The Focused Ultrasound Surgery Foundation has announced that its Research Awards Program is funding a Mayo Clinic study that will be the first to use U.S. commercial database information to compare the costs of three minimally-invasive treatments for symptomatic uterine fibroids, a benign and often debilitating condition that affects more than one in four American women.
Bijan Borah, PhD of the Mayo Clinic has become the FUS Foundation's newest Research Award recipient. Borah, who is an Assistant Professor in the College of Medicine and an Associate Consultant in the Division of Healthcare Policy and Research at the Mayo Clinic, has received $100,000 for a yearlong research project entitled, "Costs of Uterine Fibroid Treatments Including Focused Ultrasound Surgery."
During the project, which is expected to launch in December 2011, Borah will collaborate with Thomson Reuters. Their goal is to provide much-needed evidence on healthcare cost comparisons of MR-guided focused ultrasound, uterine artery embolization (UAE) and myomectomy for the treatment of uterine fibroids. The study will use Thomson Reuters' proprietary database of healthcare claims from approximately 130 large, self-insured American employers, a database that provides a good representation of the insured women in the U.S.
According to Borah, very limited information exists about the cost-effectiveness of MR-guided focused ultrasound relative to other uterine fibroid treatments. "There is a critical need to gather comparative evidence data on economic outcomes associated with MRgFUS as compared to the existing alternatives - UAE and myomectomy," he explains. To address this need, the Mayo Clinic study will provide healthcare cost comparisons of the three modalities for periods of one-year, two-years and three-years.
Despite the FDA's 2004 approval of a MR-guided focused ultrasound system (InSightec's ExAblate 2000) to treat uterine fibroids, few healthcare insurers currently provide reimbursement for the procedure. Most of the 2,500 American women who have undergone focused ultrasound treatment for uterine fibroids have either paid out of pocket or participated in no-cost clinical trials.
If the Mayo Clinic study shows that the cost of MR-guided focused ultrasound procedures for uterine fibroids is equivalent to, or lower than, comparative procedures, Borah believes it could be a game-changer in terms of reimbursement. "Payers/insurers will be incentivized to begin covering MR-guided focused ultrasound for the treatment of uterine fibroids," he says. "Since uterine fibroids are the first FDA-approved indication for MR-guided focused ultrasound treatment, this study may also have implications for other indications which are now investigational."
Clinical trials are now underway or pending in the U.S. to investigate MR-guided focused ultrasound as a treatment for pain associated with metastatic bone cancer and for essential tremor, Parkinson's disease and malignant tumors of the brain, breast and prostate.
Focused Ultrasound Surgery Foundation