The Medicare Evidence Development and Coverage Advisory Committee has postponed its consideration of the use of anti-VEGF drugs in diabetic macular edema to March 21, 2012, to allow more time for preparation.

The meeting previously was scheduled for Sept. 21 (Also see "CMS To Compare Anti-VEGF Drugs And Laser Treatments In MedCAC Review" - Pink Sheet, 1 August, 2011.).

The Centers for Medicare and Medicaid Services have asked the committee to consider whether use of drugs, including Roche's Avastin (bevacizumab) and Roche/Genentech's Lucentis (ranibizumab), are "reasonable and necessary" for treatment of DME. CMS is interested in how the drugs compare with the current standard of care involving focal and grid laser treatment.

In its recently posted questions to the committee, CMS also asks MEDCAC to compare available drug treatments to each other: "How confident are you that there is adequate evidence to conclude that there is a clinically meaningful difference in the health outcomes among the intravitreal targeted anti-VEGF treatments that are approved for marketing in the United States?"

No anti-VEGF agents are approved for DME in the U.S., but Avastin and Lucentis have been used to treat the condition off-label. Avastin's approved indications cover a range of cancers, and Lucentis currently is approved for age-related macular degeneration and macular edema secondary to retinal vein occlusion. Genentech plans to apply to FDA this fall for a DME indication for Lucentis.

CMS asks the panel to consider both the benefits and potential harm from anti-VEGF treatment. The agency would like the panel to address "meaningful changes to beneficiaries' visual function that enable their independent accomplishment of routine daily activities."

CMS lists a series of outcomes or intermediate endpoint measurements for discussion. They include visual acuity, grade of diabetic retinopathy and ocular adherence tomography. MEDCAC previously used the outcomes measures to evaluate anti-VEGF drugs for wet age-related macular degeneration in 2005 (Also see "Macular Degeneration Agents Need Randomized Trials, Medicare Panel Says" - Pink Sheet, 5 December, 2005.).

CMS additionally seeks direction on the extent to which the committee's conclusions regarding the available evidence on DME are "generalizable to the management of other forms of diabetic retinal vascular disease beyond DME." Diabetic macular edema strikes 10% of people with diabetes, or about two million people in the U.S., and can lead to blindness if left unchecked. About 75,000 new cases are diagnosed each year in the U.S.

-Cathy Kelly (c.kelly@elsevier.com)

MEDCAC Review Of Anti-VEGF Drugs Rescheduled To March 21, 2012

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