There are three pieces. The piece that everyone is very aware of is our evidence-based information: our clinical trials, systematic
reviews, and meta-analyses. These are data that tell us which interventions work—and which don't work—from the standpoint
of improving something. But they don't tell us the effect of that change and how it improves someone's quality of life. So
the second piece of what we call value-based medicine is then taking the clinical trial data and really turning it into a
value measurement—and we do that using time trade-off qualities. An example is vision: If you can change someone from a visual
acuity of 20/80 to 20/25 with cataract surgery, that's what your clinical trials will tell you. What it doesn't tell you is,
Who cares? Do we necessarily want that? Does everyone want it? Now, intuitively it sounds very valuable, but then you take
a look at someone who might be able to take a medicine that improves the ejection fraction of the heart from 35 to 55 percent.
That also sounds pretty good intuitively but then you think, Does anybody value that? How do any of these things improve quality
of life, and can we measure it?
When we talk about value, we're talking only about quality of life, improvement of life, length of life—not dollars. But,
if you measure correctly, you can then add the final piece, a cost-utility analysis.
What's driving the shift from evidence-based to value-based medicine?
These issues have been looked at throughout the world for a long time, because many other countries have single-payer systems.
In the US, we're now finding that costs are going up, particularly technology costs. It's a great problem to have, but the
key is how to afford it.
Right now we don't have laws that support looking at money to make treatment decisions. Medicare and Medicaid can't look at
cost. But I would say evidence alone doesn't give you the most complete picture. Take cancer: In that calculation, as a patient,
when someone offers you an intervention that's supposed to extend life, almost everyone would love to have a measure of what's
it going to cost, not just in dollars, but also in quality of life to get to that point. Wouldn't it be nice to give someone
an analysis of what the average person with side effects would feel about his or her quality of life?
We've measured what the changes in your quality of life are from a number of drug side effects. Generally speaking, our clinical
trials and our evidence-based medicine look more at efficacy than at giving you good measures of what the adverse effects
are. Value-based medicine adds that piece onto it as well.
What are the implications for the pharmaceutical industry?
From the standpoint of the pharmaceutical industry, value-based medicine is a double-edged sword. It is tremendously helpful
if you've got a good drug. We can identify why it's a good drug, what the value of the drug is from the standpoint of the
clinical evidence, and what happens from the standpoint of quality of life with adverse effects. And you could clearly come
out the big winner. It also could tell you what a good price might be to keep it within the general guidelines of cost effectiveness.
It could be helpful in marketing because it would allow the company to show why its product is better than another drug in
every single way.
The second side of the sword, though, is that most companies don't have all the clear winners. If you've got an inferior drug,
this analysis will highlight that, too.
I would imagine that they would move into value-based medicine with caution. But I think this is a benefit, in total, to pharmaceutical
companies because it gives them data early on, even in their beginning research, to take a look at additional variables and
to know whether they should continue on with a particular drug or not. It really is an information system that can help them
every step of the way.