In a new development, health insurer Blue Shield of California has decided not to pay for Roche Holding's drug Avastin to treat breast cancer after health advisers said it was not safe or clinically beneficial. Blue Shield of California with around 3.3 million members, said in a notice posted on its web site that the drug would no longer be covered as a treatment for metastatic breast cancer beginning October 17. It said exceptions may be considered on a case-by-case basis.
The Food and Drug Administration in June also unanimously rejected use of Avastin for breast cancer. Their vote endorsed an FDA move in December to revoke its approval for Avastin in breast cancer. FDA Commissioner Margaret Hamburg is due to make a final decision later. Without FDA approval, other insurers and government health programs likely will stop covering the $8,000-a-month drug.
Avastin won U.S. clearance for the disease in 2008 based on a study showing the drug stalled breast cancer growth by 5.5 months more when used in combination with standard chemotherapy. As part of an accelerated approval, the FDA required Roche to run follow-up studies. Later studies found only a one- to three-month delay in breast cancer growth. None of the studies showed Avastin extended the lives of patients with advanced breast cancer.
Some patients also had severe side effects, including holes in the stomach and intestines, severe bleeding and blood clots. The company says the incidence of these serious side effects was just under 3 percent greater for those taking Avastin. Roche was not immediately available for comment.
Because it is an emotional and politically contentious issue, with some women saying the drug is keeping them alive, many insurers have said they will wait until a final decision from the F.D.A. before re-evaluating their coverage policies. And Medicare has indicated it will continue paying for the drug even if the F.D.A. revokes the approval.
“We agreed with the F.D.A. panel,” Stephen M. Shivinsky, a spokesman for Blue Shield, said on Friday. He said the insurer would continue to pay for the drug for women who were already using it.
A spokesman for Genentech said the company was aware of three other insurers that had decided not to pay — Regence, which operates Blue Cross Blue Shield plans in the Northwest; Excellus BlueCross BlueShield in Rochester; and Dakotacare in South Dakota.
The spokesman, Edward Lang Jr., said those insurers acted before the F.D.A. advisory committee meeting but after the F.D.A. first announced its intention to withdraw the approval last December. “We believe women should have access to the medicine and that insurers should cover it,” Mr. Lang said.
Only last week, on Sept. 26, Avastin was approved as a treatment for breast cancer in Japan.
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