiviralguidance11232021.pdf. Accessed 2022.