SEELEY: We need to do whatever we can to promote enrollment in clinical trials, because that's the way we are going to get answers about off-label use. That's really going to be worth a lot more to payers and patients than anything else that we do.

And Everything Price

CLINTON: Many companies have been drawn into the oncology field by the specter of very high prices—with payers willing to reimburse them. But that's not always the case today. How is the environment surrounding pricing changing?

AYERS: In the case of the Pfizer drug Sutent, we haven't actually had payers who were refusing to pay for it. Instead, in the United Kingdom, the NICE Commission has been slow to complete its evaluation. They're postponing the review of the data. And until they come out with the health–economic analysis, no budgets are apportioned to it.

And the patients are beginning to protest. We've also seen NICE rejecting Tarceva, Avastin, and Altima because they consider anything that costs over £30,000 [sterling] per quality-adjusted life-year as not good use of National Health Service expenditures. They've put a cap on what they're willing to pay, and anything that's more than that, they don't consider cost effective.

The worrying thing is that there are now more European countries that are considering adopting that kind of health–economic cost-effectiveness approach. We just have to see how far that goes.

There's also much less willingness to pay for off-label use now. Going back to 10 years ago, it would have been very rare for anybody to challenge what an oncologist wanted to give to his patient if he believed the data was there. Now, there are a lot of countries that only will pay for a drug to be used within its strict-labeled indication, even if there is really good data about its activity.

CLINTON: How does the United States compare to Europe?

SEELEY: In the United States, we are not seeing the same sweeping NICE type of judgments regarding oncology reimbursement. But there is no doubt that the pricing of oncology drugs and the overall expense is a very big concern of payers. Now, they're paying much more attention to it, and they are hiring specialists who deal with oncology within their organizations.

NAEYMI-RAD: Europe is just so much more difficult. If we were to look at the United States, there is more choice in terms of payer coverage.

CLINTON: What are the most important pricing issues for companies to keep their eye on?

SEELEY: Once your product is approved and on the market, drug development doesn't end there. In fact, it's really just beginning. Drugs are in a continual state of development in oncology, and yet we price at a single point in time.