Blue Shield, with 3.2 million members, is apparently the first large insurance company to end payments since a federal advisory committee unanimously recommended in June that the Food and Drug Administration rescind Avastin’s approval as a treatment for breast cancer, saying the drug did not really help patients.
The F.D.A. commissioner, Dr. Margaret A. Hamburg, has not made a final decision, so Avastin retains its approval for now.
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.
But Blue Shield decided not to wait. In a note posted on its Web site, it said reimbursement would end Oct. 17, though “exceptions may be considered on a case-by-case basis.”
“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.
Because Avastin, which is sold by Genentech, is approved to treat other forms of cancer, it will remain on the market even if its approval for breast cancer is revoked. So doctors could use the drug to treat breast cancer even if it were not approved for the disease.
But some patients and doctors say that insurers would be less likely to pay for such off-label use. That would put Avastin, which costs about $88,000 a year, out of reach for many women.
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.
In a final appeal, Genentech, which is based in South San Francisco, Calif., and owned by Roche, asked the F.D.A. in August to retain approval, at least for women with the most aggressive forms of breast cancer and the fewest treatment options, while the company conducts another clinical trial in an effort to prove the drug works.
In the most recent clinical trials, Avastin did not prolong the lives of women with breast cancer but it did delay the progression of the disease by one to three months. Whether that is a meaningful benefit, especially in light of some dangerous side effects, has split patient advocacy groups and the medical community.
Shortly after the F.D.A. advisory committee’s negative vote, a panel of breast cancer doctors convened by the National Comprehensive Cancer Network, an organization of major cancer hospitals, reaffirmed that Avastin was “an appropriate therapeutic option for metastatic breast cancer.”
That is important because Medicare and UnitedHealthcare are supposed to pay for drugs listed in the cancer network’s guidelines.
Only last week, on Sept. 26, Avastin was approved as a treatment for breast cancer in Japan.
Blue Shield of California in March dropped plans to sharply increase rates for individual policies after coming under fierce criticism from consumers and regulators. In June, the nonprofit insurer said it would cap its profits and return any excess to policyholders.
Article source: http://feeds.nytimes.com/click.phdo?i=6bc974bc0b216f7eb0040594e953ba69
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