In the coming days and weeks, the FDA will decide whether to provide emergency use authorization to two new antiviral pills for COVID-19 from Merck and Pfizer, which have shown moderate or strong efficacy (respectively) in studies to date, in the reduction of hospitalization or death. The decision on Merck's pill -- molnupiravir -- will likely come first, following a vote yesterday from an expert committee narrowly recommending FDA authorize the treatment for high-risk adults.
Unlike prior treatments, which required injections or were only used to treat hospitalized patients, these medications -- if one or both are authorized -- would be available as simple oral medications. Although the drugs won't reduce the spread of the virus, they may offer a path out of the extreme death and disease caused by the virus.
These drugs have been rightfully hailed as a medical breakthrough. Despite the full analysis of molnupiravir showing the drug isn't as effective as originally believed, the efficacy of the Pfizer drug still appears high. With tens of millions of Americans still unvaccinated and case numbers ticking up again in parts of the country, these treatments have the potential to save many lives.
As with every medical breakthrough, however, there is the looming problem of lack of access. The pandemic exposed time and again the unequal access and unequal outcomes in the American healthcare delivery system. It was critical to scale testing to anyone who needed it in the early days, and we couldn't. It's critical now to get shots in arms, but we're still struggling to do so. Our broken healthcare delivery system -- not scientific innovation -- is the bottleneck.
These new antiviral drugs will challenge our healthcare delivery system even more. To be effective, individuals must take them within the first 3 to 5 days of symptom onset, with even higher efficacy if they are taken sooner. Like nearly all new drugs, the medication will require a physician's prescription. That sounds simple enough: if someone has COVID-19 symptoms, they can get tested, and if positive, their doctor orders the medication. But the reality isn't that simple.
As a practicing primary care physician for the underserved, I know all too well the realities on the ground. A full don't have a primary care physician. Even for those with access, the wait time for primary care is often days to weeks -- well outside of the narrow time window for the antiviral medications. In many parts of the country, rapid antigen tests for COVID-19 are out of stock and the wait time to process PCR tests is 2 to 3 days.
The problem is even greater in socially marginalized communities with large populations of people of color, members of the LGBTQ+ community, and those in rural areas without nearby care -- the same populations disproportionately affected by COVID-19 cases and death, and with the lowest rates of vaccination.
To overcome these challenges, we need to pair biomedical innovation with delivery system innovation. We need new care models to improve timely and equitable access, just like we did by administering COVID-19 tests in drive-thrus and community testing sites, and by getting shots into arms at pop-up vaccination sites, nursing homes, and pharmacies.
Here are the steps we need to take immediately:
Expand access to telehealth. Telehealth's on-demand nature makes it highly suitable to distribute the antiviral medications (if authorized) within the requisite 3- to 5-day window from symptom onset or diagnosis. To further reduce costs, physicians can prescribe the medication without a synchronous visit, which means a single physician can care for hundreds of patients in a day instead of dozens. Telehealth dramatically expanded during the pandemic, but restrictions such as poor reimbursement and requiring physicians to hold licenses in the state in which they are practicing are already limiting access to medically underserved areas. Moreover, the digital divide -- broadband connectivity, device access, and digital literacy -- will need to be addressed to ensure telehealth improves equitable access to care, or at least does not worsen it.
Enable non-physicians to prescribe the pill(s). If someone tests positive for COVID-19 at a pharmacy or community testing site they would need to make an appointment to see a doctor to get the medication prescribed (if authorized). This creates unnecessary delays in care and adds the expense and inconvenience of a doctor's visit, which disproportionately impacts socially marginalized communities. Instead, we should allow pharmacies, community testing sites, and public health departments to dispense the medication directly -- without a physician visit -- based on a positive COVID-19 result and a questionnaire to understand their medical history and indications for treatment.
Consider fast-tracking the medications as over-the-counter (OTC). The typical process for a prescription drug to become available OTC is usually 3 to 6 years. We don't have that long. Generally, drugs can become OTC if they can be used safely and effectively without a healthcare provider's instruction, have a low potential for misuse and abuse, and are used for self-diagnosed conditions. Just like people can now walk into a pharmacy and pick up a COVID-19 test, they should be able to get antiviral medication for COVID-19 on the shelf. More safety and efficacy testing for the medications will need to be completed before this can happen, but speeding up the typical OTC approval process is paramount to access.
These delivery system innovations will need to be enabled by price support. The medications are expected to cost hundreds of dollars per treatment. While insurance companies will likely cover it, many Americans are underinsured or uninsured.
The country rallied to get shots in arms. It's time for us to rally again to get pills in hands.
is a practicing primary care physician, author of , and chief medical officer at Accolade, a personalized healthcare company, which provides telemedicine services to employers and consumers.