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streda 16. apríla 2014

More Medicare Musings: Why Lucentis is Worth the Price Tag

Macular Degeneration is the leading cause of blindness
in the United States.  It can be found during routine eye exams,
but don't wait to get your eye health checked until you
have vision issues!  There is no cure of macular degeneration,
and treatments that exist work best when started early in the
disease process!
With Medicare announcing its 2012 payments last month, ophthalmology had a microscope upon them as questions about why $20 million was paid out to a single ophthalmologist in Florida that year.  While there is an investigation about whether these charges were fraudulent, the entire world of ophthalmology has been getting lambasted in the press over the expensive use of Lucentis to treat wet macular degeneration.



You see, Lucentis costs Medicare about $2000/injection.   But Avastin, a drug made by the same company (Genentech) that is biologically similar, cost only $50/injection.  
Lucentis is a "snip"  off the larger Avastin molecular, designed to
be specifically used in the eye via









Why aren't ophthalmologists saving Medicare (and taxpayers) an estimated $1 billion by using Avastin? These recent news articles would lead you to believe they are the exact same drug, with the exact same efficacy.  And it is true that studies have shown Avastin and Lucentis do have a very similar efficacy when used to treat macular degeneration.  But Lucentis has been FDA tested and approved for intravitreal injection to treat macular degeneration, and Avastin has not.  Avastin usage in the eye is still considered "off-label" since Genentech has never sought FDA approval for this use of Avastin.

Doctor's use off-label applications of medications very frequently, and using Avastin for macular degeneration does have science to support the doctor's decision to do so.  But are we forgetting why so many doctors that were often using Avastin made the switch over to Lucentis in 2012 any way?

via
Unlike Lucentis that comes ready from the parent company Genentech for doctors to inject in their offices, Avastin has to be compounded into formulation for ocular injection.  This is the job of a compounding pharmacist, someone that the ophthalmologist or surgery center would contract with to ready their injections.  Unfortunately Florida, Tennessee, Texas, and a VA hospital in Los Angeles all had separate instances of contamination during this compounding procedure in 2011.  At least 21 people across those instances were infected by the Avastin injection, and in some cases the infection resulted in blindness.  One of the patients that lost vision sued for a reported $4 million, with litigation against the ophthalmologist, the pharmacy, and Genentech who manufactured Avastin.

Under this heavy fire, here was Genentech's statement to the New York Times:

“Avastin is not manufactured or approved and to date has not been proven safe for use in the eye,” a spokesman for the company said Tuesday.

So why would any ophthalmologist be willing to risk infection of a patient by using Avastin, if they would not have the support of the company who made that drug?  It would be a huge financial and ethical risk if doctors did not disclose to patients this risk of infection (no matter how small), and if both treatments are covered by the patient's insurance, why would the patient choose the off-label treatment with infection risk, versus the FDA-approved treatment?

It has been hard reading the news the last few days as the media has continued to spin against ophthalmology's practices.  But the truth is, ophthalmologists were using the FDA-approved treatment they had on the market to treat a condition that is the leading cause of blindness in the United States. Would you want your parent or grandparent to be blinded by macular degeneration, when there is a safe, FDA-approved treatment?  Absolutely not.  And until ophthalmologists get industry and FDA support for using Avastin safely, why would they make the switch?  Doctors have to think about their patients, and not about tax payer dollars, unfortunately.  And when you are the patient looking at 2 treatment options: one FDA approved, and one not, which would you pick?  You probably aren't thinking about taxpayer dollars at that moment either; just about your vision which is in imminent risk of permanent loss.

Optometrists, ophthalmologists, healthcare practitioners of all branches, and mostly the patients who are getting these treatments need to band together right now for what makes sense.  This is not the time for finger pointing, even though the financial burden on our health care system seems so overwhelming, blaming someone is the easiest option to "fix" things.  We want the best treatments for ourselves and our families, and doctors want to offer their patients the best standard of care.  When we want so much, sometimes it starts to get expensive.  And unfortunately, there is just no one that can be blamed for that simple fact.

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