Focused Ultrasound Foundation Calls for Reimbursement Solutions 
to Broaden Access to Popular Procedure for Women

Charlottesville, VA -- April 23, 2015 – The Ontario Health Technology Advisory Committee (OHTAC) has recommended Magnetic Resonance-Guided High-Intensity Focused Ultrasound (MRgHIFU or MRgFUS) as a possible “cost-effective strategy” and a “safe and effective, noninvasive, uterine-preserving” option for women seeking treatment for uterine fibroids. A new evidence review by Health Quality Ontario (HQO) has led to a recommendation by OHTAC finding MRgHIFU offers significant improvement in fibroid symptoms and rapid post-procedure recovery for women, with a rare occurrence of complications and a low risk of needing further treatments. A companion OHTAC economic analysis also concluded that MRgHIFU could result in an annual savings of up to $4.15 million for Ontarians.

MRgHIFU is a therapeutic technology which uses focused ultrasound energy to heat and destroy targeted tissue while real-time magnetic resonance imaging (MRI) is used to guide and monitor the treatment. The treatment is completely noninvasive and enables women to return to normal activity within a couple days.

“These findings by HQO and OHTAC are an important step in recognizing the body of evidence that supports the efficacy and cost benefit of the technology,” said Dr. Neal Kassell, founder and chairman of the Focused Ultrasound Foundation. “We were pleased and not surprised to see that after a thorough review of the evidence, OHTAC found focused ultrasound to offer significant treatment advantages for women, including possible fertility preservation, at a reasonable cost. We expect these reports to facilitate full adoption of focused ultrasound in Ontario and help address the challenges to widespread acceptance of the technology globally, such as insurance reimbursement for procedure costs.”

The ExAblate focused ultrasound system developed by INSIGHTEC was approved to treat uterine fibroids in Canada in 2013 and in the U.S. in 2004. The Sonalleve focused ultrasound system, developed by Philips, was first approved for routine clinical use in Canada in 2011 and is in clinical trials in the U.S. Focused ultrasound has been used to treat more than 10,000 women for uterine fibroids in Europe, Asia, Latin America, the Middle East, and the United States. Uterine fibroids are noncancerous tumors that occur in up to 8 in 10 women by age 50.

Economic Analysis
The companion OHTAC economic analysis -- which evaluated the cost-effectiveness and budgetary impact of implementing MRgHIFU in Ontario – compared the treatment against three other common fibroid procedures (hysterectomy, myomectomy and uterine artery embolization or UAE) and concluded that “MRgHIFU may be a cost-effective strategy at commonly accepted willingness-to-pay thresholds.” The authors estimated that Canada’s Ministry of Health and Long-Term Care spends about $35.5 million a year on fibroid treatments and that MRgHIFU could result in a savings of $1.38 to $4.15 million annually. The report also cited logistical and financial challenges to implementing MRgHIFU while suggesting those barriers may be offset by the “promising technology’s” benefits to women including “complete noninvasiveness” and faster recovery times.

In addition to uterine fibroid treatment, focused ultrasound has received regulatory approval for several clinical indications in at least one region of the world, including prostate cancer, liver tumors, thyroid nodules, palliative treatment for bone metastases, breast fibroadenoma and neurological disorders (essential tremor, neuropathic pain and tremor-dominant Parkinson’s disease).

Read the HQO evidence review.

Read the economic analysis.

Read the final OHTAC recommendation.

About Health Quality Ontario (HQO)
Health Quality Ontario (HQO) is a partner and leader in transforming Ontario’s health care system so that it can deliver a better experience of care and better outcomes for Ontarians and better value for money. HQO’s legislated mandate under the Excellent Care for All Act, 2010 is to evaluate the effectiveness of new health care technologies and services, report to the public on the quality of the health care system, support quality improvement activities and make evidence-based recommendations on health care funding. HQO is an arms-length agency of the Ontario government.

About The Focused Ultrasound Foundation
The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by accelerating the development and adoption of focused ultrasound therapies. The Foundation works to clear the path to global adoption by coordinating and funding research and educational activities, creating partnerships and fostering collaboration among stakeholders, and building awareness of the technology among patients and professionals. The Foundation is dedicated to ensuring that focused ultrasound finds its place as a mainstream therapy for uterine fibroids, cancer, brain tumors, Parkinson's disease, epilepsy, stroke and other life-threatening conditions within years, not decades. Since its establishment in 2006, the Foundation has become the largest non-governmental source of funding for focused ultrasound research. More information about the Charlottesville, Virginia based Foundation can be found at www.fusfoundation.org.

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