We are going to see shifts in the traditional ways in which the industry sells drugs. I think it will require a cultural shift
within the industry. I think there's a real need for clinical medicine—whether it's in managed care or in these PDPs or wherever—to
participate in this research. Because if they're demanding this kind of real-world effectiveness and safety evidence, they've
got to be willing to participate in collecting it—and that costs money.
What has been Medicare's role in collecting patient data?
Medicare has a fabulous data set that can track how patients are doing. But it's going to have to include this new drug
benefit into the data set. The whole process needs to move more quickly so that we have the data from patients' claims in
sufficient time to make use of that information. Because right now there appears to be a two-year lag between the time the
data is collected and the time it's available to look at. This obviously is too long.
Where do pharmacoeconomics and evidence-based medicine intersect?
Well, they definitely do intersect. The cost of healthcare has become so great that it's important to review the evidence
to determine whether the drug is a good value for the money. And so pharmacoeconomics plays an integral role in the decision-making
process about what makes sense for Medicare, what makes sense for managed care, and what makes sense for Medicaid, in terms
of which drugs should be available for patients. Having said that, very few organizations, including Medicare, formally include
pharmacoeconomics in their decision processes.
Why is that the case?
It's mostly political in nature. Congress has been very skeptical about not providing healthcare technologies and drugs
to Medicare beneficiaries solely because of the cost. And so Congress has not really been supportive of Medicare in using
pharmacoeconomics as a formal criterion. Having said that, it's very clear that the products and procedures that are very,
very expensive go through a more stringent review. And we know that Medicare is more likely to put conditions around the use
of very expensive products. So those that are very expensive are likely to be indicated for very special populations, or only
used in certain major hospitals that specialize in that area.
Will the coverage decisions made be permanent or will they evolve?
We honestly don't know. But we do know that Mark McClellan has instituted a new coverage policy, "Coverage with Evidence
Development." McClellan basically said that for certain kinds of important products and services where the evidence for the
drug's effectiveness is not sufficient, it will require a formal post-marketing survey that's either going to be a practical
clinical trial—which is a real-world effectiveness trial—or it's going to be some kind of registry. The registry would help
to continue to develop evidence so that coverage decisions will be explicit and that only patients that participate in these
trials or in this registry will be covered.
So, the government will only pay for patients who agree to be in these trials. I believe they are still working out who's
paying for this because I don't believe Centers for Medicare and Medicaid Services is prepared to pay for this research. This
would assume that the manufacturer pays for a great deal of this research effort and that Medicare pays for the healthcare
Will this type of shared responsibility be the norm in the future?
Yes. This could be the norm in the next three to five years. Medicare is stepping forward and saying that it will only
cover the important and expensive products under these set conditions. And then the assumption is that it is going to review
that evidence down the road and make a final decision.
Bryan Luce is the founder and senior research leader for The Medtap Institute at United BioSource Corporation (UBC), and director of
science policy at UBC. Previously, he was chairman,president, and CEO of Medtap. The author of more than 80 scientific publications
and three textbooks, Luce also has worked as a consultant for many government agencies and pharmaceutical and device firms.
He currently serves on the Medicare Coverage Advisory Committee, and on the Advisory Board of Harvard University's Center
for Risk Analysis.