Avastin/Lucentis Update 7: BREAKING NEWS – NEI/NIH Will Fund Comparative Study
On October 6th, after the New England Journal of Medicine had gone to press, the National Eye Institute and the National Institute of Health announced that they will proceed with a comparative study of Avastin and Lucentis.
As noted in my previous three updates (see links below in the Author’s Note), I and others felt that common sense dictated that a comparative study be undertaken particularly because of the disparity in price between the two drugs – Lucentis priced at $1950 per dose, and Avastin (used off-label) at about a tenth of that price.
As stated on their web site: “The National Eye Institute (NEI) of the National Institutes of Health (NIH) will fund a new multicenter clinical trial to compare two drugs currently used to treat advanced age-related macular degeneration (AMD)... Lucentis (ranibizumab) and Avastin (bevacizumab).”
In addition, the announcement said: “In advanced AMD, abnormal new blood vessels grow beneath the retina. These abnormal blood vessels can leak blood and fluid, and can cause severe vision loss. NEI-supported research has helped establish that VEGF is an important part of the biological pathways involved in triggering and sustaining the growth of new blood vessels in the retina. Research also demonstrated that VEGF is present in higher levels in a number of eye diseases, such as AMD. NEI has supported more than 300 research studies at a cost of nearly $95 million to better understand the role of VEGF in eye diseases.”
At this point, two anti-VEGF therapies, Macugen (pegaptanib sodium) and Lucentis, have already been approved by FDA specifically for the treatment of advanced AMD. Paul A. Sieving, M.D., Ph.D., director of NEI, said, "We are pleased that NIH-supported research is stimulating the development and testing of new, effective treatments for AMD."
I contacted the NEI and learned that patient enrollment will begin after the first of the year.
As I learn more about this important clinical trial, I will continue to update my web site.
According to a report in the New York Times, if the drugs prove to be equivalent in treating age-related macular degeneration, it would probably mean that many eye doctors would switch to the cheaper drug, hurting Genentech's sales but saving the Medicare program hundreds of millions of dollars a year.
Both Avastin and Lucentis work in a similar way, and some eye doctors say they believe Avastin is equally as effective. However Avastin has not been tested in rigorous clinical trials as Lucentis has. So interest has been growing for a trial to compare the drugs. It is estimated that there are 200,000 new cases each year of the type of macular degeneration for which Lucentis is approved.
Dr. Maryann Redford, the administrator of the NEI grant for the study, said it will involve a two-year trial costing about $16 million. The trial will follow about 1,200 people divided into four groups: one group will get a Lucentis injection every four weeks, one group will get an Avastin injection every four weeks; and two groups will get either Lucentis or Avastin on an as-needed basis. Redford said the study will take four years to complete.
Dr. Redford added that cost is not the primary reason that NEI decided to fund the study. "Right now there is an uncontrolled experiment being done, in that many clinicians are using Avastin, but its safety and efficacy for this use hasn't been tested," adding, "If the fallout also is that it can be done much less expensively, great."
Hal Barron, Genentech's chief medical officer, said the company is not interested in paying for a study comparing Lucentis and Avastin because it is unlikely that Avastin is a superior treatment and because the company prefers to spend money developing new treatments. Barron added that 81% of patients pay less than $50 out of pocket for each Lucentis dose because they have Medicare or other insurance.
Author’s Note on Avastin
Since posting the original article on January 31, 2006, I have now posted eight updates on this important drug for treating age-related macular degeneration. In addition to the posting you are reading, here is a listing (with links) to the others:
Avastin: A New Hope for Treating AMD (January 2006)
Avastin Update: Medicare not Likely to Cover its Use (March 2006)
Avastin Update II: AAO supports Medicare Coverage for Off-label Avastin Use (April 2006)
ARVO 2006: A Further Update on Both Avastin and Lucentis for Treating AMD (May 2006)
Avastin/Lucentis Update 4: FDA Approves Lucentis for Treating Wet AMD (July 2006)
Avastin Update 5: NIH Considers Comparing Lucentis and Avastin (August 2006)
Avastin/Lucentis Update 6: Latest Results Published in NEJM and Another Call for a Trial Between Them (October 2006)