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Off-Label Drug Offers Similar Results at Lower Price

It seems highly unlikely that one company would produce two drugs, at different prices, that treat the same ailment, and be in the middle of a medical industry dispute, but that's exactly the case of Genentech Inc. Lucentis, a federally approved drug for the most severe form of macular degeneration has been on the market since 2006. It has been clinically proven to be effective, but another drug, Avastin, developed in 2004 to treat colon cancer, is said to be its equal. Many eye doctors say either drug is appropriate to treat the wet form of age-related macular degeneration, also known as AMD, which has become increasingly common among people over 60. If untreated, this disease can leave people with severely impaired vision which makes reading, driving and watching television difficult. Wet AMD occurs when abnormal blood vessels leak blood and fluid, affecting the part of the eye that perceives fine detail. Monthly or bimonthly injections of either drug can, in many cases, lead to improvement. The drug specifically approved for macular degeneration, Lucentis, costs $2,000 per treatment. The one approved for colon cancer, Avastin, costs $60 per eye treatment. With monthly administered treatments for at least a year, the Lucentis treatment costs up to $24,000 per eye, while Avastin is $720. Genentech has refused to seek FDA approval for Avastin as a treatment for macular degeneration. However, many doctors are using Avastin on AMD "off-label" - meaning to remedy an illness it is not approved to treat. NEI Study A study has been commissioned by the National Eye Institute (NEI) to determine whether the drugs are truly comparable in treating macular degeneration. Genentech declined to seek federal approval for the cheaper drug, Avastin, nor would it help finance, or cooperate with, the NEI study. Genentech makes no promises that it will act upon the trial's final results. The company has raised concerns that safety issues were not properly addressed. In particular, the trial doesn't have enough patients to show some of the rare but serious side effects that could occur with use of the cheaper drug, the company contends. "No matter the income, we continue to believe Lucentis is the most appropriate treatment for wet AMD," said Krysta Pellegrina, a company spokeswoman. Health officials pleaded with Genentech to participate in the clinical trial to compare the two drugs. At one point the company considered doing so by providing the medicines in masked, identical vials, according to e-mail exchanges obtained by the Senate Aging Committee. In the end, the board did not support the study. Dr. Philip Rosenfeld, who has treated hundreds of his eye patients in South Florida with Avastin, said Genentech had little economic incentive to help finance the trial, unless it was confident Lucentis was truly superior. "By fact they didn't support the clinical study leads me to conclude that in reality there is no difference between the two drugs," Rosenfeld said. "The result is clearly not in Genentech's best interest. "I see this as a public health study, not only for us, but for the whole world. It gives everyone the license to use both drugs interchangeably," he said. "Clearly, for Medicare it would make economic sense to put preference on the use of Avastin. If the study, expected to be completed in two or three years, shows the drugs are comparable, Medicare will be able to cover the less expensive treatment. The agency has the authority to mandate equal payments for different drugs which have been proven to achieve the same results.

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