Medicare feels evidence on DME Drugs not sufficient to support use

Vascular endothelial growth factor (VEGF) inhibitors, such as ranibizumab (Lucentis) or bevacizumab (Avastin), may enhance vision in patients with diabetic macular edema (DME), but more research on specific risks and benefits is required according to a Medicare Insurance plan advisory panel.

There is dearth of evidence to support use of one of these agents over any other in DME, according to the Medicare Evidence Development and Coverage Advisory Committee, an advisory group to the Centers for Medicare and Medicaid Services (CMS).

The meeting was called to help CMS come to a decision on whether to embark on a formal National Coverage Determination for anti-VEGF therapies in DME. One specific object was to advise on future trial designs that would give CMS the information it needs.

Although laser photocoagulation of the retina has long been the standard of care for treating DME, clinicians have been using VEGF inhibitors off-label for the condition, according to the researchers at last year’s American Diabetes Association meeting.

The National Eye Institute sponsored a 1,161-patient study called CATT found that both agents appeared to have similar clinical efficiency in wet age-related macular degeneration, a condition for which ranibizumab is now accepted, and for which bevacizumab is frequently prescribed off-label.

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