The goal is clearly articulated in President Joe Biden’s State of the Union address: Test to Treat. He challenged America to “get back to work and fill our great downtowns again.” He was no longer declaring independence from the virus, adding, “I cannot promise you a new variant won’t come. But I can promise you we’ll do everything within our power to be ready if it does.”
The opportunity to fulfill that promise is here. Weeks later, in the shadow of the BA.2 variant, the country is still averaging an unacceptable 600 daily COVID-19 deaths, 1,500 new hospitalizations, and 2,000 patients in the ICU. This is a major impediment to a safe return to normal lives.
The good news is this challenge can be met head-on by redeploying our existing formidable public health and medical arsenal. With vaccination rates hitting a wall and boosters plateauing in effectiveness, leaning on new highly-effective oral treatments is the single most critical strategic step to allow society to return to a safe new normal. With early treatment of those who get sick and continuing to focus on decreasing transmission, we can sustainably tip the pandemic scales in our favor. With a federal initiative the scale of our vaccination effort, our conservative estimate is that we could achieve at least a 50 percent sustained decrease in both national mortality and hospitalizations.
Ensuring availability of treatment for all high-risk people, combined with at-home tests, is our pandemic response get-out-of-jail card. However, too few people today know of or are able to get these life-saving oral medications. President Biden was prescient when he launched the Test-to-Treat initiative in his address. It makes free treatment available to those eligible who can receive a diagnosis from a medical provider at a “one-stop” approved Test-to-Treat facility, and can be filled only where the medicines are in-stock. In practice, perhaps less than 10 percent of pharmacy outlets have the providers and clinics that can promptly evaluate and deliver the treatment all in one location. The resulting paradox is that while nine out of 10 Americans live within 5 miles of a pharmacy, millions of treatments, more than half of the available supply, is sitting on shelves unused, because of difficulty accessing this medical diagnostic pathway.
To fully capture its powerful life-saving potential with the urgency required, significant enhancements to this program must be made and barriers removed. There are daunting but surmountable manufacturing, logistical, regulatory and financing challenges. But there is precedent for overcoming these in the prior federal vaccine and at-home rapid testing programs. We can’t wait months to make these life saving medicines available to vulnerable Americans. Here’s a six-point roadmap of how we can achieve this now:
First, set a clear initiative goal
The goal of a national Test-to-Treat (T3) program must be to safely get the treatment course of pills in the mouths of every eligible COVID-19 positive person within 3 days of onset of symptoms. The country’s 80 million vulnerable population stands to benefit the most from T3. Although less than a quarter of the population, they suffer over 80 percent of all deaths and hospitalizations. For them these pills are a lifeline.
Second, expand program eligibility
The “vulnerable” are defined as those over age 65, immunocompromised or who have specific underlying conditions. The oral antivirals are indispensable to this population because their vaccine effectiveness wanes most quickly. They are reliant on these medications when they become sick.
When taken within the critical first 3 days of symptom onset, Pfizer’s oral antiviral Paxlovid can lower the risk of severe disease by almost 90 percent. Merck’s Lagevrio is an alternative that lowers risk by 30 percent. Both are taken at home as a 3-5 day course of pills. Equitable and timely access to these treatments is the delivery highway to get to our new normal while cutting down on hospitalizations and deaths even as some community transmission inevitably continues.
As supply increases, extending coverage to those less vulnerable will have additional benefits: reduced hospitalizations, enhanced virus clearance in the community, and further reduction in transmission. This will diminish the need for isolation and allow faster return to work or school. As more data accrues, we optimistically may find that oral antivirals could cut the risk of long COVID-19, too.
Third, leverage reach and speed through a new at-home program
This requires a well-choreographed one-stop system: 1) rapid test diagnosis of COVID-19; 2) an evaluation and, if medically indicated, a prescription by an authorized medical provider; 3) rapid dispensing of the medicine through a local pharmacy, health-care provider, or direct delivery to the home.
The CDC recommends that people who test positive stay home so that they do not spread the virus. Facility-based T3 requires infectious people to leave home while sick, often using public transport, and to enter crowded health facilities. A dangerous formula that could be avoided with at-home testing.
With the limitations of this facility-based system, the only way to realize the goal of reliably and rapidly getting oral treatments to 80 million eligible Americans is to supplement it with a new federally-authorized at-home user channel. This could immediately expand T3 from the current sparse 2,000 national locations to hypothetically every household in America. It would take advantage of the same distribution channels that the government already has in place to deliver hundreds of millions of free rapid tests to American homes. This would be an exponential force-multiplier.
The components of a necessary one-stop, verified and safe at-home T3 program already exist. “T3-enabled” QR coded rapid test boxes could be used anywhere to take a virtually-supervised telehealth test. If positive and meeting medical indications, the patient could be immediately evaluated for and prescribed treatment. The medication would be delivered from the nearest supplier pharmacy. All from the convenience of the home and with a high level of quality, safety, security, and timeliness. Patients can start treatment a few hours from symptom onset and gain maximum health benefit with the least friction.
Several testing companies have already demonstrated proof-of-concept feasibility of this at-home delivery model with states, employers and individuals. (One of these is eMed where Dr. Mina is the Chief Science Officer.) Another key public health benefit of at-home T3 is that it incentivizes individuals to report results, both positive and negative, automatically and in real-time to public health agencies without relying on unverifiable self-attestation. This helps close a major gap in epidemic surveillance that results from the ubiquity of self tests that go unreported.
Fourth, ensure treatment is provided safely
Drugs like Paxlovid come with potential significant safety concerns. Side-effects and interactions with other prescribed drugs are not uncommon and must be evaluated by a qualified health professional. Whether at-home or on-site, a thorough assessment of current medications and relevant past medical history is obligatory to assure safe treatment. As this is already part of the telehealth evaluation protocol, high standards of safety should be met.
Fifth, stand-up an enhanced federal program
The only viable solution to fulfill the promise of a program of this scale is through government leadership. The complexity and scope of the required end-to-end supply chain management, multiple clinical, retail and at-home distribution channels, enabling regulatory approvals and large-scale financial backing makes this enhanced T3 initiative a leading candidate for an Operation Warp-speed type government-private sector partnership. This initiative has the potential to replicate the success of the vaccine and at-home rapid test programs that have earlier turned the tide of the pandemic.
Sixth, the incalculable human and financial return-on-investment
We estimate the annual cost of the enhanced T3 program to cover the 80 million vulnerable Americans to be in the $10 billion range. This “back-of-the-envelope” forecast is based on a high-end estimate of 20 million symptomatic cases of COVID-19 per year, a $500 per treatment drug cost, and $50 per eligible person for distribution and support costs.
The tangible cost offsets relate to savings from medical visits, hospitalizations and deaths avoided. The average cost to Medicare for a COVID-19 hospitalization is approximately $21,000, and $42,000 for a private payer. The projected cost savings from avoided hospitalizations alone is about 15 billion dollars. Additional economies will be captured through reducing outpatient clinic visits, limiting transmission, and avoiding more costly on-site testing. In addition there are incalculable “soft gains” in individual and societal mental and physical well-being, productivity and related economic benefits.
Test to Treat is by far the highest return-on-investment in the endemic phase of “living with the virus.” With the political will, this roadmap to a successful program can be realized. Just as with vaccine development the urgency and time value is huge—we must stand-up these enhancements to T3 so that every eligible American starts treatment within 3 days of symptom onset.
COVID-19 is both seasonal and cyclical. It will surge again and again in the not too distant future. Now is the time to invest in “endemic preparedness.” We can avoid a repeat of health system overload, business closures, social distancing, virtual schooling, and, most importantly, avoidable lives lost. Let’s play our societal get-out-of-jail card.
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Contributor: Steven Phillips and Michael Mina