The FDA has denied Avastin and indication for breast cancer.
This medication is used in other cancers and works by preventing growth of blood vessels to nourish the fast-growing cancer cells. Although this medication should, in theory, work in all solid tissue cancers, it appears to be less effective in some.
Avastin has shown benefits in a small portion of breast cancer patients, but it is not broadly effective. It does not help most women.
The FDA is acting for two reasons: First, to prevent it’s widespread use when it is not effective and may cause more side effects than benefits; Second, to limit the governments cost exposures as Avastin is about $88,000 dollars a year for treatment.
Although I’m not an expert in cancer treatment, this issue presents two big dilemmas: First…is coverage of expensive medications with limited value. With the government budget issues looming large, and expanding coverage coming in 2014, I think the government is trying to limit it’s exposures to expenses that are not considered ‘cost effective’.
Second, this medication works in a small minority of patients, but when it works, it’s effects can be enormous. For this reason, it is incumbent upon the researchers to identify specific patient ‘subtypes’ that would benefit from this medication, and that is part of the ongoing research aspect.