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Esketamine for the Treatment of Treatment-Resistant Depression: Effectiveness and Value

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Esketamine for the Treatment of Treatment-Resistant Depression: Effectiveness and Value Esketamine for the Treatment of Treatment-Resistant Depression: Effectiveness and Value Final Evidence Report June 20, 2019 Prepared for ©Institute for Clinical and Economic Review, 2019 The University of Illinois at Chicago College of ICER Staff and Consultants Pharmacy’s Center for Pharmacoepidemiology and Pharmacoeconomic Research* Steven J. Atlas, MD, MPH Daniel R. Touchette, PharmD, MA Associate Professor of Medicine Professor of Pharmacy Harvard Medical School, Boston Assistant Director, Center for Pharmacoepidemiology Director, Practice Based Research & Quality and Pharmacoeconomic Research Improvement University of Illinois at Chicago Division of General Internal Medicine Massachusetts General Hospital, Boston Nicole Boyer, PhD Research Fellow Foluso Agboola, MBBS, MPH University of Chicago Director, Evidence Synthesis Institute for Clinical and Economic Review Brian Talon, PharmD PhD Student University of Illinois at Chicago Katherine Fazioli Senior Research Assistant Bob G. Schultz, PharmD Institute for Clinical and Economic Review PhD Student and Research Fellow University of Illinois at Chicago Varun M. Kumar, MBBS, MPH, MSc Associate Director of Health Economics Institute for Clinical and Economic Review *The role of the University of Illinois at Chicago College of Ellie Adair, MPA Pharmacy’s Center for Pharmacoepidemiology and Program Manager Pharmacoeconomic Research is limited to the development of the cost-effectiveness model, and the resulting ICER reports do not Institute for Clinical and Economic Review necessarily represent the views of the UIC. David Rind, MD Chief Medical Officer Institute for Clinical and Economic Review Steve Pearson, MD, MSc President Institute for Clinical and Economic Review Date of Publication: June 20, 2019 Steven Atlas served as the lead author for the report. Foluso Agboola led the systematic review and authorship of the comparative clinical effectiveness section in collaboration with Katherine Fazioli and Noemi Fluetsch. Varun Kumar was responsible for oversight of the cost-effectiveness analyses and developed the budget impact model. Noemi Fluetsch and Madeline O’Grady coauthored the section on coverage policies. David Rind and Steve Pearson provided methodologic guidance on the clinical and economic evaluations. The role of the UIC modeling group is limited to the development of the cost-effectiveness model, and the resulting ICER reports do not necessarily represent the views of UIC. None of the authors above disclosed any conflicts of interest. ©Institute for Clinical and Economic Review, 2019 Page i Final Evidence Report – Esketamine for Treatment-Resistant Depression Return to TOC About ICER The Institute for Clinical and Economic Review (ICER) is an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs. Through all its work, ICER seeks to help create a future in which collaborative efforts to move evidence into action provide the foundation for a more effective, efficient, and just health care system. More information about ICER is available at http://www.icer-review.org. The funding for this report comes from government grants and non-profit foundations, with the largest single funder being the Laura and John Arnold Foundation. No funding for this work comes from health insurers, pharmacy benefit managers, or life science companies. ICER receives approximately 19% of its overall revenue from these health industry organizations to run a separate Policy Summit program, with funding approximately equally split between insurers/PBMs and life science companies. Janssen is the only life science company relevant to this review that participates in this program. For a complete list of funders and for more information on ICER's support, please visit http://www.icer-review.org/about/support/. About Midwest CEPAC The Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) – a core program of ICER – provides a public venue in which the evidence on the effectiveness and value of health care services can be discussed with the input of all stakeholders. Midwest CEPAC seeks to help patients, clinicians, insurers, and policymakers interpret and use evidence to improve the quality and value of health care. The Midwest CEPAC is an independent committee of medical evidence experts from across the Midwest, with a mix of practicing clinicians, methodologists, and leaders in patient engagement and advocacy. All Council members meet strict conflict of interest guidelines and are convened to discuss the evidence summarized in ICER reports and vote on the comparative clinical effectiveness and value of medical interventions. More information about Midwest CEPAC is available at https://icer-review.org/programs/midwest-cepac/. The findings contained within this report are current as of the date of publication. Readers should be aware that new evidence may emerge following the publication of this report that could potentially influence the results. ICER may revisit its analyses in a formal update to this report in the future. ©Institute for Clinical and Economic Review, 2019 Page ii Final Evidence Report – Esketamine for Treatment-Resistant Depression Return to TOC In the development of this report, ICER’s researchers consulted with several clinical experts, patients, manufacturers and other stakeholders. The following clinical experts provided input that helped guide the ICER team as we shaped our scope and report. None of these individuals is responsible for the final contents of this report or should be assumed to support any part of this report, which is solely the work of the ICER team and its affiliated researchers. For a complete list of stakeholders from whom we requested input, please visit: https://icer-review.org/material/trd-stakeholder-list/. Expert Reviewers Cristina Cusin, MD Assistant Professor in Psychiatry Massachusetts General Hospital Dr. Cusin served as site PI for an esketamine trial sponsored by Janssen. Phyllis Foxworth Vice President of Advocacy Depression and Bipolar Support Alliance No relevant conflicts of interest to disclose, defined as more than $10,000 in health care company stock or more than $5,000 in honoraria or consultancies during the previous year from health care manufacturers or insurers. William S. Gilmer, MD Clinical Professor of Psychiatry and Behavioral Sciences Northwestern University Feinberg School of Medicine Dr. Gilmer has received consulting and speaker fee honorarium from Sunovion and Otsuka and owns equity in Organovo, Jounce, and Gilead Sciences. ©Institute for Clinical and Economic Review, 2019 Page iii Final Evidence Report – Esketamine for Treatment-Resistant Depression Return to TOC Table of Contents Executive Summary ............................................................................................................................ ES1 Background .................................................................................................................................... ES1 Comparative Clinical Effectiveness ................................................................................................ ES4 Long-Term Cost Effectiveness ...................................................................................................... ES15 Potential Other Benefits and Contextual Considerations ............................................................ ES20 Value-Based Price Benchmark ..................................................................................................... ES22 Potential Budget Impact .............................................................................................................. ES23 Midwest CEPAC Votes .................................................................................................................. ES25 Key Policy Implications ................................................................................................................. ES27 1. Introduction ....................................................................................................................................... 1 1.1 Background .................................................................................................................................. 1 1.2 Scope of the Assessment ............................................................................................................. 3 1.3 Definitions .................................................................................................................................... 7 1.4 Insights Gained from Discussions with Patients and Patient Groups .......................................... 8 1.5 Potential Cost-Saving Measures in TRD ..................................................................................... 10 2. Summary of Coverage Policies and Clinical Guidelines ................................................................... 11 2.1 Coverage Policies ....................................................................................................................... 11 2.2 Clinical Guidelines ...................................................................................................................... 12 3. Comparative Clinical Effectiveness .................................................................................................. 15 3.1 Overview ...................................................................................................................................
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