PCORI Biweekly COVID-19 Scan: Baricitinib and Remdesivir, Mobile Health Clinics (December 10-23, 2020)
The Briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.
Good news! The first vaccine doses have been given, and many more are being delivered and prepared for patients right now. However, the pandemic is far from over. Infection rates are high. In the United States, more than 300 000 COVID-19–related deaths have been reported. In addition, effective treatments for COVID-19 remain few and often far between (see Topics to Watch for interventions to address treatment and testing).
The virus continues to take a toll on the mental health of those who had it and those left behind by the death of a loved one. Many critically ill patients with COVID-19 have experienced delirium. Researchers are hoping to follow up on those who have survived to see whether short-term confusion associated with COVID-19 might lead to long-term dementia. Disruptions to the grieving process and the impact of lives lost could have long-term societal and individual mental health impacts. In addition, the extended nature of the COVID-19 pandemic has placed a significant strain on mental health services around the world.
All eyes are—understandably—on the vaccines to help us return to some sense of normalcy, but the fight is not over. Continued vigilance by all against COVID-19 and its many possible deleterious effects on individual and public health remains paramount.
ECRI Horizon Scanning has selected the topics below as those with potential for impact relative to COVID-19 in the United States within the next 12 months. All views presented are preliminary and based on readily available information at the time of writing.
Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.
Combination Baricitinib and Remdesivir to Treat COVID-19
At a Glance
- Baricitinib and remdesivir constitute the first combination therapy to receive an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Granted on November 19, this combination therapy is for treating hospitalized adult and pediatric patients with COVID-19 requiring respiratory support.
- Baricitinib is an oral drug that purportedly reduces COVID inflammation by blocking proinflammatory signaling. Remdesivir is an intravenous drug that directly inhibits the replication of SARS-CoV-2, the virus that causes COVID-19, and was previously approved by the FDA for treating patients hospitalized with COVID-19.
- The Adaptive COVID-19 Treatment Trial (ACTT-2) demonstrated that patients taking the drug combination experienced improved recovery time, better clinical status at day 15, lower progression to ventilation, and decreased death compared with remdesivir alone.
- Based on available dosing information and pricing, 1 treatment course of the drug combination for COVID-19 might cost up to $8300.
Baricitinib for use in combination with remdesivir received an EUA from the FDA on November 19, 2020. The EUA defines its use for treating COVID-19 in hospitalized adult and pediatric patients requiring respiratory support, including supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. The EUA decision was based on data reported by the developer from the ACTT-2 trial, which demonstrated that patients taking the drug combination, compared with remdesivir alone, experienced improved recovery time (7 versus 8 days), better clinical status at day 15, lower progression to ventilation (23% versus 28%), and decreased death (4.7% versus 7.1%).
Baricitinib and remdesivir constitute the first combination therapy to receive an EUA from the FDA for COVID-19. Baricitinib is an oral Janus kinase inhibitor intended to reduce inflammation in COVID by blocking a proinflammatory signaling pathway. It is FDA-approved to treat moderate to severe rheumatoid arthritis. It is the first drug acting on an inflammatory pathway in the body to receive an EUA for COVID-19. Remdesivir is an intravenous antiviral that the FDA approved on October 22, 2020, to treat patients hospitalized with COVID-19 and works by inhibiting replication of the novel coronavirus.
Based on available dosing information and pricing, up to 14 days of treatment with baricitinib costs about $2200. Based on prescribing information and pricing, up to 10 days of treatment with remdesivir costs about $6100, making the cost of a single course of the combined regimen up to $8300.
Baricitinib and remdesivir together is the first combination treatment for COVID-19 to receive an EUA from the FDA. It combines primary anti-inflammatory and antiviral mechanisms of action and might treat patients with severe disease better than a single mechanism alone. However, some experts have questioned the appropriateness of adding baricitinib to remdesivir instead of dexamethasone given the cost and efficacy data available.
Early feedback from ECRI internal stakeholders commenting on this topic thought that, although the drug combination’s results might be incremental to remdesivir alone, it is arriving at a critical time. Hospitals are overcrowded nationwide. Reduced mortality risk combined with a 1-day earlier hospital discharge or 1 fewer patient who needs mechanical ventilation would likely make a difference in population health outcomes and decrease the burden on the health care system during this critical surge. Additionally, effective COVID-19 treatments will still be needed during and after widespread distribution and administration of COVID-19 vaccines. Combination baricitinib and remdesivir is a relatively inexpensive treatment that might help bridge the gap. However, stakeholders warned that limited supply and access to baricitinib might lead to disparities.
- Category: Treatments
- Areas of potential impact: Patient outcomes, health care delivery and process, health care costs
Mobile Health Clinics to Increase Access to COVID-19 Health Services
At a Glance
- Mobile health clinics, customized motor vehicles that travel to communities to provide health care, might help meet shortages in COVID-19 health services, including access to testing and treatment.
- In addition to existing infrastructure, companies are offering mobile clinics for rent or sale. Aardvark Mobile Health vehicles (Aardvark Mobile Tours, LLC) offer mobile health trucks that are equipped with proper positive and negative air pressure and the ability to become certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) up to biosafety level 2.
- Mobile health clinics can be used for rapid testing, vaccinations, and health screenings. With 2 to 4 testing windows, staff can administer up to 400 tests a day, comparable with drive-thru testing facilities, which are inaccessible to people using public transportation.
As the COVID-19 pandemic continues, many underserved and rural communities, as well as COVID-19 hotspots around the United States, still face challenges surrounding access to testing and treatment. An estimated 2000 mobile clinics, customized motor vehicles that travel to communities to provide health care, are active in the United States. These mobile clinics might help meet demand for COVID-19 health services.
In addition to existing mobile clinic infrastructure, companies are offering mobile clinics for rent or sale. For example, Aardvark Mobile Health vehicles (Aardvark Mobile Tours, LLC, Conshohocken, Pennsylvania) offers mobile health trucks that are equipped with proper positive and negative air pressure and the ability to become CLIA certified up to biosafety level 2. The vehicles can be used for rapid testing, vaccinations, and health screenings. The easily sterilized areas and partitions, which separate the nurses conducting the tests from the individuals receiving them, help maintain the safety of all those involved. Two to 4 testing windows allow nurses to give up to 400 tests a day, similar to drive-thru testing facilities, which are inaccessible to people relying on public transportation.
Mobile health clinics might increase access to COVID-19 testing in underserved hot spots and rural communities. Ease of movement and set-up of mobile testing might improve implementation of testing initiatives in scattered or harder-to-reach populations.
Early feedback from ECRI internal stakeholders suggested that mobile health clinics might greatly benefit rural areas where COVID-19 cases are surging and health facilities are lacking. Accessible care could reduce health care disparities and costs by increasing diagnostic care, allowing earlier intervention in the disease course. Stakeholders noted that although these clinics might improve accessibility to care, the usability of mobile clinics hinges on the availability of health care workers to staff these units, given the current health care staff shortages and burnout, even in highly populated regions. Also, economic incentives or resistance to unconventional medical care in rural areas might promote the use of mobile health units in urban areas, increasing disparities in rural areas.
- Categories: Systems and management
- Areas of potential impact: Patient outcomes, population health, health care delivery and process, clinician and/or caregiver safety
Horizon scanning is a systematic process that serves as an early warning system to inform decision makers about possible future opportunities and threats. Health care horizon scanning identifies technologies, innovations, and trends with potential to cause future shifts or disruptions—positive or negative—in areas such as access to care, care delivery processes, care setting, costs of care, current treatment models or paradigms, health disparities, health care infrastructure, public health, and patient health outcomes.
The PCORI Health Care Horizon Scanning System (HCHSS) conducts horizon scanning to better inform its patient-centered outcomes research investments. Initially, PCORI defined the HCHSS project scope to focus on interventions with high potential for disruption in the United States in 5 priority areas: Alzheimer’s disease and other dementias, cancer, cardiovascular diseases, mental and behavioral health conditions, and rare diseases. In addition, the system captures high-level disruptive trends across all clinical areas, which may lead PCORI to expand the project scope to include other priority areas in the future.
In early 2020, the COVID-19 pandemic created a fast-moving, widespread public health crisis. In May 2020, PCORI expanded its HCHSS to elucidate the landscape of potentially impactful applications for COVID-19. The HCHSS COVID-19 supplement scans for, identifies, monitors, and reports on emerging and available COVID-19-related treatments, diagnostics, preventive measures, management strategies, and systems changes with potential for high impact to patient outcomes—for individuals and populations—in the United States in the next 12 months.
The HCHSS COVID-19 supplement produces 3 main outputs:
- Biweekly COVID-19 Scans (eg, this document) provide ECRI Horizon Scanning with a vehicle to inform PCORI and the public in a timely manner of important topics of interest identified during ongoing scanning and topic identification or through the ECRI stakeholder survey process.
- Status Reports (quarterly) briefly list and describe all COVID-19-related topics identified, monitored, and recently archived.
- High Impact Reports (every 4 months) highlight those topics that ECRI internal stakeholders (eg, physicians, nurses, allied health professionals, public health professionals, first responders, health systems experts, clinical engineers, researchers, business and finance professionals, and information technology professionals) have identified as having potential for high impact relative to COVID-19 in the United States.
Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.
We welcome your comments on this Scan. Send them by email to [email protected].
Posted: December 30, 2020
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