Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Leiomyoma of uterus
Treatment: Radiofrequency surgery
The insurer denied Radiofrequency surgery.
The determination is upheld.

The patient has with uterine fibroids, heavy menses, dysmenorrhea and pelvic pressure. She was counseled and decided on radiofrequency uterine ablation of the fibroids (Sonata) procedure with the transcervical approach. At issue is whether this is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed health service or treatment radiofrequency surgery is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.
The Sonata procedure's safety and effectiveness has not been well-established. In a prospective, multi-center, single-arm, interventional trial, Chudnoff and colleagues (2019) examined the 12-month safety and effectiveness of transcervical ablation for the treatment of symptomatic uterine leiomyomas. The authors concluded that transcervical ablation was associated with a significant reduction in leiomyoma symptoms with no device-related adverse events (AEs) and a low surgical re-intervention rate through 12 months, demonstrating its potential to safely and effectively treat all non-pedunculated leiomyoma types through a uterus-conserving, incisionless approach. The authors stated that drawbacks of this study included a non-randomized design, a limit of 5 centimeters (cm), and the exclusion of patients who desired fertility.
In a retrospective, single-arm, long-term data-collection study, Garza-Leal (2019) examined the long-term (greater than 5 years) clinical outcomes of transcervical radiofrequency ablation (RFA) of uterine fibroids. Bradley and co-workers (2019) carried out a systematic review of prospective studies for treatment of uterine fibroids with RFA. The authors stated that there were several drawbacks pertaining to the quality of the included studies that may influence conclusions. First, there was less precision in the RFA results following 12 months of follow-up since fewer studies reported longer term data. Second, the number of included studies was insufficient to perform statistical comparisons among RFA delivery approaches for several outcomes. In these cases where these investigators reported the results descriptively, it was plausible that clinically important differences in patient outcomes existed among RFA delivery approaches that were not detectable in this meta-analysis due to insufficient statistical power. More importantly, since the comparative RFA outcomes reported in this study were derived from different studies and analyzed through meta-regression, the post-hoc results should be considered hypothesis-generating only. Third, it was not possible to determine from this analysis whether RFA efficacy was influenced by fibroid type or volume due to concerns of aggregation bias whereby real associations observed at the patient level (e.g., fibroid volume in each patient) often did not agree with those observed at the study level (e.g., mean fibroid volume in each study). Finally, these researchers planned to report the frequency of complications in this meta-analysis; however, complication reporting was highly inconsistent and inadequate such that any attempts at reporting these data would have led to inaccurate and misleading results.
Brooks et al (2020) noted that the INSPIRE study compared peri-operative and 12-month health economic and clinical outcomes associated with hysterectomy, myomectomy, and sonography-guided transcervical fibroid ablation (TFA) using the Sonata system. These researchers stated that this study had several drawbacks. Because Sonata payment data were obtained from a subset of sites that participated in the clinical trial, the sample size was small. Also, as described previously, several assumptions had to be made about payments.
Lukes and Green (2020) reported on 3-year clinical outcomes of the SONATA pivotal trial of TFA in women with symptomatic uterine myomata. This prospective, controlled, multi-center, interventional trial enrolled 147 pre-menopausal women with symptomatic uterine fibroids who underwent uterus-preserving, US-guided TFA with the Sonata System. Clinical outcomes were examined over 3 years and included surgical re-interventions, sphincter-saving surgery (SSS), and health related quality of life (HR-QOL) subscales of the Uterine Fibroid Symptom and quality of life (QOL) Questionnaire, EQ-5D [standardized measure of health-related quality of life developed by the EuroQol Group] questionnaire, overall treatment effect, treatment satisfaction, physical activity, work impairment, pregnancy outcomes, and adverse events (AEs). The authors concluded that women treated with ultrasound (US)-guided TFA in the SONATA pivotal trial experienced significant and durable reduction of fibroid-related symptoms, with low surgical re-intervention rates over 3 years of follow-up. Moreover, these researchers stated that additional long-term data with the Sonata System will be available from the Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry [SAGE] registry (ClinicalTrials.gov Identifier: National Clinical Trial (NCT) 03118037), a worldwide observational post-market study trial with goal of characterizing long-term (5 years) outcomes after treatment of uterine fibroids with the Sonata System in real-world clinical practice settings.
Furthermore, an UpToDate review on "Uterine fibroids (leiomyomas): Laparoscopic myomectomy and other laparoscopic treatments" (Parker, 2020) states that "Radiofrequency ablation (RFA) is a minimally invasive, energy-based treatment that reduces fibroid-related symptoms by reducing fibroid volume. RFA of fibroids may be accomplished using a laparoscopic or transcervical approach. Procedures are performed on an outpatient basis with return to normal activity within approximately 1 week. Using ultrasound guidance to identify the fibroid, a conductive needle array punctures the fibroid and transmits radiofrequency energy, which causes coagulative necrosis. Both the transcervical and laparoscopic approaches use the ultrasound probe to ensure that the energy is not close to the uterine serosa and to monitor the tissue effect until the bulk of the fibroid is treated. Over subsequent months, fibroids are reabsorbed with a decrease in fibroid volume and a resultant reduction in fibroid-related symptoms". However, the transcervical approach is not listed in the Summary and Recommendations section of this review.
The Sonata system may prove to be beneficial in the future as some initial studies are promising, however, there are no long-term prospective randomized studies available to show its superiority to traditional methods.