Off-Label Avastin Use For Wet Macular Degeneration
Researchers have determined that off-label use of Avastin is an effective treatment for wet AMD, the leading cause of blindness in people over 50 years old. Although physicians and researchers are debating the effectiveness of Avantis versus Luncentis, a drug that costs 40 times more than Avastin, some ophthalmologists consider the two to be equal.
The Food and Drug Administration (FDA) has only approved Avastin for cancer of the colon and lungs. In off-label use, however, Avastin is proving itself as a “miracle drug” that is currently used by some doctors to treat other cancers, including breast, prostate, renal cell, head and neck, pancreatic, ovarian, and hepatocellular.
Some ophthalmologists are also turning to Avastin for wet age-related macular degeneration (AMD), the leading cause of blindness in people over 50 years old. Wet AMD is a growing concern for aging adults. There are 200,000 new cases of the disease every year, and experts project the number will increase rapidly as baby boomers age and their life expectancy increases. Experts estimate that 6.3 million people will lose their vision to wet AMD by 2030. They also predict the disease will cost half a million people their sight each year.
In wet AMD, abnormal blood vessels grow at the back of the eye and leak blood and fluids into the macula, the central part of the retina. Like a high-definition digital camera, the eye's macula picks up fine-grained pictures so one can see their detail. Untreated wet AMD causes rapid vision loss and without the macula it is difficult, if not impossible to read fine print or recognize faces.
"Because wet AMD is a devastating disease that progresses swiftly, ophthalmologists want to treat it immediately," explains Dr. Skip Freedman, executive medical director at AllMed Healthcare Management, a leading independent review organization (IRO). "And there is strong medical evidence that Avastin and Luncentis are the most effective treatments for wet AMD today."
According to Freedman, both drugs bind and inactivate the growth of blood vessels in the macula. In 2006, the FDA approved Genentech's Luncentis for wet AMD. However, because Genentech researchers derived both Luncentis and Avastin from the same monoclonal antibody (a substance that can find and bind to cancer cells anywhere in the body) some ophthalmologists began using Avastin. Researchers viewed them as equal, but saw Avastin as a more cost-effective treatment, since Luncentis is about $2,000 a dose, and Avastin about $50.
Genentech claims it is concerned about public safety and believes that compounding Avastin might increase the risk of eye infections during treatment. The company also says that because Avastin is a much larger protein, it may not be as efficacious as Lucentis. However, ophthalmologists currently have reported no contamination issues or increased eye infections using Avastin instead of Lucentis. The National Eye Institute is conducting a study comparing the safety and efficacy of Avastin and Lucentis. However, Genentech declined taking part in it, saying it is unnecessary and potentially too costly. Early results of this comparison are expected to be available in 2009.
Today ophthalmologists consider Avastin and Lucentis to be equivalent treatments. Both are superior to others available and are the standard of care for wet AMD. Most states have started coverage for Avastin injections into the eye. Nationally, the use of Avastin instead of Lucentis to treat wet AMD could potentially save several billion dollars a year.
"Healthcare insurers need to consider working with independent review organizations to decide the right balance of treatment cost versus efficacy," said Dr. Freedman. "The case of whether ophthalmologists should use Avastin or Lucentis to treat wet AMD is just one example of how medical knowledge about drugs is changing more rapidly than health insurers can keep up. To contain healthcare costs, insurers must consider the medical necessity of a drug, as well as the lowest possible treatment cost for both its on- and off-label use to deliver patients cost-effective treatments that work."
For more information on cutting-edge treatments and their medical necessity check out http://www.allmedmd.com/peerpoints/cuttingedge/cutting_edge_email.htm. To find out more about the review services IROs offer, go to AllMed's website at www.allmedmd.com.
