Avastin remains on the market to treat certain colon, lung, kidney and brain cancers. Doctors are free to prescribe any marketed drug as they see fit. So even though the FDA formally revoked Avastin’s approval as a breast cancer treatment, women could still receive it — but their insurers may not pay for it. Some insurers already have quit in anticipation of FDA’s long-expected ruling.
However, “Medicare will continue to cover Avastin,” said Brian Cook, spokesman for the Centers for Medicare & Medicaid Services. The agency “will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies.”
Including infusion fees, a year’s treatment with Avastin can reach $100,000.
The ruling disappointed patients who believe Avastin is helping to curb their incurable cancer.
“It’s saved my life,” said a tearful Sue Boyce, 54, of Chicago. She’s taken Avastin in addition to chemotherapy since joining a research study in 2003. Her breast cancer eventually spread to her lungs, liver and brain, but Boyce says she is stable and faring well.
“So I’m hoping the insurance company will grandfather me in to continue taking it,” she said.
The Avastin saga began in 2008, when an initial study suggested the drug could delay tumor growth for a few months in women whose breast cancer had spread to other parts of the body. Over the objection of its own advisers and to the surprise of cancer groups, FDA gave Avastin conditional approval — it could be sold for such women while manufacturer Genentech tried to prove it really worked.
The problem: Ultimately, the tumor effect was even smaller than first thought. Across repeated studies, Avastin patients didn’t live longer or have a higher quality of life. Yet the drug causes some life-threatening risks, including severe high blood pressure, massive bleeding, heart attack or heart failure and tears in the stomach and intestines, the FDA concluded. In two public hearings — one last year and one this summer — FDA advisers urged the agency to revoke that approval.
“The science is clear: Breast cancer patients are more likely to be harmed than helped by Avastin,” said Diana Zuckerman of the National Research Center for Women and Families in Washington.
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