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Going Off Label: Cancer Drug Saves Sight & Money

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MADISON, Wisc.  (Ivanhoe Newswire) - It is the leading cause of legal blindness in older Americans. Every year 250,000 people in the US 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,"  Harriet Corstvet told Ivanhoe.

Opthalmologist 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," Ophthalmologist at the University of Wisconsin, Dr. Suresh Chandra, MD, told Ivanhoe.

 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 said 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 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 said 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. Dr. Chandra believes the incidents were isolated and is now under control.

RESEARCH SUMMARY

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)

INTERVIEW

Suresh Chandra, Professor of Ophthalmology and Retina Surgeon at University of Wisconsin School of Medicine and Public Health, talks about a new drug to treat macular degeneration.

Tell me a little bit about Avastin versus Lucinda. What is the difference in the drugs?

Dr. Chandra: Well both Lucentis and Avastin are produced by the same company.  Lucentis is manufactured for use of the eye and that had really rigorous clinical trials. But while it was waiting for the FDA approval there was another drug called Avastin that was approved by FDA for colorectal cancer.  A doctor in Florida tried it in very small doses and he found really excellent results. So, from then on Avastin became the most used drug for macular degeneration.

So it was used for colorectal cancer. How did he decide it might work for AMD?

Dr. Chandra: Because the pathology physiology is the same. In cancer there are abnormal blood vessels which grow and spread the cancer, whereas in macular degeneration it is the same process. Abnormal blood vessels grow, they leak, and they bleed. So that was the common denominator and how the idea came to use that drug.

And have you adopted it as your standard of care versus Lucentis?

Dr. Chandra: Yes, I think most of the people all around the world are using Avastin as the most common drug. But because it was not FDA approved it was being used off label.

And it is still off label?

Dr. Chandra: It is still off label.

How long ago did you start using it?

Dr. Chandra: It's been about five to six years that we started using it. There is a growth factor in the eye which increases in patients who have  neovascularization, it's called vascular  endothelial growth factor. And both Avastin and Lucentis work against that. That's how they cause shrinkage of these blood vessels.

There's two trials that you guys did here, the CATT Trial Part 1 and 2, is that right?

Dr. Chandra:  The main results came out in one year which we published last year. And the two year results came out recently.

And what did they find?

Dr.Chandra: The main thing they found is that the visual results are not too different in both cases. Avastin has the same visual results at the end as Lucentis. The difference is cost, Lucentis costs $1000 to $2000 for a single treatment whereas Avastin costs about $50 for the same treatment.

That is amazing. That's a huge bump.

Dr. Chandra: A very significant difference, twenty times more. So if you look at twenty two thousand injections done in the United States for Medicare patients it's billions of dollars. Whereas if you use Avastin it's only a few million.

Does Medicare only use Lucentis because it's the only thing with FDA approval?

Dr. Chandra: If you use Lucentis and if you use Avastin, Medicare pays for both of them. They have not made a decision that they will pay just for Avastin only.

Even though it's not approved?

Dr. Chandra: Yes, because that's FDA approved. So you can't really deny a person for an already tested drug.

So what was the point of the study?

Dr. Chandra: Well the study was really mainly two things. One is Avastin as good as Lucentis in terms of the final visual outcome.  Lucentis was used once a month for two years in the study. The other question was can we use less often and reduce the cost. So those were the two main questions and of course the safety of the drug.

So what did you find, can you do less dosages with Lucentis?

Dr. Chandra: Well it seems like less dosages work but it's better to have a monthly type of treatment.

Is that what it is, they come in every four to six weeks for the treatment whether it be Lucentis or Avastin?

Dr. Chandra: Four weeks. But in general most people in the country are using not the protocol persa but their own way of doing it which is inject and then wait four weeks to six weeks to extend the time. If there is no recurrence of the disease then they can extend more. Although in the study we used every four weeks.

Are most people covered by insurance to take care of the cost of either then?

Dr. Chandra:  Oh yes. Medicare takes care of that. Of course eighty percent is covered by Medicare and twenty percent by supplemental insurance.

So do you think it will eventually be FDA approved for AMD? If so what would that do?

Dr. Chandra: Well there is one thing we are looking at and that is the safety factor. In Avastin there were a little bit more safety signals, severe side effects which were more in Avastin than in the Lucentis group. So we are not sure whether that is related to the drug or it is just the aging or some other factor.

What were some of the side effects?

Dr. Chandra: For example patients who were on Avastin had more hospitalization, more fractures, more GI infections so it was involving almost all the systems. So we were not sure whether that is because of the Avastin or it's just a coincidence. There are five other studies which are going to be going on in the world again comparing Avastin and Lucentis and I think they are looking at those side effects. And one of the studies from England did not show those side affects so we think that it is a coincidence. It's not really the real side effect of the Avastin.

So what does that mean for patients, do you use Lucentis at all anymore?

Dr. Chandra: Well, we explain to the patients and tell them what is the correct thing -- which is Lucentis is approved by FDA.  Avastin is not approved. But the study that we did showed that final visual outcomes were the same. There were slightly more side affects with Avastin, but we are not sure whether it's a coincidence or it just was from the drug, and let the patient decide. But I think in general most of the people around the country are still using Avastin as a primary line of treatment.

I read there were some cases of people going blind after the Avastin injection, what happened?

Dr. Chandra:  Yes, well I think there were some which were contaminated or manufactured without specifications and that's what caused it. But I think it is now under control.

What is the risk of blindness with Lucentis, does it have a risk at all?

Dr. Chandra:  Well both have risk of blindness or infection of the eye which is really the worse side affect that can happen. But the incidence of that is so low that the benefits for the treatment outweigh the risk.

How did it help Harriet, she had already lost the vision of one eye to AMD?

Dr. Chandra: Harriet's left eye had laser treatment and it didn't work, it didn't do good. So she lost her vision in her left eye. Unfortunately she developed the problem in the right eye and we were fortunate to pick it up early and we were fortunate that these drugs were available so that we could use those drugs. Harriet is having Avastin injection every four to six weeks and her vision is very stable at 20/40. So she's very happy, we are very happy.

So what's the future for Avastin?

Dr. Chandra: I feel that Avastin will stand the test of time. I think the cost is a very important factor not only for United States but especially if you look around the world. Developing countries they can't afford Lucentis for every patient. The CATT study which is really remarkable showed that the visual outcome in both is about the same.

Before that did the doctors take the results from the Florida doctor and say I'm going to try this too?

Dr. Chandra: No. They tried in many, many patients and it was really very effective, as effective as the Lucentis. They continued and it became one of the most common. There were no safety indicators that would stop us from using Avastin.

So this kind of reinforces the use that the CATT trial did?

Dr. Chandra: Yes. I think the major implication of the CATT trial is to prove that Avastin has the same effect as Lucentis. And also the cost was an important factor in deciding to go ahead with CATT study.

How can there be so much of a discrepancy between the price of the drugs?

Dr. Chandra: Well I think if you ask Genentech which produces it, they will give you the answer it's research and development, it's advertisements, it's publicity, it's medical legal, aspect and of course the profit. So all those combined make Lucentis a very expensive drug.

FOR MORE INFORMATION, PLEASE CONTACT:

Susan Lampert Smith, Media Relations
University of Wisconsin School of Medicine and Public Health
(608) 262-7335
ssmith5@uwhealth.org

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