WASHINGTON -- Medicare will continue to pay for bevacizumab (Avastin) when it's used to treat metastatic breast cancer, even if the FDA decides to remove that indication from the drug, a spokesman for the Centers for Medicare and Medicaid Services (CMS) said.
After an FDA panel voted unanimously on Wednesday that bevacizumab's breast cancer indication should be removed, patients who seem to be responding well to the drug were fearful that their insurance would no longer cover the $8,000-a month medication.
"If FDA removes the breast cancer indication for this drug, my insurance likely wouldn't cover it and I can't afford to pay," said Crystal Hanna, a woman with breast cancer who has been taking bevacizumab in combination with standard chemotherapy and has had no sign of cancer for one year.
But Don McLeod, a spokesman for the Centers for Medicare and Medicaid Services (CMS), said Medicare, at least, won't stop paying for the drug.
"We will NOT stop covering it just because of an FDA label change," he told 番茄社区.
The FDA's Oncologic Drug Advisory Committee voted 6-0 that bevacizumab, made by Genentech, is not safe or effective when used against metastatic HER2-negative breast cancer and should no longer be approved to treat it.
FDA Commissioner Margaret Hamburg will make the final decision on whether to pull the breast cancer indication from the drug's label. But that decision doesn't automatically affect CMS' coverage decisions, McLeod said.
"Pulling the label is an FDA issue," he said. "Medicare coverage is ours."
Bevacizumab will still remain on the market. It's also approved to treat metastatic colorectal cancer, metastatic nonsquamous non-small cell lung cancer, metastatic renal cell carcinoma, and as a second- or third-line treatment for glioblastoma multiforme. So doctors would still be able to prescribe it off-label for breast cancer.
Medicare covers others drugs for off-label uses, and most private insurance companies cover off-label uses for drugs if they're considered medically necessary, said Lori McLaughlin, corporate communications director for WellPoint.
Private insurance companies generally take their coverage cues from Medicare.
McLaughlin said the company currently considers bevacizumab to be "medically necessary in the treatment of metastatic breast carcinoma," and that WellPoint will wait for the final determination from Hamburg before revising medical necessity for the drug.