Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Fibroid tumors in uterus
Issue under review: Sonata procedure

Determination:
The health plan should not cover the Sonata procedure.

The patient is an adult woman with a history of symptomatic uterine fibroids. SONATA transcervical radiofrequency fibroid ablation has been recommended.

Hysterectomy and myomectomy are the most commonly performed surgical interventions for the treatment of uterine fibroids. Hysterectomy involves extirpation of the uterus (and generally, the cervix), with or without ovarian conservation. Myomectomy is an operation where individual fibroids are removed, retaining the uterus and the potential for pregnancy.

Sonata provides a TFA for symptomatic uterine fibroids. It is a sonography-guided, incisionless, and uterus-preserving radiofrequency ablation treatment and is approved and commercially available in Europe and the US, as well as FDA-approved. Sonata uses a single-use radiofrequency ablation handpiece connected to a reusable intrauterine ultrasound probe, forming a single integrated treatment device designed to ablate uterine fibroids. This integration of real-time ultrasound (for imaging) with radiofrequency ablation (for treatment) in a single device, enables a gynecologist to visualize, target and ablate a greater range of fibroid types transcervically than can be approached via operative hysteroscopy.

Operative hysteroscopy is limited to the treatment of intracavitary and smaller submucosal fibroids; at least in the case of submucosal fibroid, it represents a gold standard for treatment. Sonata reportedly uses intrauterine ultrasound to image and treat all non-pedunculated fibroids.

Recent peer reviewed studies have reported on SONATA treatment of uterine fibroids. The prospective SONATA pivotal IDE trial was performed in the US and Mexico to examine the safety and effectiveness of TFA in the treatment of symptomatic uterine fibroids. An analysis of 12-month clinical outcomes in the US cohort was recently published. TFA with the Sonata System was performed on women with symptomatic uterine fibroids. The 12-month co-primary endpoints were reduction in menstrual blood loss and freedom from surgical re-intervention. Symptom severity, quality of life, patient satisfaction, safety, and reductions in uterine and fibroid volumes were also evaluated. One hundred twenty-five patients were enrolled and treated in the US. Both co-primary endpoints were achieved in this US-based cohort, as 65.3% of patients reported >=50% reduction in menstrual bleeding and 99.2% of patients were free from surgical re-intervention. Symptom improvement was noted by 97.4% of patients and 98.3% were satisfied. Ninety-five percent of patients reported reduced menstrual bleeding at 12 months, and 86.8% noted >20% reduction. Significant mean improvements at 12 months were realized in both symptom severity and health-related quality of life (33.8 points and 45.8 points, respectively; all P<0.0001). Mean maximal fibroid volume reduction per patient was 63.8%. There was a 0% incidence of device related adverse events. Mean length of stay was 2.5 hrs and 50% of patients returned to normal activity within one day.

The authors reported that this analysis of US patients in the SONATA pivotal IDE trial demonstrated results consistent with those in the full cohort. TFA with Sonata significantly reduced fibroid symptoms with a low surgical re-intervention rate through 12 months. They reported that these results support the efficacy and safety of the Sonata system as a first-line treatment for women affected by symptomatic uterine fibroids.

There are no published, peer-reviewed, randomized controlled studies evaluating direct comparisons of effectiveness of the SONATA device, and current standard of care treatments. Therefore, it is not confirmed that the requested health service or procedure likely to be more beneficial than any standard treatment or treatments for the insured's condition or disease.