Characterization of therapy and costs for patients with ...

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watchful waiting are similar to costs in patients receiv- ing UF-related drugs. Consideration should be given to using non-surgical therapies for the treatment of ...
Arch Gynecol Obstet DOI 10.1007/s00404-007-0332-6

O RI G I NAL ART I C LE

Characterization of therapy and costs for patients with uterine Wbroids in Utah Medicaid Gary Oderda · Carl Asche · Kirtly Parker Jones · Ray M. Merrill · James Spalding

Received: 25 July 2006 / Accepted: 22 January 2007 © Springer-Verlag 2007

Abstract Objectives To determine in an eligible Utah Medicaid population (1) medical and drug costs associated with treating uterine Wbroids (UFs) and (2) the cost and incidence of hysterectomy complications. Methods Medical and drug cost analyses were based on data from 897 premenopausal patients with UFs included in the Utah Medicaid database from 1996 to 2004. UF-related medical and pharmacy costs were determined from Wrst diagnosis of UFs until a related procedure or until estimated menopause. Outcomes for patients treated with a procedure (hysterectomy,

G. Oderda (&) · C. Asche Department of Pharmacotherapy, Pharmacotherapy Outcomes Research Center, University of Utah College of Pharmacy, 421 Wakara Way, Suite 208, Salt Lake City, UT 84108, USA e-mail: [email protected] C. Asche e-mail: [email protected] K. P. Jones Department of Obstetrics and Gynecology, School of Medicine, 30 N 1900 E Rm 2B200, Salt Lake City, UT 84112, USA e-mail: [email protected] R. M. Merrill Department of Health Science, Brigham Young University, 229-A Richards Building, Provo, UT 84602, USA e-mail: [email protected] J. Spalding Health Economics and Outcomes Research, Medical AVairs, TAP Pharmaceutical Products Inc., 675 N. Field Drive, Lake Forest, IL 60045, USA e-mail: [email protected]

myomectomy, or embolization), medication, and watchful waiting (no procedure, no UF-related drug) were compared. When determining hysterectomy complication rates for the population of women in the Medicaid database, a total of 1,323 pre- or postmenopausal patients with UFs were included. Results Overall, 20% of patients were treated with medication, 33% with a procedure, and 47% with watchful waiting. Mean total UF costs were: $11,996 (procedure), $2,703 (medication), and $2,118 (watchful waiting). Mean eligibility months were 8.8, 28.8, and 14.1, respectively. Costs/eligible month were: $1,358 (procedure), $151 (watchful waiting), and $94 (medication). The mean hysterectomy cost was $12,107. Conclusion Treatment for UFs is expensive with a mean cost of $5,504 per study patient. The highest costs are seen in patients receiving procedures, which can lead to complications; 15% in this study. Costs for watchful waiting are similar to costs in patients receiving UF-related drugs. Consideration should be given to using non-surgical therapies for the treatment of UFs before procedures are performed. Keywords Fibroids · Uterine Wbroid costs · Myomas · Leiomyoma · Hysterectomy

Introduction Uterine Wbroids (UFs), also known as leiomyomata uteri or myomas, are benign tumors that potentially can grow to over 20 cm in size on or within the smooth muscle tissue of the uterus. They are the most commonly found tumors in women of reproductive age and are a frequent reason for gynecology visits and

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hysterectomies in the United States [5, 6, 12, 17]. Fewer than 25% of women with UF manifest symptoms [12]. When symptoms do arise, the most common are heavy vaginal bleeding, pain in the abdomen or lower back, masses palpated in the lower abdomen, feelings of heaviness and pressure, frequent urination or urge to urinate, and potential infertility or spontaneous abortion [5, 6, 17]. The presentation of such symptoms can decrease a women’s health-related quality of life [5, 6]. Only one of four women with UF experiences symptoms severe enough to require treatment [16]. Appropriate treatment depends on the size and location of the Wbroids, the severity of symptoms, risks and beneWts of each intervention, and the patients’ reproductive desires [3, 19]. Because Wbroids are rarely dangerous to a woman’s health, watchful waiting (checking the Wbroid at annual gynecologic examinations and monitoring for symptoms) is sometimes a reasonable option, especially in those nearing menopause [2]. Drug therapy is usually a Wrst course of action and may include non-steroidal anti-inXammatory drugs (NSAIDs), oral contraceptives containing an estrogen/ progestin combination, and other hormone therapy [e.g., gonadotropin-releasing hormone (GnRH) agonists or levonorgestrel-releasing intrauterine systems] [10]. Surgical procedures, myomectomy (surgical removal of the Wbroids) or hysterectomy (surgical removal of the uterus), remain the most common ultimate treatment strategies [17]. In 2001, 38.8% of the 606,791 cases of UF in the United States were treated with hysterectomy [10]. Uterine artery embolization is an additional option. Fee-for-service Medicaid oVers the advantage of access to integrated data including outpatient visits, hospitalizations and drugs while allowing the researcher the opportunity to examine UF treatment, and costs for low-income women. We identiWed no literature concerning the cost of managing UF, or the current costs for hysterectomy and managing complications post-hysterectomy among Medicaid recipients. Such information would serve to enhance the understanding of the costs of managing this condition. Objectives The objectives of this study were to determine: (1) the cost and incidence of complications of hysterectomy post surgery in pre- or postmenopausal patients with UF and (2) the medical and drug costs associated with treating UF from the time of diagnosis until either menopause or surgical procedure for patients enrolled in Utah Medicaid.

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Methods This was an observational study examining usual care within a Medicaid population. Description of Utah Medicaid data Medical claims were evaluated from the Utah Medicaid database from June 1, 1996 through November 6, 2004. Medicaid patients qualify for services for a minimum of a 1-month period, and are continued if they continue to meet eligibility criteria. Because of that, the number of recipients changes each month. In 1996 Utah Medicaid provided medical beneWts to 199,048 residents for at least 1 month. This increased to 337,123 in 2004, with 237,792 at the midpoint of the study in 2000. Services covered by Medicaid include prescription drugs, hospital care, laboratory monitoring, radiographs, nursing facility, and physician services. Services are provided under both managed-care (urban populations) and fee-for-service programs (rural populations) [15]. Medicaid patients have more medical problems than individuals with similar incomes and private insurance [11]. This study was determined to be exempt by the IRBs at the University of Utah and the Utah Department of Health. Data were obtained from the Medicaid Data Warehouse from multiple Wles that included eligibility information and information on medical and pharmacy claims. An analysis data set was constructed that was linked by a unique patient identiWer that could not be linked to information that would reveal patient identity. Determination of study groups Patients with UF were identiWed from the Utah Medicaid database by using the International ClassiWcation of Disease, Ninth Revision, Clinical ModiWcation (ICD-9-CM) procedure codes 218.x (any four-digit code starting with 218) for UF and 654.1 (the threedigit code or any four-digit code starting with 654.1) for tumors of the body of the uterus (normal delivery). These patients served as a source for the two subpopulations that were used to address the study objectives. All patients with UF were used for the Wrst objective; that is to determine cost and incidence of hysterectomy complications. The second objective was to determine medical and drug costs associated with treatment of UF from the time of diagnosis to until either menopause or a procedure. The population used for this objective consisted of all women with a UF diagnosis who were premenopausal and who had not had a prior

Arch Gynecol Obstet

procedure, such as a myomectomy. These two populations were not mutually exclusive. The distribution of these patient groups is shown in Fig. 1. Age was used as a proxy for menopause since reliable coding of menopause was not available in the data set. The mean age of menopause onset in the United States is 51 years, with most women experiencing menopause between the ages of 48 and 55 years [8]. A Dutch study found the mean age of menopause to be 51.16 years with a standard deviation of 4.15 years. Accordingly, initial analyses considered three diVerent ages (48, 52, and 56 years) for the onset of menopause. An age of 52 years was selected as the reference case. Sensitivity analysis using a low of 48 years and high of 56 years showed that varying the age for onset of menopause did not signiWcantly inXuence the results; therefore age 52 years was used as a proxy for menopause [20].

Women with UF were divided into three baseline groups: procedure, medication, and watchful waiting (Fig. 2). The procedure group included any patient with a diagnosis of UF and a claim for a hysterectomy, myomectomy, embolization, or Wbroid removal. Hysterectomy was deWned as ICD-9-CM procedure codes 68.3– 68.8. Current procedure terminology (CPT) codes, which involve physician billing, used for assessing costs, were also used. UF-associated procedures are listed as follows: myomectomy (58140, 58145, 58146, 58545, 58546), hysterectomy (58150, 58152, 58180, 58260, 58262, 58263, 58267, 58270, 58561), and embolization (37204, 75894, 75898). Diagnosis related groups (DRGs) 358 (Uterine & Adnexa for non-malignancy without complications) and 359 (Uterine & Adnexa for non-malignancy with complications) were also used to

Uterine Fibroid Patients 1996-2004 N=1,323

Hysterectomy Cost and Complications Subset N=448#

Hysterectomy Patients with DRG Information Available to Determine Hysterectomy Cost N=374

Pre-Menopausal Patients Subset to Determine Costs from Diagnosis to Menopause N=897 Medication Only N=177

Procedure N=297

Directly Related to UF N=20

Myomectomy ** N=9

Directly and Likely Related to UF N=157

Hysterectomy N=289

Watchful Waiting N=423*

Embolization *** N=2

Note: * This includes 227 patients who received drugs likely related to UF (analgesics) ** One person had a hysterectomy and myomectomy *** Two people had embolization and hysterectomy # Patients in this subset may also be in the Pre-Menopausal Patient subset

Fig. 1 Description of the study population. Single asterisk: This includes 227 patients who received drugs likely related to UF (analgesics). Double asterisk: One person had a hysterectomy and Fig. 2 Proportion of patients in each treatment category (watchful waiting, medication—directly applicable UF drugs—and procedure; developed from entire population of 1,323 patients with a diagnosis of UF)

myomectomy. Triple asterisk: Two people had embolization and hysterectomy. Hash: Patients in this subset may also be in the premenopausal patient subset Patients by Group

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