Molecular Imaging Insight - September 2007 - (Page 16) 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 “[The Dra has] 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.” 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 peutic 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. 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. It takes a lot of push from all of us in this room to actually get to change how [the FDA] approves new radiopharmaceuticals 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 will see in the market in the next three or four years. Q 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 patient groups and other advocacy groups to step up and say, ‘you know, my parents were diagnosed.’ 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 Q ImagIng BIomarkers Q 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 [coronary] events. How has the DRA affected your business and quality of care you provide your patients? CerQueira: Certainly all the cutbacks that have occurred [with the DRA] 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. Q Q 16 Molecular Imaging Insight How long will it take to bring biomarkers 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. And I think this is due to radiopharmaceutical agents being treated [by the FDA] like thera- Are there relevant comparisons you can draw between the United States and your country in terms of justifying new imaging technology to policymakers? KuwerT: 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. September 2007
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