Expert Panel Defines State of the Art and Future of Molecular Imaging
Note: An abridged version of this roundtable discussion appears in the digital issue of Molecular Imaging Insight.
Molecular imaging is a quickly evolving field in which clinical practice and clinical studies are steadily proving its merits in better patient management and outcomes. It is having a large impact on clinical practice in the diagnosis and staging of cancer, diagnosis, evaluating heart and neurological diseases, and beginning to help in infection imaging, particularly to diagnose fevers of unknown origin.
What’s fueling all this? Innovation. Innovation and its translation into clinical practice within molecular imaging was topic of a roundtable discussion attended by about 500 people in Washington, D.C., that coincided with the Society of Nuclear Medicine meeting in June. The event was sponsored by Siemens Medical Solutions. The discussion focused on four areas: personalized medicine, clinical adoption of molecular imaging technologies, biomarker research and the Deficit Reduction Act (DRA).
The expert panel included Manuel Cerquiera MD, chairman of nuclear medicine and professor of radiology and medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; Professor Torsten Kuwert, MD, Chairman of the Department of Nuclear Medicine, University of Erlangen-Nuremberg, Germany; Rodney J. Hicks, MD, FRACP, Professor, Department of Medicine, the University of Melbourne, Director, Centre for Molecular Imaging, Peter MacCallum Cancer Centre, Melbourne, Australia; Douglas Hadley, MD, medical officer and director of Cigna’s coverage policy unit; Tim Trysla, counsel of the healthcare group at Alston and Berg and executive director of the Access to Medicare Imaging Coalition. He also serves as chief of staff to the Centers for Medicaid and Medicare; Michael Reitermann, president of Siemens Medical Solutions Molecular Imaging Division; and Ron Petrocelli, MD, chief medical officer of Siemens Medical Solutions Molecular Imaging Division.
Personalized Medicine
Can you describe personalized medicine?
Manuel Cerquiera, MD: As a clinician who both sees patients and performs diagnostic studies, to me personalized medicine is trying to make the right diagnosis on the patient and then using that information with imaging or other techniques to make decisions about therapy. It also means selecting a therapy which is appropriate for the patient – not something that's based on 1,000 patients – but something that's unique that's going to be the right treatment without undue side effects and get the best cure.
In what areas are personalized medicine accelerating, and what are the challenges?
Tim Trysla: Clinical medicine as it has been practiced for thousands of years necessarily always has been personalized medicine. And the major advance that we have nowadays is that we are increasingly developing tools to determine the individual situation of the patient. On the one hand with regard to his or her psychological status, and on the other hand of course to the status of his or her disease. I think imaging is of course a very good example for this.
The challenge in clinical medicine is always to bring together the soul and the body and how they interact. There are areas of research that look into that matter more deeply, and also look at imaging and how the individual brain functions. Of course a doctor caring for his patients would always – and this has also been stated by medieval physicians – talk to his patients, and this is the challenge of course of technological medicine that although we have new technology at hand which is very powerful, we should still keep the close contact with the patient.
What does all this mean to the patient?
Ron Petrocelli, MD: It means that the patient has to become more involved in the decision-making and partnering with his or her physicians. It's incumbent on the average patient to learn more about what's going on in the healthcare field. As an example of where we need to make some inroads, a study was done in January asking “what is a PET/CT scanner?” to average Joe Public. These are among the answers that were given: 10 percent of the people thought it was a high- resolution imaging machine to monitor pregnant women; 22 percent thought it was a high-intensity screening device used in airport security; and 15 percent thought it was a monitoring device used by a veterinarian to monitor brainwaves in animals. So clearly we have a lot of education to do. But I also think it means for the patient that when he or she selects a physician and the site of healthcare that he or she needs to know that the places are using up-to-date technology, but also bearing in mind that the individual patient has to be involved in the decision- making and discussing with the physician. Otherwise, decisions will be made for them instead of with them, and I think ultimately that would not be in their best interest.
What particular challenges must be overcome as these types of personalized treatments become available?
Douglas Hadley, MD: As new technologies such as molecular imaging come out, it's incumbent upon members of the insurance community that pay for these things to examine the evidence, to take a look at how effective they are. That's what our group [Cigna] does. And the kind of evidence that we think are the most important to look at are what we call “poem” – patient-oriented evidence that matters. What kinds of things matter to a patient? Obviously, mortality, whether they'll live or die; morbidity, whether they'll have more complications or not; symptom control, the quality of their life; and finally, cost. Consumers are becoming much more involved in having to share healthcare costs, so they do look at what new technologies cost.
Are you supportive of identifying groups who may be more responsive to a particular treatment? What about the cost? And what about those who don't respond?
Trysla: Those are incredibly important questions, but I think something we haven't talked about is value. Personalized medicine is the cross reference of science, education and a voice of the patient. Once that education is done, and there are clinical pathways that are universally accepted by the medical profession, there's a role for government to increase the use of those and utilize those kinds of tools, But the No. 1 cost driver still remains the physician's need to show value and how she practices medicine. So getting that information both in the hands of the patient as well as the physician to do the right thing the first time is critically important. But it's going to be incumbent upon manufacturers, clinicians, researchers to really show value for that incremental increase in health. It won't get paid for unless you're bringing the value equation to payors as well as government.
Molecular Imaging Technologies
What do molecular imaging technologies bring to the table for diseases such as cancer and coronary artery disease?
Torsten Kuwert, MD: This question sounds quite simple, but this answer could take several hours. With the advances in molecular biology, increasingly we think that diseases originate in disturbances of molecular processes and that these disturbances are earlier than disturbances in the structure of the human body. Having the means to image these molecular processes allows for an earlier diagnosis of disease in many cases, and in many other cases, more specific diagnosis of a disease since alterations in structure may signify a different disease process, and by looking more specifically at the molecular pathogenesis, we get an earlier diagnosis.
What are some of the newest applications in molecular imaging?
Rodney Hicks, MD: In my particular area, the greatest interest is oncology. I work at a cancer center, and the major purpose is to develop new tracers or individualizing the care to an individual patient. This is critically important in cancer because of the diversity of the biology that we're looking at, and as we have progressive advances in molecular biology, understanding what's driving diseases, having traces that can identify those processes, imaging them in the individual fashion and then testing whether we're modulating those signals with imaging. It becomes an integrated process as part of the care of those patients, and I'm very excited about that advance.
How can we accelerate adoption rates? What are some examples of using the technology to improve quality of care?
Cerquiera: I think to implement a technology we need to really become much more efficient at what we do in terms of the way we perform the studies and improving the accuracy of the studies. I think, as Dr. Hicks said, identifying more specific markers so that these imaging instruments can more closely identify biological processes will make a better diagnosis, correct diagnosis earlier and help to modulate the type of treatment that needs to be used for the patient and then also monitor for efficacy of the treatment or undue side effects and then change it appropriately. Those would be desirable features.
What other issues are important with molecular imaging technologies?
Hicks: One of the focuses we often have…with [payors] and individual patients is the unit and cost of the PET/CT versus a CT, and that seems inordinately higher to many patients. Why should I pay $900 vs. $300 or $2,000 vs. $1000 – whatever the cost is in your particular jurisdiction. The reality is that the decisions that are made from the diagnostic test are so important, and the expenditure that flows from that is so high. We need to get the diagnosis right, from the get-go.
We were asked recently to do an evaluation of how much the cost of it was in our institutions and to try to come up with a figure. We looked at the cost in our center of the PET service. It's less than 1 percent of the total cost in our institution, and we're a dedicated cancer center. That's all we do. Yet everyday major decisions are being made on how the 99 cents in every dollar are being spent on the basis of that PET scan. Is a patient suitable for surgery? Do he or she need radiotherapy? Is the patient going to have radiotherapy? How do we deliver to the sites of disease? Does the patient need chemotherapy? Is the chemotherapy working?
Particularly as we're going forward with targeted therapy, they’re in niche markets and take a huge amount of money to develop. So knowing does the patient have the right target for that target of therapy or when you're giving them the treatment is the target they modulate and is the patient responding? You want to know that early. What we do now with CT is wait until the tumor grows. And that's usually three months or so after treatment has begun, at least, before you're making that decision – whereas with PET we can potentially tell [whether the therapy is working] within days, sometimes weeks of starting therapy. This can save the patient the cost, the morbidity of an extensive therapy and get them onto alternative therapies before they've exhausted their physiological reserves and their emotional reserves thinking that they're responding when they're not.
All those sort of issues come into play, and so if we can direct people to the right treatment from the get-go, we’re far better off. I use the analogy often that it’s like going into a bank. If you've got a simple transaction, you want to go to the teller, and you give them your money. And they give you something in return. Or you give them your slip, and they give you money back. That's like going to the surgeon. That's fine. You get your tumor, and it's gone. But for most people who transact with cancer, the transaction is not so simple. You might need to go and see the teller to have a long-term loan, and that's what radiotherapy is. And sometimes you're in overdrive. You've lost, you're bankrupt. You have to see a financial advisor, and he's right up on the top of the building, and you might never get out of it. So you want to know where to go. You don't want to have to go through all those phases.
If we can guide people through that journey, and really that's what cancer is for most people. I'm sure you know that. It's a journey. You can guide them to have a direct trip and help to lead them on.
(To read more from Dr. Hicks on the cost of PET, please see the cover story, "Can we Afford NOT to Use FDG-PET?")
Trysla: Just to make a comment. Not only is there a human face or a patient face to what you just described doctor [Hicks], but there's a public policy role. If you explain to the patient the critical pathway and the use of diagnostic services and quantify foregoing another round of chemotherapy – from the government side [in terms of] cost and value – [you not only address] human suffering, but also the cost. There's a critical role for education of patients, but there also is a public policy role to show the value and to educate people about the critical roles that diagnostic services play in the treatment of disease. It's something that we in Washington have to work to help quantify and bring that value equation to bear to policymakers, to patients as well as to decision-makers in the government.
Reitermann: Clearly you see the benefits. We usually drive for approving the clinical efficacy, but I think we also should strive for what is the financial efficacy of these new methods. Globally we see a tremendous increase in healthcare cost. I think healthcare is now 16 to 17 percent of the GDP [gross domestic product] worldwide. There is tremendous pressure. We [need to] provide the analysis of the financial impact of that procedure. And then of course a study which [documents] clinical changes [such as] when we have a PET/CT, we change 40 percent of the clinical decisions or 60 percent of the clinical decisions depending on the case. We have to focus a little bit on those studies in the future as well because otherwise we will have tough times with some of the insurance companies and with organizations like CMS because they ask us what's the savings if I do this? It is helpful, but what is also the financial benefit and what are the numbers of patient who we have saved? What are the unnecessary chemotherapy costs saved? We definitely, as a group, have to focus a little bit more on that because otherwise we will face further reimbursement cuts and [proper patient management] discussions all day long.
Petrocelli: I'd like to add a comment. I think part of it is that in order to make money, you have to spend money. In this case, to save money, you have to spend money. We need to develop additional technologies, [such as] biomarkers backing up the point at which we can make the diagnosis before the disease is clinically evident to be really effective at managing it. To do that, we have to spend millions and millions of dollars in research and development. Without that we will never get to the point where we can justify the cost of the studies that we're doing because we don't have the right ones yet.
This is an evolutionary process where we take a small step which leads us to another small step which leads us to another small step. Eventually each of these little evolutions, when you add them all up, becomes revolutionary. But to get there, we have to spend research dollars and that means public funding as well as private funding as well as partnerships between industry and pharma and universities and the public and payors so that we develop a general policy on how we're going to handle this and pool our resources so that we're not working against each other but in a concerted effort to use that money the most effective way possible.
With a fixed pot [of governmental funding], you don't have additional funding. You've just got to reapportion how it gets split up, which makes it extremely difficult because there's not much in the terms of research funding that we're doing that doesn't need to be done. It all needs to be done, and more needs to be done, but we just can't afford to do it or at least not yet. But what does it mean to the patient? It means that when you go to a physician, the true personalization starts when you pick your physician, and you are treated based on not the fact that you have breast cancer, but it's what kind of breast cancer you have. It's what stage of breast cancer you have, what tests are necessary to get you to the place where you and your physician or your team of physicians can make an appropriate choice on how to manage you at this point in your disease so that all of the tests that are done are done with a specific end in mind before you begin therapy, and then after you've begun therapy to monitor that using appropriate testing to know whether you're responding to the treatment not whether 12,000 other women who have had breast cancer respond because you have this kind of breast cancer, but how you as an individual patient responds to this particular course of treatment that was designed just for you.
Where do your particular challenges lie? How do you plan to respond to major changes in the standard of care as molecular imaging technologies are adopted? And how do you see the payment model shifting to accommodate them?
Hadley: I agree with many of the comments that were made just in the last few minutes that certainly funding and paying for new technologies and how to account for a new technology that comes. Unfortunately when something new comes on we tend not to get rid of the old. We tend to add it on. So we just keep adding layer upon layer. I think the biggest challenge lies in there's a lot of the basic biomedical research is done – but there's very little that is being done around the medical economic aspect which as you mentioned Tim [Trysla].
Trysla: I just want to add there's an old saying in healthcare: healthcare is expensive, but wait until it's free. It's going to be an incredible challenge to fund the technology for the future, and you've got to be able to bring those critical pathways and value equations to bear, but you also have to show and have a patient's voice in this. The environment – the fastest growing proponent of Medicare – at least the Medicare side, is diagnostic services, and it's colored with evidence of self- referral or financial incentives to drive and do more testing. It's not really focusing on the value of the patients, and that patient voice has to be captured. I don't know any other person in the room other than the physician who is in a better position to carry that voice and this argument forward. So it's not just the technology, but it's also the business side of practicing medicine that has colored the cynicism around the adoption of this technology. You can't just skip over those realities whether it is return on investment marketing or self-referral type scams where doctors are capturing more and more reimbursement. It is critically important that we change the discussion back to what's best for the patient and the advancements in medicine.
Petrocelli: There are other ways that we ought to start looking at things, too. Using the same level of thinking that got us here is not going to get us out of here. We have to come up with new and creative ways to do those things, an some of those would be, for example, the National Oncology PET registry where we developed a methodology between industry, government to be able to start to pay for PET scans, for things that we were not paying for before but collecting data on them so that we would get evidence-based decision making much sooner than we could otherwise. If we had to do individual trials for those cancer patients, we probably would be looking at five to seven years, and I can't imagine how many hundreds of millions of dollars it would have taken. This approach has gotten results within two years because we did it on a national scale, and we did it in a coordinated way throughout the United States. That kind of thinking and that kind of partnering is what we need to do more of to be able to get us to the place where we can do all of the things that are beneficial to the patient and yet be efficient about it being careful that we don't expect every single patient to get a scan. In many cases, it isn't necessary. And we don't want to do it where it isn't necessary, but we want to do it where it is. But to do that, we have to do this kind of new thinking and new ways of partnering together to get us to that place much sooner.
Cerquiera: Well just a comment here because I think that the truth is we can do all these things correctly. I mean we can show value. We can show efficacy. We can show efficiency and effectiveness, but what we're doing is we're keeping people alive longer, and in my own area of cardiology, where people used to die from heart attacks, that was cheap. Once you're dead, you don't run up any bills. But now we're preventing people from dying from their heart attacks, but they have heart failure. So there are bound to get more tests. They get more medications, and so we're doing the right things, but the reality is the cost. Even if we're very efficient at doing these things, it's going to go up, and you come back to the pairs. We can do all of these things. We can generate evidence-based medicine, but the bottom line is appropriate efficacy, value – that it's still going to be more tests. How do we deal with that?
Hicks: When we set it to [look at this] and established a program 12 years ago now, most people in Australia told me that I was crazy. This was a research tool and had no future at all. And one of our great politicians said that if you have an idea five minutes before everyone else you're a visionary. If you have it five years before everyone else, you're a lunatic. And so I've spent a lot of my life being a lunatic. But you've got to show us the evidence. You want randomized studies. You want to follow-up those to show that this particular diagnostic test saved this patient's life when there's a very long link between a test and that kind of outcome. Yet we're able to show in many, many diseases – lung cancer, colorectal cancer, malignant melanoma, ovarian cancer – when all traditional tests had been done and management decisions are being prospectively recorded for that patient by the managing clinician that it change their course of management in between a third and a half of all patients. That’s a huge impact, and we've been able to replicate that in Australia-wide. It’s [having] a huge impact on patients' lives, and yet this process is taking [a long time]. Yet, the payors were able to say – because of lack of randomized control evidence – there's no common sense for it. If you go back and look at the evidence-base for MRI and CT and bone scans, it's a no-brainer. Yet we're told we can't use this because the evidence isn't strong enough.
Kuwert: I'd also like to add some points. The first thing is that I think you're right, Dr. Cerquiera. My personal belief is that medicine will become even more expensive than it is now. And this is more or less a consequence, not of imaging, but of developing new therapies. If you think of new medication, for example the treatment of colorectal carcinomas was maybe ten years ago a surgery, and that was that. And then there came chemotherapy, and this added further. In Germany it may be $5000 or $500 euros per year per treatment. And now they're coming up with new compounds. They cost further $10,000 euros per year, and there is evidence showing that these treatments are efficient for the patient and prolong their survival. So these are costs that we will have to cover when we want to help people deal with their disease, and imaging is just a very small part of the increase in costs that will come.
The second point is that we are getting in a situation, in my eyes, that is very difficult to control, and this is due to the fact that the complexity of healthcare is steeply increasing. So we have a very record turnover in technologies if you look at imaging modalities. We get maybe new radio pharmaceuticals every two or three years. Progress in MRI has been tremendous. We also have tremendous progress of course in nuclear medicine, and so when we want to produce evidence then we just don’t have the time since when we have produced an evidence that maybe PET would be better suited or MRI for a certain purpose, then PET has evolved and is not the PET that we have studied in our evidence-based studies.
And the third point also is maybe a critical remark. We were talking about personalized medicine, and this is somehow a bit paradoxical when you look at evidence-based medicine since when you are doing an evidence-based study, you have various strict criteria of inclusion and exclusion of patients, and every second patient that you have with that disease does not meet this criteria. So the question then would be how do you use evidence and evidence-based stuff from evidenced based studies so to speak? But the major challenge is the complexity [of molecular imaging technologies], and I feel if we want to deal with that complexity, we as clinicians always want to do the best for our patients. I think that's clear. We have to have systems that somehow help us to avoid unnecessary procedures, and this is something that you have mentioned, so what you need of course is systems where you have very narrow gates to expensive technologies, and you wouldn't like to have systems with free access and uncontrolled access. That may be one way to deal with this and also, of course, it has also been mentioned that self referral and all these other mechanisms that increase costs without increasing efficiency are somehow gotten rid of.
Hadley: I think one of the problems with this whole area is that companies, such as Siemens, are able to advance the technology faster than we can collect the evidence to support the underlying clinical efficacy, and so that is one of the problems that we see. The technology evolves faster than we can really understand it.
I also agree with you that as a new technology, [such as] PET scans, molecular imaging and so forth, becomes adopted, many insurance carriers will adopt prior authorization rules which are not really popular with physicians. But they are a way of being able to accept a new technology and then review the cases. We like to review new technologies for a year or two. If we find that the requested uses are the vast majority of the time appropriately used, then we can take it off of prior authorization. So I think that's one response to that which will allow earlier adoption by insurance carriers because then we have some protection, and we're also promoting the critical pathways so that when we get requests for that we can compare those to what a leading clinicians feels are the correct uses of those technologies. So I do think that is one way to help deal with financing for new and emerging technologies.
Trysla: I think what Dr. Petrocelli and I are talking about is a third paradigm of not an apparatus that becomes a physician hassle system or paperwork system, but the development of clinical protocols with the different medical societies so we're not only focusing on the 3 percent of the procedures that are adopted and paid for, but how about the 20 percent that are unnecessary and stopping the procedures that shouldn't have been done in the first place in order to promote better decision making?
[Here’s what has to happen:] the development of these tools for physicians and the wide education of physicians to make better decisions and again and patients patient groups and other advocacy groups to step up and say, ‘you know, my parents were diagnosed.’
Imaging Biomarkers
Why has there been so much effort dedicated to researching new imaging biomarkers, and what effect will they have on disease?
Cerqueira: As we said, in cancer and cardiology and neurology, if you can identify either a disease process earlier or pickup things like coronary stenosis earlier, you'll be able to put in more preventive measures that may keep people alive longer and healthier and eventually end up having less overall expense to the system for the care. And I think it's very critical to go in that area and certainly an area of oncology to look for the very specific biomarkers so that you can identify which patient is going to benefit from the particular type of therapy, and cardiology to be able to identify vulnerable plaque, an area that's not necessarily causing the flow limitation, but it's going to progress and potentially cause a heart attack. So to develop those, you need specific markers. I think they will allow, again, earlier detection, more effective treatment before people go on to have events.
How long will it take to bring them to the patients?
Reitermann: The easy answer would be ‘it depends.’ We see new radiopharmaceutical agents coming online as we speak on the SPECT side. On the PET side, a lot of research is being done in different areas, but I think today we see in many cases that the approval processes are still requiring – and Dr. Petrocelli said it – a time from let's say inception animal trials until we get the FDA approval. We're probably talking six to eight years. And I think this is due to radiopharmaceutical agents being treated [by the FDA] like therapeutic drugs with all the side effects and with all the danger for side effects. We have a huge difference if we compare the amount that we inject and administer compared to a therapeutic drug, it's a factor of thousands or sometimes millions less than [what is needed] to achieve a therapeutic effect. The process with which we approve new radiopharmaceuticals is pretty similar to therapeutic drugs, and if we don’t' change them, then I think we actually have one of the leading cost drivers behind those new radiopharmaceuticals identified. If we could cut that time from say six to eight years maybe to three or four years, we would save hundreds of millions in the healthcare system because at the end of the day somebody invests in them, so somebody wants to get a return at the end.
At the end of the day, we have an obligation also to our companies, and at the end of the day we invest in order to have a good return. And I think there is a huge opportunity. We see a lot of small steps in the right direction from the regulatory authorities. But I think it takes a lot of push from all of us in this room to actually get to change how we approve new radio pharmaceuticals or biomarker imaging agents. I think only then will we see many more [biomarkers] coming online much faster. On the PET side, I know personally of a few which I hopefully see in the market in the next three or four years.
How do you see the pharmaceutical development as a result of new imaging biomarkers, and what does that mean for the patients?
Trysla: They will continue to advance. We’ll see that the growing investment continues. The real question is what kind of reception you'll see with the payors and whether we can get the critical questions answered that we've been discussing earlier.
DRA
How has the DRA affected your business and quality of care you provide your patients?
Cerqueira: Certainly all the cutbacks that have occurred have made it more difficult to provide the service and basically get state-of-the-art equipment that's capable of doing the very best. It's caused us to become more efficient than we already were but there comes a point where you're not going to be able to continue doing this. A lot of the cuts have been to the Medicare population, and so a lot of these patients in some ways are not getting the care because of cherry picking by some hospitals and some healthcare systems. For people in underserved areas, it's much more difficult to get the services [they need]. You're going to have to travel further to get the appropriate test done. So [the effect of DRA has been] drastic.
Are there relevant comparisons you can draw between the United States and your country in terms of justifying new imaging technology to policymakers?
Kuwert: I can start to answer the question, but I don't know the American system very well. It's a general problem that people who have the money, so to speak, are not so easily convinced to spend it. And when I look at the situation in the states now it is better than it is now in Germany with regard to PET since we have major difficulties in getting reimbursement for the procedure. But things are changing now also in Germany due to the fact that the evidence is so overwhelming that policymakers cannot really try to get PET off the market any longer. In Germany, it has been and also will be a long process until we get full reimbursement. You are lucky here in the states that you got it earlier than we did.
Hicks: Internationally, there's been a rather pernicious movement of what's called health technology assessment bodies. In fact, there's a group called the International Network of Agencies of Health Technology Assessment (INAHTA) which lined up together to look at the evidence of various technologies, but particularly including PET. There have been, I think, six separate international reviews of the evidence relating to PET and I like to call them the six colorblind men. They're all asked to comment on what they think of that lady's frock, skirt, dress, and they all say isn't it a dull shade of gray because they don't have the wherewithal and the right benchmarks with which to assess it. This goes back to the evidence base that I was talking about. The standards of evidence that they've looked for are evidence which is appropriate of therapeutic interventions, not to diagnostic tools, and it's only just recently that the health technology assessment agencies have started to recognize that what's important in a diagnostic test is to make a diagnosis firstly to make it accurately and secondly to impact management. It's not about improving outcomes because that's dependent on the therapies that you apply subsequent to that. We're getting around to a situation now where that separation between what's realistically expected of a diagnostic test becomes the level of evidence that needs to be used, rather than this focus always on showing outcomes from the process. As a profession, as a group, we need to start taking responsibility for defining that value. Where is the value in our diagnostic test? Don't have it imposed on us. Those health technology associations are generally funded by payors, and they have a vested interest in being the critic rather than the artist. They want to find what's wrong with the evidence and not what's right with the evidence, and so we need to work collaboratively with the industry, with payors to say is it logical; is it sensible to do this?
In my particular area in cancer, to put it in perspective, each day in the United States the equivalent of the [people who died on 9/11/01 with the] World Trade Towers falling down die of cancer. And when you put it in that perspective, it's pretty incredible. Last year I got to speak to the American Association of Cancer Research meeting in Los Angeles. They were trumpeting for the second year in a row there's been a decrease in cancer deaths in America, a reduction last year of about 3,000 in the total number of patients who died of cancer, but that's on the background of 557,000 people who died of cancer. When you look at that in terms of change, it's minuscule. So we have to do better, and if we're making diagnoses only 60 percent of the time correctly with our conventional technology, surely it's got to be an advantage to do it with 80 or 90 [percent]. It's not perfect, and that's the thing that I always get coming back to me. ‘Oh you've got one wrong. It's not a specific test.’ There are false positives, and false negatives. I sort of see [this debate] being like your children. You have a really good child. If they do anything wrong, you'll come down and say ‘you naughty kid; you've done a bad thing; you're in trouble.’ And if you've got a really difficult child, the first time they do anything good, you say ‘aren't you good; you've really done a great thing.’ PET is like that. Every time it gets it wrong, we say ‘it's a bad technique; it has false positives and false negatives.’ And every time CT gets it right, isn't it wonderful?!
Molecular imaging is a quickly evolving field in which clinical practice and clinical studies are steadily proving its merits in better patient management and outcomes. It is having a large impact on clinical practice in the diagnosis and staging of cancer, diagnosis, evaluating heart and neurological diseases, and beginning to help in infection imaging, particularly to diagnose fevers of unknown origin.What’s fueling all this? Innovation. Innovation and its translation into clinical practice within molecular imaging was topic of a roundtable discussion attended by about 500 people in Washington, D.C., that coincided with the Society of Nuclear Medicine meeting in June. The event was sponsored by Siemens Medical Solutions. The discussion focused on four areas: personalized medicine, clinical adoption of molecular imaging technologies, biomarker research and the Deficit Reduction Act (DRA).
The expert panel included Manuel Cerquiera MD, chairman of nuclear medicine and professor of radiology and medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; Professor Torsten Kuwert, MD, Chairman of the Department of Nuclear Medicine, University of Erlangen-Nuremberg, Germany; Rodney J. Hicks, MD, FRACP, Professor, Department of Medicine, the University of Melbourne, Director, Centre for Molecular Imaging, Peter MacCallum Cancer Centre, Melbourne, Australia; Douglas Hadley, MD, medical officer and director of Cigna’s coverage policy unit; Tim Trysla, counsel of the healthcare group at Alston and Berg and executive director of the Access to Medicare Imaging Coalition. He also serves as chief of staff to the Centers for Medicaid and Medicare; Michael Reitermann, president of Siemens Medical Solutions Molecular Imaging Division; and Ron Petrocelli, MD, chief medical officer of Siemens Medical Solutions Molecular Imaging Division.
| What To Do About DRA: https://www.mi-lifenet.com/miudemo/features/toolkits/dra/ |
Personalized Medicine
Can you describe personalized medicine?
Manuel Cerquiera, MD: As a clinician who both sees patients and performs diagnostic studies, to me personalized medicine is trying to make the right diagnosis on the patient and then using that information with imaging or other techniques to make decisions about therapy. It also means selecting a therapy which is appropriate for the patient – not something that's based on 1,000 patients – but something that's unique that's going to be the right treatment without undue side effects and get the best cure.
In what areas are personalized medicine accelerating, and what are the challenges?
Tim Trysla: Clinical medicine as it has been practiced for thousands of years necessarily always has been personalized medicine. And the major advance that we have nowadays is that we are increasingly developing tools to determine the individual situation of the patient. On the one hand with regard to his or her psychological status, and on the other hand of course to the status of his or her disease. I think imaging is of course a very good example for this.
The challenge in clinical medicine is always to bring together the soul and the body and how they interact. There are areas of research that look into that matter more deeply, and also look at imaging and how the individual brain functions. Of course a doctor caring for his patients would always – and this has also been stated by medieval physicians – talk to his patients, and this is the challenge of course of technological medicine that although we have new technology at hand which is very powerful, we should still keep the close contact with the patient.
What does all this mean to the patient?
Ron Petrocelli, MD: It means that the patient has to become more involved in the decision-making and partnering with his or her physicians. It's incumbent on the average patient to learn more about what's going on in the healthcare field. As an example of where we need to make some inroads, a study was done in January asking “what is a PET/CT scanner?” to average Joe Public. These are among the answers that were given: 10 percent of the people thought it was a high- resolution imaging machine to monitor pregnant women; 22 percent thought it was a high-intensity screening device used in airport security; and 15 percent thought it was a monitoring device used by a veterinarian to monitor brainwaves in animals. So clearly we have a lot of education to do. But I also think it means for the patient that when he or she selects a physician and the site of healthcare that he or she needs to know that the places are using up-to-date technology, but also bearing in mind that the individual patient has to be involved in the decision- making and discussing with the physician. Otherwise, decisions will be made for them instead of with them, and I think ultimately that would not be in their best interest.
What particular challenges must be overcome as these types of personalized treatments become available?
Douglas Hadley, MD: As new technologies such as molecular imaging come out, it's incumbent upon members of the insurance community that pay for these things to examine the evidence, to take a look at how effective they are. That's what our group [Cigna] does. And the kind of evidence that we think are the most important to look at are what we call “poem” – patient-oriented evidence that matters. What kinds of things matter to a patient? Obviously, mortality, whether they'll live or die; morbidity, whether they'll have more complications or not; symptom control, the quality of their life; and finally, cost. Consumers are becoming much more involved in having to share healthcare costs, so they do look at what new technologies cost.
Are you supportive of identifying groups who may be more responsive to a particular treatment? What about the cost? And what about those who don't respond?
Trysla: Those are incredibly important questions, but I think something we haven't talked about is value. Personalized medicine is the cross reference of science, education and a voice of the patient. Once that education is done, and there are clinical pathways that are universally accepted by the medical profession, there's a role for government to increase the use of those and utilize those kinds of tools, But the No. 1 cost driver still remains the physician's need to show value and how she practices medicine. So getting that information both in the hands of the patient as well as the physician to do the right thing the first time is critically important. But it's going to be incumbent upon manufacturers, clinicians, researchers to really show value for that incremental increase in health. It won't get paid for unless you're bringing the value equation to payors as well as government.
Molecular Imaging Technologies
What do molecular imaging technologies bring to the table for diseases such as cancer and coronary artery disease?
Torsten Kuwert, MD: This question sounds quite simple, but this answer could take several hours. With the advances in molecular biology, increasingly we think that diseases originate in disturbances of molecular processes and that these disturbances are earlier than disturbances in the structure of the human body. Having the means to image these molecular processes allows for an earlier diagnosis of disease in many cases, and in many other cases, more specific diagnosis of a disease since alterations in structure may signify a different disease process, and by looking more specifically at the molecular pathogenesis, we get an earlier diagnosis.
What are some of the newest applications in molecular imaging?
Rodney Hicks, MD: In my particular area, the greatest interest is oncology. I work at a cancer center, and the major purpose is to develop new tracers or individualizing the care to an individual patient. This is critically important in cancer because of the diversity of the biology that we're looking at, and as we have progressive advances in molecular biology, understanding what's driving diseases, having traces that can identify those processes, imaging them in the individual fashion and then testing whether we're modulating those signals with imaging. It becomes an integrated process as part of the care of those patients, and I'm very excited about that advance.
How can we accelerate adoption rates? What are some examples of using the technology to improve quality of care?
Cerquiera: I think to implement a technology we need to really become much more efficient at what we do in terms of the way we perform the studies and improving the accuracy of the studies. I think, as Dr. Hicks said, identifying more specific markers so that these imaging instruments can more closely identify biological processes will make a better diagnosis, correct diagnosis earlier and help to modulate the type of treatment that needs to be used for the patient and then also monitor for efficacy of the treatment or undue side effects and then change it appropriately. Those would be desirable features.
What other issues are important with molecular imaging technologies?
Hicks: One of the focuses we often have…with [payors] and individual patients is the unit and cost of the PET/CT versus a CT, and that seems inordinately higher to many patients. Why should I pay $900 vs. $300 or $2,000 vs. $1000 – whatever the cost is in your particular jurisdiction. The reality is that the decisions that are made from the diagnostic test are so important, and the expenditure that flows from that is so high. We need to get the diagnosis right, from the get-go.
We were asked recently to do an evaluation of how much the cost of it was in our institutions and to try to come up with a figure. We looked at the cost in our center of the PET service. It's less than 1 percent of the total cost in our institution, and we're a dedicated cancer center. That's all we do. Yet everyday major decisions are being made on how the 99 cents in every dollar are being spent on the basis of that PET scan. Is a patient suitable for surgery? Do he or she need radiotherapy? Is the patient going to have radiotherapy? How do we deliver to the sites of disease? Does the patient need chemotherapy? Is the chemotherapy working?
Particularly as we're going forward with targeted therapy, they’re in niche markets and take a huge amount of money to develop. So knowing does the patient have the right target for that target of therapy or when you're giving them the treatment is the target they modulate and is the patient responding? You want to know that early. What we do now with CT is wait until the tumor grows. And that's usually three months or so after treatment has begun, at least, before you're making that decision – whereas with PET we can potentially tell [whether the therapy is working] within days, sometimes weeks of starting therapy. This can save the patient the cost, the morbidity of an extensive therapy and get them onto alternative therapies before they've exhausted their physiological reserves and their emotional reserves thinking that they're responding when they're not.
All those sort of issues come into play, and so if we can direct people to the right treatment from the get-go, we’re far better off. I use the analogy often that it’s like going into a bank. If you've got a simple transaction, you want to go to the teller, and you give them your money. And they give you something in return. Or you give them your slip, and they give you money back. That's like going to the surgeon. That's fine. You get your tumor, and it's gone. But for most people who transact with cancer, the transaction is not so simple. You might need to go and see the teller to have a long-term loan, and that's what radiotherapy is. And sometimes you're in overdrive. You've lost, you're bankrupt. You have to see a financial advisor, and he's right up on the top of the building, and you might never get out of it. So you want to know where to go. You don't want to have to go through all those phases.
If we can guide people through that journey, and really that's what cancer is for most people. I'm sure you know that. It's a journey. You can guide them to have a direct trip and help to lead them on.
(To read more from Dr. Hicks on the cost of PET, please see the cover story, "Can we Afford NOT to Use FDG-PET?")
Trysla: Just to make a comment. Not only is there a human face or a patient face to what you just described doctor [Hicks], but there's a public policy role. If you explain to the patient the critical pathway and the use of diagnostic services and quantify foregoing another round of chemotherapy – from the government side [in terms of] cost and value – [you not only address] human suffering, but also the cost. There's a critical role for education of patients, but there also is a public policy role to show the value and to educate people about the critical roles that diagnostic services play in the treatment of disease. It's something that we in Washington have to work to help quantify and bring that value equation to bear to policymakers, to patients as well as to decision-makers in the government.
Reitermann: Clearly you see the benefits. We usually drive for approving the clinical efficacy, but I think we also should strive for what is the financial efficacy of these new methods. Globally we see a tremendous increase in healthcare cost. I think healthcare is now 16 to 17 percent of the GDP [gross domestic product] worldwide. There is tremendous pressure. We [need to] provide the analysis of the financial impact of that procedure. And then of course a study which [documents] clinical changes [such as] when we have a PET/CT, we change 40 percent of the clinical decisions or 60 percent of the clinical decisions depending on the case. We have to focus a little bit on those studies in the future as well because otherwise we will have tough times with some of the insurance companies and with organizations like CMS because they ask us what's the savings if I do this? It is helpful, but what is also the financial benefit and what are the numbers of patient who we have saved? What are the unnecessary chemotherapy costs saved? We definitely, as a group, have to focus a little bit more on that because otherwise we will face further reimbursement cuts and [proper patient management] discussions all day long.
Petrocelli: I'd like to add a comment. I think part of it is that in order to make money, you have to spend money. In this case, to save money, you have to spend money. We need to develop additional technologies, [such as] biomarkers backing up the point at which we can make the diagnosis before the disease is clinically evident to be really effective at managing it. To do that, we have to spend millions and millions of dollars in research and development. Without that we will never get to the point where we can justify the cost of the studies that we're doing because we don't have the right ones yet.
This is an evolutionary process where we take a small step which leads us to another small step which leads us to another small step. Eventually each of these little evolutions, when you add them all up, becomes revolutionary. But to get there, we have to spend research dollars and that means public funding as well as private funding as well as partnerships between industry and pharma and universities and the public and payors so that we develop a general policy on how we're going to handle this and pool our resources so that we're not working against each other but in a concerted effort to use that money the most effective way possible.
With a fixed pot [of governmental funding], you don't have additional funding. You've just got to reapportion how it gets split up, which makes it extremely difficult because there's not much in the terms of research funding that we're doing that doesn't need to be done. It all needs to be done, and more needs to be done, but we just can't afford to do it or at least not yet. But what does it mean to the patient? It means that when you go to a physician, the true personalization starts when you pick your physician, and you are treated based on not the fact that you have breast cancer, but it's what kind of breast cancer you have. It's what stage of breast cancer you have, what tests are necessary to get you to the place where you and your physician or your team of physicians can make an appropriate choice on how to manage you at this point in your disease so that all of the tests that are done are done with a specific end in mind before you begin therapy, and then after you've begun therapy to monitor that using appropriate testing to know whether you're responding to the treatment not whether 12,000 other women who have had breast cancer respond because you have this kind of breast cancer, but how you as an individual patient responds to this particular course of treatment that was designed just for you.
Where do your particular challenges lie? How do you plan to respond to major changes in the standard of care as molecular imaging technologies are adopted? And how do you see the payment model shifting to accommodate them?
Hadley: I agree with many of the comments that were made just in the last few minutes that certainly funding and paying for new technologies and how to account for a new technology that comes. Unfortunately when something new comes on we tend not to get rid of the old. We tend to add it on. So we just keep adding layer upon layer. I think the biggest challenge lies in there's a lot of the basic biomedical research is done – but there's very little that is being done around the medical economic aspect which as you mentioned Tim [Trysla].
Trysla: I just want to add there's an old saying in healthcare: healthcare is expensive, but wait until it's free. It's going to be an incredible challenge to fund the technology for the future, and you've got to be able to bring those critical pathways and value equations to bear, but you also have to show and have a patient's voice in this. The environment – the fastest growing proponent of Medicare – at least the Medicare side, is diagnostic services, and it's colored with evidence of self- referral or financial incentives to drive and do more testing. It's not really focusing on the value of the patients, and that patient voice has to be captured. I don't know any other person in the room other than the physician who is in a better position to carry that voice and this argument forward. So it's not just the technology, but it's also the business side of practicing medicine that has colored the cynicism around the adoption of this technology. You can't just skip over those realities whether it is return on investment marketing or self-referral type scams where doctors are capturing more and more reimbursement. It is critically important that we change the discussion back to what's best for the patient and the advancements in medicine.
Petrocelli: There are other ways that we ought to start looking at things, too. Using the same level of thinking that got us here is not going to get us out of here. We have to come up with new and creative ways to do those things, an some of those would be, for example, the National Oncology PET registry where we developed a methodology between industry, government to be able to start to pay for PET scans, for things that we were not paying for before but collecting data on them so that we would get evidence-based decision making much sooner than we could otherwise. If we had to do individual trials for those cancer patients, we probably would be looking at five to seven years, and I can't imagine how many hundreds of millions of dollars it would have taken. This approach has gotten results within two years because we did it on a national scale, and we did it in a coordinated way throughout the United States. That kind of thinking and that kind of partnering is what we need to do more of to be able to get us to the place where we can do all of the things that are beneficial to the patient and yet be efficient about it being careful that we don't expect every single patient to get a scan. In many cases, it isn't necessary. And we don't want to do it where it isn't necessary, but we want to do it where it is. But to do that, we have to do this kind of new thinking and new ways of partnering together to get us to that place much sooner.
Cerquiera: Well just a comment here because I think that the truth is we can do all these things correctly. I mean we can show value. We can show efficacy. We can show efficiency and effectiveness, but what we're doing is we're keeping people alive longer, and in my own area of cardiology, where people used to die from heart attacks, that was cheap. Once you're dead, you don't run up any bills. But now we're preventing people from dying from their heart attacks, but they have heart failure. So there are bound to get more tests. They get more medications, and so we're doing the right things, but the reality is the cost. Even if we're very efficient at doing these things, it's going to go up, and you come back to the pairs. We can do all of these things. We can generate evidence-based medicine, but the bottom line is appropriate efficacy, value – that it's still going to be more tests. How do we deal with that?
Hicks: When we set it to [look at this] and established a program 12 years ago now, most people in Australia told me that I was crazy. This was a research tool and had no future at all. And one of our great politicians said that if you have an idea five minutes before everyone else you're a visionary. If you have it five years before everyone else, you're a lunatic. And so I've spent a lot of my life being a lunatic. But you've got to show us the evidence. You want randomized studies. You want to follow-up those to show that this particular diagnostic test saved this patient's life when there's a very long link between a test and that kind of outcome. Yet we're able to show in many, many diseases – lung cancer, colorectal cancer, malignant melanoma, ovarian cancer – when all traditional tests had been done and management decisions are being prospectively recorded for that patient by the managing clinician that it change their course of management in between a third and a half of all patients. That’s a huge impact, and we've been able to replicate that in Australia-wide. It’s [having] a huge impact on patients' lives, and yet this process is taking [a long time]. Yet, the payors were able to say – because of lack of randomized control evidence – there's no common sense for it. If you go back and look at the evidence-base for MRI and CT and bone scans, it's a no-brainer. Yet we're told we can't use this because the evidence isn't strong enough.
Kuwert: I'd also like to add some points. The first thing is that I think you're right, Dr. Cerquiera. My personal belief is that medicine will become even more expensive than it is now. And this is more or less a consequence, not of imaging, but of developing new therapies. If you think of new medication, for example the treatment of colorectal carcinomas was maybe ten years ago a surgery, and that was that. And then there came chemotherapy, and this added further. In Germany it may be $5000 or $500 euros per year per treatment. And now they're coming up with new compounds. They cost further $10,000 euros per year, and there is evidence showing that these treatments are efficient for the patient and prolong their survival. So these are costs that we will have to cover when we want to help people deal with their disease, and imaging is just a very small part of the increase in costs that will come.
The second point is that we are getting in a situation, in my eyes, that is very difficult to control, and this is due to the fact that the complexity of healthcare is steeply increasing. So we have a very record turnover in technologies if you look at imaging modalities. We get maybe new radio pharmaceuticals every two or three years. Progress in MRI has been tremendous. We also have tremendous progress of course in nuclear medicine, and so when we want to produce evidence then we just don’t have the time since when we have produced an evidence that maybe PET would be better suited or MRI for a certain purpose, then PET has evolved and is not the PET that we have studied in our evidence-based studies.
And the third point also is maybe a critical remark. We were talking about personalized medicine, and this is somehow a bit paradoxical when you look at evidence-based medicine since when you are doing an evidence-based study, you have various strict criteria of inclusion and exclusion of patients, and every second patient that you have with that disease does not meet this criteria. So the question then would be how do you use evidence and evidence-based stuff from evidenced based studies so to speak? But the major challenge is the complexity [of molecular imaging technologies], and I feel if we want to deal with that complexity, we as clinicians always want to do the best for our patients. I think that's clear. We have to have systems that somehow help us to avoid unnecessary procedures, and this is something that you have mentioned, so what you need of course is systems where you have very narrow gates to expensive technologies, and you wouldn't like to have systems with free access and uncontrolled access. That may be one way to deal with this and also, of course, it has also been mentioned that self referral and all these other mechanisms that increase costs without increasing efficiency are somehow gotten rid of.
Hadley: I think one of the problems with this whole area is that companies, such as Siemens, are able to advance the technology faster than we can collect the evidence to support the underlying clinical efficacy, and so that is one of the problems that we see. The technology evolves faster than we can really understand it.
I also agree with you that as a new technology, [such as] PET scans, molecular imaging and so forth, becomes adopted, many insurance carriers will adopt prior authorization rules which are not really popular with physicians. But they are a way of being able to accept a new technology and then review the cases. We like to review new technologies for a year or two. If we find that the requested uses are the vast majority of the time appropriately used, then we can take it off of prior authorization. So I think that's one response to that which will allow earlier adoption by insurance carriers because then we have some protection, and we're also promoting the critical pathways so that when we get requests for that we can compare those to what a leading clinicians feels are the correct uses of those technologies. So I do think that is one way to help deal with financing for new and emerging technologies.
Trysla: I think what Dr. Petrocelli and I are talking about is a third paradigm of not an apparatus that becomes a physician hassle system or paperwork system, but the development of clinical protocols with the different medical societies so we're not only focusing on the 3 percent of the procedures that are adopted and paid for, but how about the 20 percent that are unnecessary and stopping the procedures that shouldn't have been done in the first place in order to promote better decision making?
[Here’s what has to happen:] the development of these tools for physicians and the wide education of physicians to make better decisions and again and patients patient groups and other advocacy groups to step up and say, ‘you know, my parents were diagnosed.’
Imaging Biomarkers
Why has there been so much effort dedicated to researching new imaging biomarkers, and what effect will they have on disease?
Cerqueira: As we said, in cancer and cardiology and neurology, if you can identify either a disease process earlier or pickup things like coronary stenosis earlier, you'll be able to put in more preventive measures that may keep people alive longer and healthier and eventually end up having less overall expense to the system for the care. And I think it's very critical to go in that area and certainly an area of oncology to look for the very specific biomarkers so that you can identify which patient is going to benefit from the particular type of therapy, and cardiology to be able to identify vulnerable plaque, an area that's not necessarily causing the flow limitation, but it's going to progress and potentially cause a heart attack. So to develop those, you need specific markers. I think they will allow, again, earlier detection, more effective treatment before people go on to have events.
How long will it take to bring them to the patients?
Reitermann: The easy answer would be ‘it depends.’ We see new radiopharmaceutical agents coming online as we speak on the SPECT side. On the PET side, a lot of research is being done in different areas, but I think today we see in many cases that the approval processes are still requiring – and Dr. Petrocelli said it – a time from let's say inception animal trials until we get the FDA approval. We're probably talking six to eight years. And I think this is due to radiopharmaceutical agents being treated [by the FDA] like therapeutic drugs with all the side effects and with all the danger for side effects. We have a huge difference if we compare the amount that we inject and administer compared to a therapeutic drug, it's a factor of thousands or sometimes millions less than [what is needed] to achieve a therapeutic effect. The process with which we approve new radiopharmaceuticals is pretty similar to therapeutic drugs, and if we don’t' change them, then I think we actually have one of the leading cost drivers behind those new radiopharmaceuticals identified. If we could cut that time from say six to eight years maybe to three or four years, we would save hundreds of millions in the healthcare system because at the end of the day somebody invests in them, so somebody wants to get a return at the end.
At the end of the day, we have an obligation also to our companies, and at the end of the day we invest in order to have a good return. And I think there is a huge opportunity. We see a lot of small steps in the right direction from the regulatory authorities. But I think it takes a lot of push from all of us in this room to actually get to change how we approve new radio pharmaceuticals or biomarker imaging agents. I think only then will we see many more [biomarkers] coming online much faster. On the PET side, I know personally of a few which I hopefully see in the market in the next three or four years.
How do you see the pharmaceutical development as a result of new imaging biomarkers, and what does that mean for the patients?
Trysla: They will continue to advance. We’ll see that the growing investment continues. The real question is what kind of reception you'll see with the payors and whether we can get the critical questions answered that we've been discussing earlier.
DRA
How has the DRA affected your business and quality of care you provide your patients?
Cerqueira: Certainly all the cutbacks that have occurred have made it more difficult to provide the service and basically get state-of-the-art equipment that's capable of doing the very best. It's caused us to become more efficient than we already were but there comes a point where you're not going to be able to continue doing this. A lot of the cuts have been to the Medicare population, and so a lot of these patients in some ways are not getting the care because of cherry picking by some hospitals and some healthcare systems. For people in underserved areas, it's much more difficult to get the services [they need]. You're going to have to travel further to get the appropriate test done. So [the effect of DRA has been] drastic.
Are there relevant comparisons you can draw between the United States and your country in terms of justifying new imaging technology to policymakers?
Kuwert: I can start to answer the question, but I don't know the American system very well. It's a general problem that people who have the money, so to speak, are not so easily convinced to spend it. And when I look at the situation in the states now it is better than it is now in Germany with regard to PET since we have major difficulties in getting reimbursement for the procedure. But things are changing now also in Germany due to the fact that the evidence is so overwhelming that policymakers cannot really try to get PET off the market any longer. In Germany, it has been and also will be a long process until we get full reimbursement. You are lucky here in the states that you got it earlier than we did.
Hicks: Internationally, there's been a rather pernicious movement of what's called health technology assessment bodies. In fact, there's a group called the International Network of Agencies of Health Technology Assessment (INAHTA) which lined up together to look at the evidence of various technologies, but particularly including PET. There have been, I think, six separate international reviews of the evidence relating to PET and I like to call them the six colorblind men. They're all asked to comment on what they think of that lady's frock, skirt, dress, and they all say isn't it a dull shade of gray because they don't have the wherewithal and the right benchmarks with which to assess it. This goes back to the evidence base that I was talking about. The standards of evidence that they've looked for are evidence which is appropriate of therapeutic interventions, not to diagnostic tools, and it's only just recently that the health technology assessment agencies have started to recognize that what's important in a diagnostic test is to make a diagnosis firstly to make it accurately and secondly to impact management. It's not about improving outcomes because that's dependent on the therapies that you apply subsequent to that. We're getting around to a situation now where that separation between what's realistically expected of a diagnostic test becomes the level of evidence that needs to be used, rather than this focus always on showing outcomes from the process. As a profession, as a group, we need to start taking responsibility for defining that value. Where is the value in our diagnostic test? Don't have it imposed on us. Those health technology associations are generally funded by payors, and they have a vested interest in being the critic rather than the artist. They want to find what's wrong with the evidence and not what's right with the evidence, and so we need to work collaboratively with the industry, with payors to say is it logical; is it sensible to do this?
In my particular area in cancer, to put it in perspective, each day in the United States the equivalent of the [people who died on 9/11/01 with the] World Trade Towers falling down die of cancer. And when you put it in that perspective, it's pretty incredible. Last year I got to speak to the American Association of Cancer Research meeting in Los Angeles. They were trumpeting for the second year in a row there's been a decrease in cancer deaths in America, a reduction last year of about 3,000 in the total number of patients who died of cancer, but that's on the background of 557,000 people who died of cancer. When you look at that in terms of change, it's minuscule. So we have to do better, and if we're making diagnoses only 60 percent of the time correctly with our conventional technology, surely it's got to be an advantage to do it with 80 or 90 [percent]. It's not perfect, and that's the thing that I always get coming back to me. ‘Oh you've got one wrong. It's not a specific test.’ There are false positives, and false negatives. I sort of see [this debate] being like your children. You have a really good child. If they do anything wrong, you'll come down and say ‘you naughty kid; you've done a bad thing; you're in trouble.’ And if you've got a really difficult child, the first time they do anything good, you say ‘aren't you good; you've really done a great thing.’ PET is like that. Every time it gets it wrong, we say ‘it's a bad technique; it has false positives and false negatives.’ And every time CT gets it right, isn't it wonderful?!
Mary C. Tierney, MS, Vice President & Chief Content Officer, TriMed Media Group
Mary joined TriMed Media in 2003. She was the founding editor and editorial director of Health Imaging, Cardiovascular Business, Molecular Imaging Insight and CMIO, now known as Clinical Innovation + Technology. Prior to TriMed, Mary was the editorial director of HealthTech Publishing Company, where she had worked since 1991. While there, she oversaw four magazines and related online media, and piloted the launch of two magazines and websites. Mary holds a master’s in journalism from Syracuse University. She lives in East Greenwich, R.I., and when not working, she is usually running around after her family, taking photos or cooking.