Tuesday, September 09, 2008

Interesting Ying and Yang

I noted recently that the EU has begun to approve biosimilar drugs -- a topic which our Congress has yet to address. This American Magazine interview with Genentech's product development president, Susan Desmond - Hellman provides an interesting EU vs. US perspective on specialty drugs:

The biotech industry gets heat from critics who claim that they charge overly high prices for their products. What do you make of this critique?
We challenge ourselves to make important, valuable new medicines. We’re not trying to do something new for small problems. We’re trying to innovate and make a difference for big problems. And the investments necessary and the risk the company takes and the failure rates are such that the business model of biotechnology relies on premium pricing.

But we’re sensitive to the most important thing of all for us, which is patient access. My team and the folks at Genentech who work in research and development don’t just want to make drugs that make a difference. We want patients to have access to them. Genentech works very hard to have a strong support mechanism for patients who can’t pay or for patients who can’t afford their copayments, which is more and more common these days.

I understand that it has been harder for women in countries outside the United States to get access to Herceptin for breast cancer due to regulatory obstacles. Could you discuss this?
It’s a huge issue for cancer patients. HER2-positive metastatic breast cancer is a very special form of breast cancer. We made a remedy, Herceptin, specifically for the 20 percent of breast cancer patients who have this form of breast cancer that is especially difficult to treat.

When a company does trials, it isn’t enough just to do the trial; then one must go to the regulators, not just in the United States but outside the United States, and request approval. An extra layer is that in Europe one has to get approval for the pricing of the product as well. We really find that difficult for patients.

The FDA approved Herceptin in less than five months. It was really outstanding. Everyone knew patients were waiting. The sense of urgency that we had, that the FDA had, that physicians in practice had, was huge. That’s what patients deserve.

This is the balance that all of us are facing over the next several years as more and more pressure to control healthcare costs comes about. My plea is not to squash innovation. I would submit that in countries like the United Kingdom, where access to Herceptin was delayed because of concerns over the cost of healthcare, there needs to be a healthy public policy debate about patients waiting, their need for new medicines and for innovation, and balancing that with the cost of healthcare.

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