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Penn study: Costly eye drug no safer than alternative

When critics lamented the treatment of macular degeneration with a drug that costs up to 40 times as much as the alternative, physicians defended the practice by pointing to infections in patients who got the cheaper drug.

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When critics lamented the treatment of macular degeneration with a drug that costs up to 40 times as much as the alternative, physicians defended the practice by pointing to infections in patients who got the cheaper drug.

That argument no longer holds water, according to a new University of Pennsylvania study.

Researchers reviewed insurance claims data for 58,612 patients who received more than 380,000 injections of the two drugs, Avastin and Lucentis, and found they posed equally low risks of infection.

Lucentis is priced at up to $2,000 a dose, while Avastin costs $50 to $80 a dose. Both are made by California-based Genentech, are owned by the Roche Group in Switzerland, and work in the same way, by inhibiting the growth of abnormal blood vessels.

But Lucentis comes in ready-to-use vials from the manufacturer, whereas Avastin is packaged in much larger doses because, though chemically similar, it is designed as a cancer treatment. Doctors who use Avastin for macular degeneration must have the drug divided into smaller doses by a compounding pharmacy - a use that is legal but considered off-label.

Physicians have reported scattered incidences of endophthalmitis, a serious eye infection, in patients treated with Avastin, including 12 such cases tied to one compounding pharmacy in Florida. But the rate of infection associated with Lucentis is similar - just one in several thousand cases - according to the new study, published Thursday by JAMA Ophthalmology.

The findings come as the U.S. Food and Drug Administration has proposed that Avastin be used within five days of repackaging.

That would effectively prevent most ophthalmologists from using it, said Penn's Brian L. VanderBeek, the study's lead author. That is because compound pharmacies generally need 14 days to test the repackaged product for sterility, he said.

"My hope is that the news of this study reaches them prior to a final decision being made," said VanderBeek, an assistant professor of ophthalmology at the Perelman School of Medicine and Scheie Eye Institute.

Michael X. Repka, professor of ophthalmology at the Johns Hopkins University School of Medicine, said the Penn study would be useful not only for the agency.

"I think this is great information for the consumer and for the physician," said Repka, medical director for governmental affairs with the American Academy of Ophthalmology.

Genentech has pushed the use of Lucentis, even paying rebates to practices that use large amounts.

The company is not allowed to promote the use of Avastin in the eye, as it is not approved for that by the FDA.

Asked about the Penn study, the company said its own analyses had found similarly low rates of the infection in patients treated with Lucentis.

"Avastin is not approved for use in the eye by the FDA, and we do not support or promote unapproved use of our medicines," the company said in a statement. "However, decisions about treatment should be made between the physician and patient. We support their right to choose an appropriate medicine."

Studies indicate the two drugs are equally effective in treating wet macular degeneration - a disease that, until a decade ago, typically led to blindness.

The Penn study sample also included patients who were injected with the drugs for retinal vein occlusions and diabetes-related swelling in the eye, but most were treated for wet macular degeneration.

Asked if the Penn study would affect its decision on the directive to use Avastin within five days of repackaging, the FDA said it generally does not comment on specific studies.

The agency said it had received more than 350 comments on its draft guidance and would take them into account in issuing a final version, but would not say when that might be.

In 2010, Medicare spent $1.1 billion for Lucentis and just $27 million for Avastin when used to treat macular degeneration, according to a report by the Office of Inspector General in the Department of Health and Human Services.

Numerous doctors say they choose the more expensive drug for the benefit of their patient, not to enrich themselves. But in one high-profile case, according to federal prosecutors, a physician used Lucentis in a multimillion-dollar fraud.

North Palm Beach, Fla., ophthalmologist Salomon Melgen was indicted this year, accused of using the same vial of Lucentis on multiple patients, and of using it to treat some patients who did not have the disease. Separately, he has been charged in a bribery case along with his friend U.S. Sen. Robert Menendez (D., N.J.).