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Q:
Avastin, breast cancer, and the FDA - I heard cost is now a factor in FDA decisions
By
Anonymous
August 2, 2010 - 6:48pm
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Hi:
it seems like the FDA is suddenly including cost of a drug in it s approval process. I saw something on google where the FDA is apparently saying the the cost of the drug is now too much given its benefits for breast cancer treatment. The FDA has never before allowed cost to be a factor - only clinical effectiveness. It seems that they said it had to show at least a 5 month improvement to be worthwhile given the cost! The average improvement was only 3 months.
Since when is adding 3 months on average to your life if you have breast cancer not valuable enough? Is this the beginning of "bending the cost curve" that we hear so much about?
Very few articles are mentioning this but it seems the cost factor was in the FDA statement cancelling approval for avatin.
Can you help?
Sophia
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Hi Sophia -
I'm not sure what information you read, but the issue with Avastin is not the cost of the drug, it's whether or not it actually helps women with breast cancer.
The FDA said the level of improvement in women treated with chemotherapy and Avastin was not significantly better than in women who received chemotherapy alone. In addition, women who took Avastin experienced more serious side effects, such as bleeding.
You can find more information here: http://www.medicalnewstoday.com/articles/195228.php
August 2, 2010 - 7:20pmThis Comment