Treatment Resistant Depression

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.

February 26, 2016

April 22, 2016

May 2, 2016

June 21, 2016

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  

8:00 – 8:15 AM

8:15 - 8:30 AM

8:30 – 9:15 AM

9:15 – 10:00 AM

10:00 – 10:15 AM

10:15 – 11:15 AM

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

Public Attendees who wish to address the panel will be given that opportunity

11:30 – 12:30 PM

12:30 – 1:30 PM

1:30 – 2:30 PM

2:30 – 3:30 PM

The Chairperson will ask each panel member to state his or her position on the voting questions.

3:30 – 4:20 PM

4:20 – 4:30 PM

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.

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. 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?


2. 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


3. If intermediate confidence (≥ 2.5) is noted in Question #1, how confident are you that this definition can be applied to Medicare beneficiaries:
   1. In primary care settings
   2. In general psychiatric settings
   3. In specialty psychiatric settings?


4. 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?
   1. Improvement or decline in function
   2. Improvement or decline in quality of life
   3. Decrease in suicide ideation
   4. Decrease in suicidal attempts
   5. Other

   Discussion:

   For each characteristic above that receives intermediate confidence (≥ 2.5), please discuss the a priori parameters that define successful or failed treatment.



5. 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?
   1. Randomized sham-controlled double blinded trial
   2. Randomized sham-controlled single blinded trial
   3. Randomized controlled unblinded trial
   4. Randomized crossover study
   5. Nonrandomized crossover study
   6. Pre/post study design
   7. Other

Download scoresheet