Anti-VEGF Treatment of Diabetic Macular Edema

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.

December 29, 2011

March 2, 2012

March 8, 2012

March 16, 2012

March 16, 2012

March 23, 2012

May 10, 2012

• Registration
• Information about visiting CMS
• Webcast of meeting

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 AM

8:00 – 8:20 AM

8:20 - 8:30 AM

8:30 – 9:00 AM

9:00 – 9:30 AM

9:30 – 10:00 AM

10:00 – 10:15 AM

10:15 – 11:00 AM

11:00 – 11:15 AM

11:15 – 12:00 PM

12:00 – 1:00 PM

1:00 – 2:00 PM

2:00 – 3:00 PM

3:00 – 4:00 PM

4:00 – 4:30 PM

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            2            3           4           5
Low                   Intermediate                      High

2. 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            2            3           4           5
   Low                   Intermediate                      High



3. 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            2            3           4           5
   Low                   Intermediate                      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.

4. 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            2            3           4           5
   Low                   Intermediate                      High



5. 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            2            3           4           5
   Low                   Intermediate                      High
   1. Ranibizumab vs Pegaptanib
   2. Bevacizumab vs Pegaptanib
   3. Ranibizumab vs Bevacizumab

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



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

   1. Medicare beneficiaries?
   2. Community-based settings?
   1            2            3           4           5
   Low                   Intermediate                      High

DISCUSSION QUESTIONS

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



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



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

Download scoresheet from meeting [PDF, 38KB]