Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Uterine myomas
Treatment: Laparoscopic Ablation of Uterine Fibroids
The insurer denied the Laparoscopic Ablation of Uterine Fibroids
The denial is overturned.

The patient is a female with menorrhagia, pelvic pressure.  She has an enlarged multifibroid uterus with 10+ [plus] fibroids.  The largest fibroid is 7 cm (centimeters). She desires preservation of her uterus. The plan is for the Acessa procedure.

The health plan denied coverage as experimental/investigational.  This is being appealed.

Yes, the health plan should cover the Laparoscopic Ablation of Uterine Fibroids.
Galen et al performed a retrospective, multicenter clinical analysis of 206 consecutive cases of ultrasound-guided laparoscopic RFVTA (radiofrequency volumetric thermal ablation) of symptomatic myomas conducted on an outpatient basis under two phase II studies at 2 sites and one phase III study at 11 sites. Descriptive and exploratory, general trend, and matched-pair analyses were applied. Results: From baseline to 12 months in the phase II study, the mean transformed symptom severity scores improved from 53.9 to 8.8, health-related quality-of-life scores improved from 48.5 to 92.0, and mean uterine volume decreased from 204.4 cubic centimeters to 151.4 cubic centimeters. Patients missed a median of 4 days of work (range, 210 days). The rate of possible device-related adverse events was 1.4% (1 of 69). In the phase III study, approximately 98% (percent) of patients were assessed at 12 months, and their transformed symptom severity scores, health-related quality-of-life scores, mean decrease in uterine volume, and mean menstrual bleeding reduction were also significant. Patients in phase III missed a median of 5 days of work (range, 129 days). The rate of periprocedural device-related adverse events was 3.5% (5 of 137). Despite the enrollment requirement for patients in both phases to have completed childbearing, 4 pregnancies occurred within the first year after treatment.

According to the American College of Obstetrics and Gynecology, 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 of 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. Although RFA (radiofrequency ablation) is a reasonable option to consider for the treatment of symptomatic uterine leiomyomas, access to this technology is currently limited.

Although laparoscopic RFA (radiofrequency ablation) with a leiomyoma-specific FDA (United States Food and Drug Administration)-approved device has been studied primarily in nonrandomized trials, two recent meta-analyses summarize long-term data on the use of RFA (radiofrequency ablation) 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 (radiofrequency ablation), 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.

In summary the literature supports that the Accessa procedure is not experimental/investigational. It is approved by the FDA (United States Food and Drug Administration) and studies have been completed outside of phase 3 trials demonstrating favorable safety and outcome improvements. It is therefore not experimental/investigational or unproven.

Accessa is a medically appropriate procedure. It is a standard of clinical practice supported as an option for management of symptomatic fibroids by the American College of Obstetrics and Gynecology. It is an appropriate treatment option for symptomatic uterine fibroids in women who desire preservation of their uterus. It is not for convenience and it is not more intensive than alternative options such as a laparoscopic myomectomy. Safety and outcome data has been reported for greater than 3 years with equivalence in outcomes when compared to other interventions that are minimally invasive, especially laparoscopic myomectomy.

Yes, the Laparoscopic Ablation of Uterine Fibroids is more beneficial.
Acessa is a minimally invasive technique that provides improved benefits due to less blood loss and pain than myomectomy.