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MEDCAC Meeting 3/21/2012 - Anti-VEGF Treatment of Diabetic Macular Edema

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The Centers for Medicare and Medicaid Services (CMS) has convened this meeting for the panel to review the available evidence on anti-vascular endothelial growth factor (anti-VEGF) treatment of diabetic macular edema (DME). The standard of care for DME has been focal and grid laser, and we are interested in evaluating results of studies using anti-VEGF agents to treat this condition. CMS does not have a national coverage determination for the use of anti-VEGF treatment in DME. In diabetic retinopathy there may be damage to or formation of small blood vessels in the eye's light-sensitive retinal tissue. If these damaged blood vessels begin to leak near the center of the retina, known as the macula, the surrounding area swells and causes a condition called macular edema. DME can lead to vision loss if left untreated. Repeated eye injections of anti-VEGF medications may help to manage these conditions, preventing visual loss and promoting recovery.

Tree/Earth - CMS Goes Green

CMS WILL NO LONGER BE PROVIDING PAPER COPIES OF THE HANDOUTS FOR THE MEETING. ELECTRONIC COPIES OF ALL THE MEETING MATERIALS WILL BE POSTED HERE.


December 29, 2011 Updated Panel Voting Questions to align with ongoing Technology Assessments
March 2, 2012 Posted Technology Assessment for meeting.
March 8, 2012 Posted additional Technology Assessment for meeting.
March 16, 2012 Posted presentations [PDF, 11KB] for meeting.
March 16, 2012 Posted agenda, roster and speakers list
March 23, 2012 Posted scoresheet [PDF, 38KB] from meeting.
May 10, 2012 Posted minutes [PDF, 130KB] and transcript [PDF, 318KB] from meeting.

Federal Register Notice
Agenda
Medicare Evidence Development & Coverage Advisory Committee
March 21, 2012
7:30 AM – 4:30 PM
CMS Auditorium

Clifford Goodman, PhD, Chair
Steve Phurrough, MD, Vice Chair
James Rollins, MD, Division Director, Division of Items and Devices, Coverage and Analysis Group
Maria Ellis, Executive Secretary

7:30 – 8:00 AMRegistration
8:00 – 8:20 AM Opening Remarks— Maria Ellis/James Rollins, MD/Clifford Goodman, PhD
8:20 - 8:30 AM CMS Presentation & Voting Questions – Kimberly Long
8:30 – 9:00 AMRobert Frank, MD, The Robert S. Jampel, MD, PhD, Professor of Ophthalmology and Professor of Anatomy and Cell Biology, Wayne State University School of Medicine
9:00 – 9:30 AM TA Presentation: Donna M. Dryden, PhD, Associate Director, University of Alberta, Evidence-based Practice Center
9:30 – 10:00 AM TA Presentation: Daniel Ollendorf, MPH, ARM, Chief Review Officer, Institute for Clinical and Economic Review
10:00 – 10:15 AM BREAK
10:15 – 11:00 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.
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11:00 – 11:15 AM Open Public Comments
Public Attendees who wish to address the panel will be given that opportunity
11:15 – 12:00 PM Questions to Presenters
12:00 – 1:00 PM LUNCH
(on your own)
1:00 – 2:00 PMInitial Open Panel Discussion: Dr. Goodman
2:00 – 3:00 PMFormal Remarks and Voting Questions
The Chairperson will ask each panel member to state his or her position on the voting questions.
3:00 – 4:00 PMFinal Open Panel Discussion: Dr. Goodman
4:00 – 4:30 PM Closing Remarks/Adjournment: Dr. Rollins & Dr. Goodman
Download meeting minutes [PDF, 130KB]

Outcomes of Interest: CMS is most interested in meaningful changes to beneficiaries’ visual function that enable their independent accomplishment of routine daily activities. We also seek the panel’s input on the preferred measures for determining progression in clinical trials of DME treatment.

DISCUSSION QUESTION

  1. In a 2005 MEDCAC on wet age-related macular degeneration (WAMD), the following commonly used outcomes or intermediate endpoint measures were discussed:

    1. Visual acuity
    2. VFQ 25
    3. Dilated eye exam (to assess retinal damage)
    4. Grade of diabetic retinopathy (DR)
    5. Amsler grid
    6. Extent/progression as measured by retinal photography
    7. Fluorescein angiography (to assess blood flow/leakage in retina and choroid)
    8. Visual fields
    9. Ocular coherence tomography (OCT) (to assess retinal thickening, other damage)

    Please discuss the suitability of these measures for assessing DME treatment-related health outcomes, i.e., benefits and harms.

VOTING QUESTIONS

    For the voting questions, use the following scale identifying level of confidence - with 1 being the lowest or no confidence and 5 representing a high level of confidence.
    1
    Low    		 2 3
    Intermediate    		 4 5
    High

  1. How confident are you that there is adequate evidence to determine whether or not DME management using intravitreal targeted anti-VEGF treatment improves patient health outcomes compared to DME management without intravitreal targeted anti-VEGF treatment?

    1
    Low    		 2 3
    Intermediate    		 4 5
    High


  2. If the result of Question 2 is at least intermediate (mean vote ≥ 2.5), how confident are you that there is adequate evidence to conclude that DME management using intravitreal targeted anti-VEGF treatment improves patient health outcomes compared to DME management without intravitreal targeted anti-VEGF treatment?

    1
    Low    		 2 3
    Intermediate    		 4 5
    High

    Please discuss any patient characteristics, treatment regimens, or other factors that may have important impacts on the degree of patient benefit or harm from these treatments.

  3. If the result of Question 3 is at least intermediate (mean vote ≥ 2.5), how confident are you that there is also adequate evidence to determine whether or not there are clinically meaningful differences in health outcomes among the available intravitreal targeted anti-VEGF treatments for the management of DME?

    1
    Low    		 2 3
    Intermediate    		 4 5
    High


  4. If the result of Question 4 is at least intermediate (mean vote ≥ 2.5), how confident are you that there is adequate evidence to conclude that there are clinically meaningful differences in the health outcomes when comparing the following available intravitreal targeted anti-VEGF treatments?

    1
    Low    		 2 3
    Intermediate    		 4 5
    High

    1. Ranibizumab vs Pegaptanib
    2. Bevacizumab vs Pegaptanib
    3. Ranibizumab vs Bevacizumab

    5. Please discuss whether your conclusions are based on evidence of:

    1. Different benefits with similar harms
    2. Similar benefits with different harms
    3. Different benefits and different harms


  5. How confident are you that the conclusions above are generalizable to:

    1. Medicare beneficiaries?
    2. Community-based settings?

    1
    Low    		 2 3
    Intermediate    		 4 5
    High

DISCUSSION QUESTIONS

  1. To what extent are the conclusions above generalizable to the management of other forms of diabetic retinal vascular disease beyond DME?

  2. Are there significant gaps in the evidence base on the management of diabetic macula edema?

  3. What study designs would support the narrowing or closure of these gaps?

Download scoresheet from meeting [PDF, 38KB]

Clifford Goodman, PhD CHAIR
Senior Vice President
The Lewin Group

Steve E. Phurrough, MD Vice Chair
Chief Operating Officer/Senior Clincal Director
Center for Medical Technology Policy

Wendolyn S. Gozansky, MD, MPH
Investigator, Institute for Health Research
Physician, Continuing Care Department
Kaiser Permanente Colorado

Willard K. Harms, MD, MBA
Medical Policy and Adjudication
Blue Cross Blue Shield of Illinois

Peter Heseltine, MD
Professor of Clinical Medicine
University of California, Irvine

Susan A. Levine, DVM, MS, PhD
Vice President
Technology Assessment/Editor-in Chief
Hayes, Inc.

Pamela R. Massey, Pt, MS
Physical Therapist

Robert McDonough, MD, JD
Head
Clinical Policy Research &
Development
Medical Policy and Program
Administration
National Medical Services
Aetna, Inc.

Prabashni Reddy, PharmD
Director
Center for Drug Policy
Partners Healthcare

Art Sedrakyan, MD, PhD
Associate Professor & Director
Patient Centered Comparative
Outcomes Research Program
Weill Cornell Medical School

Robert L. Steinbrook, MD
Professor Adjunct of Internal Medicine
Yale University School of Medicine

Industry Representative

Robert W. Dubois, MD, PhD
Chief Science Officer
National Pharmaceutical Council

Guest Panel Member

James E. Puklin, MD, FACS
Professor of Ophthalmology
Department of Ophthalmology
Kresge Eye Institute
Wayne State University School of Medicine

Invited Guest Speaker

Robert N. Frank, MD
The Robert S. Jampel, MD, PhD
Professor of Ophthalmology
Professor of Anatomy & Cell Biology
Wayne State University School of Medicine
Kresge Eye Institute

CMS Liaison

James Rollins, MD
Director
Division of Items and Devices
Coverage and Analysis Group

Executive Secretary

Maria Ellis
Coverage and Analysis Group

Medicare Evidence Development & Coverage Advisory Committee
March 21, 2012

SPEAKER LIST

*7 MINUTES PER SPEAKER*

  • Jason S. Ehrlich, MD, PhD, Associate Medical Director for Ophthalmology, Genentech, Inc.


  • Helen D. Nickerson, PhD, Senior Scientific Program Manager, JDRF - No Powerpoint Presentation


  • Victor Gonzalez, MD, Representing: The American Diabetes Association


  • Trex Topping, MD, Chair, Health Policy Committee, American Academy of Ophthalmology, Representing: American Academy of Ophthalmology


  • John Thompson, MD, President, American Society of Retina Specialists, Representing: American Academy of Ophthalmology


  • Neil M. Bressler, MD, Chief of Retina Services, Wilmer Eye Institute, Johns Hopkins Hospital, Representing: American Academy of Ophthalmology
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