The Real CER: Lost in Translation

“Comparative effectiveness research, ” or CER, has become a loaded term in our ongoing wrangling over healthcare policy. Often, however, what even knowledgeable people understand by CER is significantly at odds with what actual policy makers have in mind. To help set the record straight about what CER will really mean in practice, the editors of ONCOLOGY spoke with Dr. Steven Pearson, President of the Institute for Clinical and Economic Review at the Massachusetts General Hospital Institute for Technology Assessment in Boston. Dr. Pearson often speaks about CER and how it relates to oncology.

Steven Pearson, MD, MSc

ONCOLOGY: Can you please describe the mission of the Institute for Clinical and Economic Review?

DR. PEARSON: Yes, our mission is to be a leader in CER that really integrates considerations of clinical benefit with those of economic value.

ONCOLOGY: Now, CER remains, at least to the lay public, a vague term that opponents have sometimes linked to a rationing of care. How can CER, used properly, help better guide our practices?

DR. PEARSON: That's a good point-a lot does depend on the implementation, and that's where I think peoples' concerns are focused. As most people recognize, we are making decisions right now-whether we're patients, doctors, health plans, or the government-everybody's making decisions about whether to cover certain medical services, how much to pay for them, how to get patients to use them more often or less often, etc. We make all those decisions right now with the best available evidence. The whole goal of CER as an initiative, and of the funding that's been channeled into it through the stimulus package and now healthcare reform, is to provide better evidence that will really get down to the levels that will be truly helpful to individual decision making. It's really to try to figure out what interventions work best for which kinds of patients, rather than having relatively poor evidence-and often not head-to-head evidence. CER really is meant to help guide our practice and policy by giving us better evidence than we have now to make decisions. There has been talk about how it's going to be implemented, whether it's through coverage decisions or guidelines or other things. I think that always does raise the question of who's doing the implementation and with what ultimate purposes. I think ultimately that comparative effectiveness information can be made available to patients and doctors, and can be used by payers, in ways that will really improve patient outcomes and reduce costs-but not through the kind of blind rationing and up-down coverage decisions that people spend a lot of time worrying about.

ONCOLOGY: In your recent article in Health Affairs, you and fellow author Peter Bach from Memorial Sloan-Kettering proposed a Medicare payment model incorporating CER. You looked at three different types of radiotherapy in prostate cancer, the costs of which vary widely. This is a contentious issue within the oncology community. In this particular clinical instance, how can CER make a case that the most expensive therapy is not necessarily the best therapy?

DR. PEARSON: Well, it's an interesting question-because part of what Dr. Bach and I were trying to convey in our article was, shouldn't the question be “How can CER help us know when the most expensive therapy IS best?” The point is not to help prove the negative, it's to help turn the question on its head and say “We should pay more when we have a new intervention for which there is good evidence that it does provide better patient outcomes.” And our model says that if we have evidence that it's only JUST as good as what we're currently doing, then we should not pay more for it, we should pay as much as we pay for other options. And as you probably know, we have a time-limited phase, during which something new would be reimbursed at the higher price while we have a chance to obtain better evidence and to find out more about which patients it really does work better for and which it doesn't.

ONCOLOGY: That's very interesting, because with virtual colonoscopy, we've seen CMS (the Centers for Medicare and Medicaid Services) make a decision that it wasn't cost-effective. So this is really at the cutting edge of a new paradigm for how we're looking at things.

DR. PEARSON: Yes. One interesting thing about CMS is that they have to follow very specific regulations. For colorectal screening options, they are required to look at cost effectiveness; it's basically the only type of service for which they are required to do this. Again, our approach is not really an application of cost effectiveness, since basically it doesn't take a given price as given. Instead, it asks what the price should be in order to reflect the evidence we have about the intervention's effectiveness.

ONCOLOGY: Unfortunately, I think that gets lost in the translation, and CER is often linked to cost effectiveness.

DR. PEARSON: I know. Our approach is not to use CER to say “yes” or “no,” it's using it to say “yes, and…” Yes, we'll cover it, and yes, we'll pay more if there's evidence that it works better. So there's an incentive for clinical researchers and manufacturers to do the work ahead of time and get that evidence as the new intervention comes into practice. And, if it's just as good as but no better than what we currently do, we'll pay you for it-but we won't pay you more. We'll even give you a period of time during which you can have the benefit of the doubt and go out and get better evidence, but after that period of time, we have to get real and figure out what to do with those interventions for which we don't have evidence that they're any better, but which are much more costly.

ONCOLOGY: As you know, the drivers of healthcare costs are price and quantity, and it's easier to control price than quantity. Overutilization of screening and imaging technology is driving up healthcare costs. Does CER address the quantity side of that equation-address how often screening and things like that are used?

DR. PEARSON: That's a good question. It is very possible to do comparative effectiveness research on different protocols of care, so you could easily compare a protocol in which a patient would have six follow-up MRIs after a cancer treatment, with a protocol in which a patient would have three MRIs. That sort of thing is very much within the scope of CER. It really is trying to look at total approaches to care. On the other hand, there's a limit to what we can investigate with CER; we can't look at every potential question regarding the best number of scans to order. So often it does come down to the profession taking responsibility and saying, given the evidence we have, we recommend that doctors only do two tests to follow up over the next year, unless there are special circumstances. It's kind of a combination: while CER will be providing better evidence, there has been and will continue to be a very strong role for the professions to play in setting up appropriate or consensus guidelines about what to do.

ONCOLOGY: Within our rapidly evolving healthcare environment, with all the difficulties we currently have, what do you see as the future of CER, moving forward?

DR. PEARSON: I think it's reasonable to think hard about who should be generating this evidence, how it should be interpreted, and how it should be applied. I think the most important thing going forward is for physicians to realize the incredible opportunity the new national focus on CER provides for them to take leadership roles and become active participants in these efforts, to help inform the way in which research questions are framed and to lead the way in deciding how best to apply the results of this research to practice. I think they have a real role here, and my biggest concern is that physicians will get turned off, or will become too hesitant. I think it's critically important for everyone that physicians take a leadership role.

As a physician myself, I also think that, in addition to our taking a strong leadership role, it is important for us physicians not to forget how much we have to learn from our patients. In order to really frame research and use it in ways that can help patients, we cannot work alone; we really need to partner with others. For both us and patients, there's a real opportunity here that shouldn't be missed. We also need to learn more from everyday practice; that's going to be another critical part of it.