Hum. Reprod. Advance Access originally published online on April 3, 2006
Human Reproduction 2006 21(7):1878-1883; doi:10.1093/humrep/del088
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A cost-utility analysis of hysterectomy, endometrial resection and ablation and medical therapy for menorrhagia
1 Centre for Pharmacoeconomics Research, School of Pharmacy 2 Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Hong Kong, China
3 To whom correspondence should be addressed at: Centre for Pharmacoeconomics Research, School of Pharmacy, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, China. E-mail: joyceyou{at}cuhk.edu.hk
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Abstract |
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BACKGROUND: Four types of treatment [hysterectomy, endometrial resection/ablation, levonorgestrel-releasing intrauterine system (LNG-IUS) and oral medical therapy] are available for management of menorrhagia. The objective of this study was to compare the cost and quality-adjusted life-years (QALYs) gained by these four treatment alternatives. METHODS: A Markov model was designed to simulate the healthcare resource utilization and QALYs of the four treatment alternatives for patients presenting with menorrhagia over 5 years. Clinical inputs were estimated from literature, and the cost analysis was conducted from the perspective of healthcare provider in Hong Kong. RESULTS: The base-case analysis showed that the hysterectomy group was the most effective (4.725 QALYs) alternative with the highest cost (USD6878, 1USD = 7.8HKD). The incremental cost per additional QALY (ICER) gained by hysterectomy was USD23 500. The probability of extra surgery in the endometrial resection/ablation was an influential factor. Probabalistic sensitivity analysis of 10 000 simulations of the Monte Carlo model showed that the hysterectomy group gained higher number of QALYs than the LNG-IUS, oral medical treatment and endometrial resection/ablation groups, 99, 99 and 98% of the time, and it was more costly than the other three groups over 85% of the time. CONCLUSIONS: Hysterectomy appears to be cost effective, with ICER less than USD50 000, for management of menorrhagia.
Key words: cost-utility analysis/endometrial resection and ablation/hysterectomy/medical therapy/menorrhagia
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Introduction |
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Heavy menstrual bleeding or menorrhagia is a common gynaecological problem, affecting women with significant effects on their quality of life. Menorrhagia is the major symptom among the majority of women who undergo hysterectomy (Vuorma et al., 1998
; Stirrat, 1999). The management options of menorrhagia vary from medical to surgical treatment. Hysterectomy has been the effective and traditional surgical treatment, but it is associated with significant morbidity. Endometrial resection/ablation offers a less invasive surgical alternative than hysterectomy for the management of menorrhagia and is associated with lower morbidity (Gannon et al., 1991; Dwyer et al., 1993; Pinion et al., 1994; Crosignani et al., 1997a; O’Connor et al., 1997). Oral medical treatment is more safe, but less effective than surgical interventions (Cooper et al., 1999). The selection of conventional medical treatment included a number of drug regimens such as progestogens, combined oral contraceptive pills, tranexamic acid, danazol and hormonal replacement therapy (Cooper et al., 1997). Levonorgestrel-releasing intrauterine system (LNG-IUS) is a new medical treatment with improved effectiveness for the treatment of menorrhagia (Hurskainen and Paavonen, 2004).
The clinical effectiveness of various medical and surgical interventions has been compared in a number of trials and most of the treatment alternatives showed high treatment success rate (Lethaby et al., 2005; Marjoribanks et al., 2005). With the call for increased attention to patient preference in treatment decision-making, clinicians need to be better informed on not only the clinical outcome and cost of treatment alternative, but the impact of treatment on patients’ quality of life, usually expressed in quality-adjusted life-years (QALYs). We therefore carried out a cost-utility analysis to compare the cost and QALYs of conventional medical therapy, LNG-IUS, endometrial resection/ablation and hysterectomy for management of menorrhagia.
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Materials and methods |
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Model design
A Markov model was designed to simulate, over a time horizon of 5 years with yearly cycle, the healthcare resource utilization and QALYs of four treatment approaches in a hypothetical cohort of patients with menorrhagia: (1) hysterectomy, (2) endometrial resection/ablation, (3) LNG-IUS and (4) oral medical therapy (Figure 1). The patient selection criteria of the Markov model were adopted from the Cochrane reviews on surgery, endometrial resection and ablation, and medical therapy for menorrhagia (Lethaby et al., 2005
; Marjoribanks et al., 2005). Patients included were women of reproductive years (aged 
40 years old) with regular heavy menstrual periods measured objectively or subjectively. Exclusion criteria were post-menopausal bleeding, irregular menses and inter-menstrual bleeding and presence of pathological or iatrogenic causes of heavy menstrual bleeding. The primary outcome to be simulated for each study arm was the total number of QALYs gained. Total direct medical cost for each arm was estimated from the perspective of a public healthcare provider in Hong Kong.
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In the hysterectomy arm, patients might experience surgical complications and various length of hospital stay. The major surgical complications that consumed healthcare resources included in the model were sepsis, need for blood transfusion, vault haematoma, perforation, gastrointestinal obstruction/ileus and laparotomy (Lethaby et al., 2005
). Minor events with no or minimal medical resource consumption, such as use of analgesics, were not included. Two possible clinical outcomes in the hysterectomy group were the following: (1) no need for extra surgery and (2) need for extra surgery because of surgical complications. Both clinical outcomes would result in the resolving of menorrhagia.
In the endometrial resection/ablation arm, similar to the hysterectomy group, patients might also experience major surgical complications and various length of hospital stay (Lethaby et al., 2005). Two possible clinical outcomes were anticipated in every yearly cycle: (1) abatement or subsiding of the menorrhagia symptoms (no need for extra surgery) and (2) salvage hysterectomy for heavy menstrual bleeding because of treatment failure.
In the medical treatment (LNG-IUS and oral medical treatment) arms, menorrhagia might be resolved after initiation of the medical treatment, and two possible clinical outcomes anticipated in every yearly cycle were the following: (1) no need for extra surgery and (2) salvage hysterectomy for heavy menstrual bleeding.
Clinical inputs
The clinical inputs of the model (Table I) were derived from clinical trials included in two meta-analyses on endometrial resection/ablation versus hysterectomy (Lethaby et al., 2005) and surgery versus medical therapy for menorrhagia (Marjoribanks et al., 2005). In these two meta-analyses, inclusion criteria were studies on the first- or second-generation techniques (such as transcervical resection of endometrium, endometrial ablation by electrocautery, laser or balloon therapy) for endometrial resection/ablation and studies on abdominal, vaginal, laparoscopic or laparoscopically assisted vaginal routes for hysterectomy. Medical regimens included were LNG-IUS and oral medical therapy (non-steroid anti-inflammatory agents, tranexamic acid, oral contraceptive pills, progestogens and danazol).
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The yearly rates of additional surgery in the arms of hysterectomy, endometrial resection/ablation (Gannon et al., 1991
; Dwyer et al., 1993; Pinion et al., 1994; Crosignani et al., 1997a; O’Connor et al., 1997), LNG-IUS (Crosignani et al., 1997b; Hurskainen et al., 2001; Istre and Trolle, 2001; Soysal et al., 2002) and oral medical therapy (Cooper et al., 1999) were estimated from 10 clinical trials. The rates of surgical complications in the hysterectomy group and the endometrial resection/ablation group (derived from odds ratios of surgical complications in endometrial resection/ablation versus hysterectomy) were estimated from four clinical trials (Gannon et al., 1991; Dwyer et al., 1993; Pinion et al., 1994; O’Connor et al., 1997) and the meta-analysis on endometrial resection/ablation versus hysterectomy (Lethaby et al., 2005). The rates (r) of clinical events were converted to transition probabilities (p) using the following equation (Sonnenberg and Beck, 1993):
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Utility inputs
The QALYs gained were calculated from the duration of convalescence period post-surgery (for surgical arms) and duration of menorrhagia and resolved menorrhagia, together with their corresponding utility scores. The utility scores of chronic menorrhagia and resolved menorrhagia were estimated from an interview with patients with menorrhagia (Sculpher, 1998). The utility of convalescence post-surgery was assumed to be two-thirds of the utility of resolved menorrhagia, with the lower limit to be the same as the utility of chronic menorrhagia and the upper limit equal to the utility of resolved menorrhagia. In the surgical arms, the convalescence periods of hysterectomy and endometrial resection/ablation were estimated from time to return to work (Gannon et al., 1991; Dwyer et al., 1993; Olsson et al., 1996; Crosignani et al., 1997a; O’Connor et al., 1997). Menorrhagia was considered to be resolved in a yearly cycle if salvage hysterectomy was needed for treatment failure. If additional surgery was needed, it was assumed to occur at the mid-point of the yearly cycle. The convalescence period of the additional surgery would also be included for QALY estimation. The remaining study period after the extra surgery was considered to be symptom free.
Cost inputs
The total direct medical cost per patient was estimated for each treatment approach, including cost of primary treatment option for menorrhagia, cost of surgical complication treatment (for surgical arms) and cost of additional hysterectomy (including the cost of surgical complications) when the primary treatment option failed.
The cost inputs of the model were estimated from the perspective of a public health organization in Hong Kong (Table I). The Hospital Authority is non-profit-making and the largest public health organization in Hong Kong. The services provided by the Hospital Authority are almost completely subsidized by the government. It charges patients who are non-residents of Hong Kong based upon the charges of healthcare services of public hospitals and clinics posted in the Hong Kong Gazette. Assuming the charges listed in the Gazette represent only the cost components (including labour costs) with no addition of profits, the costs associated with each treatment outcome were therefore approximated using the charges as listed in the Hong Kong Gazette. The costs of medical treatment were estimated from the drug acquisition costs per Hospital Authority of the trial regimens in the studies. The cost was discounted with an annual discount rate of 3%.
Incremental cost-effectiveness ratio (ICER) for each treatment arm, comparing individually with the least costly treatment option, was calculated using the following equation:
 | (2) |
A treatment strategy was the dominant strategy if it costs less and was equal or greater in effectiveness compared with other strategies.
Sensitivity analysis
Sensitivity analysis was performed by TreeAge Pro 2005 (TreeAge Software, Williamstown, MA, USA) and Microsoft Excel 2000 (Microsoft Corporation, Redmond, WA, USA) to examine the robustness of the model. Vaginal and laparoscopic hysterectomy are associated with shorter recovery time and less surgical complications. The probabilities of surgical complications, duration of hospitalization and convalescence period for abdominal, vaginal and laparoscopic hysterectomy were therefore examined over a broad range in the sensitivity analysis. All the parameters were examined over the high/low values or 95% confident interval (CI), if available. An univariate sensitivity analysis on all parameters was conducted to screen for potentially influential factors. To evaluate the impact of the uncertainty in all the variables simultaneously, a probabilistic sensitivity analysis was performed using Monte Carlo simulation. The cost and QALYs of each study arm were recalculated 10 000 times by randomly drawing each of the model input from a triangular probability distribution to determine the percentage of times in which each study arm would be the most cost-effective strategy.
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Results |
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TopAbstractIntroductionMaterials and methodsResultsDiscussionAcknowledgements References |
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The results of the cost-utility analysis are shown in Table II. The base-case analysis showed that the hysterectomy group was the most effective (4.725 QALYs) alternative. Compared with the least costly treatment option (LNG-IUS), the incremental cost per additional QALY (ICER) gained by hysterectomy was USD23 500 (1USD = 7.8HKD) (Table III). Both the oral medical treatment and endometrial resection/ablation groups were dominated by LNG-IUS, i.e. they were more costly with lower number of QALYs gained. One-way sensitivity analysis showed that hysterectomy remained the most effective management option with the highest QALYs gained of all the model inputs. The least costly treatment option was sensitive to the variation of the probability of need for additional surgery in the endometrial resection/ablation group (Figures 2 and 3).
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When the probability of need for extra surgery in the endometrial resection/ablation group was lower than 0.055, the cost per patient of the endometrial resection/ablation group would be the lowest while the QALYs gained would become higher than those of the oral medical treatment and the LNG-IUS groups. The endometrial resection/ablation group would therefore dominate these two groups. Compared with the endometrial resection/ablation group, the increment cost per additional QALY gained by the hysterectomy group would be USD53 024 and would further increase to >USD209 000 when the probability of extra surgery in the endometrial resection/ablation group declined from 0.055 to 0.024. The robustness of the model was further examined over a study period from 1 to 5 years and no threshold value was identified.
The probabilistic sensitivity analysis of 10 000 simulations showed that the hysterectomy group was more costly than the LNG-IUS, oral medical treatment and endometrial resection/ablation groups 100, 100 and 85% of the time, with mean cost differences of USD2528 (95% CI 2518–2539), USD1470 (95% CI 1464–1476) and USD1038 (95% CI 1018–1058), respectively. The hysterectomy group gained higher number of QALYs than the LNG-IUS, oral medical treatment and endometrial resection/ablation groups, 99, 99 and 98% of the time, with mean QALY differences of 0.0587 (95% CI 0.0581–0.0593), 0.0877 (95% CI 0.0869–0.0885) and 0.0546 (95% CI 0.0540–0.0552), respectively. When comparing between non-surgical interventions, LNG-IUS was less costly and it gained higher number of QALYs than oral medical treatment, 100 and 99% of the time, with mean difference of USD1058 (95% CI 1050–1066) and 0.0291 QALYs (95% CI 0.0288–0.0294), respectively.
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Discussion |
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TopAbstractIntroductionMaterials and methodsResultsDiscussionAcknowledgements References |
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Four types of treatment (hysterectomy, endometrial resection/ablation, LNG-IUS and oral medical therapy) are available for management of menorrhagia. A few economic analyses in the literature have compared the cost (with or without effectiveness comparison) of two interventions at a time, such as endometrial resection/ablation versus hysterectomy (Cameron et al., 1996
; Ransom et al., 1996; Vilo et al., 1996; Hidlebaugh and Orr, 1998; Fernandez et al., 2003; Garside et al., 2004) and LNG-IUS versus hysterectomy (Hurskainen et al., 2001, 2004). Endometrial resection/ablation and LNG-IUS were reported to be less costly than hysterectomy.
In the present study, we compared the cost and QALYs of all four treatment alternatives. High QALYs (4.575–4.725) were achieved in all treatment arms. The results of our analysis were consistent with the findings in the literature that hysterectomy was the treatment alternative with the highest cost. Our results further showed that hysterectomy was the strategy with the highest QALYs gained for the management of menorrhagia over a 5-year period from the perspective of a public healthcare organization in Hong Kong. Compared with LNG-IUS, the ICER of hysterectomy was USD23 500 per additional QALY gained. The generally accepted ICER threshold for supporting the decision of a treatment option is USD50 000 (30 000 pounds) (Birch and Gafni, 2004). The ICER of hysterectomy therefore supports this strategy to be the cost-effective treatment option for menorrhagia. Comparing the non-surgical options, LNG-IUS dominated oral medical therapy; it was 20% less costly even though the increment in QALYs (1%) was modest. The probabilistic sensitivity analysis in 10 000 cohorts showed that the cost and QALY differences between hysterectomy and other interventions remained substantial. Despite the cost of oral medical therapy (drug acquisition cost) being six times lower than the cost of LNG-IUS (USD135 versus USD895), the total medical cost per patient in the oral medical treatment arm was 1.2 times higher than that of the LNG-IUS group. The high total cost of oral medical treatment could be explained by the high rate of needing extra surgery. In a clinical trial comparing endometrial resection/ablation and oral medical therapy, endometrial resection has been shown to be better than medical treatment for menorrhagia in terms of reduction in bleeding, pain and patient satisfaction. At 2-year follow-up, 59% of women in the medical cohort had undergone transcervical resection of the endometrium (TCRE), hysterectomy or both, whereas 17% in the TCRE cohort had undergone further surgery (Cooper et al., 1997). At 5-year follow-up, 10% of those randomized to the medical arm still used medical treatment, whereas 77% had undergone surgical treatment and 18% had hysterectomy. In TCRE arm, 27% women underwent further surgery, 19% had hysterectomy (Cooper et al., 2001).
The univariate sensitivity analysis showed that the least costly treatment option was influenced by the probability of a greater need for extra surgery in the endometrial resection/ablation group. The endometrial resection/ablation group would dominate, least costly and most effective, the LNG-IUS and oral medical treatment groups when the probability of extra surgery declined to 0.055 or lower. Whilst hysterectomy remained the most effective alternative treatment option, the ICER of hysterectomy in comparison with the least costly option (endometrial resection/ablation) would become USD53 024 and further increase to USD209 000 when the probability of extra surgery in the endometrial resection/ablation group declined to 0.024. With the ICER exceeding USD50 000, hysterectomy would be less acceptable as a cost-effective treatment alternative.
The present Markov model was designed to simulate the economic and the quality-of-life outcomes associated with four mainstays of treatment for menorrhagia. In different countries and healthcare systems, there are various practice patterns or treatment pathways for the management of menorrhagia that could affect the utilization of healthcare resources and medical costs. The probabilities of clinical events might vary in different regions as well. Our Markov model included the major cost items and clinical factors affecting the outcomes of treatment that allowed other healthcare systems in a different country to adopt this model using the local cost of major healthcare resources and probabilities of clinical events.
Our study was limited by the fact that the clinical probabilities and utility scores were derived from overseas studies. The model was therefore examined in sensitivity analysis conducted over a broad range for all the variables in order to test for the robustness of the model and to identify the threshold values of influential variables. The threshold values identified for probability of extra surgery in the endometrial resection/ablation group provided information on the feasibility of cost-effective management of menorrhagia based upon the institution-specific rate of need for additional surgery among the patients. The mortality rates of endometrial resection/ablation and hysterectomy and the re-insertion rate of LNG-IUS in Hong Kong were extremely low that they are not included in the present cost-utility analysis. The time frame of our analysis was limited to 5 years. The analysis would result in higher uncertainty over longer time frame because the need for treatment of menorrhagia might decline as women reach menopause. Our cost analysis was conducted from the perspective of public health organization, and indirect cost such as loss of productivity because of absence from work was therefore not assessed.
In conclusion, the present cost-utility analysis shows that hysterectomy appears to be a cost-effective alternative, with ICER less than USD50 000, for management of menorrhagia over a 5-year period from the perspective of a Hong Kong public health organization. LNG-IUS seems to be the least costly and most effective alternative when non-surgical intervention is the patient’s preference. A recent survey showed that Hong Kong Chinese women were poorly informed on the treatment options of menorrhagia (Leung et al., 2005). The results of the present study could be used for development of decision aids for menorrhagia on treatment choices, which might potentially reduce treatment cost (Kennedy et al., 2002). Besides the cost-effectiveness of each treatment option, clinicians should also take into account the individual factors, including age, severity of menorrhagia and other associated symptoms (such as dysmenorrhoea), possibility of future reproduction and symbolic importance of menstruation, in the patient being counselled on selection of treatment options.
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Acknowledgements |
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TopAbstractIntroductionMaterials and methodsResultsDiscussionAcknowledgements References |
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The study was supported by Centre for Pharmacoeconomics Research, School of Pharmacy, The Chinese University of Hong Kong.
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References |
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Submitted on January 4, 2006; resubmitted on February 22, 2006; accepted on March 1, 2006.
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