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COMPARATIVE EFFECTIVENESS

A Near-Tie

Study shows two Genentech drugs almost equally effective for eye disease.

MICHAEL FITZHUGH

The Burrill Report

“Patients and clinicians can now feel confident that bevacizumab is therapeutically equivalent to ranibizumab, says Daniel Martin, chairman of the Cole Eye Institute at Cleveland Clinic.”

Eye doctors helping patients dodge blindness and rising medical costs have new support for choosing the cheaper of two similar Genentech drugs to fight age-related macular degeneration.

The monoclonal antibody medicines bevacizumab and ranibizumab, branded as Avastin and Lucentis respectively, are both developed and sold by Genentech and provide virtually identical improvements in patients' visual acuity when given monthly, a new study found. But bevacizumab costs about $50 per dose compared to the $2,000 per dose ranibizumab, which is the only one of the two drugs approved to treat the degenerative eye disease, often called AMD. Patients with AMD given the cheaper bevacizumab only as needed and less than monthly also achieved substantial gains in vision, the study found.

More than 250,000 patients are treated each year for AMD, with the majority receiving bevacizumab. But while there's plenty of data to back the effectiveness of ranibizumab in treating AMD, there was until now less data to support off-label usage of bevacizumab.

“For years, ophthalmologists have been using intravitreal bevacizumab to treat neovascular AMD without data regarding efficacy and safety from well-controlled studies,” says Daniel Martin, chairman of the Cole Eye Institute at Cleveland Clinic and the study group’s leader. “Patients and clinicians can now feel confident that bevacizumab is therapeutically equivalent to ranibizumab.”

Genentech says it continues to “believe that Lucentis is the most appropriate treatment for wet-AMD.” It also points out that bevacizumab was designed to fight certain cancers, such as metastatic colon cancer, not for use in the eye and highlighted unresolved concerns over whether patients taking bevacizumab suffer a slightly higher incidence of adverse effects than those taking ranibizumab.

But the near-parity shown in the federally funded study, published in the New England Journal of Medicine, provided just the sort finding that comparative effectiveness research aims to produce: information that informs payers (like the U.S. government) and patients about which therapies work, which do not, and at what cost.

The idea of comparative effectiveness took root in the 2009 American Recovery and Reinvestment Act, which provided $1.1 billion for such studies. And it has long been embraced by the United Kingdom's Institute for Health and Clinical Excellence, where comparative effective research has proven a formidable barrier to the coverage of many cancer drugs by the country's National Health Service, much to the chagrin of many companies trying to successfully market new drugs there.

In the United States however “there remains insufficient infrastructure for the implementation of federally sponsored (comparative effectiveness research) trials,” the Cleveland Clinic said in a statement accompanying the bevacizumab-ranibizumab study. Certainly, this study is unlikely to win the notion any new fans among drugmakers.


April 29, 2011
http://www.burrillreport.com/article-a_near_tie.html

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