Philips GEMINI TF
Big Bore PET/CT

DOTmed Industry Sector Report: Nuclear Medicine

July 08, 2009

This report originally appeared in the June 2009 issue of DOTmed Business News

Molecular imaging is proving to be a problem-solver in all three dimensions of medicine-clinical practice, research, and public health policy. As the U.S. weighs health care reform options this specialty is a perfect fit, combining clinical utility with cost-effectiveness.

"The new reforms are going to help nuclear medicine if properly used," said Henry Wagner, M.D., professor emeritus at Johns Hopkins Bloomberg School of Public Health. Dr. Wagner briefs the Society of Nuclear Medicine (SNM) each year about trends in the specialty. His theme this year is the role of molecular imaging in creating a new, smarter health care system. While policy wonks focus on administrative improvements, Dr. Wagner has the clinical perspective on trends like electronic medical records. "Recording and analyzing the data from patients' electronic records will really improve patient care and decrease costs," he said. "If we really want to know what works, we can mine electronic records on the population level. In so doing, molecular imaging will come out on top as a way to improve care and reduce expenditures."

In his 33rd annual report to colleagues at this year's SNM meeting, Dr. Wagner will cite cases in point that demonstrate the value of molecular imaging. For instance, a study from the University of Zurich (BA Herzog) demonstrates that the use of SPECT is more than justified in its ability to diagnose coronary disease and identify appropriate intervention.

"The nuclear medicine studies show that coronary angiography, which is an invasive procedure, could have been avoided in 60% of patients that had it....a great [potential] savings in costs," Dr. Wagner noted. "As the economic aspect of medicine is coming to the forefront right now, it really puts nuclear medicine or molecular imaging into a tremendously important position."

Add to the promise of the field its application in two of the most prevalent conditions-heart disease and cancer - and the potential of molecular imaging to improve patient care seems limitless.

New Technologies Propel the Specialty Forward

Generally, SPECT/CT has a largely cardiac focus, with PET/CT more utilized in cancer, although studies are done with both techniques in both fields. Both technologies are on the cutting edge in their main disciplines where molecular imaging holds the promise of earlier intervention, informing more appropriate treatment options and demonstrating treatment response faster.

GE Discovery 600 series PET/CT

"If a patient comes in with an advanced stage of cancer, you don't really need a lot of precision, the lesions are large enough that you can see them by a variety of techniques, MR, CT as well as molecular imaging," said Jean-Luc Vanderheyden, Molecular Imaging Technology Leader, GE Healthcare. "But if the lesions are quite small, then the ability of molecular imaging to detect those metabolic cells will impact the equipment you would use."
The company's Discovery PET/CT 600-series scanners can image smaller lesions and accommodate motion such as respiration that normally obscures them. Subtle changes are detected earlier so that patients don't have to undergo months of chemotherapy or radiation therapy before a response to treatment is seen.

"The whole premise is if we can catch cancer early before metastasis into other organs, the better chance of survival and cure," Vanderheyden said. "With molecular imaging, since you are really looking at the cellular level, you may be able to see treatment response in a matter of hours or days [rather than weeks or months with conventional approaches]," he said. "Then if the treatment was not going to work out properly ... you can alter the treatment right away."

On the SPECT/CT side, an area with ten times the number of procedures as PET/CT, GE is building its brand with the new hybrid Discovery NM/CT 570c, combining SPECT with a 64-slice CT gamma camera. Solid state detectors vastly reduce scan time, increase patient comfort and throughput. The system reveals anatomy as well as blood flow in a multi-duty study showing myocardial perfusion imaging (MPI), Computed Tomographic Angiography (CTA), and calcium scoring (CaSC). This can help pinpoint diagnosis to spot disease states not otherwise visible while improving diagnostic accuracy. The unneeded angiographies that this approach will eliminate can justify the high-tech investment.

"It's not technology for technology's sake. We really need to think of the impact on the patient and the clinical answer that has to be addressed," Vanderheyden said.

PET Reimbursement a Bright Spot in a Down Market

In a clear recognition of the promise and value of molecular imaging, Medicare has significantly expanded coverage of PET for initial and follow-up evaluation of many types of cancer. The CMS move is based on clinical evidence from the National Oncologic PET Registry.

It shows that PET has proved itself as an exquisite and refined tool to differentiate many types of cancers," said Don Bogutski, President, Diagnostix Plus, Inc., Rockville Centre, NY. "This may be the step before PET being accepted as a repetitive, important tool to fine-tune the therapy that's applied once a cancer diagnosis has been made."

"The PET reimbursement is very exciting news for the industry and patients because over a number of years the efficacy of PET in diagnosing, staging and helping in treatment of cancer has been expanded," said Dominic Smith, Vice President of Global Nuclear Medicine Marketing, Philips Healthcare.

Philips GEMINI TF
Big Bore PET/CT

The company's new GEMINI TF Big Bore PET/CT is reaching beyond the diagnostic, staging and follow-up procedures where PET/CT is typically used by introducing a PET/CT system for radiation oncology treatment planning. TF stands for time of flight, which accomplishes respiratory motion compensation.

The unit is installed at the University of Pennsylvania and will be used in the institution's proton therapy center, opening this year.

"For several reasons, we think the PET/CT is really significant. The first is that it has a large bore," said Chaitanya R. Divgi, M.D., head of nuclear medicine and molecular imaging at Penn. In addition to imaging large patients with the 85 cm bore, he noted that image resolution is not degraded and less radiation can be used.

"The other advantage is that we can image patients who are in their treatment planning positions, in the same position that they would have when being treated with radiation therapy," Dr. Divgi said.

With all this talk of clinical promise, you almost forget to worry about the business side of equipment sales for the high-tech scanners. The OEMs have reported sales slumps in the first quarter of the year, but things may improve with the continued application of PET/CT and SPECT/CT to prevalent disease areas, along with mounting clinical evidence of effectiveness, and the favorable reimbursements in the new PET schedule.

PET/CT looks like a wise investment for several reasons. "PET can be used to check up on expensive medicines and radiotherapy, gathering clinical evidence about them," Dr. Divgi said of the research application. "The initial investment will be costly because we will need to carry out expensive studies to determine what the cheapest way will be. I have no doubt that intelligent application of imaging, particularly PET, will lead to cost savings in the long run," he said.

"On the clinical level, the procedure volume, innovation and clinical proof are very strong in PET/CT and SPECT/CT. The clinical drivers are still there," Smith said. "In Q1, what we saw was the effect of the credit crisis. People made a decision not to make a [purchase] decision. If they can't operate with liquidity it's difficult to raise money for capital. What the industry is looking for is that institutions have the ability to fulfill their normal financial plans. We are all waiting for the natural market forces to come back into effect."

Some Business Opportunities in the Aftermarket

Investment in radiopharmaceutical laboratories is not going great guns either according to Gary Reich, President, Reich Consulting Services, Inc., a builder and equipper of hot labs that make the tracers for this field.

"It has to do with fear of cash flow and being able to finance receivables among hospitals. Many of the not-for-profit hospitals are on a capital freeze for labs, renovations, expansions, and replacement of equipment. There is some activity but it has significantly slowed," Reich said. "The opportunities right now with some signs of improvement are in radiation oncology, children's hospitals and the veterans hospitals. Those are areas that are at least evaluating purchases compared to a traditional community, not-for-profit hospital." He also noted that many hospitals begin their fiscal year in July and if they have leftover funds or put off investment till next year, things might improve over the summer.

A refurbished GE Discovery LSM
PET/CT being checked at
C&G Technologies

Meanwhile the independent service organizations continue to sell and support the aftermarket in PET/CT and SPECT/CT as well as stand-alone PET and SPECT.
"Overall, new equipment system sales are down and interest has grown in the value of used equipment. PET/CT procedures continue to grow at about 4% per year and we are starting to enter into a replacement cycle of PET and PET/CT equipment," said Greg Kramer, President, C&G Technologies, Inc., Jeffersonville, IN. "Hospitals, imaging centers and physician practices are looking to the third party market for alternatives in providing high quality equipment and service at a better value. Service contracts represent a significant operational cost for PET/CT equipment. The emergence of competent third-party service companies represents the potential to reduce these operational costs."

"Our sales have continued to grow in the dedicated PET market and now, the refurbished PET/CT market is growing. The first round of PET/CT scanners that were released are now coming out of warranty. We can buy them for a reasonable price, put the money into refurbishing, turn them around to an end user and still be below what the OEMs will want for a new PET/CT," said Kevin McGehee, President, Marquis Medical, LLC, Denham Springs, LA. "The [used] PET/CT market is growing. It's not as hot as dedicated PET. But in the next six months I think you will see PET/CT take off in the refurbished market."

"Some companies are struggling due to lenders being much more reluctant to provide capital. But, those companies with access to capital are able to keep the industry segment healthy through acquisitions and consolidations," says Ray Stachowiak, president of Shared Imaging. "Our own company did an acquisition in 2007. Last year was quiet for us, but I think that this year will be very active for us. I believe it's going to follow the pattern of the mobile MR field over the years. Right now there are literally dozens of companies competing. Over the next few years though, things will consolidate. We'll likely see just a handful in the next five to seven years if not sooner."

Stand-Alone PET Makes a Comeback

Lost in the discussion of the exciting new hybrid PET/CT scanners is the ongoing usefulness of stand-alone PET. This market was abandoned by the larger OEMs several years ago. The refurbishers have largely filled the void. But this created an opportunity for some smaller OEMs to develop new scanners for dedicated applications.

One example is Positron Corporation out of Indianapolis, which has just received FDA 510(k) approval to market its new stand-alone PET system. The Attrius is a dedicated, state-of-the-art PET molecular imaging system designed for cardiac imaging studies. Positron has a joint venture with Neusoft Medical Systems, Shenyang, China, to manufacture the device. The unit is priced somewhere between a refurbished, stand-alone PET and a new PET/CT.

"The large OEMs were appropriate for a booming economy where people were willing to buy very expensive devices and hope for reimbursement," said Positron President Joseph Oliverio. "Things have changed. We now need to focus on cost-effective provision of medicine and maximizing patient outcomes."

From "Unclear" to Molecular

This specialty has come a long way since the days when nuclear medicine was dubbed "unclear" medicine. Today, ever more diverse and specific radiopharmaceutical tracers can pinpoint and target disease on a cellular or molecular level. No wonder the preferred term is now "molecular imaging." Whether for cardiac, cancer or other conditions, nuclear medicine is gaining traction as the answer to many medical problems, including curbing health care costs.

"Nuclear medicine is a model that does a better job of getting answers [than many other radiological modalities] so in many cases there is no need to go on and have an additional scan. Nuclear is actually very well-positioned going forward," said Bogutski.

As research from this field demonstrates better ways to treat patients, replicating those findings in the entire population has important policy implications.

"If you approach health care at the individual patient level, it decreases the cost of taking care of specific patients - that's called productivity. As the costs go down the productivity goes up and the availability to more people goes up," Dr. Wagner said. "Smarter health care lets you decrease the cost of caring for a specific patient to make more money available for taking care of more patients."

In this sense, nuclear proliferation can be a good thing.

Read More Online

-Get a case example of a large cardiovascular group in Texas that chose a used stand-alone PET scanner to augment its practice. Go to
www.dotmed.com/news/story/9064.
-You'll see the full interview with Dr. Henry Wagner at
www.dotmed.com/news/story/9057.
-Read more about Positron's new stand-alone PET scanner at
www.dotmed.com/news/story/9005.
-Read details of the CMS expanded PET coverage decision at
www.dotmed.com/news/story/8695.