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Medicare said this week it will pay for two cancer treatments with hefty price tags -- and lingering questions: Avastin, the controversial drug shot down by an Food and Drug Administration panel on Wednesday for its use against advanced breast cancer, and Provenge, a treatment for advanced prostate cancer.
Even though an FDA panel said that Avastin wasn’t safe or beneficial enough in clinical trials, doctors can still prescribe it and Medicare will continue to cover it, a spokesman for the Centers for Medicare and Medicaid told Reuters. The drug costs about $8,000 per month.
Avastin was first approved in 2004 for treatment of advanced colon cancer and has been approved since for advanced lung (2006), kidney and brain (glioblastoma) cancers (2009). Avastin was approved for metastatic breast cancer in 2008 under the accelerated approval program. Under the accelerated approval program, a drug may be approved based on results of clinical data that suggest the drug has an important clinical benefit. However, additional information is needed to confirm the data.
The FDA has proposed withdrawing Avastin's indication to treat women with metastatic breast cancer. The agency is making this announcement after deciding there is not enough evidence that the drug is safe and effective for this one indication. The announcement will not have any immediate effect on the approval of Avastin to treat metastatic breast cancer and there will be no change to product labeling. Since the marketing approval remains in effect, patients with breast cancer will still have access to the drug until a final decision has been made.