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Avastin Will Be Available to Treat Macula Degeneration, Genentech Says

Dec 27, 2007 | Parker Waichman LLP Genentech—the maker of Avastin—appears to have resolved a dispute with ophthalmologists that will allow Avastin to continue to be used to treat eye diseases, both sides announced on Thursday.  Genentech angered 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 disorder that affects the macula—the central part of the retina—causing decreased vision and possible loss of central vision.  Macula degeneration is a leading cause of blindness among the elderly.  But each injection costs about $2,000 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.  Doctors are free to prescribe Food and Drug Administration (FDA)-approved medications as they see fit, including off-label.  It is off-label marketing of FDA-approved medication—marketing for uses not approved by the FDA—which is illegal.  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 these small doses, Avastin costs $20 to $100 per injection.  But Genentech said in October that it would no longer sell Avastin to compounding pharmacies, which specialize in the mixing of medications.

The move by Genentech 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 FDA, 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—effective January 1st—doctors would be able to purchase Avastin themselves and have the drug delivered to compounding pharmacies, allowing them access to the Avastin but also enabling Genentech to stop selling the drug to compounding.  The company has said that its sales to the pharmacies provoked concern at the FDA 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 take part in this new arrangement.

Genentech and the societies 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.

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