Monday, August 16, 2010

FDA may limit treatment options for advanced breast cancer

I am at high risk for breast and ovarian cancer. So when I see headlines that a breast cancer organization and an ovarian cancer organization are teaming up on something, I take notice because I can be pretty sure that it will affect either me or someone I love.

This week, the Ovarian Cancer National Alliance and Susan G. Komen for the Cure teamed up to lobby the Food & Drug Administration (FDA) and members of congress about the blockbuster cancer drug Avastin. Avastin is approved by the FDA to treat advanced metastatic breast cancer as well as colorectal cancer, lung cancer, and others.

The reason for this united front is that the FDA is considering rescinding its approval of Avastin for treatment of advanced breast cancer. If the approval is removed, use of Avastin for advanced breast cancer will be considered "off label." Use of Avastin for ovarian cancer treatment is already "off label" because Avastin has not been approved for treatment for ovarian cancer. Nonetheless, according to the Ovarian Cancer National Alliance, Avastin use is beneficial to some ovarian cancer patients.

Avastin is a very expensive drug, costing approximately $8,000 per month, and a decision to remove Avastin from the list of drugs approved for use in advanced breast cancer will undoubtedly mean that insurers including Medicare will decline to pay for Avastin treatment for women with either breast or ovarian cancer thereby making the treatment out of reach for many due to cost.

And the cost really is the crux of the issue. According to a report today in The Washington Post:
The debate over Avastin, prescribed to about 17,500 women with breast cancer a year, has become entangled in the politically explosive struggle over medical spending and effectiveness that flared during the battle over health-care reform: How should the government balance protecting patients and controlling costs without restricting access to cutting-edge, and often costly, treatments?
The cost of the drug is not supposed to factor into the FDA's decision to approve a drug for a give treatment. Nonetheless, experts acknowledge that it is hard not to consider the cost of the drug when considering Avastin. The bottom line should be the numbers, such as the number of months that a given treatment can keep the disease from advancing and whether the treatment reduces the risk of mortality over a given period of time. These numbers should be the basis of FDA drug approval. Early studies did show Avastin delayed tumor growth for an average of five months, but more recent studies suggest that Avastin's ability to delay tumor growth for advanced breast cancer may be modest, only one to three months. The FDA committee that recommended that Avastin's approval be rescinded determined that the risks from the drug, which include blood clots, digestive bleeding (including a hole in the stomach or intestine), and a long list of others, outweigh the modest life extending benefits from the drug. But patient advocate groups note that these numbers are averages and for some women, Avastin does make a difference in their life and their care. It seems to me that if this drug is beneficial to a group of patients it should be available to them and covered by their insurance. The difficulty is determining for whom this drug may be helpful and for whom it is a waste of money with potential deadly side effects. Having watched friends battle metastatic breast cancer, I know that options and hope are critical to these women.

As a consumer, it is hard to know what the right answer is but one this is clear, the FDA's decision on September 17th will be but the opening skirmish in the battle to control health care costs and treatment options.

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