Off-Label Avastin for Wet Macular Degeneration – The Debate Continues

Avastin has been approved as a colon cancer and lung cancer drug.  However, Avastin has been used off-label to treat other cancers and macular degeneration.  The off-label use of Avastin to treat other diseases has sparked debate throughout the health care industry.

With ophthalmologists turning to Avastin as a treatment for wet macular degeneration, the use of this drug for treating eye disease has come under fire.  However, macular degeneration is the leading cause of blindness in people over 50 years of age, with wet macular degeneration becoming a growing concern for aging adults.

With more than 200,000 cases of macular degeneration being diagnosed each year, finding an affordable treatment for this eye disease is crucial to lessen the burden on health care systems.  The FDA approved and most effective treatment for wet macular degeneration is Lucentis.  However this drug costs approximately 10 times more than off-label Avastin and produces identical results according to some eye care professionals.

In wet macular degeneration abnormal blood vessels grow at the back of the eye and leak both blood and fluids into the macula, the portion of the eye responsible for central vision.  Untreated wet macular degeneration causes rapid vision loss and without the macula people cannot read fine print, recognize faces or drive.

“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 treatment 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. At about $2,000 a dose for Luncentis and about $50 for Avastin, they saw them as an equal, but Avastin as a more cost-effective treatment.

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 to treat macular degeneration.

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 equivalent treatments. Both are superior to others available and are the standard of care for wet macular degeneration. Most states have started coverage for Avastin injections into the eye. Nationally, the use of Avastin instead of Lucentis to treat wet macular degeneration 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.”

Source: AllMed Healthcare Management (