Avastin for breast cancer still covered by Medicare despite FDA indecision

By Dr. Ananya Mandal, MDJul 1 2011

The Medicare will continue to cover Avastin for breast cancer treatment even if U.S. Food and Drug Administration Commissioner Peggy Hamburg decides to withdraw Avastin for such use, according to Don McLeod, a spokesman for the Centers for Medicare and Medicaid. McLeod said, in his statement, “The FDA decision, when it comes, does not affect CMS.”

An FDA advisory committee recommended unanimously that Avastin no longer be used to treat breast cancer, saying that the risks of the drug far outweighed any benefits. The FDA's recommendation came at the end of a two-day hearing that pitted the agency's Center for Drug Evaluation and Research against Genentech, Avastin's manufacturer. At present Avastin is used to treat other types of cancer in the U.S., including advanced colorectal, lung, kidney and brain cancers. The recommendation made by the advisory panel only affected its use for advanced stage breast cancer.

The drug will remain “on label” for breast cancer until Hamburg makes a final decision. Regardless, McLeod said, CMS will continue to cover Avastin for breast cancer. McLeod added, “The drug will still be on the market, doctors will still be prescribing it, and we will continue to pay for it.”

The FDA granted an accelerated conditional approval for Avastin in February 2008 to treat late-stage breast cancer patients. It had been suggested that the drug slowed the progression of the disease and improved overall survival. But results from four trials that enrolled more than 3,000 women found no significant reduction in progression of the disease or improvement of death rates among those who took Avastin and underwent chemotherapy. “The decision must be based on the totality of evidence in all clinical trials,” Dr. Richard Pazdur, director of the FDA's Office of Oncology Drug Products, said at the hearing Tuesday. “The totality of data submitted to FDA shows it's not safe and effective [for treating] breast cancer.”

According to Dr. Daniel Hayes, clinical of the breast oncology program at the University of Michigan, further studies would have determined what types of patients would benefit from the drug. “I fear we are throwing the baby out with the bathwater,” said Hayes, who was not involved in the hearing. The final regulatory decision rests with the FDA Commissioner Peggy Hamburg. It is unclear when the final decision will be made.

The Medicare statement could also influence private insurers. A WellPoint Inc spokeswoman said on Thursday it would not drop support for patients already taking Avastin and is unlikely to disrupt coverage for new patients.

The Swiss drugmaker Genetech is now poised to carry out another trial of Avastin in a bid to prove it does significantly extend the time women live without their disease getting worse.