Avastin (chemical name: bevacizumab) is a targeted therapy currently approved by the U.S. Food and Drug Administration (FDA) to be used in combination with Taxol (chemical name: paclitaxel) to treat metastatic, HER2-negative breast cancer that hasn't yet been treated with chemotherapy. Since the beginning of 2011, the FDA has been considering removing the breast cancer indication, and that decision is expected by the end of 2011.
Although the FDA hasn't made its decision, in early October 2011 a major health insurance company -- Blue Shield of California -- announced that it will no longer pay for treatment of advanced breast cancer with the targeted therapy Avastin. A number of other health insurance companies around the U.S. have also recently decided to not cover the cost of Avastin treatment for breast cancer. These insurers will continue to pay for Avastin treatment for some other cancers for which Avastin treatment is approved.
This decision by Blue Shield of California follows a June 2011 recommendation of an FDA expert panel that the breast cancer indication for Avastin be removed. The panel's recommendation came after 2 days of hearings that were part of an appeal by Genentech, the company that makes Avastin. In December 2010, another FDA expert panel made the same recommendation to remove the breast cancer indication for Avastin, and Genentech asked the FDA to reconsider.
Both FDA expert panels concluded that Avastin has not been shown to be safe and effective for treating metastatic breast cancer. The FDA experts noted that in studies combining Avastin with one of several chemotherapy medicines to treat metastatic breast cancer, the time before the cancer grew or spread (progression-free survival) increased only a little, and adding Avastin to chemotherapy didn't increase overall survival. This means that women in those studies lived for about the same amount of time whether or not they got Avastin. So the FDA experts recommended that the breast cancer indication be withdrawn.
Many doctors believe that the benefits of Avastin for certain women diagnosed with metastatic breast cancer are worth the risks and cost of treatment. In July 2011, a committee of experts from the National Comprehensive Cancer Network (NCCN) -- an alliance of 21 of the world's leading cancer centers -- voted to continue to support the current approval of 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. Doctors can choose to use Avastin to treat metastatic breast cancer whether or not that particular use is officially approved by the FDA.
The FDA doesn't have to follow the recommendation of its 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.
As the news about Blue Shield of California suggests, the possible loss of FDA approval can make it less likely that insurers will pay for Avastin to treat breast cancer. Still, the day after the June 2011 FDA expert panel's recommendation to remove the breast cancer approval, a spokesperson for Medicare announced that even if the Avastin breast cancer indication is removed, Medicare will continue to pay for Avastin to treat metastatic breast cancer. Medicare's announcement 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. The NCCN's continued support for Avastin to treat metastatic breast cancer also should make it more likely that many insurers will continue to pay for it even if the FDA removes the breast cancer indication.
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 both the FDA and the NCCN experts' 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.
Stay tuned to Breastcancer.org Research News for more information about the final FDA decision on Avastin.