Foundation Health Systems, Inc.
“Position Statement: Uterine Artery Embolization for Treatment of Fibroids”
Dated 10/08/98

I. Objective

This document establishes guidelines for the consistent determination and application of benefit coverage decisions that are supported by scientific evidence and determinations from regulatory bodies. The Position Statement is a means by which new and emerging technologies are presented and documented in accordance with the National Technology Assessment Policy and Committee decisions.

II. Introduction

Transcatheter arterial embolization is an established and effective pelvic angiographic technique used to control acute and chronic pelvic bleeding for a variety of diagnoses outside the field of obstetrics and gynecology. Uterine leiomyomata represent the most common pelvic tumors in women age 35 years and older. Treatment options for leimomata include hormonal therapy (e.g. progestagens and gonadotropin-releasing hormone (GnRH) analogues), “watchful-waiting” until after menopause when fibroids often regress, myomectomy, and hysterectomy. Hysterectomy is the primary treatment for symptomatic fibroid tumors unresponsive to other forms of treatment and accounts for one-third of all hysterectomies performed in the United States.

Uterine artery embolization for the treatment of uterine fibroids is a new application of the established transcatheter arterial embolization procedure. Researchers postulate that blood deprivation to the fibroid will result in shrinkage, decrease symptomatology (e.g., gleeding, and possibly pain), and may also allow woment to retain childbearing potential. Studies to date are limited by small sample size and lack of long-term follow-up. In addition there is no definitive agreed upon angiographic technique for this procedure, and a standardized particle size for polyvinyl alcohol (PVA) embolization of uterine fibroids has not been established.

Short-term safety appears to be established and is consistent with the safety of other embolization procedures. Due to the lack of published data, it is not possible to determine if uterine artery embolization provides durable therapeutic benefit. Long-term follow up studies are being conducted to compare embolization of uter fibroids to alternative therapies (e.g., myomectomy and menopause onset). Thus far, there is no evidence that embolization will obviate the need for a subsequent hysterectomy.

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III. Position Statement

A. Uterine artery embolization for the treatment of uterine fibroids remains investigational/experimental

1. Clinical trials have not established long-term efficacy of uterine artery embolization for the treatment of uterine fibroids

2. Clinical trials have not produced evidence that uterine artery embolization for the treatment of uterine fibroids obviates subsequent need for hysterectomy or myomectomy

3. Clinical trials are small, uncontrolled pilot studies, and focus on feasibility and safety of the procedure rather than the efficacy and appropriate indications for the procedure

4. Clinical trials have not established the effect of this procedure on retaining fertility

5. Clinical trials have established the short-term safety and efficacy for the one to two year ranges without recurrence of symptoms. However, this timrframe does not appear to be sufficient length of therapeutic benefit to consider this technology equivalent to alternative therapies.

B. The investigational/experimental exclusion applies to services that remain in the research setting and for which efficacy has not been proven and as such uterine artery embolization for the treatment of uterine fibroids is excluded from coverage.

IV. Codes

36247 Selective catheter placement, arterial system; initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family
37204 Transcatheter occlusion or embolization, percutaneous, any method, non-central nervous system, non-head or neck
75625 Aortography, abdominal, by serialography, radiological supervision and interpretation
75736 Angiography, pelvic, selective or supraselective, radiological supervision and interpretation

ICD-9-CM 218. Uterine fibroids

V. Attachments

Attachment A: Associated Policies (pg. 4)

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VI. References

The following were used in the development of this position statement:

Aziz, Adel, et al. “Transarterial Embolization of the Uterine Arteries: Patient Reactions and Effects on Uterine Vasculature.” Acta Obstetricia et Gynecologica Scandinavica. 1998; 77(3):334-340.

Bradley, E.A., et al. “Transcatheter Uterine Artery Embolization to Treat Large Uterine Fibroids.” British Journal of Obstetrics and Gynaecology. February 1998; 105(2): 235-240.

Goodwin, S.C., et al. “Uterine Artery Embolization for the Treatment of Uterine Fibroids.” Current Opinion Obstetrics and Gynecology, August 1998; 10(4):315-320.

Goodwin, S.C., et al. “Preliminary Experience with Uterine Artery Embolization for Uterine Fibroids.” Journal of Vascular and Interventional Radiology. July-August 1997; 8(4):517-526.

HAYES Directory. “Uterine Artery Embolization for Treatment of Fibroids.” March 16, 1998 UTER0102.03.

Vedantham, S., et al. “Uterine Artery Embolization: An Underused Method of Controlling Pelvic Hemorrhage.” American Journal of Obstetrics and Gynecology. April 1997; 176(4):938-948.

VII. Review and Revision History

This document was reviewed by the National Technology Assessment Committee and approved for adoption as a corporate wide standard. Any existing policies, guidelines, and/or position statements implemented in one or more of the FHS Regional Offices were compiled to create a composite document. The following delineates both the Regional history prior to corporate wide adoption, when applicable, and the review and revision history as an FHS Position Statement.

Originally adopted: Foundation Health Systems - 10/98
Reviewed/No revision: Foundation Health Systems
Reviewed/Revised: Foundation Health Systems

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VIII. Approval Signatures

The FHS Executive Vice President of Medical Affairs and Chief Medical Officer and the FHS Director of Medical Policy have reviewed this position statement and attest that it has been approved by the National Technology Assessment Committee as applicable to all FHS regional affiliates.

__________(no signature___________________ ______(no date)_____
Dale Berkbigler, MD Date
FHS Executive Vice President of Medical Affairs
and Chief Medical Officer

__________(no signature___________________ ______(no date)_____
Jacqueline Sandvik, RN Date
FHS DIrector of Medical Policy

Attachment A (Associated Policies)

Administrative Policies:
Technology Assessment

Medical Policies: