Cost effectiveness of fesoterodine and tolterodine for the treatment of overactive bladder with urge urinary incontinence in Spain and Finland.

BACKGROUND: Overactive bladder is a prevalent condition worldwide that is associated with a considerable burden, both on the patient and on society. OBJECTIVE: Our objective was to assess the economic value of fesoterodine compared with tolterodine extended release (ER) for the treatment of overactive bladder (OAB) with urge urinary incontinence (UUI) in Spain and Finland. METHODS: A decision-tree economic model estimated the 52-week costs and quality-adjusted life-years (QALYs) of OAB/UUI patients initiating treatment with fesoterodine 4 mg/day or tolterodine ER. Individuals were evaluated for treatment response (UUI fewer than one episode/day) and persistence at weeks 4, 12, and 24. Titration from fesoterodine 4 mg/day to 8 mg/day was permitted at week 4. At week 12, non-responders discontinued treatment permanently. Efficacy, discontinuation, and utility data were derived from four clinical trials of fesoterodine. OAB-related costs, including physician visits, laboratory tests, incontinence pads, and comorbidities (fracture, skin infection, urinary tract infections, depression, and nursing home) were also included. RESULTS: A total of 19.5 % and 18.0 % of fesoterodine and tolterodine ER patients remained on treatment until week 52, respectively. QALYs were higher with fesoterodine than tolterodine ER (0.762 vs. 0.760). In Spain, fesoterodine treatment had higher total costs than (generic) tolterodine ER (€6,697 vs. 6,597), resulting in a cost of €15,633/QALY gained. In Finland, fesoterodine was cost saving relative to (non-generic) tolterodine ER (€7,885 vs. 8,024). Sensitivity analysis confirmed that these findings were robust to the expected price decrease for generic tolterodine ER in Finland. CONCLUSION: Fesoterodine is cost effective or cost saving relative to tolterodine ER for the treatment of OAB with UUI in two European countries. Payers and prescribers should consider a broad scope of costs to make informed cost-conscious choices of antimuscarinic treatment.

Economic burden of urgency urinary incontinence in the United States: a systematic review.

BACKGROUND: The International Continence Society (ICS) identifies several urinary incontinence (UI) subtypes: urgency urinary incontinence (UUI), stress UI (SUI), and mixed UI (MUI). UUI is a common symptom of overactive bladder (OAB) syndrome. Based on the current ICS definition of OAB, all patients with UUI have OAB, whereas not all patients with OAB have UUI. Because UUI is a chronic condition that is expected to increase in prevalence as the population of elderly individuals grows, it is important to understand its economic burden on society and patients and its cost components.  OBJECTIVE: To summarize the published English language medical literature on estimates of the economic burden of UUI in the United States from a societal and patient perspective, including direct costs (diagnosis, treatment, routine care [including incontinence pads], and UUI-associated comorbidities/complications); indirect costs (lost wages by patients and caregivers and lost work productivity due to absenteeism and presenteeism); and intangible costs (pain, suffering, and decreased health-related quality of life).  METHODS: A PubMed search of the literature for articles on the economic burden of UUI in the United States was conducted using the search terms (urgency urinary incontinence OR urge incontinence OR mixed incontinence OR overactive bladder) AND (burden OR cost OR economic) AND (United States), with limits for English language, publication from 1991 to 2011, humans, and adults (19+ years). Only primary articles of non-neurogenic UUI in the United States were retained.  RESULTS: Seven studies were identified that included data on the economic burden of UUI in the United States from a societal and patient perspective. Although estimates of the total economic burden of UUI include direct, indirect, and intangible costs, none of the 7 U.S. studies included all of these cost components. Furthermore, the costs of UUI often could not be fully extracted from the costs of OAB, which include patients with and without UUI, or the costs of other types of UI. The most recent cost analysis incorporated OAB with UUI prevalence rates and data on use of each cost component to calculate the total annual direct costs in 2007 for adults aged ≥ 25 years. The estimated total national cost of OAB with UUI in 2007 was $65.9 billion, with projected costs of $76.2 billion in 2015 and $82.6 billion in 2020. This 2007 estimate was markedly higher than those reported in older studies. Direct costs are the main driver of the overall cost of UUI in the United States. Studies that assessed patient costs indicated that the personal costs of routine care items for UUI and MUI represent a meaningful contribution to the overall economic burden of these conditions. These substantial personal expenditures may explain why patients reported that they were willing to pay considerable amounts for a treatment that would reduce the frequency of their UUI episodes.  CONCLUSIONS: UUI in the United States is associated with a substantial economic burden from both a societal and patient perspective. Studies evaluating the impact of interventions that reduce the frequency of UUI episodes on the overall economic burden of UUI are warranted. 

Antimuscarinic persistence patterns in newly treated patients with overactive bladder: a retrospective comparative analysis.

INTRODUCTION AND HYPOTHESIS: Treatment persistence is low in patients with overactive bladder (OAB), but persistence may vary among antimuscarinic agents. This study compared treatment persistence in patients with OAB receiving fesoterodine, solifenacin, or tolterodine as their initial OAB prescription in a routine clinical practice setting. METHODS: This retrospective study used medical records from primary healthcare centers in three locations in Spain; records from patients aged ≥18 years with a diagnosis of OAB who initiated antimuscarinic treatment for OAB (fesoterodine, tolterodine, or solifenacin) were included. The first prescription of one of the OAB study medications was considered the index date; patients were followed for ≥52 weeks. Persistence was estimated using Kaplan-Meier curves and Cox proportional hazard regression models, adjusting for covariates. RESULTS: A total of 1,971 records of patients (58.3 % women; mean age 70.1 years) initiating treatment with fesoterodine (n = 302), solifenacin (n = 952), or tolterodine (n = 717) were included. Unadjusted mean (±SD) treatment duration was 31.5 ± 17.6 weeks for fesoterodine, 29.9 ± 21.4 for solifenacin and 29.0 ± 21.6 for tolterodine (p = 0.217). At week 52, 35.8 % of fesoterodine-treated patients remained on their initial therapy, versus 31.9 % of solifenacin-treated (hazard ratio [HR], 1.24; 95 % CI, 1.05-1.47; p = 0.011) and 30.9 % of tolterodine-treated (HR = 1.28; 95 % CI, 1.07-1.52; p = 0.006) patients. Findings were consistent when the definition for discontinuation was varied. CONCLUSIONS: Overall persistence at week 52 was low, but the cumulative probability of persisting with initial therapy was significantly higher for fesoterodine than for solifenacin or tolterodine in clinical practice in Spain.

Global prevalence and economic burden of urgency urinary incontinence: a systematic review.

CONTEXT: The prevalence and economic burden of urgency urinary incontinence (UUI) are difficult to ascertain because of overlap with data on overactive bladder and other types of incontinence. OBJECTIVE: To summarize the evidence on the global prevalence and economic burden of UUI. EVIDENCE ACQUISITION: A PubMed search was performed used the following terms: (urgency urinary incontinence OR urge incontinence OR mixed incontinence OR overactive bladder) AND (burden OR cost OR economic OR prevalence). A similar search was conducted using Embase. English-language articles published from 1991 through 2013 on non-neurogenic UUI were retained. EVIDENCE SYNTHESIS: We retained 54 articles (50 studies); 22 large-scale, population-based surveys indicated varying UUI prevalence estimates with ranges of 1.8-30.5% in European populations, 1.7-36.4% in US populations, and 1.5-15.2% in Asian populations, with prevalence dependent on age and gender. Nineteen smaller-scale studies supported these findings. Despite varying methods, 11 studies estimating the costs of UUI worldwide consistently concluded that the economic burden is substantial and will increase markedly as the population ages. In a 2005 multinational study, the annual cost-of-illness estimate for UUI in Canada, Germany, Italy, Spain, Sweden, and the United Kingdom was €7 billion. A US cost-of-illness study reported a total cost of $66 billion in 2007 US dollars. The costs of routine care and nursing home admissions for UUI were major contributors to the cost. CONCLUSIONS: UUI affects millions of men and women worldwide. Current evidence demonstrates the substantial economic burden of UUI to patients and society. Worldwide public health and clinical management programs are needed to improve UUI awareness and highlight the need for early diagnosis and management.

Health economics perspective of fesoterodine, tolterodine or solifenacin as first-time therapy for overactive bladder syndrome in the primary care setting in Spain.

BACKGROUND: Overactive bladder (OAB) is associated with high healthcare costs, which may be partially driven by drug treatment. There is little comparative data on antimuscarinic drugs with respect to resource use and costs. This study was conducted to address this gap and the growing need for naturalistic studies comparing health economics outcomes in adult patients with OAB syndrome initiating treatment with different antimuscarinic drugs in a primary care setting in Spain. METHODS: Medical records from the databases of primary healthcare centres in three locations in Spain were assessed retrospectively. Men and women ≥18 years of age who initiated treatment with fesoterodine, tolterodine or solifenacin for OAB between 2008 and 2010 were followed for 52 weeks. Healthcare resource utilization and related costs in the Spanish National Health System were compared. Comparisons among drugs were made using multivariate general linear models adjusted for location, age, sex, time since diagnosis, Charlson comorbidity index, and medication possession ratio. RESULTS: A total of 1,971 medical records of patients (58.3% women; mean age, 70.1 [SD:10.6] years) initiating treatment with fesoterodine (n = 302), solifenacin (n = 952) or tolterodine (n = 717) were examined. Annual mean cost per patient was €1798 (95% CI: €1745; €1848). Adjusted mean (95% bootstrap CI) healthcare costs were significantly lower in patients receiving fesoterodine (€1639 [1542; 1725]) compared with solifenacin (€1780 [€1699; €1854], P = 0.022) or tolterodine (€1893 [€1815; €1969], P = 0.001). Cost differences occurred because of significantly fewer medical visits, and less use of absorbent products and OAB-related concomitant medication in the fesoterodine group. CONCLUSIONS: Compared with solifenacin and tolterodine, fesoterodine was a cost-saving therapy for treatment of OAB in the primary care setting in Spain.

European content validation of the Self-Assessment Goal Achievement (SAGA) questionnaire in patients with overactive bladder.

INTRODUCTION AND HYPOTHESIS: The Self-Assessment Goal Achievement (SAGA) questionnaire is a patient-completed instrument designed to assess goal attainment in the behavioral or pharmacologic treatment of lower urinary tract symptoms (LUTS), including overactive bladder (OAB). The SAGA questionnaire allows patients to identify and rank the importance of treatment goals before treatment is initiated; the follow-up SAGA questionnaire quantifies the achievement of these patient-identified goals. The objective of this qualitative research was to confirm the content validity of the German, Spanish, Swedish, and English (UK) language versions of the SAGA questionnaire in patients with OAB with or without other LUTS. METHODS: The SAGA questionnaire was translated to each language in accordance with a well-established forward and backward harmonization method. Patient interviews were then conducted according to a cognitive debriefing methodology. Qualitative analysis of patients' input allowed assessment of content validity of each linguistically adapted SAGA questionnaire. RESULTS: All patients (n = 29; six to eight per targeted country) found the SAGA questionnaire easy to understand and to complete. Most patients completed the nine prespecified (fixed) treatment goals and were able to add up to five personal goals in the open-ended portion and rate each goal by importance. Differences were identified in how the various languages communicated some of the concepts assessed with the SAGA questionnaire. Rewording of the translated versions of the questionnaire was necessary in some cases. CONCLUSIONS: This linguistic content validation study in four European languages indicates that SAGA is a comprehensive, easy-to-understand, and relevant questionnaire for patient-completed evaluation of LUTS/OAB symptoms and treatment goal attainment.

Urinary incontinence and its relationship to mental health and health-related quality of life in men and women in Sweden, the United Kingdom, and the United States.

BACKGROUND: Differences in health burden associated with urinary incontinence (UI) subtypes have been previously described, but the majority of studies are in women. Additional research is needed to examine the prevalence and burden of UI subtype including postmicturition incontinence, nocturnal enuresis, coital incontinence, and incontinence for unspecified reasons. OBJECTIVE: Examine the burden of UI in men and women in Sweden, the United Kingdom, and the United States. DESIGN, SETTING, AND PARTICIPANTS: Secondary analyses of the Epidemiology of Lower Urinary Tract Symptoms (EpiLUTS), a cross-sectional Internet survey, were performed. Participants who reported UI were categorized as (1) urgency urinary incontinence (UUI) only, (2) stress urinary incontinence (SUI) only, (3) mixed urinary incontinence (MUI), (4) UUI plus other incontinence (OI), (5) SUI plus OI, or (6) OI. Differences in health outcomes across UI groups were explored by gender using descriptive statistics and general linear models. MEASUREMENTS: Outcomes included treatment seeking for urinary symptoms, perception of bladder condition, depression, anxiety, and health-related quality of life (HRQL). RESULTS AND LIMITATIONS: Of 14 140 men and 15 860 women, 6479 men (45.8%) and 10 717 women (67.6%) reported UI. The most prevalent UI subgroups were OI in men and SUI in women. MUI and SUI plus OI had the greatest treatment seeking among men, whereas MUI and UUI plus OI had the greatest treatment seeking among women. Men with MUI had the highest rates of anxiety, followed by those with UUI plus OI and SUI plus OI, and OI with a similar trend observed for depression. Anxiety and depression were highest in SUI plus OI and MUI women. MUI and UUI plus OI men and women had significantly lower HRQL compared with other UI groups. CONCLUSIONS: UI is common in men and women aged >40. Individuals with UUI combined with SUI or OI bear a greater mental health burden and report poorer HRQL.

Development and validation of the Economic Assessment of Glycemic Control and Long-Term Effects of diabetes (EAGLE) model.

BACKGROUND: The Economic Assessment of Glycemic control and Long-term Effects of diabetes (EAGLE) model was developed to provide a flexible and comprehensive tool for the simulation of the long-term effects of diabetes treatment and related costs in type 1 and type 2 diabetes. METHODS: EAGLE simulations are based on risk equations, which were developed using published data from several large studies including the Diabetes Control and Complications Trial, the United Kingdom Prospective Diabetes Study, and the Wisconsin Epidemiological Study of Diabetic Retinopathy. Risk equations for the probability of complications (including hypoglycemia, retinopathy, macular edema, end-stage renal disease, neuropathy, diabetic foot syndrome, myocardial infarction, and stroke) were based on regression analyses, using linear, exponential, and quadratic regression formulae. Subsequent cost calculations are made from the simulated event rates. Internal validation of the EAGLE model was completed by comparing simulated event rates with the published event rates used as the basis for the model. RESULTS: EAGLE provides microsimulations of virtual patient cohorts for type 1 and type 2 diabetes over n years in 1-year cycles. Complications include microvascular and macrovascular events and death, which are calculated over time as cumulative incidences. Glycosylated hemoglobin levels over time are simulated in relation to treatment regimen. Internal validation demonstrated that each mean event rate simulated by EAGLE overlapped with the published mean event (within a range of +/-10%). CONCLUSIONS: The EAGLE model is an evidence-based, internally valid tool for the assessment of the long-term effects of diabetes treatment and related costs.