New York—Ophthalmologists who choose to use bevacizumab (Avastin, Genentech) for off-label treatment of wet age-related macular degeneration (AMD) should not expect Medicare to reimburse those expenses, according to George A. Williams, MD.
New York-Ophthalmologists who choose to use bevacizumab (Avastin, Genentech) for off-label treatment of wet age-related macular degeneration (AMD) should not expect Medicare to reimburse those expenses, according to George A. Williams, MD.
The therapy has become a hot topic for the promise it holds in improving visual acuity in patients with wet AMD, he said.
Bevacizumab was approved by the FDA in 2004 to treat metastatic colorectal cancer and was the first FDA-approved therapy to inhibit angiogenesis. Ophthalmologists became interested in it for its anti-vascular endothelial growth factor (VEGF) properties, similar to another treatment for AMD, ranibizumab (Lucentis, Genentech), which is under review by the FDA and is not yet approved.
Although early results released in 2005 by Philip J. Rosenfeld, MD, PhD, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, tested its systemic use ("Off-label bevacizumab shows promise for treating AMD," Ophthalmology Times, Feb. 1, 2006, Page 1), the bevacizumab treatment has evolved to intra-vitreal injections in much smaller doses to avoid complications relating to hypertension and increased thromboembolic events.
"Positive presentations at retinal meetings and the two published case reports of visual acuity improvement and decreased retinal thickness have led the retinal community to embrace this new treatment," Dr. Lim wrote. She is associate professor of ophthalmology, University of Southern California, and medical director of clinical trials, Doheny Eye Institute, Los Angeles.
Weighing off-label use
"Carriers decide whether they're going to cover an off-label use based on a variety of evidence such as published trials, clinical trials, and published reports. [Bevacizumab] has moved so quickly [that] we still don't have publications out," Dr. Lim said. "Until they see these publications, their decision will be they can't cover it."