FDA Approval Of Eye Medication Expected Amid Controversy Over Cost

FDA this week is expected to approve Genentech’s Lucentis for the treatment of wet age-related macular degeneration, but the approval will “pose a conundrum” for physicians, patients and insurers because the treatment is expected to cost 10 to 100 times more than a similar Genentech product that also can treat the condition and is already on the market, the New York Times reports. The older drug, Avastin, is approved to treat cancer, but some doctors since late 2005 have been using the injectable medication to treat wet macular degeneration. Avastin costs about $50,000 per year to treat cancer, but because the amount needed for eye injections is small, the cost for treating wet macular degeneration is about $1,000 or less per year. Lucentis is expected to cost at least $10,000 per year. According to the Times, “Genentech has no interest in getting Avastin approved for macular degeneration, because that would undermine the sales of Lucentis, which some analysts predict will have annual sales of several hundred million dollars” (Pollack, New York Times, 6/29). The drugs share some components, and both were designed to block vascular endothelial growth factor — a molecular signal Genentech discovered in 1989 — which controls abnormal blood vessel growth. Lucentis was designed to be a smaller drug that more effectively penetrates the eye and concentrates its effects, minimizing side effects, according to Susan Desmond-Hellmann, president of product development at Genentech (Tansey, San Francisco Chronicle, 6/29).

Concerns
“Use of Avastin instead of Lucentis could save patients and insurers hundreds of millions of dollars a year,” and it is unclear whether they will consider the new treatment “worth” the price, according to the Times. However, many specialists already plan to switch to Lucentis after it is approved because, unlike Avastin, there are clinical trials to support the drug’s safety and efficacy as a treatment for macular degeneration, the Times reports (New York Times, 6/29). In addition, Avastin has a risk of serious side effects, including heart failure, high blood pressure, kidney problems and stroke. Some doctors — including Philip Rosenfeld, an associate professor of ophthalmology at the University of Miami and one of the first doctors to use Avastin for macular degeneration — say the risk of serious side effects from Avastin is much lower when used in small doses in the eye than in the large doses needed to treat cancer. Rosenfeld and a group of doctors hope to conduct their own study to prove the safety and efficacy of the treatment. Rosenfeld said they hope to obtain funding from NIH for the research.

Comments
Desmond-Hellmann said Lucentis is superior to Avastin for treating macular degeneration because it was designed specifically to target the eye. In addition, she said, Lucentis clears out of the body within days, while Avastin remains in the body for weeks (San Francisco Chronicle, 6/29). Desmond-Hellmann said Lucentis would save the health care system money by preventing blindness, which can lead to other injuries and the need for nursing home care. Rosenfeld said, “The whole experience really opens your eyes to how our whole health care system is operating,” adding, “We could be incentivized to use the most effective therapy at the most reasonable cost. But that’s not how our system is set up” (New York Times, 6/29).

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View drug information on Avastin; Lucentis.