Genentech Restricts Use of Avastin for Ophthalmic Use

The National Eye Institute (NEI) of the National Institutes of Health announced that it will conduct a study comparing the effectiveness of two Genentech drugs, Lucentis® and Avastin®, for the treatment of age-related macular degeneration (AMD). This was not good news for Genentech, because although treating with Avastin is an off label use (Avastin is FDA approved for treating colon and certain lung cancers), the cost of the treatment is between 1% and 3% of the Lucentis treatment, $20 to $60 per dose versus $2,000 per dose.

Not surprisingly, Genentech has refused to supply the NEI with either drug for the trial. Genentech CEO Dr. Arthur Levinson recounted the history of the development of both drugs. According to work done by Judah Folkman, cancer cells produce angiogenic factors that induce blood vessel proliferation in tumors as part of the natural progression of the disease. Avastin, a monoclonal antibody that interferes with Vascular Endothelial Growth Factor (VEGF) action, a protein that induces blood vessels to form, was then developed by Genentech for use against colo/rectal and lung cancer. It was shown that patients with macular degeneration also have high levels of VEGF, in this case near the retina, which led to the development of Lucentis, another antibody-based drug.

Dr. Levinson pointed out that bringing Lucentis to market required two years of experimental work and that the drug had to undergo a full regulatory review. Dr. Levinson noted that the Phase III clinical trials for Lucentis were “the most expensive clinical-development program Genentech ever undertook,” costing $40,000 to $45,000 per patient. In Dr. Levinson’s view the cost of Lucentis is fully justified and he disputed allegations that some patients did not have access to the more expensive Lucentis, citing coverage by major health insurers and the company’s own drug purchase assistance programs.

In a letter sent to retina specialists, Genentech said that as of November 30, 2007 its wholesalers would no longer provide Avastin to compounding pharmacies, which are businesses that, under sterile conditions, divide a vial of Avastin into tiny portions for use in the eye. This move by Genentech to restrict the use of its cancer drug Avastin by ophthalmologists could substantially raise the cost of treating a common eye disease. The move is already angering some eye doctors. “I think the retinal community is deeply saddened by the decision Genentech has made to restrict the availability of Avastin,” said Dr. Philip J. Rosenfeld, a professor of ophthalmology at the University of Miami. He said the move would a have “profound” effect on retinal practices. This is because when injected into the eye in tiny amounts, Avastin costs only about $50 a dose. Genentech said it was taking the step because Lucentis was now widely available, and it also mentioned the FDA’s expressed concern about possible microbial contamination when a vial of Avastin is split into multiple doses. Such contamination could lead to serious eye infections.

But Dr. Rosenfeld and some other ophthalmologists have argued that Avastin has been used safely by many physicians for about two years and appears 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. Retina doctors say that Avastin accounts for nearly half the market. 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. While Lucentis is FDA approved for wet macular degeneration, retina specialists have been using Avastin to treat not only AMD but other retinal diseases.

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