Special interview: Susan Klees, FUSF Director of Patient Access

Susan Klees

The scientific community has a critical role to play in gaining optimal insurance reimbursement for MR-guided focused ultrasound. As Susan Klees, Director of Patient Access for the Focused Ultrasound Surgery Foundation, reports, “Evidence is the key driver for reimbursement, and it all begins with the way studies are designed. Research priorities must be grounded in sound science as well as the realities of the marketplace.” 

Designing studies that address marketplace realities requires an understanding of what is valued by different groups. “We know that physicians are seeking cutting-edge treatment modalities to solve medical challenges, patients want to avoid complex surgery and lengthy recovery times and medical payers expect enhanced outcomes and efficiencies in treatment,” she explains.

Although there has been reimbursement success in countries like Germany, Klees says, private payers in the U.S. are not yet consistently covering focused ultrasound treatments for uterine fibroids. In fact, some have adopted ‘negative’ policies that actively seek to deny coverage. “This is happening even though focused ultrasound has been approved by the Food and Drug Administration and demonstrated important advantages over competing therapies,” she notes. “These advantages include being an outpatient procedure, offering quick recovery and preserving the potential for future fertility.”

Because they view the current body of evidence as unconvincing, many American healthcare insurers are asking for randomized comparative trials and long-term outcomes before reconsidering their stance on MR-guided focused ultrasound therapy.

To avoid such stalemates in the future, the FUS Foundation is encouraging researchers, industry and other stakeholders to collaborate in setting priorities for investigating new focused ultrasound applications. Examples include essential tremor and Parkinson’s disease. “We’re pushing for studies that target the most commercially viable focused ultrasound applications, address safety and efficacy, and generate data that demonstrates the technology’s comparative superiority in long-term benefits, quality of life and cost-effectiveness,” Klees explains.

Clinician interview: Matthias Matzko, MD, Amper Kliniken AG, Dachau, Germany

Matthias Matzko, MD has emerged as a leading European advocate for MR-guided focused ultrasound. In his native Germany, he has also played a key role in eliminating one of the most challenging barriers to widespread adoption of the promising medical technology: reimbursement.

Head of Interventional and Diagnostic Radiology at the 450-bed Amper Kliniken AG in Dachau, Matzko learned about focused ultrasound in 2008 from a colleague. He admits to becoming “kind of infected” with enthusiasm for the technology after visiting Wladyslaw Gedroyc, MD at St. Mary’s Hospital in London.

Matzko immediately recognized the potential of focused ultrasound and wanted to offer it at his hospital’s Myomzentrum, a center for the treatment of uterine myoma (fibroids), which had opened in June 2008. The center was already performing uterine artery embolization, myomectomy and hysterectomy.

“When I came back from London, I was very excited about the technology, and I was thinking about how to implement this in our environment,” he recalls. “Talking with the hospital administration, they were unsure about investing in the risk of a new method.”

Matthias Matko, MD

De-risking equipment acquisition

So strong was his conviction, the business-savvy Matzko offered to rent a focused ultrasound system through an imaging company he heads and have it set up in the hospital. “I took the risk off the hospital administration,” he says. Arrangements were made through GE Financial to lease an ExAblate System from InSightec, Ltd.

At first, Matzko and his team performed focused ultrasound procedures only on Wednesdays and Saturdays, during time slots when the Myomzentrum’s MRI was made available to them. They performed five to ten treatments a month. As more patients learned about the availability and benefits of focused ultrasound, the center’s monthly treatment volume increased to 10-12 patients. “Our machine was fully booked in advance for about a four-month period of time,” Matzko explains.

Careful patient selection aids reimbursement

From the start, Matzko and his colleagues were convinced that careful patient selection was essential to achieving good results with focused ultrasound. Only a third of their uterine fibroid patients met the treatment criteria. “When you want to have reimbursement for such a new method, you have to produce good results, and that’s why you have to select patients very carefully,” he says.

With good results and patient satisfaction documented, Matzko and colleagues applied for reimbursement from Techniker Krankenkasse (TK), one of the largest insurance companies in Germany. Company representatives visited Amper Kliniken and focused ultrasound treatment sites in Berlin and Bochum.

Matzko says two factors were of greatest interest to the insurance company: 1) that only patients suited for focused ultrasound were treated with it; and 2) the Myomzentrum’s interdisciplinary team, which includes a gynecologist who provides both treatment and information to patients.

Although pleased with both the clinic’s results and services, the insurance company raised a red flag. The capacity to treat only three patients a week seemed too limited to qualify for reimbursement from a nationwide insurer.

Rather than a barrier, this objection became the basis of collaboration between the clinic, the insurance company and – ultimately – Amper Kliniken’s administration. Together, they planned the expansion of the existing focused ultrasound center. By this point, Matzko explains, “The hospital administration was convinced about the method of focused ultrasound and convinced about the business model.” 

The expanded center opened in March 2010 with a fully dedicated MRI and ExAblate 2000. By then, the two largest German medical insurers were covering MR-guided focused ultrasound treatments. With all the pieces in place, the center’s monthly treatment volume quickly doubled.

The Dachau clinic continues to be on the leading edge of focused ultrasound technology. In November 2010, it became one of the first sites in the world to install the ExAblate One, the second generation system developed by GE Healthcare and InSightec. In the future, Matzko plans to expand treatment offerings to include new applications of the technology.

Marketing is another key to success

Matzko acknowledges that marketing was initially a challenge for the focused ultrasound center. “We started in a typical radiological manner,” he says. “We did marketing to referring physicians, and we informed all of our gynecologist colleagues in the south of Germany, in Switzerland, in Austria about our new center. The result was very poor.”

Recognizing that a strategy switch was in order, the center began marketing directly to patients via a new website and the use of Google ads. Increased patient requests for information led to the creation of a 24-hour hotline staffed by two patient managers knowledgeable about uterine fibroid treatment options. “Our aim is to figure out the ideal method to treat the personal situation of the patient,” Matzko explains. 

In addition to Germany, Austria and Switzerland, the Dachau clinic is attracting patients throughout Eastern Europe and elsewhere. “They come from Poland, from Russia, from Bulgaria and even we had one patient coming in from Dubai,” Matzko notes. “We now have, in a small hospital like ours, an international customership.”

FUSF Research Award recipient: W. Jeffrey Elias, M.D, University of Virginia, USA

W. Jeffrey Elias, M.D.

Neurosurgeon W. Jeffrey Elias, M.D. first learned about the promise of MR-guided focused ultrasound a few years ago from colleague Neal F. Kassell, M.D. at the University of Virginia. At first, Elias was intrigued but, well, maybe a little busy. He was absorbed in a growing practice and had new twins at home. But he seized the chance to study the technology when UVA opened its Focused Ultrasound Center. “I realized it was going to be a very unique opportunity for us to be involved in early and innovative research,” Elias remembers.

Today, Elias is pioneering MR-guided focused ultrasound as a treatment for movement disorders. Backed by funding from the Focused Ultrasound Surgery Foundation, he has launched a first in the world clinical trial using MR-guided focused ultrasound to treat patients with essential tremor, a type of involuntary shaking with no known cause. Designed to assess the safety and initial efficacy of the treatment, the study is expected to treat as many as 15 patients and involves making a precisely targeted small lesion with focused ultrasound in the thalamus, a deep region within the brain.

Elias recently received two research awards from the Focused Ultrasound Surgery Foundation totaling $196,000. The first award is supporting preclinical research of the safety, feasibility and histology (tissue structure) of MR-guided focused ultrasound compared to other intracerebral lesioning techniques, specifically Gamma Knife radiosurgery and surgical implantation of heating probes. Gamma Knife, for instance, takes time to work, he says. It can take weeks or months for the radiation to take effect and cause a lesion in the brain and, in the meantime, the patient still has the disorder. And radiofrequency treatment carries an inherent risk of bleeding since a probe is inserted through the skull and into the brain.

“We think that focused ultrasound will provide precise and discreet lesioning that’s sharper and more well-demarcated than other techniques,” Elias said. “But that’s just the hypothesis. We’re in the process of studying and comparing these techniques. What we find may allow for very precise targeting and perhaps even safer treatments for movement disorders.”

The second research award is enabling Elias and his team to study the safety and feasibility of focused ultrasound for the further treatment of people who have undergone deep brain stimulation. DBS is currently the primary therapy for patients with Parkinson’s disease and similar movement disorders.  Elias wants to know whether MRI-guided focused ultrasound is effective in treating residual symptoms when an implanted neurostimulator is already in place.

“Our hope is that this research will provide greater understanding of focused ultrasound technology and therapy and facilitate its use and acceptance into the clinic for the treatment of movement disorders,” Elias said.

FUSF Research Award recipient: Mario Ries, Ph.D., Laboratory for Functional and Molecular Imaging, Bordeaux, France

Mario Ries, Ph.D.

Mario Ries, Ph.D., a physicist at the Laboratory for Functional and Molecular Imaging in Bordeaux, France, has been intrigued with the notion of combining noninvasive ablation with MR guidance since 1997. Today, his key ambition is help the roughly one to one and a half million people globally diagnosed with breast cancer every year.

Ries has received a $100,000 research award from the Focused Ultrasound Surgery Foundation to pursue a project he believes will result in a safer and more effective treatment for breast cancer. His objective is to solve the technical drawbacks that cause existing high intensity focused ultrasound (HIFU) transducers – devices that convert energy into sound waves and focus the waves on a target – to damage tissue around the breast, including to the thoracic cage, heart and lungs.

“Currently, there is no dedicated transducer type for breast cancer,” Ries says. “We can only use transducer designs dedicated for other types of cancer treatment, which is suboptimal. This complicates FDA approval. Finally, people understand that this has technical drawbacks because it might impair patient security. What we propose is a complex technical innovation on a transducer, which is the antenna system on acoustic emitter, which is dedicated for breast treatment.”

According to Ries, the breast structure poses special challenges for HIFU treatment because there are many different types of tissue (such as fatty and granular) that conduct sound waves differently. This ‘inhomogeneous propagation media’ means that an ultrasound beam can become unfocused and has to be corrected. And because every breast is different, every correction needs to be different as well. Ries plans a correction strategy for aberrations in breast ultrasound, based on high resolution MRI along with tissue ultrasound speed measurements.

“HIFU treatments have the potential to both reduce the cost of breast cancer treatments and reduce the side effects,” Ries observes. “The basic edge of HIFU is you could do such an intervention in one afternoon. You could treat a breast and cauterize the primary tumor without having to hospitalize the  patient. And using HIFU along with chemotherapy, you could potentially skip radiation treatment altogether.”

Ries estimates he is about one year away from knowing whether his proposed solution has scientific merit. If it does, he estimates it will take about two years to begin clinical trials.

Regarding his research award, Ries says, “I’m really happy to receive this recognition. The FUS Foundation has a reasonable application scheme and a fast turnaround time. It’s a project we can conclude within a year and it’s absolutely doable. It is refreshing you can actually get your hands on funding and get something going. It’s very positive.”