0304 Fibroid Treatment - Aetna

Fibroid Treatment - Medical Clinical Policy Bulletins | Aetna

Page 1 of 49

()

Fibroid Treatment

Number: 0304

Policy

*Please see amendment for Pennsylvania Medicaid at the end of this CPB.

I. Aetna considers radiofrequency ablation (open or laparoscopic (e.g., the Acessa System)) or transcatheter uterine artery embolization (UAE) medically necessary as an alternative to hysterectomy or myomectomy for the treatment of uterine fibroids when the member has persistence of one or more symptoms directly attributed to uterine fibroids (i.e., excessive menstrual bleeding (menorrhagia), bulk-related pelvic pain, pressure or discomfort, urinary symptoms referable to compression of the ureter or bladder, and/or dyspareunia).

Aetna considers other uses of transcatheter UAE experimental and investigational because its effectiveness for indications other than the one listed above has not been established.

II. Aetna considers myomectomy or hysterectomy using power morcellation experimental and investigational for the removal of uterine fibroids because its safety and effectiveness has not been established. An exception to this policy, fibroid removal with power morcellation is considered medically necessary for the following indications in women without known or strongly suspected uterine cancer:

Proprietary

A. premenopausal women who wish to maintain fertility and who have no risk factors for uterine sarcoma (e.g., history of 2 or more years of tamoxifen therapy, history of pelvic irradiation, history of childhood retinoblastoma, Lynch syndrome, or personal history of hereditary leiomyomatosis and renal cell carcinoma syndrome);

Print Share

Policy History

Last Review 08/14/2020 Effective: 10/13/1998 Next Review: 03/25/2021

Review History Definitions

Additional Information

Clinical Policy Bulletin Notes

Fibroid Treatment - Medical Clinical Policy Bulletins | Aetna

B. premenopausal women who have clinical indications for hysterectomy and who have no risk factors for uterine sarcoma, where a vaginal hysterectomy is technically difficult due to the large size of the uterus; or

C. women with co-morbidities (e.g., cardiovascular, renal, hepatic, pulmonary, endocrine, or morbid obesity) where surgical alternatives to fibroid removal with power morcellation (hysterectomy without power morcellation, radiofrequency ablation, uterine artery embolization) pose an unacceptable risk.

In all cases, the member must be informed of alternative procedures for fibroids and the risks of power morcellation in spreading unsuspected cancerous tissue beyond the uterus.

III. Aetna considers the following treatments for uterine fibroids experimental and investigational because their safety and effectiveness have not been established:

Acupuncture Cryomyolysis Cryotherapy, interstitial thermotherapy, lasers, electrical, and

ultrasound (focused ultrasound) ablation, with or without magnetic resonance imaging (MRI) guidance. Laparoscopic uterine artery occlusion Transcervical radiofrequency ablation with ultrasound guidance (e.g., the Sonata System).

Background

Uterine fibroids (i.e., leiomyomas or myomas) are noncancerous growths that develop from the smooth muscular tissue of the uterus (also known as myometrium) usually during childbearing years. The size and growth pattern of uterine fibroids varies and may be found as subserosal, intramural, submucosal or pedunculated masses. They may also be located in the cervix or broad ligament. Although the cause is unknown, hormones seem to be a related factor.

Uterine fibroids represent the most common gynecological tumor in women of reproductive age and are responsible for over 200,000 hysterectomies per year. Most fibroids, even large ones, do not produce symptoms. However, they can cause a variety of symptoms including menometrorrhagia, dysmenorrhea, pelvic pain, reproductive failure, and compression of adjacent pelvic viscera, or be totally asymptomatic. A large array of treatment options exist for this disorder. Surgical treatments

Proprietary

Page 2 of 49

Fibroid Treatment - Medical Clinical Policy Bulletins | Aetna

include hysterectomy, abdominal myomectomy, laparoscopic myomectomy, myolysis, and more recently magnetic resonance imaging (MRI)-guided ultrasound ablation. Non-surgical treatments include medical therapy (e.g., gonadotropin-releasing hormone agonist) and uterine artery embolization (UAE).

Uterine Artery Embolization

For the last 20 years, therapeutic embolization has been successfully performed on various parts of the body. In more recent years, this technology has been applied to uterine fibroids in an effort to eliminate the nagging symptoms associated with uterine fibroids and offer women an alternative to hysterectomy and myomectomy. This outpatient procedure, which may require an over-night admission for pain control, uses angiographic techniques and fluoroscopic guidance to embolize the uterine arteries, similar to the methods used to control post-operative and postpartum hemorrhage. The embolization, consisting of tiny particles of polyvinyl alcohol (500 to 700 micron size), occludes the blood supply to the fibroids, which results in their ischemic infarction and subsequent degeneration over a period of weeks and months. Average fibroid volume reduction is approximately 50 % in 3 months and 65 % at 1 year. Uterine volume decreases by approximately 40 % in 3 months. The reduction in the fibroid's size leads to a decrease or resolution in the symptoms they cause. The procedure takes approximately 1 to 2 hours and it is anticipated that most women can return to work 7 days after the procedure.

The initial studies that have been published to date suggest that both menorrhagia and symptoms caused by the bulk of these fibroids will be significantly improved or will resolve in 80 to 90 % of patients on short-term follow-up. The patients in these series have tolerated the procedure well and patient satisfaction is high, but they all require careful post-procedural pain management. While severe ischemic injury to the uterus has been feared, the literature suggests that this occurs in only 1 to 2 % of patients. Unlike myomectomy, all fibroids can be treated simultaneously, regardless of their location or size in the uterus. Unlike Lupron, the literature indicates that premature menopause is rarely induced. It has been shown that if the procedure is not successful and surgery is needed, this surgery is rendered easier, with a likelihood of less bleeding.

However, long-term follow-up on a larger number of cases will be required before any definitive statement can be made about the ultimate role of embolization in the treatment of uterine fibroids as compared to the other available therapies. The long-term outcome is not known, in that recanalization of the arteries could occur or collateral vessels could be recruited which might allow re-growth of the fibroids. Post-procedure

Proprietary

Page 3 of 49

Fibroid Treatment - Medical Clinical Policy Bulletins | Aetna

fertility and the ability to carry a pregnancy to term are not presently known since most patients in published series have not sought to become pregnant. The effect on ovarian function has been a question, given the sporadic reports of amenorrhea after treatment. It is not known whether ovarian infarction occasionally occurs to affect function or whether merely decreasing uterine flow is sufficient to affect ovarian function. Further, it is not clear whether ovarian function is affected in only a few patients or whether it is more common and just not apparent clinically.

In a review on percutaneous UAE for the treatment of symptomatic fibroids, Lupattelli et al (2005) stated that although randomized trials are still underway, UAE appears a good option for those patients who whish to conserve their fertility or when surgery is contra-indicated. However, to assess the long-term effects of UAE longer follow-up is needed. This is in agreement with the observation of Bachmann (2006) who noted that treatment options for women with symptomatic uterine leiomyomas have been expanded to include radiological interventions with UAE and focused ultrasound surgery despite the lack of long-term efficacy data.

Despite the unknowns, it is clear that the initial experience with UAE suggests that this procedure is effective and safe in the short term and represents a promising new therapy for this very common medical condition.

A report by the American College of Obstetricians and Gynecologists (2004) stated that "UAE for the treatment of symptomatic fibroids, when performed by experienced physicians, appears to provide good short-term relief among appropriate candidates." ACOG strongly recommends that women who wish to undergo UAE have a thorough evaluation with an obstetrician/gynecologist to help facilitate optimal collaboration with interventional radiologists and ensure that the procedure is appropriate. There is insufficient data at this time to ensure that UAE is safe for women who may wish to become pregnant in the future, the report notes. Moreover, few studies have assessed the effect of embolization on pregnancy-related outcomes. For these reasons, ACOG considers the procedure investigational or relatively contraindicated in such women. Also, the report warns that UAE is rarely, if ever, indicated in postmenopausal women.

Uterine artery embolization is contraindicated in women with any of the following conditions:

Post-menopausal women with fibroid growth or rapid growth at any time (may indicate development of sarcoma); or

Proprietary

Page 4 of 49

Fibroid Treatment - Medical Clinical Policy Bulletins | Aetna

Women who have evidence of current genito-urinary infection and/or malignancy; or

Women who may wish to become pregnant in the future; or Women with a history of prior pelvic X-ray treatments, pelvic

malignancy, chronic infections or severe endometriosis.

A report on the management of uterine fibroids prepared for the Agency for Healthcare Research and Quality (Viswanathan et al, 2007) stated that women who undergo UAE have shorter recoveries and spend less time in the hospital than women who have hysterectomies.

MRI-Guided Focused Ultrasound

High intensity focused ultrasound with the imaging guidance of magnetic resonance imaging (MRI) known as magnetic resonance guided focused ultrasound sonication (MRgFUS) is now available. Currently, there is very little information regarding the effectiveness of MRI-guided ultrasound ablation for the treatment of uterine leiomyomata. In a review on the surgical and non-surgical management of uterine leiomyomata, Myers et al (2002) concluded that available evidence on the management of uterine leiomyomata is of poor quality. This is in agreement with the observation of Olive (2000) who stated that existing studies are generally small and of poor quality. There is a strong need for appropriately designed and analyzed randomized clinical trials, and surgical trials should preferably be multi-center/multi-surgeon.

Studies by Tempany et al (2003) as well as Stewart et al (2003) suggested that MRI-guided focused ultrasound surgery appeared to be safe and effective for the treatment of uterine leiomyomas. However, both studies were authored by the same group of investigators and addressed only the safety and feasibility of this approach in treating uterine fibroids. These studies had small number of patients -- 9 in the study by Tempany et al (2003), and 55 in the study by Stewart et al (2003). They only demonstrated the safety and feasibility of MRI-guided focused ultrasound ablation for the treatment of uterine fibroids; however, its clinical value has not been established.

The first FDA-approved MRI-guided focused ultrasound system for the treatment of women with symptomatic uterine fibroids is the ExAblate 2000 System (InSightec, Ltd.). The U.S. pivotal trial included 192 women who had symptomatic uterine fibroids and were randomized to a hysterectomy (n = 83) or the ExAblate procedure (n = 109). At 6 months, 70.6 % of the ExAblate patients experienced a greater than 10-point reduction in the Uterine Fibroid Symptoms and Quality of Life Questionnaire score. The mean reduction in fibroid volume at 6 months was 13.5 %, but non-

Proprietary

Page 5 of 49

Fibroid Treatment - Medical Clinical Policy Bulletins | Aetna

enhancing volume remained within the treated fibroid at 6 months. The hysterectomy patients performed better at 6 months than the ExAblate patients on several quality-of-life measurements, including role physical, body pain, general health, vitality, and mental health. The hysterectomy patients had a much higher rate of having at least 1 significant complication than the ExAblate patients (46 % versus 12 %). The ExAblate patients missed less work than the hysterectomy patients (1.2 versus 19.2 working days) during the first 30 days post-surgery (FDA Summary of Safety and Effectiveness Results).

The FDA required InSightec to conduct a 3-year post-market study to better assess the long-term safety and effectiveness of the ExAblate 2000 System. The study includes additional numbers of African-American women, because, as a group, these women have a greater incidence of uterine fibroids but were under-represented in the original study.

Further studies are needed to elucidate the exact role of MRI-guided focused ultrasound ablation in the management of uterine fibroids, especially studies that examine the correlation of treatment effect with changes in symptoms as well as comparisons of this new technology with other treatment methods such as UAE.

An assessment by the Canadian Coordinating Office of Health Technology Assessment on MRI-guided focused ultrasound for the treatment of uterine fibroids (Chen, 2005) concluded that "[l]ong-term studies of larger patient groups are needed to provide further reliable evidence on the safety of this procedure, as well as its clinical and cost-effectiveness".

An assessment by the BlueCross BlueShield Association Technology Evaluation Center (BCBSA, 2005) concluded that MRI-guided focused ultrasound for uterine fibroids did not meet the TEC criteria: "The evidence is insufficient to determine whether the use of MR-guided, focused ultrasound improves net health outcome or whether it is as beneficial as any established alternatives." The TEC assessment stated that limitations in quality of the existing evidence include significant loss to follow-up at longer follow-up intervals, lack of adequate well-controlled comparison studies, and lack of comparability between treatment groups in the available nonrandomized comparisons. The TEC assessment considered both published evidence on MRI-guided focused ultrasound and unpublished evidence from the InSightec study that was submitted to the FDA to support a PMA. The TEC assessment noted that the few available comparisons suggest that MRI-guided focused ultrasound may not be as effective as available alternatives. The TEC assessment reported that patient satisfaction from the procedure is higher with hysterectomy, as is the degree of symptom relief. The TEC assessment found no direct

Proprietary

Page 6 of 49

Fibroid Treatment - Medical Clinical Policy Bulletins | Aetna

comparisons of MRI-guided ultrasound to either UAE or myomectomy available in the literature, but that this did not preclude TEC to reach some general and preliminary comparisons. The TEC assessment noted that durability of MRI-guided ultrasound is a major concern; a substantially greater proportion of women undergo other (or repeat) procedures after MRI-guided ultrasound compared to either UAE or myomectomy. The TEC assessment also found that available data suggest that fibroid volume reduction with MRI-guided ultrasound is much lower than with comparison procedures. Uterine artery embolization appears to produce a more profound improvement in symptom severity scores than MRI-guided ultrasound. For fertility preservation, myomectomy is the treatment of choice (TEC, 2005). The TEC assessment stated that neither UAE nor MRI-guided ultrasound is recommended if the woman desires to preserve fertility. The TEC assessment concluded that further study of the procedure and its durability, especially in light of other available treatments, is needed.

The National Institute for Health and Clinical Excellence (NICE, 2007) released interventional procedures guidance that concluded that "[c]urrent evidence on the safety and efficacy of magnetic resonance image (MRI) -guided focused ultrasound for uterine fibroids does not appear adequate" and that "further research on the procedure and publication of long-term outcomes would be useful." NICE reviewed the evidence on the safety and efficacy of the procedure, which comes from three uncontrolled case series. Most of the papers excluded from the analysis were earlier reports on some of the same women. The NICE assessment noted that a majority of published data have been reported by one study group. The NICE advisors observed that the primary endpoint in these case series was change in symptom severity rather than fibroid shrinkage, and that there is limited reduction in fibroid volume following the procedure (NICE, 2007). The assessment stated that there is no evidence on the effects of this procedure on fertility.

A related NICE interventional procedure consultation document (NICE, 2006) stated that the maximum follow-up reported across all the studies was 19.5 months, and that most of the studies report on outcomes at 6 months. A significant proportion of women included in these studies were lost to follow-up. In addition, a significant proportion of women sought alternative treatments following the procedure, such as hysterectomy. The NICE assessment listed skin burns as a potential complication from the procedure, occurring in 5 % of subjects in 1 case series (NICE, 2007). Another potential complication was reversible neural damage; 2 studies reported on cases of pain in the distribution of the sciatic nerve which

Proprietary

Page 7 of 49

Fibroid Treatment - Medical Clinical Policy Bulletins | Aetna

resolved in both cases within 1 year of the procedure. The NICE advisors also commented that thermal damage to adjoining structures was a theoretical concern.

The Agency for Healthcare Research and Quality's report on management of uterine fibroids (Viswanathan et al, 2007) concluded that research is lacking for the long-term symptom relief of MRI-guided-ultrasound ablation.

An assessment of the evidence on treatment of uterine fibroids by BMJ Clinical Evidence concluded that the effectiveness of MRI-guided focused ultrasound is unknown (Lethaby and Vollenhoven, 2006).

The American College of Radiology's clinical guideline on "Radiologic management of uterine leiomyomas" (Burke et al, 2012) rendered MRIguided high-frequency focused ultrasound ablation a "2" rating for a woman with multiple uterine fibroids resulting in a 20-week-sized uterus on physical examination and menorrhagia; a "3" rating for a woman with multiple submucosal and intramural fibroids presenting with menorrhagia and pelvic pain; a "4' rating for a woman with menometrorrhagia who presents with 3 dominant leiomyomas, ranging in size from 6 to 8 cm and intramural in location; a "3" rating for a woman with menorrhagia with a single 3 cm intramural fibroid and diffuse adenomyosis; a "3" rating for a woman with pelvic discomfort and 8 cm pedunculated subserosal fibroid; and a "3" rating for a woman with constipation and a 12 cm subserosal leiomyoma compressing the rectum (Rating scale: 1,2,3 denotes usually not appropriate; 4,5,6 denotes may be appropriate). Furthermore, the guideline stated that "To date, there is little long-term information on the efficacy of this technology".

An UpToDate review on "Overview of treatment of uterine leiomyomas (fibroids)" (Stewart, 2013) states that "Magnetic resonance guided focused ultrasound surgery (MRgFUS) (e.g., ExAblate 2000) is a more recent option for the treatment of uterine leiomyomas in premenopausal women who have completed childbearing. This noninvasive thermoablative technique converges multiple waves of ultrasound energy on a small volume of tissue, which leads to its thermal destruction, and can be performed as an outpatient procedure. The maximum size of a leiomyoma for this procedure is uncertain. It is not typically size alone that limits treatment, but size, vascularity, access and other factors. This system is not indicated for leiomyomas which are resectable with a hysteroscope, heavily calcified, or when intervening bowel of bladder could be damaged by treatment. While desire for future pregnancy was originally a contraindication for this therapy, labeling for the device now allows

Proprietary

Page 8 of 49

 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download