Healthy Skepticism Library item: 11822

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Publication type: news

Pollack A.
Maker Seeks to Restrict Cancer Drug Used on Eye
New York Times 2007 Oct 12
http://www.nytimes.com/2007/10/12/business/12eye.html?_r=1&ex=1349928000&en=10914116df9e6a46&ei=5088&partner=rssnyt&emc=rss&oref=slogin

Full text:

Genentech is moving to restrict the use of its drug Avastin by ophthalmologists, a move that could substantially raise the costs of treating a common eye disease.

The move is already angering some eye doctors, who say it may force them to use Genentech’s much more expensive drug Lucentis instead.

“I think the retinal community is deeply saddened by the decision Genentech has made to restrict the availability of Avastin in the United States,” said Dr. Philip J. Rosenfeld, a professor of ophthalmology at the University of Miami. He said the move would have a “profound” effect on retinal practices.

Lucentis is approved to treat wet age-related macular degeneration, the most common cause of blindness in the elderly. But it costs about $2,000 a dose, with treatment needed as often as once a month.

As a result, many retina specialists prefer off-label use of Avastin, a cancer drug that has not been rigorously tested for macular degeneration but has the same mechanism of action as Lucentis. When injected into the eye in tiny amounts, Avastin costs about $50 a dose.

In a letter yesterday to retina specialists, Genentech said that its wholesalers would no longer provide Avastin to compounding pharmacies – companies that under sterile conditions can divide a vial of Avastin into tiny portions for use in the eye. The company said the distribution change would take effect Nov. 30.

Genentech said it was taking the step in part because Lucentis was now widely available. Eye doctors had started using Avastin before Lucentis won approval from the Food and Drug Administration in June 2006. The company also said that the F.D.A. had expressed concern about possible microbial contamination when a vial of Avastin was split into multiple doses. Such contamination could lead to serious eye infections.

The agency sent a warning letter to one compounding pharmacy about this in December. Genentech said F.D.A. inspectors had also expressed concern during a routine inspection of one of Genentech’s own factories.

But Dr. Rosenfeld and other ophthalmologists have argued that Avastin had been used safely by many doctors for about two years and appeared to be as effective as Lucentis. He said he thought Genentech’s move was for business reasons, because the cheaper Avastin was cutting into sales of Lucentis. Sales of Lucentis were $209 million in the second quarter.

In its last quarterly earnings teleconference with analysts, a Genentech executive said that Lucentis was being used to treat 55 percent of new patients with the relevant form of macular degeneration and 50 percent of all such patients. Retina doctors say Avastin accounted for most of the rest of the patients – or nearly half the market.

Genentech did not plan to compete with itself. It said it intended Lucentis specifically for use in the eye, believing that Avastin, a bigger molecule, would not work there. But while waiting for Lucentis to be approved, doctors started using Avastin and found it worked.

With 200,000 new cases of wet macular degeneration in the United States each year, the use of Lucentis instead of Avastin could easily add more than $1 billion a year in annual costs for Medicare. The National Eye Institute is sponsoring a trial that will directly compare the two drugs as a treatment for macular degeneration, but results are not expected for several years.

Genentech said it had a program to help patients unable to afford Lucentis. The company said yesterday that hospital pharmacies and doctors would still be able to buy Avastin. So retina specialists in hospitals would still have access to the drug. And doctors in private practices could buy Avastin and then send the drug to a compounding pharmacy for processing.

“It’s going to make life a little bit more difficult, but I don’t see it as an insurmountable issue,” said Dr. George A. Williams, chairman of ophthalmology at William Beaumont Hospital in Royal Oak, Mich.

But Dr. Raj Maturi, a retina specialist at the Midwest Eye Institute in Indianapolis, said the extra steps in sending the drug to a pharmacy would add to the expense and risk.

Still, he said he would try to get Avastin, because “I don’t want to see my patients go blind because they can’t afford a $2,000 drug.”