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Horizon Scanning Status Report, March 2021, Volume 3, Issue 1

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Horizon Scanning Status Report, March 2021, Volume 3, Issue 1 PCORI Health Care Horizon Scanning System Volume 3 Issue 1 Horizon Scanning Status Report March 2021 Prepared for: Patient-Centered Outcomes Research Institute 1828 L St., NW, Suite 900 Washington, DC 20036 Contract No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12 Prepared by: ECRI Institute 5200 Butler Pike Plymouth Meeting, PA 19462 Investigators: Randy Hulshizer, MA, MS Jennifer De Lurio, MS Marcus Lynch, PhD, MBA Damian Carlson, MS Christian Cuevas, PhD Andrea Druga, MSPAS, PA-C Misha Mehta, MS Prital Patel, MPH Brian Wilkinson, MA Donna Beales, MLIS Eloise DeHaan, BS Eileen Erinoff, MSLIS Kariann Hudson, MEd Madison Kimball, MS Maria Middleton, MPH Melinda Rossi, BA Kelley Tipton, MPH Rosemary Walker, MLIS Andrew Furman, MD, MMM, FACEP March 2021 Statement of Funding and Purpose This report incorporates data collected during implementation of the Patient-Centered Outcomes Research Institute (PCORI) Health Care Horizon Scanning System, operated by ECRI under contract to PCORI, Washington, DC (Contract No. MSA-HORIZSCAN-ECRI-ENG-2018.7.12). The findings and conclusions in this document are those of the authors, who are responsible for its content. No statement in this report should be construed as an official position of PCORI. An intervention that potentially meets inclusion criteria might not appear in this report simply because the Horizon Scanning System has not yet detected it or it does not yet meet inclusion criteria outlined in the PCORI Health Care Horizon Scanning System: Horizon Scanning Protocol and Operations Manual. Inclusion or absence of interventions in the horizon scanning reports will change over time as new information is collected; therefore, inclusion or absence should not be construed as either an endorsement or rejection of specific interventions. A representative from PCORI served as a contracting officer’s technical representative and provided input during the implementation of the Horizon Scanning System. PCORI does not directly participate in horizon scanning or assessing leads or topics and did not provide opinions regarding potential impact of interventions. Financial Disclosure Statement None of the individuals compiling this information has any affiliations or financial involvement that conflict with the material presented in this report. Public Domain Notice This document is in the public domain and may be used and reprinted without special permission. Citation of the source is appreciated. All statements, findings, and conclusions in this publication are solely those of the authors and do not necessarily represent the views of PCORI or its Board of Governors. This publication was developed through a contract to support PCORI’s work. Questions or comments may be sent to PCORI at [email protected] or by mail to 1828 L Street, NW, Suite 900, Washington, DC 20036. ©2021 Patient-Centered Outcomes Research Institute. For more information see www.pcori.org. Suggested citation: Hulshizer R, De Lurio J, Lynch M, et al. PCORI Health Care Horizon Scanning System: 2021 Horizon Scanning Status Report: Volume 3, Issue 1. Patient-Centered Outcomes Research Institute; March 2021. Prepared by ECRI under Contract No. MSA- HORIZSCAN-ECRI-ENG-2018.7.12. HORIZON SCANNING STATUS REPORT ● MARCH 2021 i Preface The PCORI Health Care Horizon Scanning System (HCHSS) conducts horizon scanning of new and emerging health care technologies and innovations with high potential for disruption to the current standard of care to better inform patient-centered outcomes research investments at PCORI. The HCHSS provides PCORI with a systematic process to identify and monitor technologies and innovations in health care that are in PCORI’s priority areas of interest and to create an inventory of interventions that have the highest potential for disruption to the current standard of care in terms of patient outcomes, health disparities, care delivery, infrastructure, access, and/or costs. It is also a tool for the public to identify information on selected new health care technologies and interventions. Any investigator or funder of research can use the PCORI HCHSS to help select research topics. The health care technologies and innovations of interest for horizon scanning are those that have yet to become part of established health care practices. These interventions are in late stages of research and development or very early phases of adoption, except in the case of new applications of already-diffused technologies. Consistent with the definitions of health care interventions provided by the National Academy of Medicine and the Federal Coordinating Council for Comparative Effectiveness Research, PCORI is interested—at present—primarily in innovations in drugs and biologics, medical devices, and procedures within its selected priority areas of interest for horizon scanning. PCORI may choose, upon future consideration, to expand its focus to include a wider range of interventions (eg, systems innovations). Horizon scanning involves 2 processes. The first is identifying and monitoring new and evolving health care interventions that purportedly hold potential to diagnose, treat, or otherwise manage a disease or condition or to improve care delivery. The second is analyzing the relevant health care context in which these new and evolving interventions would exist to understand their potential for disruption to the standard of care. The goal of the PCORI HCHSS is not to predict future utilization and costs of any health care intervention; rather, the reports are intended to help inform and guide planning and prioritization of research resources. This edition of the Status Report is the first of 4 volumes planned for 2021 and lists topics (ie, interventions intended for a specific use within a specific patient population) that have been identified and are being monitored. Content in this report was current as of March 15, 2021. The reader should be aware that, although forward-looking statements were accurate as of this currency date, no warranty is provided regarding the accuracy of these statements at the time of publication. We welcome comments on this report. Send comments by mail to William Lawrence, MD, MS, Patient-Centered Outcomes Research Institute, 1828 L St, NW, Suite 900, Washington, DC 20036, or by email to [email protected]. HORIZON SCANNING STATUS REPORT ● MARCH 2021 ii Contents Introduction ............................................................................................................... 1 Section 1. Alzheimer’s Disease and Other Dementias: 11 Topics .............................. 7 Table 1.1. Currently Monitored Alzheimer’s Disease and Other Dementias Topics: 10 Topics .......... 7 Table 1.2. Alzheimer’s Disease and Other Dementias Topics Archived Since Last Status Report: 1 Topic .....................................................................................................................................................17 Section 2. Cancer: 91 Topics..................................................................................... 18 Table 2.1. Cancer Topics Added Since Last Status Report: 6 Topics ...................................................18 Table 2.2. Currently Monitored Cancer Topics: 80 Topics ...................................................................24 Table 2.3. Cancer Topics Archived Since Last Status Report: 5 Topics................................................99 Section 3. Cardiovascular Diseases: 17 Topics....................................................... 104 Table 3.1. Currently Monitored Cardiovascular Diseases Topics: 17 Topics ................................... 104 Section 4. Mental and Behavioral Health: 18 Topics ............................................. 121 Table 4.1. Mental and Behavioral Health Topics Added Since Last Status Report: 1 Topic ........... 121 Table 4.2. Currently Monitored Mental and Behavioral Health Topics: 17 Topics .......................... 122 Section 5. Rare Diseases: 141 Topics ..................................................................... 139 Table 5.1. Rare Diseases Topics Added Since Last Status Report: 20 Topics .................................. 139 Table 5.2. Currently Monitored Rare Diseases Topics: 114 .............................................................. 159 Table 5.3. Rare Diseases Topics Archived Since Last Status Report: 7 Topics ................................. 269 Section 6. Potentially Disruptive Trends: 37 Trends .............................................. 274 Table 6.1. Trends Added Since Last Status Report: 13 Trends ......................................................... 274 Table 6.2. Currently Monitored Trends: 21 Trends ........................................................................... 283 Table 6.3. Trends Archived Since Last Status Report: 3 Trends ....................................................... 298 Appendix. Abbreviations and Acronyms ................................................................ 301 HORIZON SCANNING STATUS REPORT ● MARCH 2021 iii Introduction The PCORI Health Care Horizon Scanning System (HCHSS) identifies and monitors topics (ie, interventions intended for a specific use within a specific patient population) likely to be available for clinical use (ie, outside the research environment) within 3 years. For interventions subject to US Food and Drug Administration (FDA) regulatory processes, we consider those in phase 3 trials or phase 2 trials with special FDA designations (eg, Fast Track, Breakthrough Therapy) likely to accelerate time to approval.
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