PE: How will the implementation of healthcare reform complicate the pharma/payer relationship?
TS: That's exactly what everyone is trying to anticipate. Most eyes are on Medicare and CMS. Technically, Medicare is concerned
with cost containment but, legally, it's not allowed to take cost into consideration when making a coverage decision. That
doesn't mean that people at CMS won't find other characteristics of a product to focus on, in lieu of cost. In the past, what
pharma has most feared is the "national coverage determination," which occurs when CMS determines if an agent or procedure
is reasonable and necessary.
Under the evolving new healthcare system, comparative effectiveness is the biggest issue. Some organizations are being set
up now to run the comparative effectiveness research that can be used. Technically, under the current law, that research can't
be used as the only reason to make a coverage decision. There has to be at least some other justification for restricting
access to a drug, and also, comparative effectiveness, by definition, doesn't really take cost into consideration.
In oncology, for any major changes in how access is managed in the US to be successful, it will require collaboration between
payers and physicians—and the buy-in of the oncologists and clinicians, because they're not a group who will fade away quietly
if access is restricted.
JH: There are several ways of looking at the potential impact of comparative effectiveness. The typical model is, you put two
agents head-to-head in a clinical trial, see which one comes out better, and then do your evaluation of the cost of treatment.
Those kinds of head-to-head studies are less often done in the US than in Europe, particularly in oncology. You always go
back to old-fashioned chemotherapy, and only recently have people started to do trials of the newer agents. Unfortunately,
in testing a very new agent against the standard of care, there often isn't that much of a difference in terms of overall
survival. And that brings up the question of the cost of a few extra weeks of survival.
TS: To some degree, comparative effectiveness is harder to realize in an area like oncology, because things change so quickly.
It's interesting that in certain tumor types, like breast cancer, there have been amazing advances over the past 10 years
in terms of life expectancy. Products like Herceptin, which was started in a fairly late-line population, has again and again
proven its benefit, moving into earlier lines of therapy and really changing that disease state.
There's still a lot of room for improvement, but I think we'll be seeing more and more new agents that actually have active
comparators in their arms. For example, new product X versus Herceptin on top of standard background therapy. But in metastatic
prostate cancer or metastatic melanoma, it's much more difficult—and essentially unethical—to have comparative effectiveness
trials like that, because it would involve withholding standard of care from patients. So in these cases, as well as the more
competitive cancers like CML, you may see more comparisons between different trials, as opposed to within trials.