Going off label: Drug saves sight, money

Published On: Jan 15 2013 09:56:17 PM EST
Updated On: Jan 16 2013 07:55:00 AM EST

It is the leading cause of legal blindness in older Americans. Every year 250,000 people in the United States are treated for age-related macular degeneration. Now, there’s more and more evidence that a cancer drug doctors have been relying on to help patients, works just as well as a much more expensive option.

Harriet Corstvet has a passion for reading about politics.

“People don’t realize that their opinion is being swayed!” she said.

Opthalmologist at the University of Wisconsin, Dr. Suresh Chandra, is using an injectable colon cancer drug on Harriet to shrink vision-impairing blood vessels in her eye. It’s not FDA approved for that, but there is growing evidence Avastin does it just as well as Lucentis, which is approved for AMD.

“Avastin had the same visual results at the end as Lucentis,” said Chandra.

However, Avastin is $50 a dose and Lucentis is $2,000 a dose.

A federal report shows in ’08 and ’09, Medicare paid physicians $1.1 billion for 700,000 Lucentis treatments and just 40 million for many more Avastin treatments. The doctor says Avastin saves patients with co-pays a lot of money and could save people’s vision in countries where Lucentis is just too expensive.

Harriet Corstvet said without it, “I would have for certain, would have been completely blind.”

Avastin and Lucentis are made by the same drug maker. The doctor says the off-label use of Avastin has become the standard of care for AMD, but in 2011, there was concern about using the drug among some doctors. The New York Times reports tainted doses of Avastin left 21 people blind. Chandra believes the incidents were isolated and is now under control.

Additional Information:

BACKGROUND:  The leading cause of vision loss in Americans 60 and older is due to macular degeneration (or age-related macular degeneration (AMD)).  It is a chronic eye disease which causes vision loss in the center of your field of vision.  There are two types of age-related macular degeneration; dry macular degeneration and wet macular degeneration.  Dry macular degeneration (the most common form) is characterized by the deterioration of the macula (the center of the retina), while wet macular degeneration is shown through swelling caused by leaky blood vessels located in the back of the eye (Source:  mayoclinc.com).  AMD does not hurt; however, it causes macula cells to die.  The macula is what makes the eye see fine detail for activities such as driving or reading. (Source: nlm.nih.gov)

HOW IS AMD DETECTED?  Early stages and even intermediate stages of AMD start without symptoms.  Usually only a comprehensive dilated eye exam can detect the disease.  The eye exams can include:  visual acuity test (measures distances), dilated eye exam (better view of the back of the eye), amsler grid, and/or fluorescein angiogram (performed by an ophthalmologist to detect leaky blood vessels).  In some cases, AMD progresses so slowly that people notice little change in their vision.  In other circumstances, it can progress faster and can lead to vision loss in both eyes.  The key to catching the disease before it causes vision loss is regular comprehensive eye exams. (Source:  National Eye Institute)

TREATMENT:  Wet macular degeneration is most commonly treated with injections.  Doctors prescribe certain supplements for dry macular degeneration to reduce the risk the disease developing because there is no specific treatment available.  Angiogenesis inhibitors are used to treat the wet form of AMD, including EYLEA, Lucentis, Avastin, and Macugen.  EYLEA is a protein injected to block proteins that increase abnormal blood vessel growth.  Lucentis is an antibody fragment that binds to and inhibits the human vascular endothelial growth factor, VEGF (a protein that is important to the formation of new blood vessels).  Macugen blocks VEGF also.  The newest treatment option is Avastin. (Source: Macular Degeneration Research)

NEW TREATMENT- AVASTIN:  Avastin has been approved by the FDA not for AMD treatment, but as a blood-vessel growth inhibitor used to treat colorectal cancer.  It is manufactured by Genentech, Inc., the same pharmaceutical company that produces Lucentis.  Lucentis is actually a form of Avastin developed to treat AMD through the use of small molecules for increased penetration of the retina.  They are both administered through injections into the vitreous portion of the eye over several scheduled intervals.  The main difference between the two is that Lucentis costs close to $2,000 per injection, while Avastin treatment costs anywhere from $20 to $100.  Although Avastin is not yet FDA approved, many doctors believe that both drugs are equally effective.  Side effects from using Avastin are not yet known since it is still in clinical trial. (Source:  Macular Degeneration Research)

CLINICAL TRIALS:  The National Eye Institute of the National Institutes of Health conducted clinical trials to study the efficacy and safety of Lucentis and Avastin.  In May 2011, they found them to be nearly equally effective in treating AMD.  By April 2012, researchers found that for the best results injections should be done every four weeks.  Physicians use Avastin as an “off-label” treatment for wet age-related macular degeneration while ongoing clinical trials work to provide more information about the risks of taking Avastin. (Source: Macular Degeneration Research)

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