Gynesonics, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced the publication of healthcare economics studies INSPIRE and COMPARE. Both peer-reviewed studies demonstrate significant cost advantages to both facility and payer stakeholders in the utilization of the Sonata® System for Transcervical Fibroid Ablation (TFA) when compared to myomectomy and hysterectomy procedures. The Sonata treatment advantages included reductions for the index procedure cost, length of stay and complication costs.
The INSPIRE study focused on payer claims data over a 12-month period to capture all costs of care. Mean payer payments for hysterectomy ($24,156) and myomectomy ($22,784) were significantly higher than Sonata ($8,941) all P<.001. Hysterectomy and myomectomy mean total payer costs were shown to be 170% and 155% higher than the Sonata treatment costs, respectively.
The COMPARE study focused on facility costs for these fibroid treatment options. The Sonata treatment showed a significantly lower mean cost to the facility, even after removal of robotic assisted procedures or high cost outliers, with the Sonata treatment averaging $7,701, hysterectomy $10,353 and myomectomy $12,003 (all P<.001). Hysterectomy and myomectomy mean total facility costs were shown to be 34% and 56% higher than the Sonata treatment costs, respectively.
Elizabeth Brooks, Ph.D., healthcare economist and lead author on both publications, stated, “MedTech manufacturers understand that positive clinical outcomes supporting the application of a breakthrough technology are a critical first step but not enough to support widespread adoption. Payers and healthcare institutions need to understand the costs associated with new technologies compared to the standard of care. In that regard, the studies published by INSPIRE and COMPARE provide relevant positive economic outcomes for the Sonata treatment in relation to data available for hysterectomy and myomectomy.”
“These studies, which include real-world data regarding cost and payment, show that the impressive patient outcomes achieved with the Sonata treatment also provide a significant cost savings for both payers and facilities compared to hysterectomy and myomectomy,” said Gynesonics President and CEO Christopher Owens. “To date, the clinical data has been impressive showing that the Sonata system, an incision-free, uterus-preserving, transcervical treatment for symptomatic fibroids that can treat nearly 80% of fibroid types, provides high rates of symptom reduction and patient satisfaction. These first healthcare economic publications show positive clinical outcomes can be achieved while providing economic advantages to the health care system.”
In the INSPIRE payer analysis (Brooks E, Mihalov L, Delvadia D et al. ClinicoEconomics and Outcomes Research. 2020;1-11), claims data were obtained from a subset of sites involved in the SONATA pivotal IDE clinical trial, while the hysterectomy and myomectomy patients included data from the claims database (the Truven Health MarketScan commercial payer claims). The analyses were from women 25–50 years of age, with uterine fibroid diagnosis up to 12 months prior to the date of the index procedure. Analysis demonstrated TFA with Sonata had a significantly lower mean length of stay of 5 hours (hrs) versus hysterectomy (73 hrs) or myomectomy (79 hrs); all P<.001. The average payer cost for TFA treatment with Sonata, including the associated postoperative period, was $8,941. This was significantly lower compared to hysterectomy ($24,156) and myomectomy ($22,784); all P<.001. In the TFA Sonata arm, there were no device- or procedure-related costs associated with complications during the peri- or postoperative time frame. TFA subjects had significantly lower costs associated with complications, prescription medications, and radiology.
In the COMPARE facility analysis (Brooks E, Mihalov L, Delvadia D et al. Managed Care. 2019;40-45), length of stay (LOS) and charge data for the TFA Sonata arm were collected as part of the SONATA pivotal IDE clinical trial. In order to compare to hysterectomy and myomectomy, hospital-specific cost-to-charge ratios (CCRs) were used to convert charges to facility costs for those procedures. Charge data and LOS for hysterectomy and myomectomy were collected retrospectively from the Truven Health MarketScan Commercial Database and converted to costs using Medicare national average CCRs. In this study, LOS results for TFA Sonata patients were similar to INSPIRE at 5.1 hours compared with hysterectomy (73 hours) or myomectomy (80 hours); all P<.001. Converted facility costs for TFA Sonata were $7,701, significantly lower than the $10,353 for hysterectomy and the $12,003 for myomectomy (all P<.001).
“I am impressed with the company’s unwavering commitment to understand how this procedure clinically impacts patients and the balance of economic value to hospitals and the payer community,” said Kelly Petrucci, Vice President of Healthcare Economics and Market Access for Gynesonics. “Each study shows a high level of consistency in outcomes making Sonata a reliable treatment for each stakeholder. These studies show that Sonata can help address clinical concerns while driving down the cost of healthcare.”
About Sonata System
The Sonata System uses radiofrequency energy to ablate fibroids under real time intrauterine sonography guidance. The Sonata System, including the SMART Guide, enables the operator to target fibroids and optimize ablations within them. The Sonata system’s design provides a straightforward, transcervical access for a uterus-preserving, incision-free fibroid treatment. This intrauterine approach is designed to avoid the peritoneal cavity.
Gynesonics is a women’s healthcare company focused on advancing women’s health, by developing minimally invasive, incision-free, uterus-preserving, transcervical technologies for diagnostic and therapeutic applications. Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids. The Sonata System is CE marked. Sonata is approved for sale in the European Union and the United States. Gynesonics is a privately held company with headquarters in Redwood City, CA. For more information, go to www.gynesonics.com.