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Vagal Nerve Stimulation for Epilepsy and Depression Final Evidence Vagal Nerve Stimulation for Epilepsy and Depression Final Evidence Report April 14, 2020 Health Technology Assessment Program (HTA) Washington State Health Care Authority PO Box 42712 Olympia, WA 98504-2712 (360) 725-5126 www.hca.wa.gov/hta [email protected] Vagal Nerve Stimulation for Epilepsy and Depression Final Evidence Report April 14, 2020 Prepared by: Center for Evidence-based Policy Oregon Health & Science University 3030 SW Moody, Suite 250 Portland, OR 97201 Phone: 503.494.2182 Fax: 503.494.3807 http://centerforevidencebasedpolicy.org/ Authors: Beth Shaw, MSc, Valerie King, MD, MPH, Shannon Robalino, MSc, Andrea Vintro, MS, MPH, Curtis Harrod, PhD, MPH The authors would like to acknowledge the independent peer reviewers for their contributions to this report. The authors would also like to acknowledge Erica Shaw and Amanda Delzer Hill from the Center for Evidence-based Policy for their contributions to this work. WA – Health Technology Assessment April 14, 2020 This health technology assessment report is based on research conducted by the Center for Evidence-based Policy (Center) under contract to the Washington State Health Care Authority (HCA). This report is an independent assessment of the technology question(s) described based on accepted methodological principles. The findings and conclusions contained herein are those of the authors, who are responsible for the content. These findings and conclusions do not necessarily represent the views of the Washington HCA and thus, no statement in this report shall be construed as an official position or policy of the HCA. The information in this assessment is intended to assist health care decision makers, clinicians, patients, and policy makers in making evidence-based decisions that may improve the quality and cost-effectiveness of health care services. Information in this report is not a substitute for sound clinical judgment. Those making decisions regarding the provision of health care services should consider this report in a manner similar to any other medical reference, integrating the information with all other pertinent information to make decisions within the context of individual patient circumstances and resource availability. About the Center for Evidence-based Policy The Center is recognized as a national leader in evidence-based decision making and policy design. The Center understands the needs of policymakers and supports public organizations by providing reliable information to guide decisions, maximize existing resources, improve health outcomes, and reduce unnecessary costs. The Center specializes in ensuring that diverse and relevant perspectives are considered and appropriate resources are leveraged to strategically address complex policy issues with high-quality evidence and collaboration. The Center is based at Oregon Health & Science University in Portland, Oregon. Conflict of Interest Disclosures: No authors have conflicts of interest to disclose. All authors have completed and submitted the Oregon Health & Science University form for Disclosure of Potential Conflicts of Interest, and none were reported. Vagal Nerve Stimulation for Epilepsy and Depression: Final Evidence Report iii WA – Health Technology Assessment April 14, 2020 Table of Contents List of Tables ..................................................................................................................................................... vi List of Figures .................................................................................................................................................. vii List of Abbreviations ..................................................................................................................................... viii Executive Summary ......................................................................................................................................... 1 Structured Abstract ..................................................................................................................................... 1 Background ................................................................................................................................................... 4 Methods ......................................................................................................................................................... 5 Results ............................................................................................................................................................ 6 Clinical Practice Guidelines ...................................................................................................................... 10 Selected Payer Coverage Determinations ............................................................................................ 11 Ongoing Studies ......................................................................................................................................... 12 Conclusions ................................................................................................................................................. 12 Technical Report ............................................................................................................................................ 16 Background ................................................................................................................................................. 16 Washington State Utilization and Cost Data ....................................................................................... 17 Methods ....................................................................................................................................................... 18 Evidence Summary .................................................................................................................................... 29 Clinical Practice Guidelines ...................................................................................................................... 72 Selected Payer Coverage Determinations ............................................................................................ 78 Ongoing Studies ......................................................................................................................................... 79 Conclusions ................................................................................................................................................. 80 References ....................................................................................................................................................... 85 Appendix A. Search Strategy ....................................................................................................................... 97 Appendix B. Additional Methods ................................................................................................................ 98 Appendix C. Evidence Tables .................................................................................................................... 104 Appendix D. Risk of Bias Assessments .................................................................................................... 212 Appendix E. GRADE Quality of Evidence ............................................................................................... 221 Epilepsy ...................................................................................................................................................... 221 Depression ................................................................................................................................................ 231 Appendix F. Best and Worst Case Sensitivity Analyses ....................................................................... 240 Epilepsy ...................................................................................................................................................... 240 Depression ................................................................................................................................................ 241 Appendix G. MAUDE and Medical Device Recall Reports .................................................................. 242 Vagal Nerve Stimulation for Epilepsy and Depression: Final Evidence Report iv WA – Health Technology Assessment April 14, 2020 Appendix H. CMS Medicare Decision Memo......................................................................................... 246 Appendix I. Studies Registered at ClinicalTrials.gov ............................................................................. 249 Epilepsy ...................................................................................................................................................... 249 Depression ................................................................................................................................................ 249 Appendix J. Excluded Studies .................................................................................................................... 250 Appendix K. Washington State Utilization and Cost Data .................................................................. 251 Vagal Nerve Stimulation for Epilepsy and Depression: Final Evidence Report v WA – Health Technology Assessment April 14, 2020 List of Tables Table 1. Key Study Inclusion and Exclusion Criteria for Epilepsy .......................................................
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