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 overturned  the health plans determination. 

The patient presented with a long history of menorrhagia with bleeding reported as much as 8 days of each month, along with significant dysmenorrhea. Her evaluation showed uterine fibroids, including a 3.4 centimeter submucosal fibroid believed to be responsible for the bleeding. She has failed conservative therapies, including oral contraceptive pills, progestin intrauterine device (IUD), and four hysteroscopic myomectomies. The patient desires future childbearing and requested minimally invasive treatment of the fibroids. She has requested the Sonata procedure for transcervical radiofrequency ablation of the fibroids, and the Health Plan has denied that procedure as experimental. That denial has been appealed. 

The health plan's denial is overturned in whole. 

It is reasonable to assume the patient would do better with the proposed Sonata procedure rather than older, more "standard" methods. The longstanding treatment for submucosal fibroids has been hysteroscopic myomectomy for decades. This patient has undergone this procedure an alarming four times. Each time, the fibroids have returned along with their symptoms. Her physician wrote a note in the record detailing concerns about failure of a fifth hysteroscopy given the recurrence of her fibroids, and the limited amount of uterine tissue covering the fibroid. Based on the imaging and the patient's history, the patient's own physician predicts the "traditional" treatment will fail. Therefore, Sonata transcervical radiofrequency ablation of the fibroid would be an appropriate alternative for this patient. 

A review of the literature finds feasibility and safety studies from the U.S. and abroad, but also several clinical trials that demonstrate safety and efficacy. A precursor to this technology was reported on in 2008 by Cho et al. where a trans-vaginal route was utilized with only a 4.3% reoperation rate. Reoperation rate is often a good measure of a minimally invasive technology, used in the literature and patient counseling where the question is asked "what are your chances of undergoing this procedure, and then being dissatisfied such that you return to have a hysterectomy?". Most telling, a manufacturer-sponsored trial has published a 3-year prospective study of 104 patients, showing that there was a reoperation rate of only 11%. Quality of life improvement was also seen. Retrospective data for the Sonata procedure show a 96% satisfaction rate, and also establish safety. The Food and Drug Administration (FDA) demonstrates only three adverse events, all second-degree skin burns from the same clinic, suspected to be from careless use of the electrodes. There are several after-market studies ongoing, as is customary for new medical technology. A recent metanalysis (reference 20) shows the breadth of effectiveness data that is available at this time for radiofrequency ablation of fibroids. The reviewed data is relatively new but is more than sufficient to show a benefit to the patient without significant safety concerns. The reoperation rate of 4-19% should be looked at in comparison to the more established procedure of endometrial ablation (another minimally invasive technology that is used to treat specifically menstrual bleeding, not fibroids). The older versions of that technology (used primarily prior to 2010) carried putative reoperation rates of 25% or higher. Those numbers were considered entirely acceptable, and those procedures became mainstream with improvements seen only in the third generation of devices. Of note, again in comparison to data used for endometrial ablation, a 10-year follow-up on endometrial ablation patients confirmed what most practicing gynecologists have seen anecdotally, where 73% of those who would undergo reoperation presented for reintervention in the first 2 years after the original procedure. This finding suggests that the early data is suggestive of who will do well in the long-term from minimally invasive procedures. There is appropriate data in place to support routine use of this procedure for appropriate candidates.