Healthy Skepticism Library item: 12259

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Publication type: news

Pollack A.
Drug Maker and Eye Doctors Settle Dispute Over Avastin
The New York Times 2007 Dec 21
http://www.nytimes.com/2007/12/21/business/21avastin.html?ex=1355893200&en=087cfdb3d61345ee&ei=5088&partner=rssnyt&emc=rss

Full text:

Genetech appears to have resolved a dispute with ophthalmologists that will allow the company’s drug Avastin to continue to be used to treat eye diseases, both sides announced on Thursday.

Genentech infuriated many eye doctors in October when it announced a change in the distribution of Avastin that would have made it difficult for the doctors to use the drug. The doctors accused the company of trying to force them to use a much more expensive Genentech drug, Lucentis, instead.

Lucentis is approved to treat macular degeneration, a leading cause of blindness among the elderly.

But it costs about $2,000 for each injection into the eye, and injections are needed as often as once a month.

Many ophthalmologists are instead resorting to off-label use of Avastin, which is approved only to treat cancer but works in the same way as Lucentis. The eye doctors have been relying on compounding pharmacies to divide a vial of Avastin meant for cancer treatment into tiny portions for use in the eye under sterile conditions. In the tiny doses, Avastin costs $20 to $100 an injection.

But Genentech said in October that it would no longer sell Avastin to compounding pharmacies, which specialize in mixing drugs.

That prompted an inquiry by Senator Herb Kohl, Democrat of Wisconsin, chairman of the Special Committee on Aging. In letters requesting documents from Genentech, Medicare and the Food and Drug Administration, Mr. Kohl said the use of Lucentis instead of Avastin could cost Medicare $1 billion to $3 billion a year.

But on Thursday, Genentech and two societies of eye doctors announced that doctors would be able to purchase Avastin themselves and have the drug delivered to compounding pharmacies.

That would allow them access to the Avastin but would also enable Genentech to stop selling the drug to compounding pharmacies as of Jan. 1. The company has said that its sales to the pharmacies provoked concern at the F.D.A. because Avastin was not manufactured for use in the eye.

In a joint e-mail message sent to their members on Thursday, the American Academy of Ophthalmology and the American Society of Retina Specialists said they believed that the plan addressed “the needs of most of their members.”

The message cautioned, however, that some states might have regulations that would make it difficult to use this new arrangement.

Genentech and the societies also agreed to work together to improve Genentech’s programs for helping patients pay for Lucentis, the more expensive drug, or to find ways to provide it free to those who cannot pay. They also said they would work together to expedite reimbursement to doctors, who generally buy the Lucentis themselves and must wait to recover the outlay from patient bills or insurers.