Wednesday, August 31, 2011

Expensive targeted therapies are on the rise. Does cost ever play a role drug treatment? I think we are going to have to deal with this soon.

As the pharma and biotech industry moves towards more targeted therapies, cost of treatment increase dramatically. The latest cancer drugs are targeted to specific DNA sequeneces and mutations and their costs can be over $100,000 per course of treatment. They also might only extend life for a few months. However, expensive and targeted treatments have given some patients years.

Avastin, which lost its approval for breast cancer, is one of those extremely expensive treatments. Patients and even oncologists do not like losing treatments even if they do not seem to work all of the time or even predictively. Patients on Avastin were horrified to lose the drug's approval and it was heart-wrenching to read their stories.

But does cost play a role in the delivery of US drug treatments? It does in other countries.

Does stronger efficacy and more precise patient stratification make very expensive drug use more defensible? Targeted therapies are supposed to be just that, targeted to a particular marker and theoretically they don't work as well or at all in the absence of that marker. But patients report being on Herceptin who do not have HER2+ breast cancer. And we see that there are lung cancer patients on Tarceva who do not have have the EGFR mutation. Sometimes after patients fail on other treatments, we do see the use of targeted therapies in untargeted ways. Should they be if there is no evidence that they would work?

Unfortunately Avastin lost its approval because it was considered to be ineffective and Genentech could not explain why the 17,500 women who found the drug valuable were different. Why does Avastin work for some patients and not for others? If the brand knew that then I think the FDA would have allow the drug to keep its approval for the right patient and people would have been less likely to call out the death panels.

Development of more targeted drugs is a trend on the rise. So astronomical cost for treatment will be on the rise as well. Do we demand more patient stratificatoin and then make everyone stick to it? What is fair to the patient and what is fair for everyone else?

I think we are all going to have to really deal with these issues in the very near future.


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