Cheaper Drug to Treat Eye Disease Is Effective

A drug that costs about $50 a dose is just as effective at preserving and improving vision in elderly people with an age-related eye disease as one that costs $2,000 a dose, according to the results of a government-sponsored clinical trial released Thursday.

The trial compared the effectiveness of Lucentis, a drug approved to treat one form of macular degeneration, with Avastin, a cancer drug that many eye doctors have been using off-label instead of Lucentis because of its far lower cost. The drugs, both made by Genentech, work in a similar manner.

The findings could possibly save Medicare hundreds of millions of dollars a year — and cost Genentech an equivalent amount in lost sales — if more doctors begin using Avastin instead of Lucentis.

Macular degeneration is the leading cause of severe vision loss among the elderly. More than 250,000 Americans get treated for it each year. The wet form of the disease, for which Lucentis is approved, is characterized by abnormal blood vessels in the back of the eye that leak fluid, obstructing the vision essential for reading, driving, watching TV and recognizing faces.

“Health care providers and payers worldwide will now have to justify the cost of using” Lucentis, Dr. Philip J. Rosenfeld, a retina specialist at the University of Miami, wrote in an editorial in The New England Journal of Medicine, which published the trial results online Thursday.

Still, supporters of Lucentis said there are benefits of the drug. Lucentis was better at drying the fluid in the eye that is believed to be the cause of vision loss from the disease. While this did not translate into a difference in vision at the end of one year, the time point measured in the trial, it might do so over longer time periods, they said.

Moreover, 24 percent of the patients who received Avastin had a serious health complication compared with 19 percent of those who got Lucentis, the trial showed. However, the complications were varied and not those typically seen when Avastin is used, at much higher doses, as a cancer treatment. The authors of the study said there were too few patients in the trial to resolve the safety issue.

Both Lucentis and Avastin are meant to stop blood vessel formation and leaks. Lucentis was created specifically for use in the eye, but many doctors have used Avastin because when a vial of that drug meant for cancer treatment is divided into tiny doses for the eye, each injection costs much less than Lucentis.

Despite the widespread use of Avastin, the drug had never been thoroughly tested in treating the eye disease. So the National Eye Institute, part of the National Institutes of Health, sponsored a study involving 1,200 patients.

In the trial, patients who got Avastin every month could read an average of 8 more letters on an eye chart after one year — about the same improvement as patients using Lucentis, who were able to read 8.5 more letters a year later. The percentages of patients who had gains or losses of vision of more than 15 letters, equivalent to three lines on the eye chart, were also similar for the two drugs.

Avastin and Lucentis also were equivalent when the drugs were given as needed, depending on the course of a patient’s disease, rather than on a fixed monthly schedule. However, it was unclear if Avastin given as needed was as good as Avastin given monthly.

Still, the authors of the study said that giving the drugs as needed, which resulted in average vision gains around six letters, could be an acceptable alternative. It would mean an average of four or five fewer injections per year, reducing the cost of treating a patient with Lucentis by about $10,000 a year.

In 2008, Medicare paid for 480,000 injections of Avastin to treat macular degeneration and for 337,000 injections of Lucentis, according to a study done by Medicare researchers and by Dr. Rosenfeld of the University of Miami. Yet Medicare paid only $20 million for the Avastin compared with $537 million for the smaller number of Lucentis injections.

Genentech, which is owned by Roche, said in a statement on Thursday that it continued to believe that Lucentis was safer and better. The company sells Lucentis in the United States while Novartis sells it elsewhere. Each company had sales of roughly $1.5 billion year.

The trial results are also likely to affect Regeneron Pharmaceuticals and Bayer, which are trying to win approval of another drug to treat macular degeneration.

http://www.nytimes.com/2011/04/29/bu....html?_r=1&hpw