Cost-effectiveness analysis of antimuscarinics in the treatment of patients with overactive bladder in Spain: A decision-tree model
© Arlandis-Guzman et al; licensee BioMed Central Ltd. 2011
Received: 15 November 2010
Accepted: 20 May 2011
Published: 20 May 2011
Fesoterodine, a new once daily antimuscarinic, has proven to be an effective, safe, and well-tolerated treatment in patients with overactive bladder (OAB). To date, no analysis has evaluated the economic costs and benefits associated with fesoterodine, compared to antimuscarinics in Spain. The purpose of this analysis was to assess the economic value of OAB treatment with fesoterodine relative to extended release tolterodine and solifenacin, from the societal perspective.
The economic model was based on data from two 12-week, randomized, double-blind, and multicenter trials comparing fesoterodine and tolterodine extended released (ER). Treatment response rates for solifenacin were extracted from the published literature. Discontinuation and efficacy were based on the results of a 12-week multinational randomized clinical trial extrapolated to 52 weeks. Changes in health related quality of life were assessed with the King's Health Questionnaire, which was transformed into preference-based utility values. Medical costs included (expressed in € 2010) were antimuscarinics, physician visits, laboratory tests, incontinence pads and the costs of OAB-related comorbidities, fractures, skin infections, urinary tract infections, depression, and nursing home admissions associated with incontinence. Time lost from work was also considered. Univariate sensitivity analyses were also performed.
At week 12, continents accounted for 50.6%, 40.6% and 47.2% of patients in the fesoterodine, tolterodine, and solifenacin groups, respectively. By week 52, the projected proportions of patients remaining on therapy were 33.1%, 26.5% and 30.8%, respectively. The projected quality- adjusted life years (QALY) gain (compared to baseline) over the 52-week simulation period were 0.01014, 0.00846 and 0.00957, respectively. The overall treatment cost was estimated at €1,937, €2,089 and €1,960 for fesoterodine, tolterodine and solifenacin, respectively. Therefore, treatment with fesoterodine resulted in similar overall costs and greater QALY gain than treatment with either tolterodine or solifenacin. Sensitivity analysis showed that these results were robust to all changes performed.
The results of this economic analysis suggest that fesoterodine is a cost-effective alternative to tolterodine and solifenacin for the treatment of patients with OAB in Spain. Fesoterodine provides additional health benefits while maintain a similar level of costs being a cost-effective treatment strategy from a societal perspective.
Overactive bladder (OAB) is a symptom-driven condition defined as urinary urgency, with or without urgency urinary incontinence, usually with increased daytime frequency and nocturnal voiding [1, 2]. It is a highly prevalent condition, related to an overall OAB prevalence of 11.8% in adults above 18 years of age in Western countries ; affecting men (10.8%) and women (12.8%) comparably and increased with age . This corresponds to approximately 1 in 8 adults. These numbers are similar to a 17% prevalence previously reported in 6 European countries (France, Germany, Italy, Spain, Sweden, and the United Kingdom)  as well as in the United States in adults above 40 years of age . In Spain, the latest prevalence data showed an OAB and/or urinary incontinence prevalence around 10% in women (between 25 and 64 years), and 5% in men (ages between 50 and 65) . In people over 40, prevalence is set between 20-22%, and higher than 50% over 65 years old . Therefore there should be about 3 million people over 40 suffering this condition in Spain .
OAB has devastating consequences for sufferers both genders which impact upon their health related quality of life (HRQoL), self-esteem and relationships . The constellation of OAB symptoms has a profound negative effect on patients' quality of life and general well-being and can affect social, psychological, occupational, domestic, physical and sexual aspects of living [9, 10]. Despite the high prevalence of OAB and the significant impact OAB has on patients' daily lives, up to 75% of patients remain untreated . The reasons for this lack of treatment-seeking behaviour include patient embarrassment, the misconception that OAB and urinary incontinence (UI) are natural consequences of ageing, lack of knowledge regarding available treatments and unrealistic expectations [11, 12]. OAB often precipitates other medical conditions, such as skin infections, urinary tract infections (UTIs), falls and fractures, and depression [5, 13, 14]. All these symptoms and facts results in a staggering €4,2 billion in the year 2000 OAB-related healthcare cost in 5 European countries (Germany, Italy, Spain, Sweden, and the United Kingdom); and is predicted to reach € 5,2 billion by 2020, a 25% increase. Incontinence pads were the source of the largest cost, accounting for approximately 63% of the annual per-patient OAB management .
A probing article recently stated that successful treatment of OAB depends on persistence with the prescribed medication, and efficacy and tolerability are key influencers of persistence. New antimuscarinic agents are now available for treating OAB that significantly improves symptoms of incontinence, urgency and frequency with few adverse effects. An improved efficacy and tolerability profile should result in greater patient satisfaction and persistence with treatment during long-term therapy . Fesoterodine, a new once daily antimuscarinic, which has been recently marketed in Spain, has proven to be an effective, safe, and well-tolerated treatment in patients with OAB in two large pivotal phase III studies [17, 18]. Fesoterodine has also demonstrated clinically and statistically significant improvements health-related quality of life (HRQoL) compared to placebo in subjects with OAB .
Health economic analyses assess the implications of projected outcomes and cost of medical interventions. Economic assessments of new therapies are often required by many health decision-making authorities. These are evaluated in order to properly allocate scarce healthcare resources. To date, no analysis has been performed to evaluate the economic costs and benefits associated with fesoterodine related to other existing antimuscarinics in Spain. Thus, the objective of this analysis was to assess the 1-year economic value of OAB treatment with fesoterodine relative to extended release (ER) tolterodine and solifenacin, from the societal perspective.
Economic Model description
Following Spanish CEA guidelines, the comparators considered in the analysis should be the relevant ones in current clinical practice; i.e. the most commonly used in the higher number of patients . The 96% of the I.M.S. reported Spanish antimuscarinic sales  are attributed to fesoterodine, tolterodine and solifenacin; the three most consumed drugs in Spain; with the rest of antimuscarinics commercialized in Spain included in the remaining 4% of the OAB treatment market, and are not considered in this study due to its low economic impact on health budgets. As the time horizon for this analysis is 1 year, no discount rate was included in the analysis . As this analysis was not carried out on humans, it represents a hypothetical patient ant the treatment pathway simulation, it was not needed to get the approval of any ethics committee.
Clinical trial data
Efficacy (% resolution of incontinence) and discontinuation data included into the economic model
% Resolution of incontinence (<1 episode/24 hrs)
Fesoterodine 4 mg
Fesoterodine 8 mg
Solifenacin 5 mgc
Solifenacin 10 mge
% Nocturia (> = 2 episodes/night) % of patients with nocturia at baseline without nocturia at W12
Fesoterodine 4 mg
Fesoterodine 8 mg
Solifenacin 5 mg
Solifenacin 10 mg
Fesoterodine 4 mg
equal to placebo data h
Fesoterodine 8 mg
equal to placebo data h
equal to placebo data h
Solifenacin 5 mg
equal to placebo data h
Solifenacin 10 mg
equal to placebo data h
Some published data have not shown 12-week discontinuation rates for antimuscarinics to be significantly different than placebo . Therefore, the values considered in this analysis are equal to placebo discontinuation (Table 1). Fesoterodine phase III clinical trials were also the source for the percentage of patients with nocturia at baseline (48.58%) and for the percentage of patients with nocturia at baseline without nocturia at W12 is shown in Table 1.
Direct medical and productivity costs included into the fesoterodine economic model
Cost per incontinence pad
Cost of general practitioner visit
Cost of specialist visit
Cost of laboratory tests (urinalysis)
Fesoterodine 4 mg (cost/day, with taxes)
Fesoterodine 8 mg (cost/day, with taxes)
Tolterodine ER (cost/day, with taxes)
Solifenacin 5 mg (cost/day, with taxes)
Solifenacin 10 mg (cost/day, with taxes)
Skin Infection episode
Urinary Tract Infection episode
Average hourly wage
Average number of hours worked per week
% Employed in population
Decrease in hours worked due to incontinence b
Reduced daytime productivity due to nocturia c
Healthcare resource utilization and other data included into the fesoterodine economic model
Proportion using incontinence pads
Number of incontinence pads/day
Number of general practitioner visits/month
Number of specialist visits/month
Number of laboratory tests/month
OAB-related Co morbidities: rate per year
Fracture: 6-month probability of a fall with fractures (4% decrease in utility values **)
Skin infection: 6-month probability
10.7% (0.3 infections per person in entire population) (2.8 events/affected patient)
9.3% (0.6 infections per person in entire population) (6.5 events/affected patient)
UTI: 6-month probability
19% (0.3 infections per person in entire population) (1.6 events/affected patient)
30.7% (0.7 infections per person in entire population) (2.3 events/affected patient)
Depression (48% decrease in utility values )***
% female in clinical trial data
80.87% OAB w/UUI****
Nursing home: Admission rate per 1000 patient-years
(% decrease in utility values )*****
0.9332 (baseline value)
Analogously, we calculate the expected number of UTIs per unsuccessfully-treated patient as well as the expected number of skin infections for both treatment categories. The utility decrements for fracture, depression, and nursing home are also considered in the analysis (Table 3), with its corresponding literature sources.
An assessment of the indirect productivity costs associated with OAB and incontinence was also included. Lost productivity at work due to OAB can come from many sources. For one, frequent voiding during sleep time (nocturia) can deprive one of needed sleep, mimicking the symptoms of insomnia. We assume the decreased productivity during work hours for those with nocturia relative to those without nocturia to be 9.2% , representing the difference between the percent work impairment for patients with nocturia (13.8%) and control patients (4.61%), Table 2. Another cause for lost work is the presence of incontinence, where patients may choose to work fewer hours because of their condition. Data show women who work for pay report working fewer hours per week (38 vs. 30) . Incontinent men with OAB factor their symptoms into decisions about location and hours worked more than continent men or women with OAB and more than twice as much as women with incontinence (21% vs. 8%). A conservative assumption to capture the monetary value of this productivity loss would be to assume those incontinent patients who are employed work 21% fewer hours than those without incontinence (the percent difference between the number of hours worked per week for women without incontinence versus women with incontinence [38 hours-30 hours]/38 hours). Spanish employment and wage data were entered into the model to estimate the decreased productivity while at work due to interrupted sleep by nocturia episodes and lost time from work due to incontinence (Table 2). The model inputs the productivity costs of each treatment arm compared to no-treatment, as relative productivity gains. As explained, incontinence and nocturia episodes were related, respectively, with reduced work hours and lost productivity while at work and their associated costs. If no treatment is considered, higher productivity costs are observed compared to receiving an adequate treatment. For this reason, negative values (or productivity gains) would be obtained for each treatment arm compared in this study.
In this analysis, effectiveness of medical interventions was expressed in term of Quality-Adjusted-Life-Years (QALY) gain. Changes in HRQL were assessed from a disease specific HRQL tool during the trial: the King's Health Questionnaire , which was transformed into preference-based utility values for responders and non-responders . KHQ is an instrument specifically designed to assess the impact of bladder problems on HRQL in women and has been shown to be reliable, internally consistent and valid in men and women . The items of the KHQ cover 5 domains: role limitations; physical functioning; social functioning; emotional problems; sleep disturbance and general health. Each patient's 5 domain scores from the KHQ were incorporated into a regression algorithm developed by Brazier et al. to generate preference-based utilities . The authors have previously used this approach to estimate preference-based utilities from the SF-36 . KHQ responses were collected from trial participants at baseline and again at week 12 (Table 3). Utility for patients not on therapy was assumed equal to the baseline value. The QALY gains from baseline to week 12, from week 12 to week 24, and from week 24 to week 52 were calculated based on patient's treatment status (continent, incontinent, or no treatment). The difference between week 52 utilities and baseline utilities for responders and non-responders were the effect measure in the cost-effectiveness ratio. As described in Table 3, fracture, depression, and nursing home admissions are assumed to be associated with a decrement in utility relative to not having these conditions. The percent decrease is included as a model condition.
Cost-effectiveness analysis (CEA)
For each of the treatment interventions, the model calculates the expected total one-year costs (including both direct and indirect costs). The model also determines the expected proportion of patients on each treatment having restoration of continence at the end of 1 year and the QALYs gained for each intervention. These outputs are combined to create the incremental cost effectiveness ratio (ICER), representing the additional cost associated with fesoterodine treatment divided by the additional QALYs gained with fesoterodine treatment relative to tolterodine and solifenacin, respectively.
Several univariate sensitivity analyses of fesoterodine versus tolterodine ER or solifenacin were performed in order to find if the results were robust to changes in main assumptions or inputs of the analysis: trial time horizon, co morbidities costs and rate per year, utility estimates, direct medical services costs, utilization and productivity data, proportion of continent patients at 12 and 52 weeks, and proportion of responders to fesoterodine 4 mg and solifenacin 5 mg who elect to titrate to the higher dose at week 4, as well as the proportion of non-responders who elect not to titrate. All the variables were changed in a range of ±25%, a plausible range of variation of both costs and health effects. Following Spanish CEA guidelines , the payer perspective results (Spanish National Healthcare system, which considered only direct costs) were obtained and presented separately as a sensitivity analysis.
Outcomes of the OAB economic model for the base-case scenario
Continent at Week 12
Continent at Week 52
Total costs (€)
Univariate sensitivity analyses of fesoterodine versus tolterodine ER or solifenacin
Fesoterodine ICER relative to:
Base-case scenario: Results weeks 52, societal perspective
Weeks 52, health system perspective
Weeks 12, health system perspective
Weeks 12, societal perspective
+/- 25% in OAB-related co morbidities costs
+/- 25% in OAB-related co morbidities rate per year in continent patients
+/- 25% in OAB-related co morbidities rate per year in incontinent patients
+/- 25% in utility estimates
+/- 25% in % of responders to fesoterodine 4 mg and solifenacin 5 mg that titrate to the higher dose at week 4
+/- 25% in % of non-responders to fesoterodine 4 mg and solifenacin 5 mg that do not to titrate to the higher dose at week 4
+25% in % continent patients at week 12
- 25% in % continent patients at week 12
+/- 25% in % continent patients at week 52
+/- 25% in medical services costs*
Medical services utilization
+/- 25% % of incontinent patients using pads
+/- 25% No. pads/day for incontinent patients
+/- 25% in # GP visits/month
+/- 25% in # specialist visits/month
+/- 25% in # lab tests/month
+/- 25% in decrease in hours worked due to incontinence
+/- 25% in reduced daytime productivity due to nocturia
+/- 25% in % employed in population
+/- 25% in average hourly wage
This decision-tree model cost-effectiveness analysis, the first one that compares fesoterodine and other salient antimuscarinics in Spain, showed that the treatment with fesoterodine resulted in similar overall costs but greater QALY gain than treatment with either tolterodine or solifenacin. In other words, fesoterodine acquisition cost is outweighed by the lower costs related to both direct and indirect resources used considered in this study. This analysis tried to be as much robust as possible, including the relevant comparators (the ones that represent 96% of the Spanish year 2010 OAB treatment market), the adequate efficacy data and the adequate costs. Additionally, several univariate sensitivity analyses were done, to demonstrate the strength of the assumptions. As explained in the results section, fesoterodine continued being the dominant option in most sensitivity analyses done, particularly when the time horizon of analysis is set at 52 weeks. When the time horizon is changed to 12 weeks only (this happening in some particular patients who abandon the OAB treatment rapidly), fesoterodine would still be a cost-effective option when the NHS perspective is considered only: incremental cost-effectiveness ratios per QALY gained of 574€ and 14,568€ compared to tolterodine and solifenacin, respectively. However, if it is considered the societal perspective in the 12-weeks scenario, fesoterodine would be cost-effective relative to tolterodine only. Nevertheless, the plausibility of this scenario is really low even considering than persistence rate with antimuscarinics has been showed to be lower than with other treatments for chronic conditions . At least, in the case of solifenacin persistence, it has been communicated to be above 90% after 12 weeks of starting the therapy .
The model is considered to be comprehensive by including several aspects of OAB affecting the overall economic burden of disease. These include the cost of incontinence pads and the cost of lost productivity due to impairment at work or lost time at work due to OAB symptoms. Also, it includes the cost of associated co morbidities arising with uncontrolled OAB. The main reason of incorporating indirect costs is due to their relevance for OAB. Kobelt et al (2003)  conclude that in an otherwise healthy and professionally active group of individuals, waking at night to void, significantly diminishes their overall well-being, vitality and productivity, leading to a significant level of indirect and intangible costs. Additionally, over 21% of the OAB population worried about interrupting meetings with frequent trips to the toilet and 3% of the population changed jobs or were fired because of their bladder control problems . Considering these figures, lost productivity and lost wages were included in this analysis. Nevertheless, results are consistent with base case scenario even if indirect costs are not included in the analysis and the perspective of National health System is analyzed solely.
As in all scientific works, this analysis includes limitations and strengths. One of the strengths of the model is the use of the clinical trial data for the comparison of all alternatives, which ensures comparable patient populations among the treatments. However, unlike in the actual trial, the model assumes patients whose OAB is not controlled by treatment at each assessment point will discontinue therapy at that point, replicating a treatment pattern more reflective of real clinical practice. On the other hand, solifenacin was not included in the clinical trial and was modelled using published data. In order to diminish the possible impact in the results of solifenacin data, the meta-analysis of phase III clinical trials by Cardozo and colleagues was chosen , which examined data from 2,030 incontinent subjects. Inclusion criteria for these studies were rather similar to the fesoterodine trials. Another possible limitation is that our analysis was not able to incorporate the so-called out-of-pocket expenses, i.e.: incontinence pads not funded by the NHS, particularly because studies used as a sourcing data for the analysis were unable to differentiate it. Finally, this economic model was designed as deterministic, then; only point estimates are showed not allowing for statistical comparison between drugs in both costs and effectiveness. However, these results encourages for development of more sophisticated economic modelling of such drugs using, i.e., probabilistic approach.
As previously mentioned, this is the first cost-effectiveness analysis performed with Spanish data that compares fesoterodine with another antimuscarinics highly used in our health context. However, several economic analyses have been previously published with different antimuscarinic drugs in other settings. Considering the comparators included in this analysis, four economic evaluations have compared solifenacin to ER tolterodine in three different settings [38–41]. These analyses showed that treatment with solifenacin was less costly and more effective than tolterodine. Only one of the four economic evaluations includes fesoterodine as a comparator , with controversial findings in comparison with the results include in our work. The article included some information based in the experience in clinical practice use of all antimuscarinics except for fesoterodine since it was not marketed yet at the time of the analysis included in the paper (year 2008). Due to the lack of available data, fesoterodine inputs were based on extrapolated assumptions from the use of other antimuscarinics instead of data from clinical trials. Another difference is the type of resources and corresponding cost considered in the analysis, since only were considered some direct medical costs, while in the present economic analysis, following Spanish guidelines, indirect costs were also included . Drug-specific treatment persistence data were obtained from the Information Management System database and covered the 12-month period ending in April 2008. As fesoterodine was only on the market since July 2008, treatment persistence data from longitudinal databases were not yet available. To approximate the percentage of patients stopping and switching treatment with fesoterodine in the base-case analysis, Cardozo et al.  used the persistence rates for tolterodine ER, which could potentially represent a bias against fesoterodine. Finally, the percentage of patients who stop or switch treatment due to poor compliance was based on expert opinion.
In conclusion, the results of this economic analysis, supported by sensitivity analyses and despite the limitations mentioned, suggest that fesoterodine is a cost-effective alternative to tolterodine and solifenacin for the treatment of patients with OAB in Spain. Fesoterodine provides additional health benefits while maintain a similar level of costs being a cost-effective treatment strategy from a societal perspective and from the National Health System as well.
The authors thank Mercedes García-Vargas and Belen Martí that contributed towards the preliminary phases of the study by making substantial contributions to, respectively, acquisition and analysis of data. The authors also wish to acknowledge MEISYS for editorial support in preparation of the manuscript, on behalf of Pfizer Inc Spain, and also for final adaptation of the model to the Spanish context.
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- The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2490/11/9/prepub