Executive Perspective: Falko Busse, PhD, Philips Healthcare
Busse explains that the early adoption being achieved in Asia, “Has not so much to do with regulatory hurdles, but it has to do with the health care system. You have a relatively low level of health insurance in these economies, so patients are used to paying for therapies out-of- pocket and they inform themselves.” He says that market adoption in Asia is being led by “a whole group of entrepreneurial radiologists who drive these new technologies because they see a business and a value for the patient.”
By comparison, regulatory hurdles are slowing adoption in traditionally large and important markets like Europe and the U.S. While it generally takes less time to achieve regulatory approval in Europe than in the U.S., Busse says, “You have challenges with adoption because of the reimbursement structure.”
While Busse believes that the U.S. “can still be a very large market” for focused ultrasound, he sees regulatory approval and reimbursement as daunting challenges, both in terms of time and investment. “Every approval, every indication in the U.S., takes several years and many millions of dollars to get it done. So, for every indication, we have to make an economic assessment as a company if this is a viable investment,” he notes.
He describes the current market situation as a “tipping point.” Explaining, he says, “Right now, we nicely address these early adopters, but if we really want to continue the growth, we also need to be able to get consensus adopters convinced.”
According to Busse, market momentum requires that focused ultrasound is:
- Broadly known to radiologists and referring physicians;
- Embedded in the clinical workflow and regarded as a valid treatment option;
- Embedded in treatment guidelines;
- Incorporated into a business model that allows physicians to commercialize the technology.
Overall, Busse is optimistic about focused ultrasound’s prospects. The technology, he says, has a strong chance of becoming an established treatment option in most major markets. To succeed in markets beyond Asia, he believes that device makers must understand how the healthcare system works and where its incentives are distributed. According to Busse, helping customers develop physician referral networks and market directly to patients will be essential.
Sonalleve installations increasing
Phillips has installed around 50 of its Sonalleve MR-HIFU systems worldwide, and Busse reports that the number is growing “relatively strongly.”
The Sonalleve is approved for treating uterine fibroids in Europe, most of Asia, the Middle East and South America. “We will have approval in Canada very soon,” Busse reports. “In the United States, we have approval for the pivotal trial and that’s going to start any time now.” The system has also received CE-marking for the treatment of bone metastases, a palliative application. The CE-marking covers Europe, most of Asia, the Middle East and South America.
In the near future, Philips will be evaluating prototype devices for the treatment for breast and prostate cancer and for primary and metastatic liver cancer. The company is also working with pharmaceutical companies to develop focal drug delivery applications for breast, liver, bone and pancreatic cancers.
Written by Ellen C., McKenna