F.D.A. Revokes Approval of Avastin for Use as Breast Cancer Drug Andrew Pollack NY Times November 18,

Did not help patients The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling on an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials.Food and Drug AdministrationAvastin The commissioner, Dr. Margaret A. Hamburg, said that clinical trials had shown that the drug was not helping breast cancer patients to live longer or to meaningfully control their tumors, but did expose them to potentially serious side effects like severe high blood pressure and hemorrhaging.Margaret A. Hamburg

Will remain on market Avastin will remain on the market as a treatment for other types of cancers, so doctors can use it off-label for breast cancer. But insurers might no longer pay for the drug, which would put it out of reach of many women because it costs about $88,000 a year. Federal officials said on Friday that Medicare would still provide coverage for the drug’s use in breast cancer, though the government plans to “monitor the issue and evaluate coverage options.” (???? Why ????)Medicare

Genentech’s response The drug’s manufacturer, Genentech, which fought long and hard to retain the approval, said it was “disappointed.” The decision could cost Genentech and its Swiss parent company, Roche, up to $1 billion in annual sales. Use of Avastin has already declined to 20 percent, from 60 percent, of American patients with newly diagnosed metastatic breast cancer, the condition for which the drug was approved, according to Genentech. About 29,000 women each year are found to have metastatic breast cancer.Genentech A Genentech spokeswoman said the company would continue to provide some help to breast cancer patients in securing insurance coverage. But it will no longer provide co-payment assistance and will no longer cap combined expenses for many patients and their insurers at $58,000 a year.

Why Medicare? Medicare is obligated to pay for off-label use of cancer drugs that are listed in certain references, like the one published by the National Comprehensive Cancer Network, an organization of major cancer hospitals. National Comprehensive Cancer Network In July a committee of breast cancer specialists from those centers reaffirmed that Avastin should remain listed as “an appropriate therapeutic option for metastatic breast cancer.” A third of the committee members had financial ties to Genentech, according to Dr. Hamburg’s memorandum.

The Economics – Why Regulate Drugs? Patent Protection – It is expensive to develop drugs. What do patents do? Information – Drugs can have: –No impact –Adverse impact Government is asked to pay for drugs Regulatory delays may delay: –Bad things –Good things

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