As I read the news release from the NEI/NIH yesterday morning, about the one-year results of the clinical trial evaluating the combination use of Lucentis with pan-retinal laser therapy to treat diabetic macular edema, prior to posting it online, and later, when I read the complete study as posted in Ophthalmology, the one thought that kept running through my mind was, why was Lucentis, at $2000 per dose chosen for the study, rather than Avastin at $50 per dose?
As quoted in the NY Times story, from Dr. Philip Rosenfeld of Bascom Palmer in Miami, “the decision was ‘clearly a case of pay to play’ since Genentech’s money dictated the choice of drugs.”
Organizers of the trial conceded that a major reason Lucentis was chosen was that Genentech agreed to provide the drug for free and contributed $9 million in additional financing – but only if Lucentis was used!
"Obviously you can't underplay $9 million," said Dr. Ferris of the National Eye Institute, which is part of the part of the National Institutes of Health. But he said there were other factors as well, like a belief that Lucentis might have been the better drug.
As shown in the study, nearly half the people whose eyes were treated with Lucentis, often in combination with standard pan-retinal laser therapy, had an improvement in vision of at least two lines on an eye chart after one year. That compared with only about 30 percent of those receiving laser therapy alone. And fewer people treated with Lucentis experienced a big loss of vision.
"This is the first new treatment for people with diabetic macular edema in a quarter of a century," Dr. Frederick L. Ferris III, clinical director of the National Eye Institute, which sponsored the trial, said in a telephone news conference on Tuesday.
The trial involved 691 patients, some of whom had both eyes treated, resulting in 854 total eyes. There were four treatment groups: One group got Lucentis injections into the eye as often as every four weeks, plus laser therapy. Another got Lucentis, with laser therapy used only after six months and only if needed. The third group got laser therapy plus injections into the eye of triamcinolone, a steroid sold by Allergan under the name Trivaris. The fourth group got laser therapy plus a sham injection.
Some doctors criticized the organizers of the trial for testing Lucentis rather than the other Genentech drug, Avastin, which works in the same way as Lucentis. Avastin, approved for use in treating colon cancer is not approved for use in the eye, but has been used “off-label” since early 2005 and, because of its lower cost and anecdotal results and a few comparative studies, appears to work as well as Lucentis. According to Market Scope, an ophthalmic market research company, more than 60% of intraviteal injections used in treating AMD are done with Avastin, rather than Lucentis, probably because of the cost differential.
As stated in the NY Time article, Avastin is undercutting sales of Lucentis, which totaled $1.1 billion in the United States last year.
It is interesting to note that Genentech refused to supply either of the drugs or support the clinical trial, when the NEI/NIH agreed to fund a comparative study of the two drugs in treating neovascular AMD, the CATT Study (Comparison of Age-Related Macular Degeneration Treatment Trials). The CATT Study was initiated, without Genentech aid in February 2008, finished recruiting its 1200 patients in November 2009, and will report initial results in early 2011.
It will be interesting to see what the effect on sales of Lucentis will be if the CATT Study shows little or no difference in the two drugs in the treatment of AMD.