Asks Medicare to cover the eye injection in patients

SAN FRANCISCO—The American Academy of Ophthalmology said today in a letter to the Centers for Medicare and Medicaid Services (CMS) that it supports reimbursement for treating age-related macular degeneration (AMD) with intravitreal injections of bevacizumab, to meet the medical needs of many patients who have not responded to therapy with ocular photodynamic therapy (OPT) with verteporfin or intravitreal pegaptanib.  

The letter reported that intravitreal bevacizumab, sold under the brand Avastin, is being used by “a large number of retinal specialists (who) believe that it is reasonable and medically necessary for treatment of some patients with neovascular AMD.” The Academy cautioned that while “the scientific studies related to the use of intravitreal injections of bevacizumab for the treatment of neovascular AMD are supportive,” they are “not conclusive of its safety and efficacy.”

“We acknowledge and recognize the great contributions made by drug and device companies when they invest time and resources to bring new therapies to market that provide significant advances in disease management,” said H. Dunbar Hoskins, M.D., Academy executive vice president. “This is not an endorsement of intravitreal Avastin. It is a recommendation that those physicians who choose to use it should be reimbursed as they are with other off-label therapies.”

The Academy’s support for coverage is limited to “such patients who are deemed by their treating physician to have failed FDA- approved therapies, or in the judgment of their treating physician, based on his/her experience, are likely to have greater benefit from the use of intravitreal bevacizumab.” It issued the letter in response to its members’ and Medicare carriers’ requests for clarification on the coverage issue. 

“The Academy is concerned that in spite of the current treatments available, fewer than 10 percent of patients have had significant improvement in visual acuity,” “said Dr. Hoskins said. “Most patients continue to lose vision after one year of therapy.”

The two FDA-approved and CMS-covered drug therapies for the treatment of neovascular AMD are OPT with verteporfin (Visudyne, Novartis) and pegaptanib sodium (Macugen, Eyetech, Pfizer). Bevacizumab is a potent vascular endothelial growth factor (VEGF) inhibitor, developed initially for the treatment of colorectal cancer. There is increasing clinical consensus that intravitreal bevacizumab is beneficial in select AMD patients. To date, more than 6,800 injections in 5,055 patients from 68 centers in 12 countries have been documented with a low rate of ocular or systemic adverse events.

A survey completed March 20, 2006, by the American Society of Retinal Specialists of its membership found that 92 percent of 289 respondents felt intravitreal bevacizumab was “somewhat better” or “much better” than other approved or covered therapies. Only 4 percent of respondents had seen any thromboembolic complications thought related to the intravitreal bevacizumab, and 96 percent thought intravitreal bevacizumab was the same or better in terms of overall safety compared to other FDA-approved or covered therapies.

The Academy will continue to monitor new information regarding the safety and efficacy of these treatments and will release new position statements as appropriate. It also encourages physicians to provide appropriate informed consent with respect to the off-label use of bevacizumab.

Neovascular AMD is the most common cause of legal blindness in the U.S. population 65 years or older. It is estimated that in 2000, more than 1,220,000 people suffered visual loss from neovascular AMD. There were 7.3 million  people at risk of developing advanced AMD defined as neovascular AMD or geographic atrophy.

Both intravitreal pegaptanib sodium and OPT with verteporfin and pegaptanib sodium represent major therapeutic advances in the treatment of neovascular AMD and are recommended treatments in the Preferred Practice Pattern for Age-related Macular Degeneration published by the Academy.

A clinical trial, sponsored by Genentech, the makers of Avastin, is also available for patients. The trial, known as SAILOR, is a one-year Phase IIIb study designed to evaluate the safety of their drug Lucentis, another vascular endothelial growth factor (VEGF) inhibitor, which is not yet approved by the FDA. The trial provides access to the drug for eligible patients in advance of the FDA's response and is open to patients with all subtypes of new or recurrent active subfoveal wet AMD. For more information or to enroll patients, go to http://www.clinicaltrials.gov/ct/show/NCT00251459?order=2.
Up to 5,000 patients will be accepted into this study before the FDA's response, which should be no later than June 30, 2006.