On June 29, 2011, an expert panel that advises the U.S. Food and Drug Administration (FDA) unanimously recommended removing the indication for Avastin (chemical name: bevacizumab) in combination with Taxol (chemical name: paclitaxel) to treat metastatic, HER2-negative breast cancer that hasn't been treated with chemotherapy. The next day, a spokesperson for Medicare announced that even if the Avastin breast cancer indication is removed by the FDA, Medicare will continue to pay for treatment with Avastin to treat metastatic breast cancer.
The expert panel's recommendation came after two days of hearings that were part of an appeal by Genentech, the company that makes Avastin. In December 2010, another expert panel made the same recommendation to remove the breast cancer indication for Avastin, and Genentech asked the FDA to reconsider.
Both expert panels concluded that Avastin has not been shown to be safe and effective for treating metastatic breast cancer. So the experts recommended that the breast cancer indication should be withdrawn. The FDA doesn't have to follow the recommendation of the expert panels, but it usually does. Margaret Hamburg, FDA commissioner, will make the final decision about withdrawing the breast cancer indication for Avastin.
An FDA decision to withdraw the Avastin breast cancer indication will not affect the approvals of Avastin to treat advanced cancers of the lung, colon, and rectum.
Despite the panels' recommendations, many doctors believe that the benefits of Avastin for certain women diagnosed with metastatic breast cancer are worth the risks and cost of treatment. Doctors can choose to use Avastin to treat metastatic breast cancer whether or not that particular use is officially approved by the FDA. Still, loss of approval can make it less likely that insurers will pay for Avastin to treat breast cancer.
Medicare's announcement that it will continue to pay for Avastin to treat metastatic breast cancer is important because many insurers follow Medicare's payment policies. Medicare and insurance companies often pay for treatments prescribed by doctors for a condition even if the treatment isn't FDA-approved for that specific use.
If you've been diagnosed with metastatic breast cancer, you and your doctor will develop a treatment plan that will likely include chemotherapy and possibly hormonal therapy and/or targeted therapy medicines. No matter which treatments are recommended for you, you may want to talk to your doctor about:
- why each treatment is recommended (including any combinations)
- treatment timing and sequence
- the expected benefits, risks, and side effects of each treatment
If you're already getting Avastin and are responding to treatment, you may want to ask your doctor about the expert panels' recommendations. It's likely that your doctor will recommend that you stick with your treatment plan unless it stops being effective or unacceptable side effects develop. The announcement by Medicare makes it more likely that your treatment will continue to be covered by your insurer (if it's already covered).
Stay tuned to Breastcancer.org Research News for more information on the final decision on Avastin.