Yanking Avastin’s Breast Cancer Indication –the Right Thing To Do

November 19, 2011
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As expected the FDA today removed Avastin’s approval for use as a breast cancer treatment. The drug will remain on the market for other cancer indications, so if a physician wants to prescribe it for breast cancer they can. However, some patients may have a hard time getting reimbursement from their commercial health plan.

As expected the FDA today removed Avastin’s approval for use as a breast cancer treatment. The drug will remain on the market for other cancer indications, so if a physician wants to prescribe it for breast cancer they can. However, some patients may have a hard time getting reimbursement from their commercial health plan. Not everyone will have this problem, though, because Medicare and some health plans (including United) will continue to reimburse as long as the drug is listed as appropriate for breast cancer by the National Comprehensive Cancer Network (NCCN).

This provides a good opportunity to discuss the benefits of rationing using evidence based guidelines.

In my view, FDA has handled this exactly right. Avastin was approved for breast cancer in 2008 under an accelerated review process designed to allow potentially life-saving treatments on the market on a provisional basis before all the evidence is in. In this case follow-up studies failed to demonstrate efficacy but did show plenty of harsh side effects, including hemorrhage and severe high blood pressure. FDA review panels voted overwhelmingly to remove the breast cancer indication, and after five months of further analysis and deliberation FDA decided to follow that recommendation.

It’s possible that Avastin works well for some breast cancer patients. No matter what there will be people who insist it’s saved them or been worth the risk. But late stage cancer patients tend to undergo all sorts of desperate and costly treatments and I firmly believe this label change will get doctors and patients to think twice or three times about whether Avastin is really the right choice. The advisory panels’ recommendations have already had that effect to some degree.

I’m not familiar enough with the NCCN’s process to know how they will react to the data FDA and its panelists have reviewed. But in addition to the clinical dangers faced by those taking Avastin there is a very real financial cost to Medicare and commercial payers. That $50,000+ treatment cost gets reflected in the cost base for taxpayers and health plan customers.


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