Is the Battle Over Bevacizumab Coverage Looming?

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The FDA's approval of the cancer drug bevacizumab (Avastin; Roche/Genentech) in February 2004 validated a 30-year-old theory, championed by Judah Folkman, MD, of Harvard, that tumors can be stopped by choking off their blood supply. Enthusiasm for the drug was almost universal, as investors said at the time that it could one day command $2 billion a year in global sales.1 Seven years and 4 label expansions later, bevacizumab is Roche Holding AG's biggest product, with sales of 6.46 billion Swiss francs in 2010,2 or $6.22 billion, based on the average annual exchange rate. The drug is approved in the United States for colorectal cancer, lung cancer, glioblastoma, kidney cancer, and breast cancer and is being tested in more than 50 tumor types.1 The FDA announced in December that it planned to withdraw the drug's approval in breast cancer, where it has been widely used in advanced cancers. Breast cancer strikes 207,000 women in the United State each year and kills about 40,000. The news was striking in part because WellPoint Inc., UnitedHealth Group Inc., and other top insurers said they will continue to pay $8100 a month for the drug's use in breast cancer cases. When asked for the basis of a decision that would undoubtedly increase their breast cancer treatment costs by millions, the insurers pointed to a recommendation by NCCN. How can it be that a little-known, nongovernmental advisory group carries greater credibility with health insurers than the FDA? Avastin won conditional approval in the United States...

Catherine Larkin is a reporter for Bloomberg News in Washington, D.C., where she covers health-care regulation and the U.S. Food and Drug Administration. She earned her Bachelor of Science degree in journalism from Northwestern University.

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    Roche Business Report 2010: Pharmaceuticals. Roche Web site. Available at: Accessed February 2, 2011.

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    FDA Media Call: Recommendation to remove Avastin indication for metastatic breast cancer. U.S. Food and Drug Administration Web site. December 16, 2010. Available at: Accessed February 4, 2011.

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    About NCCN: Breast Cancer Panel. National Comprehensive Cancer Network Web site. Available at: Accessed January 28, 2011.

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    Submission of Genentech Inc. in response to the Food and Drug Administration's Notice of Opportunity for a Hearing and proposal to withdraw approval of Avastin (bevacizumab) in combination with weekly paclitaxel for the first-line treatment of patients with metastatic breast cancer. Docket No. FDA-2010-N-0621. Genentech, Inc. Web site. Available at: Accessed January 28, 2011.

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