Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Gynecological-uterine myoma. 
Treatment: Surgical Services-Radiofrequency ablation with imaging guidance. 

The health plan denied the treatment as experimental/investigational. The reviewer has upheld the health plans determination. 

This patient is a gravida(G)0para(P)0 with uterine fibroids and abnormal uterine bleeding. The patient underwent intrauterine device (IUD) removal due to uterine cramping. The patient also reported vaginal discharge. She was noted to have resection of a prior submucosal leiomyoma by hysterectomy. The patient was switched from oral contraception to Mirena IUD. The patient had a 2 stage hysteroscopic myomectomy for removal of myxomas. Following the second myomectomy, there was palpable evidence of additional myomas in the wall of the uterus. However, the endometrial cavity appeared normal at that time. The patient underwent a saline infused sonohysterogram on and was noted to have recurrent fibroids present. These had an intramural component to the fibroids. The patient was offered the Sonata procedure given the overlying serosal tissue was only 5 millimeter (mm) and this was an option available. The patient was maintained on continuous oral contraception while considering this option. The patient is now under consideration for the Sonata procedure (radiofrequency ablation guided by ultrasound) for treatment of fibroids. 

The health plan's determination of upheld in whole. 

In this case, the patient is under consideration of the Sonata procedure (radiofrequency ablation guided by ultrasound) for treatment of fibroids. The Sonata procedure utilizes real-time intrauterine ultrasound guidance with targeted radiofrequency ablation to treat symptomatic uterine fibroids. This therapy is Food and Drug Administration (FDA) cleared at this time. The procedure in this case for a patient with fibroids in the wall of the uterus that are small as described in the clinical material would be considered experimental and investigational and would not be a recommended therapy for management of leiomyomas in the uterus. There are short term studies of this technology - a 12-month trial of Sonata among 147 patients who were treated in a single arm interventional trial. The bleeding was noted to decrease but not totally abate with the therapy. Satisfaction was noted with the procedure. However, this was a short-term follow-up trial without long term outcomes. There was a second study also accessed at clinicaltrials.gov that noted an increased risk for intrauterine adhesions following the procedure which would be associated with abnormal bleeding and pain. Unfortunately, this was a smaller study of 34 evaluable patients with 6 having the outcome of adhesions in the uterus. A study of 125 patients noted a low surgical reintervention rate at 12 months after the Sonata procedure. However, again, long term outcomes from randomized controlled trials are missing. 
The American College of Obstetrics & Gynecology recommends the following in their practice bulletin entitled "Management of symptomatic uterine leiomyomas": 

"Radiofrequency Ablation Laparoscopic radiofrequency ablation can be considered as a minimally invasive treatment option for the management of symptomatic leiomyomas in patients who desire uterine preservation and are counseled about the limited available data on reproductive outcomes. Radiofrequency ablation (RFA) can be delivered by a laparoscopic, transvaginal, or transcervical approach, using ultrasound guidance to induce coagulative necrosis in targeted uterine leiomyomas. All the approaches are similarly effective in reducing uterine leiomyoma volume and in improving quality of life metrics, but the laparoscopic approach has been studied the most rigorously 61. Although RFA is a reasonable option to consider for the treatment of symptomatic uterine leiomyomas, access to this technology is currently limited. 
Although laparoscopic RFA with a leiomyoma-specific FDA-approved device has been studied primarily in nonrandomized trials, two recent meta-analyses summarize long-term data on the use of RFA to treat a wide variety of leiomyoma types and sizes. In these two meta-analyses, which included over 1,800 patients, uterine leiomyoma volume reduction ranged from 32% to 66% at 12 months, and 77% at greater than 12 months follow up. The cumulative rate of postoperative surgical reintervention for leiomyoma-related symptoms was 4.2%, 8.2%, and 11.5% at 1, 2, and 3 years, respectively. Statistically and clinically significant improvements were observed in health-related quality of life and symptom severity in long-term follow up (up to 36 months). Complication reporting was highly inconsistent, but no serious procedural complications such as death or injury to visceral structures was reported in any of the included studies. Neither meta-analysis reported outcomes on menstrual bleeding. 
In a case-series of 30 pregnancies after laparoscopic RFA, there were 26 full-term live births and four pregnancy losses. Although in this small case series there were no cases of preterm delivery, uterine rupture, placental abruption, placenta accreta, or intrauterine growth restriction, sample size precludes any definitive conclusions about risk or incidence of pregnancy complications." 

Thus, in this case, the Sonata system is a new option in the management of leiomyomas that lacks long term outcomes to support this specific technology. Thus, this remains experimental and investigational until sufficient randomized controlled trials with long term outcomes are available. In this case, the patient should be considered for other therapies. If pregnancy is being considered, myomectomy should be considered as pregnancy data is limited in these cases of Sonata use and there are risks for intrauterine adhesions based upon the clinical studies. The use of the Sonata procedure (radiofrequency ablation guided by ultrasound) for treatment of fibroids is not likely to be more beneficial than other standard treatments for fibroids as presented in this case.