Genentech will restrict use of Avastin for eye disease.

Genentech is moving to restrict the use of its cancer 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 instead use Genentech's much more expensive drug Lucentis. 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 a dose needed as often as once a month.

As a result, many retina specialists prefer off-label use of Avastin, which 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 only about $50 a dose.

In a letter sent today to retina specialists, Genentech said that its wholesalers would no longer provide Avastin to compounding pharmacies, which, under sterile conditions, divide a vial of Avastin into tiny portions for use in the eye.

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 FDA in June 2006.

The company also said that FDA had expressed concern about possible microbial contamination when a vial of Avastin is split into multiple doses. Such contamination could lead to serious eye infections.

The agency sent a warning letter to one compound pharmacy about this last December. Genentech said FDA inspectors had also expressed concern on routine inspection of one Genentech's own factories.

It said it had a program in place to help patients who had trouble paying for Lucentis. The company said the distribution change would take effect Nov. 30 to allow physicians and pharmacies time to adjust.

But some ophthalmologists have argued that Avastin has been used safely by many physicians for about two years and appears to be as effective as Lucentis; they think Genentech's move is for business reasons, because the cheaper Avastin is cutting into sales of Lucentis.

In its last quarterly earnings teleconference with analysts, a Genentech executive said that Lucentis was being used to treat 55% of new patients and 50% of all 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 designed 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.

Using Lucentis instead of Avastin to treat all patients with wet macular degeneration could add hundreds of millions of dollars in annual costs for Medicare. The National Eye Institute is now sponsoring a trial that will directly compare the two drugs as a treatment for macular degeneration.

Genentech said that hospital pharmacies and physicians would still be able to purchase Avastin, so retina specialists in hospitals would still have access to the drug. And it seems possible that private practices could purchase Avastin and then send the drug to a compound pharmacy for processing.

George Williams, M.D., chairman of ophthalmology at William Beaumont Hospital in Royal Oak, MI, told The Times Genentech did face some legal risks by having allowed sales of Avastin to compound pharmacies, because it could be perceived that the company was facilitating off-label use of the drug. Doctors are allowed to use drugs off-label but drug companies cannot promote such uses.

But Raj Maturi, M.D., a retina specialist at Midwest Eye Institute in Indianapolis, said the extra steps of having to take 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."

He said that the possible loss of Avastin would have the biggest impact on patients getting the drug to treat certain eye diseases other than macular degeneration, like diabetic retinopathy. About 45% of his use of Avastin is for these other diseases.

"Lucentis is not FDA-approved for anything besides macular degeneration, and insurance companies are reluctant to approve use of Lucentis for other diseases, given its cost," Maturi said.