Treatment Resistant Depression

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=71 | meeting_date=2016-04-27

On April 27, 2016, the Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). The purpose of this meeting is to obtain the MEDCAC's recommendations regarding the definition of treatment resistant depression (TRD) in clinical research as well as advise CMS on the use of the definition of TRD in the context of coverage with evidence development and treatment outcomes. MEDCAC panels do not make coverage determinations, but may advise CMS how to use evidence as the basis for any future coverage decisions.

Actions Taken: February 26, 2016 Posted Federal Register notice announcing meeting & questions to panel. April 22, 2016 Posted agenda , roster , speakers list , presentations , written comments , and background materials for meeting. May 2, 2016 Posted scoresheet from meeting. June 21, 2016 Posted minutes and transcript from meeting Webcast of meeting Registration Information about visiting CMS Driving directions to CMS Recommended hotels Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee April 27, 2016 7:30 AM – 4:30 PM CMS Auditorium Peter Bach, MD, Acting Chair Aloysius B. Cuyjet, MD, MPH , Acting Vice Chair Tamara Syrek Jensen, JD, Director, Coverage and Analysis Group Maria Ellis ,Executive Secretary 7:30 – 8:00 AM Registration 8:00 – 8:15 AM Opening Remarks - Maria Ellis/Tamara Syrek Jensen, JD/Peter Bach, MD 8:15 - 8:30 AM CMS Presentation & Voting Questions – Linda Gousis, JD 8:30 – 9:15 AM Matthew Rudorfer, MD , Program Chief, National Institute of Mental Health 9:15 – 10:00 AM Madhukar Trivedi, MD, Professor of Psychiatry, Betty Jo Hay Distinguished Chair in Mental Health and Director, Center for Depression Research and Clinical Care, University of Texas Southwestern Medical Center 10:00 – 10:15 AM BREAK 10:15 – 11:15 AM Scheduled Public Comments (Refer to Speaker List) Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting. 11:15 – 11:30 AM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 11:30 – 12:30 PM LUNCH (on your own) 12:30 – 1:30 PM Questions to Presenters 1:30 – 2:30 PM Initial Open Panel Discussion: Dr. Bach 2:30 – 3:30 PM Formal Remarks and Voting Questions The Chairperson will ask each panel member to state his or her position on the voting questions. 3:30 – 4:20 PM Final Open Panel Discussion: Dr. Bach 4:20 – 4:30 PM Closing Remarks/Adjournment: Tamara Syrek Jensen & Dr. Bach Issue: On April 27, 2016, the Centers for Medicare & Medicaid Services (CMS) will convene a panel of the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC). The purpose of this meeting is to obtain the MEDCAC's recommendations regarding the definition of treatment resistant depression (TRD) in clinical research as well as advise CMS on the use of the definition of TRD in the context of coverage with evidence development and treatment outcomes. MEDCAC panels do not make coverage determinations, but may advise CMS how to use evidence as the basis for any future coverage decisions. Minutes: Download meeting minutes Other Material: Transcript 1 Panel Voting Questions: Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) Treatment Resistant Depression (TRD) April 27, 2016 The purpose of this meeting is to obtain the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) recommendations regarding the definition of TRD as well as to advise CMS on the use of the definition of TRD in the context of clinical studies, coverage with evidence development and treatment outcomes. MEDCAC panels do not make coverage determinations, but may advise CMS how to use evidence as the basis for any future coverage decisions. Voting Questions: For each voting question, please use the following scale identifying your level of confidence - with a score of 1 being low or no confidence and 5 representing high confidence. 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence How confident are you that there is a standard definition of TRD that can be applied to Medicare beneficiaries in clinical studies of therapies for this disease? If intermediate confidence (≥ 2.5) is noted above, please vote by “yes or no” as to whether the following are important defining characteristics of TRD that are to be considered in clinical research: The number, duration, dosage, and/or classes of antidepressants attempted The use of augmentation/combination pharmacological therapies Type of depressive episode (unipolar, bipolar, psychotic, atypical, other) The use of nonpharmacological treatments such as electroconvulsive therapy The use of psychotherapy Score changes on standardized and validated depression rating instruments (e.g. Hamilton Depression Rating Scale) Suicidal ideation and suicide attempts Other If intermediate confidence (≥ 2.5) is noted in Question #1, how confident are you that this definition can be applied to Medicare beneficiaries: In primary care settings In general psychiatric settings In specialty psychiatric settings? How confident are you that each of the below is a reliable, valid and meaningful health outcome for Medicare beneficiaries in a clinical study on TRD? Improvement or decline in function Improvement or decline in quality of life Decrease in suicide ideation Decrease in suicidal attempts Other Discussion: For each characteristic above that receives intermediate confidence (≥ 2.5), please discuss the a priori parameters that define successful or failed treatment. How confident are you that the strategies below, when applied to Medicare beneficiaries, represent meaningful and realistic study designs in research investigations performed to evaluate interventions for TRD? Randomized sham-controlled double blinded trial Randomized sham-controlled single blinded trial Randomized controlled unblinded trial Randomized crossover study Nonrandomized crossover study Pre/post study design Other Download scoresheet Roster: MEDCAC ROSTER April 27, 2016 Committee Acting Chair Peter Bach, MD, MAPP Attending Physician & Director Center for Health Policy and Outcomes Memorial Sloan-Kettering Cancer Center Committee Acting Vice Chair Aloysius B. Cuyjet, MD, MPH Medical Director HealthCare Partners, IPA MEDCAC Members Harry Burke, MD, PhD Associate Professor Department of Medicine Uniformed Services University of the Health Sciences Clinician Internal Medicine Service Salvador Cruz-Flores, MD, MPH Professor and Founding Chairman Department of Neurology Paul L. Foster School of Medicine Texas Tech University Health Sciences Center Roger J. Lewis, MD, PhD, FACEP Professor and Vice Chair, Academic Affairs Department of Emergency Medicine Harbor-UCLA Medical Center Gail Melkus, EdD, C-NP, FAAN Florence and William Downs Professor in Nursing Research Director, Muriel and Virginia Pless Center for Nursing Research Daniel A. Ollendorf, PhD Chief Review Officer Institute for Clinical and Economic Review Thaddeus M. Pope, JD, PhD Director of the Health Law Institute Professor of Law Mitchell Hamline School of Law Marcel Salive, MD, MPH Medical Officer National Institute on Aging National Institute of Health Martha Stearn, MD Director and Co-Founder St. John's Institute for Cognitive Health Diplomate, American Board of Internal Medicine Due to unforeseen circumstances, Dr. Stearn is unable to attend the meeting Guofen (Evelyn) Yan, PhD Associate Professor of Biostatistics Department of Public Health Sciences School of Medicine Clinical Associate Professor of Nursing School of Nursing University of Virginia Industry Representative Theodore C. Lystig, PhD Lead Corporate Biostatistician Strategic Scientific Operations Medtronic, Inc. Guest Panel Members William T. Carpenter Jr., MD Professor of Psychiatry and Pharmacology University of Maryland School of Medicine Maryland Psychiatric Research Center Bradley Gaynes, MD, MPH Professor and Associate Chair Research Training and Education University of North Carolina Health Psychiatry Carlos A. Zarate, Jr., MD Chief Experimental Therapeutics & Pathophysiology Branch & Section Neurobiology and Treatment of Mood Disorders Division of Intramural Research Program National Institute of Mental Health Invited Guest Speakers Matthew Rudorfer, MD Program Chief National Institute of Mental Health Madhukar Trivedi, MD Professor of Psychiatry Betty Jo Hay Distinguished Chair in Mental Health Director Center for Depression Research and Clinical Care University of Texas Southwestern Medical Center CMS Liaison Tamara Syrek Jensen, JD Director Coverage and Analysis Group Executive Secretary Maria Ellis Coverage and Analysis Group Speakers List: Medicare Evidence Development & Coverage Advisory Committee April 27, 2016 SPEAKER LIST *7 MINUTES PER SPEAKER* Scott T. Aaronson, MD, Director, Clinical Research Programs, Sheppard Pratt Health System, Clinical Associate Professor of Psychiatry, University of Maryland Harold Sackeim, PhD, Professor, Departments of Psychiatry and Radiology, College of Physicians and Surgeons of Columbia University and Emeritus Chief, Department of Biological Psychiatry New York State Psychiatric Institute Charles Conway, MD, Professor of Psychiatry and Director of the Washington University Treatment-Resistant Depression Center, Washington University School of Medicine Stephanie Fox-Rawlings, PhD, Senior Fellow, National Center for Health Research – No Powerpoint Charlie Donovan – No Powerpoint Andrew Sperling, Director of Advocacy, National Alliance on Mental Illness – No Powerpoint Eric G. Scharf , Advocacy Advisor, Depression and Bipolar Support Alliance – No Powerpoint Bryan Olin, PhD , Vice President, Quality and Regulatory Affairs, Cyberonics, Inc. (LivaNova)