Off-Label Avastin Treatment for Macular Degeneration

Avastin, or bevacizumab, has become a popular off-label treatment for wet macular degeneration.  Approved as a colon cancer drug, Avastin has shown to be as effective a treatment for macular degeneration as the FDA approved drug Lucentis.

Wet macular degeneration is the leading cause of blindness in people over 50 years old.  This form of macular degeneration occurs when abnormal blood vessels grow and leak both blood and fluid into the macula, resulting in severe loss of central vision.  Lucentis has been shown to be the most promising  treatment for this eye disease at stabalizing the vision loss and in some cases reversing the damage caused to the eyes.  However, Lucentis treatments cost approximately $1,600 per injection, far less than the off-label Avastin which costs approximately $150 per injection.

Avastin has been shown through experimental treatments to hal the progression of wet macular degeneration and in approximately 40 percent of the cases reverse the damage.

Given the demonstrated effictiveness of Avastin, why is there such controversy surrounding its off-label uses for treating macular degeneration?

The debate over the off-label uses of Avastin for wet macular degeneration centres solely around GenenTech, the company that manufactures the eye disease drug.  GenenTech produces another macular degeneration drug known as Lucentis, which has received FDA approval for usage in the eye.  Avastin has not received FDA approval for usage in the eye, making its use for macular degeneration off-label.

However, Lucentis treatments cost approximately $1,600 per injection, with Avastin treatments costing approximately $150 per treatment.  The debate is not entirely over the price of the drugs.

Lucentis was developed from Avastin after research by Dr. Philip Rosenfeld showed that Avastin was effective at stopping the abnormal blood vessel growth in patients suffering from wet macular degeneration.  In fact, many doctors and ophthmalogists have been unable to determine if an eye has been treated with off-label Avastin or Lucentis.

GenenTech has indicated that it does not plan to hold clinical trials for testing the safety of Avastin for use as a macular degeneration treatment.  In fact, it has expressed concerns over the use of the drug being used in off-label treatments for the eye disease, indicating that patients are at a higher risk of angina, strokes and heart attacks.

According to GenenTech, Lucentis is a much smaller molecule than Avastin which helps lower the systemic toxicity of the drug, thereby lowering the overall risks that have been associated with off-label Avastin.

At one point, GenenTech indicated it would limit the supply of Avastin if it was destined to be used as off-label treatments for macula degeneration.  It later reversed this decision largely after many eye care professionals indicated their displeasure with such a practice, indicating that off-label Avastin was affordable and safe for seniors who were financially unable to pay for Lucentis treatments.

Even with the associated risks of using off-label Avastin as macular degeneration treatments, many patients are faced with having to make a decision based entirely on cost.  Many health plans do not cover the more expensive Lucentis treatments, and in some countries Lucentis has not been approved as a treatment for macular degeneration.  However, doctors have a supply of Avastin which costs less and has been shown to be an effective treatment for macular degeneration.

Doctors are permitted to prescribe any medication that they believe will benefit their patients as long as the drug is approved for use by a regulating body in their country.  It does not matter what the approval is for.  This practice of off-label usage is left entirely up to the physician and the decision is based entirely on their knowledge of the drug in question.  Doctors do not have to inform patients about this off-label usage but many patients when given the choice of no treatment or going blind as is the case with the off-label Avastin treatments for macular degeneration, they opt for the less expensive Avastin.  Many patients opt for the less expensive drug because the cost of Lucentis treatments for macular degeneration are prohibitive.

What does this mean for patients diagnosed with wet macular degeneration?

It is a tough decision and one that individuals must consider carefully before making a choice of treatments.  Off-label Avastin while popular, does pose risks.  Consultation with eye care professionals before making any decision should be required and patients should be given the information needed to make an informed decision.

The debate over off-label Avastin usage for macular degeneration is sure to continue.  Studies in the safety of Avastin for use in the eye continues and there are several major studies underway to compare Avastin and Lucentis treatments for macular degeneration.