Response to the COVID-19 pandemic is driving health care away from acute care settings. As people stay home to slow the spread of coronavirus, patients are also recovering at home from a variety of illnesses. Stakeholders recognized the need for remote medical visits early, prompting regulators and insurers to loosen regulations​ and reimbursement restrictions that traditionally limited telemedicine.

Health care providers are limited in what they can do over a video or phone call (eg, sampling and testing). To that end, a number of companies seek to innovate home-based sampling. For example, Pixel by LabCorp offers a do-it-yourself nasal swab kit (see “COVID-19 self-collection test kit” in Topics to Watch), but given how deep a nasopharyngeal swab needs to go and how much discomfort some people experience with nasopharyngeal swab sampling, it is likely that more patient-friendly home sampling and testing methods will come to light in the next few months.

In addition to home health care trends, manufacturers continue attempting to repurpose drugs to address COVID-19. Because patients are experiencing a wide variety of disease symptoms, researchers are exploring various mechanisms of action, and as many as 115 drugs approved by FDA for other indications are being tested for COVID-19.

Description

Anakinra (Kineret) is an IL-1 receptor antagonist FDA approved for treating rheumatoid arthritis and cryopyrin-associated periodic syndromes that is under study for treating ARS due to COVID-19. Some patients with COVID-19 develop an inflammatory response that can lead to acute lung injury and respiratory insufficiency. Investigators are studying whether existing anti-inflammatory drugs can improve health outcomes in these patients. Anakinra is a competitive antagonist of the cytokine receptor IL-1, which normally drives proinflammatory signaling.

Results were recently published from a small, retrospective study of patients with COVID-19, moderate-to-severe ARDS, and hyperinflammation who were treated with anakinra in addition to SoC. At 21 days, survival was 90% in patients (n = 29) receiving high-dose anakinra (5 mg/kg, twice daily) plus SoC compared with survival of 56% in a cohort of patients (n = 16) receiving SoC alone.

Additionally, multiple studies involving anakinra treatment for patients with COVID-19 are registered at the US National Clinical Trials database, including a large multicenter randomized trial in France ​(NCT04364009) with a primary completion date in September 2020.​​ Assuming that the cost of intravenous anakinra is the same as subcutaneous anakinra, this would be a daily cost of about $1320 to $1580.

Commentary

Anakinra (Kineret) is an IL-1 receptor antagonist FDA approved for treating rheumatoid arthritis and cryopyrin-associated periodic syndromes that is under study for treating ARS due to COVID-19. Some patients with COVID-19 develop an inflammatory response that can lead to acute lung injury and respiratory insufficiency. Investigators are studying whether existing anti-inflammatory drugs can improve health outcomes in these patients. Anakinra is a competitive antagonist of the cytokine receptor IL-1, which normally drives proinflammatory signaling.

Results were recently published from a small, retrospective study of patients with COVID-19, moderate-to-severe ARS, and hyperinflammation who were treated with anakinra in addition to SoC. At 21 days, survival was 90% in patients (n = 29) receiving high-dose anakinra (5 mg/kg, twice daily) plus SoC compared with survival of 56% in a cohort of patients (n = 16) receiving SoC alone.

Additionally, multiple studies involving anakinra treatment for patients with COVID-19 are registered at the US National Clinical Trials database, including a large multicenter randomized trial in France ​(NCT04364009) with a primary completion date in September 2020.​​ Assuming that the cost of intravenous anakinra is the same as subcutaneous anakinra, this would  be a daily cost of about $1320 to $1580.

• Area of Potential Impact: Patient outcomes
• Category: Treatments

Description

The Pixel by LabCorp COVID-19 self-collection test kit consists of a nasal cotton swab, a biohazard specimen bag, and an overnight shipping envelope. The kit permits​ at-home collection of a sample appropriate to perform a SARS-CoV-2 nucleic acid–based molecular diagnostic test for people with COVID-19 symptoms or for those who ​have had possible exposure to the virus.​ The test kit, by enabling early at home testing, purportedly reduces the risk of infected individuals transmitting the virus to others. Because the test ​kit does not require a clinician to collect a nasal specimen, it might also reduce the demand for personal protective equipment (PPE).

According to Laboratory Corporation of America Holdings (Burlington, North Carolina), the self-collection test kit will cost $119, but out-of-pocket costs may be waived for individuals deemed eligible by the company's survey. On April 21, 2020, FDA granted the self-collection test kit Emergency Use Authorization.

Commentary

The COVID-19 self-collection test kit might immediately increase the availability of coronavirus testing to people staying at home. It also might reduce the risk of transmitting SARS-CoV-2 to medical staff, other patients in health care facilities, and the general public. Reducing the number of office visits could also reduce PPE use in patient testing departments.

However, early responses from ECRI internal stakeholders raised concerns regarding patients’ ability and willingness to obtain an appropriate sample for testing. These factors could lead to substantial false-negative rates during testing. Stakeholders were also concerned that sample collection could put household members at risk of exposure to coronavirus from aerosols from swabbing or subsequent sneezing that frequently occurs after administering a swab.

• Area of Potential Impact: Patient outcomes, population health, clinician and/or caregiver safety, health care delivery and process
• Category: Screening and Diagnostics

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.