Genentech to limit avastin availability -

Genentech to Limit Avastin Availability - October 12, 2007
Genentech to Limit Avastin Availability
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Reprints tool at the bottom of any article or visit: By JACOB GOLDSTEIN and MARILYN CHASE
October 12, 2007; Page B6
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Genentech Inc. said it will stop making its cancer drug Avastin available to certain
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pharmacies in a bid to curb its use in treating eye disease -- which has cut into sales of the company's high-priced eye drug.
Although regulators haven't authorized Avastin's use against eye disease, it is chemically similar to Lucentis, which was approved last year to treat wet macular degeneration, a leading cause of blindness in the elderly. Compounding pharmacies, which are licensed to mix and repackage drugs, put Avastin into syringes that contain a once-monthly dose of the drug for use in the eye and cost about $40. A once-monthly dose of Lucentis costs about $2,000.
In the first six months of this year, U.S. sales of Avastin were $1.1 billion, and Lucentis sales were $420 million.
Medicare, which offers health coverage for the elderly and disabled and is a big purchaser of the two drugs, has said curbing Avastin could cost taxpayers $1 billion to $3 billion a year. Using a cheaper drug not only would preserve Medicare funds, but would trim beneficiaries' exposure to high co-payments, program administrators say.
The question of the drugs' equivalence may be decided in a study sponsored by the National Institutes of Health. Genentech has refused to support the head-to-head study, nor to provide the two drugs at cost, reasoning it already has invested seven years of research and development in validating Lucentis as safe and effective.
Battle lines over usage pit retinal specialists -- many of whom have opted to prescribe Avastin -- against the company and its backers, who say recovering profits is necessary to preserve the U.S. edge in health-care innovation.
In a letter explaining its decision, Genentech, the world's second-largest biotechnology company after Amgen Inc., pointed out that Lucentis was approved expressly for use in the eyes, and said the Food and Drug Administration has voiced safety concerns about the repackaging of Avastin for that use.
Avastin, which is sold through wholesalers, will continue to be available to hospital pharmacies and directly to doctors. But it won't be available to compounding pharmacies as of Nov. 30. The FDA in December sent warning letters to a compounding pharmacy in New England complaining that the practice of splitting Avastin doses for the eye carried risk of contamination and serious eye infection.
Philip Rosenfeld, a University of Miami ophthalmologist who was one of the first doctors to use Avastin in the eye, noted the drug is used for several eye diseases for which neither Avastin nor Lucentis has been approved. "Our need for Avastin just doesn't go away with providing Lucentis" for wet age-related macular degeneration, he said.
Anne Fung, a San Francisco ophthalmologist, said she worries that some doctors now may try repackaging Avastin themselves without proper safety equipment. The new policy will take Avastin out of a regulated environment and Genentech to Limit Avastin Availability - put it into an unregulated environment, she said, possibly increasing the risk of contamination and infections. Dr. Fung said she would likely try to get Avastin from a hospital pharmacy, which could increase the cost of treating patients.
In South San Francisco, Genentech spokeswoman Dawn Kalmar said most macular-degeneration patients are covered by Medicare, and the company helps connect patients who can't cover their co-payment -- which can be $400 a month for Lucentis -- with charities that help out. Doctors complain the program is cumbersome, and some underinsured patients fall through the cracks.
Write to Jacob Goldstein at [email protected] and Marilyn Chase at [email protected]
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