Cost-Effectiveness Analysis and Budget Impact: Antimuscarinics and Mirabegron for the Treatment of Patients With Urge Urinary Incontinence: The Brazilian Public Health System Perspective.

OBJECTIVES: The Brazilian public health system does not cover pharmacotherapy for urge urinary incontinence (UUI). The aim of this study was to estimate the cost-effectiveness and budget impact of providing tolterodine, solifenacin, oxybutynin (OXY), darifenacin, and mirabegron for the treatment of UUI in Brazilian public health system. METHODS: A cost-effectiveness analysis with budget impact was performed. Six scenarios were assessed: in one scenario, all 5 therapeutic alternatives approved for coverage, and in the remaining 5 scenarios, only 1 alternative is approved for adoption for all patients. Clinical data were derived from a rapid systematic review conducted in several databases. One-way sensitivity analysis was also performed. The time horizon was 12 months. RESULTS: The cost-effectiveness analysis showed that patients treated with OXY had the lowest incremental cost-effectiveness ratio (ICER) per outcomes assessed (change in urinary incontinence episodes (UIE): R$1180.08; change in urge incontinence episodes: R$757.85 and change in micturition frequency: R$907.75), corresponding to a budget impact of R$17.9 billion over 5 years. The change in effectiveness measures was the parameter that most influenced the results of the ICER per patient-year. CONCLUSION: The results of the study have shown that OXY and solifenacin had the lowest ICER per patient-year and the lowest budget impact when compared with other drugs.

Cost-Effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial.

PURPOSE: Sacral neuromodulation and intradetrusor onabotulinumtoxinA injection are therapies for refractory urgency urinary incontinence. Sacral neuromodulation involves surgical implantation of a device that can last 4 to 6 years while onabotulinumtoxinA therapy involves serial office injections. We assessed the cost-effectiveness of 2-stage implantation sacral neuromodulation vs 200 units onabotulinumtoxinA for the treatment of urgency urinary incontinence. MATERIALS AND METHODS: Prospective economic evaluation was performed concurrent with the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment) randomized trial of 386 women with 6 or more urgency urinary incontinence episodes on a 3-day diary. Analysis is from the health care system perspective with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs are in 2018 U.S. dollars. Effectiveness was measured in quality adjusted life-years (QALYs) and reductions in urgency urinary incontinence episodes per day. We generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. RESULTS: Two-year costs were higher for sacral neuromodulation than for onabotulinumtoxinA ($35,680 [95% CI 33,920-37,440] vs $7,460 [95% CI 5,780-9,150], p <0.01), persisting through 5 years ($36,550 [95% CI 34,787-38,309] vs $12,020 [95% CI 10,330-13,700], p <0.01). At 2 years there were no differences in mean reduction in urgency urinary incontinence episodes per day (-3.00 [95% CI -3.38 - -2.62] vs -3.12 [95% CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95% CI 1.34-1.44] vs 1.41 [95% CI 1.36-1.45], p=0.60). The probability that sacral neuromodulation is cost-effective relative to onabotulinumtoxinA is less than 0.025 for all willingness to pay values below $580,000 per QALY at 2 years and $204,000 per QALY at 5 years. CONCLUSIONS: Although both treatments were effective, the high cost of sacral neuromodulation is not good value for treating urgency urinary incontinence compared to 200 units onabotulinumtoxinA.

Clinical practice of BOTOX® treatment for overactive bladder syndrome in Sweden: an assessment of resource use and external validity.

OBJECTIVE: The objective of this study was to assess the resource use of treating overactive bladder (OAB) patients in real-world clinical practice and to evaluate whether there is external validity in the treatment of OAB in clinical practice. MATERIALS AND METHODS: The study included 55 patients suffering from OAB and treated with BOTOX® at two Swedish clinics. The study was conducted as an anonymized retrospective chart review study. RESULTS: The estimated yearly direct cost of BOTOX treatment was €902. The mean age of patients in the study was 60 years, and 85% were women. The severity of OAB before BOTOX treatment, given by the mean number of daily leakages, equalled 4.8. The median interval between treatments was 210 days. CONCLUSIONS: Patient characteristics in the real world were similar to those in the clinical trials, showing a high degree of external validity. Treatment intervals were longer in the real world than in clinical trials, indicating that treatment cost could be lower when patients are treated as observed in real-world clinical practice.

Comprehensive Assessment of Compliance with Antimuscarinic Drug Treatment in the Case of Urge Urinary Incontinence of Older Patients.

AIM: To investigate the heterogeneous factors affecting the stability of patients older than 60 years in the UI treatment with Antimuscarinics. BACKGROUND: The prevalence of Urge Incontinence (UI) in older persons reaches 29.3%. The symptoms of urinary incontinence in older people reduce the health related life quality. MATERIALS AND METHODS: In 1257 patients over 60 years (857 (68.2%) women - average age 67.8, 400 (31.8%) men - 71.4), who received AM for one year, demographic, socio-economic and health parameters were studied. OABq-SF questionnaires, MOS SF-36, urination diaries, uroflowmetry, income information from the tax offices and outpatient records were used. RESULT: The compliance to AM treatment within 6 months was retained in 44.2%, and within the year - 26.8% of older patients. At least 40% of the total number of patients refused to continue the treatment for medical reasons. The persons taking Solifenacin (p≤ 0.01), Trospium (p≤ 0.05), or Darifenacin (p≤ 0.05), suffering from severe UI symptoms (p≤ 0.01), and experiencing minor side effects (p≤ 0.01), well-informed about UI treatment methods (p≤ 0.01) prevailed among the treatment compliant patients. At least 20.4% of the patients discontinued their treatment due to economic reasons. The persons with significantly larger annual income (p≤ 0.05) and annual medical cost (p≤ 0.01) prevailed among the treatment compliant patients. About 12.2% of the patients stopped their treatment for reasons related to the social background and psychological status. CONCLUSION: In this experiment, we found that AM treatment compliance in older patients, in addition to medical parameters and health conditions, is largely affected by the economic as well as social, demographic and psychological factors. The study results can be claimed by practitioners involved in correcting UI symptoms in older people.

Cost effectiveness analysis of fesoterodine compared to mirabegron in first-line therapy setting for overactive bladder with urge urinary incontinence, from the Spanish National Health System perspective. / Análisis de coste efectividad de fesoterodina comparado con mirabegron en el marco de tratamiento de primera línea para vejiga hiperactiva con incontinencia urinaria de urgencia, desde la perspectiva del Sistema Nacional de Salud español.

OBJECTIVES: To evaluate the cost-effectiveness of first-line treatment of Overactive Bladder (OAB) with fesoterodine relative to mirabegron, from the Spanish National Health System (NHS) perspective. METHODS: A decision tree model was developed to represent a typical clinical process of 52-week of treatment for an OAB patient with urge urinary incontinence (UUI) initiating first-line therapy with fesoterodine 4mg, including optional titration to 8mg, vs.mirabegron 50mg. Efficacy data were obtained from a Bayesian indirect treatment meta-analysis. Patients with UUI of less than one episode/day were defined as treatment responder and persistence was assessed at weeks 4, 12 and 24. At week 12, non-responders discontinued treatment permanently. Quality-adjusted life years (QALYs) were calculated based on time spent in responder and non-responder states. OAB-related drug and medical care costs including physician visits, laboratory tests, incontinence pads, and comorbidities (fracture, skin infection, urinary tract infections and depression) were modeled and expressed in €2015. RESULTS: At week 52, the percentage of responders was 20.8% for patients starting on fesoterodine 4mg who optionally titrated to 8mg and 19.4% for patients treated with mirabegron. QALYs were slightly higher with fesoterodine than mirabegron (0.7703vs. 0.7668, difference=0.0035). Fesoterodine treatment also had slightly higher total costs than mirabegron (3,296€vs. 3,217, difference=79€), resulting in a cost of 22,523/QALY€ gained for fesoterodine versus mirabegron. Probabilistic sensitivity analysis confirmed the slight advantage of fesoterodine with a 61.1% probability of being cost-effective at the 30,000€ willingness-to-pay for 1QALY threshold. CONCLUSIONS: Given the relatively small 1-year cost difference between the two treatments, fesoterodine can be considered a cost-effective option relative to mirabegron for the first-line management of OAB with UUI in Spain.

Economic impact of using fesoterodine for the treatment of overactive bladder with urge urinary incontinence in a vulnerable elderly population in the United States.

OBJECTIVES: To assess the costs of treating overactive bladder (OAB) with fesoterodine compared to no OAB pharmacotherapy among vulnerable elderly from the US payer perspective. METHODS: A decision analytic cost model was developed to estimate the 52-week costs of a cohort of vulnerable elderly with OAB initiating treatment with fesoterodine or no OAB pharmacotherapy. Vulnerable elderly OAB patients were defined as those aged ≥65 years with self-reported urge urinary incontinence (UUI) symptoms for ≥3 months, 2-15 UUI episodes/day, and at risk of deteriorating health by a score of ≥3 on the Vulnerable Elders Survey (VES)-13. Patients were evaluated for fesoterodine treatment response (defined as no UUI episodes) and persistence at weeks 12, 26, and 52. The model included a hypothetical health plan with 100,000 elderly members. A total of 7096 vulnerable elderly subjects were identified as the model target population based on the percentage of vulnerable elderly and annual prevalence of OAB among vulnerable elderly. OAB-related costs included fesoterodine drug acquisition costs, healthcare resource use (inpatient hospitalization, outpatient visits, and physician office visits), and OAB-related co-morbidities (falls/fractures, urinary tract infections, depression, and nursing home admissions). All costs were inflated to 2013 US$ using the medical care component of the consumer price index (CPI). RESULTS: When 7096 vulnerable elderly OAB patients were treated with fesoterodine, US healthcare payers could save $11,463,981 per year, or $1616 per patient vs no OAB pharmacotherapy. Univariate one-way sensitivity analyses supported the robustness of the findings and showed results were most sensitive to changes in fesoterodine efficacy followed by annual costs of inpatient hospitalization. CONCLUSIONS: From a US payer perspective, treating vulnerable elderly OAB patients with fesoterodine was cost-saving compared to no OAB pharmacotherapy.

Impact of Loss of Work Productivity in Patients with Overactive Bladder Treated with Antimuscarinics in Spain: Study in Routine Clinical Practice Conditions.

BACKGROUND: Overactive bladder (OAB) is a syndrome characterized by presenting symptoms of urgency, with or without urge incontinence, and normally accompanied by day and night frequency. OBJECTIVE: The aim of this study was to evaluate the impact of lost work productivity [number of days of sick leave] in patients treated with fesoterodine versus tolterodine and solifenacin to treat OAB in Spain. METHODS: A retrospective, observational study was carried out using the records (digital databases) of actively working patients (2008-2013). The study population comprised of patients from two autonomous communities; 31 primary care centres agreed to participate. Patients who began first treatment with antimuscarinics (fesoterodine, solifenacin or tolterodine) and who met certain inclusion/exclusion criteria were included in the study. Follow-up lasted for 1 year. The main outcome measures were comorbidity, medication possession ratio (MPR), treatment persistence, and number of days of sick leave and associated costs. Indirect costs were considered to be those related to lost work productivity (number of days of sick leave, exclusively), (1) due to OAB and (2) overall total. The cost was expressed as the average cost per patient (cost/unit). Multivariate analyses (Cox, ANCOVA) were used to correct the models. RESULTS: A total of 3094 patients were recruited into the study; 43.0 % were treated with solifenacin, 29.2 % with tolterodine, and 27.8 % with fesoterodine. The average age of patients was 54 years (standard deviation 9.2), and 62.2 % were women. The comparison of fesoterodine versus solifenacin and tolterodine showed a higher MPR (90.0 vs. 87.0 and 86.1 %, respectively), higher treatment persistence (40.2 vs. 34.7 and 33.6 %), lower use of sick leave (22.8 vs. 52.9 and 36.7 %), total number of days of sick leave (5.1 vs. 9.7 and 9.3 days) and costs corrected for covariates (€371 vs. €703 and €683); p < 0.05. CONCLUSIONS: Despite the possible limitations of this study, active patients who began treatment with fesoterodine to treat OAB (compared with solifenacin or tolterodine) had fewer days of sick leave, resulting in lower costs due to lost productivity.

Sacral neuromodulation and Botulinum toxin A for refractory idiopathic overactive bladder: a cost-utility analysis in the perspective of Italian Healthcare System.

OBJECTIVES: To assess the relative cost-effectiveness of two therapeutic strategies: one starting with sacral neuromodulation (SNM) versus one starting with Botulinum toxin A (BTX-A) for the management of refractory incontinent idiopathic overactive bladder (OAB) patients, from the perspective of the Italian National Health Service (INHS). METHODS: Direct medical costs (2011) and benefits (quality-adjusted life years-QALYs) were assessed over a ten-year time frame adapting to the Italian practice a published Markov model. Clinical inputs were based on the published literature and on the expert opinion. Resource consumption rates were provided by clinical experts; unit costs were collected from a single hospital accounting and from standard tariff lists and public prices. Interventional procedures and management of adverse events were costed through a micro-costing approach. The primary outcome was incremental costs per QALYs gained (i.e. differential costs divided by differential benefits). Deterministic (DSA) and probabilistic (PSA) sensitivity analyses were conducted to assess the robustness of the model. RESULTS: Starting with SNM appears to be cost effective (i.e. under 40.000/QALY) from year three (21,259/QALY) onwards and becomes dominant (i.e. more effective and less costly) at year ten: cumulative costs were 32,975 for early SNM and 33,309 for early BTX-A, while cumulative QALYs were 7.52 and 6.93, respectively. At year ten, DSA suggests the results robustness and 99.8 % of the PSA iterations fell within the cost-effectiveness threshold. CONCLUSIONS: A therapeutic strategy starting with SNM may be considered cost effective in the midterm and cost saving in the long-term treatment of idiopathic OAB from the INHS perspective.

Persistence and adherence with urinary antispasmodic medications among employees and the impact of adherence on costs and absenteeism.

BACKGROUND: Overactive bladder (OAB) and related conditions, such as urge urinary incontinence (UI), can interfere with work, leisure activities, and healthy sleep patterns. OBJECTIVES: To report (a) employee urinary antispasmodic (UA) medication persistence and adherence; (b) the impact of salary and copay on adherence; and (c) the impact of UA adherence on medical, pharmacy, sick leave (SL), short- and long-term disability (STD, LTD), workers' compensation costs, work absence days, and turnover. METHODS: This retrospective study used a 2001-2011 database of claims, payroll, and demographic data from 27 large U.S. employers. Employees aged 18-64 years taking UA medications with health plan enrollment from 6 months before the index UA medication prescription to 12 months after were included. Persistence (days until first ≥ 30-day gap in UA medication supply) and adherence (percentage of the annual post-index period with available medication) were assessed using survival analysis and generalized linear regression models that controlled for demographics, job-related factors, copay, and pre-index employee benefit utilization.  RESULTS: 2,960 employees met study criteria. Median days of persistence by OAB subtype were 76, 82, 43, 66, and 60 for urge UI, mixed UI, nocturnal UI, other OAB, and no diagnosis, respectively (P less than 0.05 for urge and mixed vs. no diagnosis). Increased copay and copay as a percentage of salary were associated with lower adherence. Employees with ≥ 80% adherence had lower medical, SL, and STD and higher overall drug costs than employees with less than 80% adherence.  CONCLUSIONS: This study suggests potential economic benefits to employers from increased UA adherence. Additionally, economic factors such as ability to pay influence adherence to UA medications.

Economic burden of urge urinary incontinence in the workplace.

OBJECTIVE: Quantify incremental employee medical, pharmacy, sick leave, short- and long-term disability, and workers' compensation costs, absence days, and turnover associated with urge urinary incontinence (UUI) in employees. METHODS: This retrospective 2001-2011 database comparison of employees with UUI versus those without UUI (controls) included employees aged 18.5 to 64.0 years at index, with 6-month preindex and 12-month postindex health plan enrollment. Logistic and generalized linear models measured postindex costs, absences, and turnover. RESULTS: The study included 1448 employees with UUI and 337,796 controls. Employees with UUI had statistically significantly higher medical (131% higher), pharmacy (52%), sick leave (30%), and short-term disability (74%) costs and more sick leave (22%) and short-term disability (99%) days than controls (all P < 0.02). CONCLUSIONS: Employees with UUI had 117% greater medical and pharmacy costs, 47% greater total absence costs, and 63% more absence days than employees without UUI.

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. 

Direct and indirect cost of urge urinary incontinence with and without pharmacotherapy.

OBJECTIVE: To evaluate the impact of treating urge urinary incontinence (UUI), including mixed urinary incontinence (MUI), on healthcare resource utilisation, productivity, activity impairment and associated costs. METHODS: The study used data from the 2011 U.S. National Health and Wellness Survey, an Internet-based questionnaire of a nationwide sample of adults. UUI or MUI respondents were identified via three Incontinence Questions. Respondents with stress urinary incontinence only, prostate cancer or (medication for) benign prostatic hyperplasia were excluded. UUI/MUI respondents were categorised as Rx users for overactive bladder (OAB) and non-Rx users (who never used Rx and whose condition reportedly interfered with life activities or was difficult to manage). Outcome measures included healthcare utilisation and Work Productivity and Activity Impairment questionnaire-based scores. Direct and indirect costs were estimated using 2010 labour and 2008 medical expenditure data sources. Generalised linear models predicted resource use and productivity as a function of treatment status, adjusting for covariates (e.g. sociodemographics, OAB severity, comorbid status) that may also predict impairment. RESULTS: Rx (vs. non-Rx) users were more likely to be female (80.7% vs. 70.0%), older (mean = 62.7 vs. 53.1) and reporting more moderate-to-severe OAB (70.9% vs. 52.6%; all p < 0.05). Adjusting for covariates, Rx (vs. non-Rx) users had significantly lower activity impairment (41.1% vs. 46.8%), more provider visits (7.42 vs. 5.60) and costs ($18,175 vs. $13,679), and higher total direct costs ($27,291 vs. $21,493), all p < 0.01. CONCLUSIONS: Urge urinary incontinence patients using, vs. never using, prescription medication reported lower activity impairment but higher direct costs. These findings may inform the degree to which UUI pharmacotherapy affects health outcomes.

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.

[Pharmacoeconomic study of using solifenacin for the treatment of urge urinary incontinence in patients with overactive bladder syndrome].

Overactive bladder syndrome (OAB), accompanied by incontinence, is a relatively common disease. Currently, in the Russian Federation, unfortunately, management of patients with OAB includes the recommendations for symptomatic use of incontinence pads without pharmacotherapy. Along with this, the market is represented by a number of drugs that can reduce the occurrence of adverse symptoms associated with OAB syndrome. This study presents the pharmacoeconomic analysis of use of solifenacin for the treatment of patients with the OAB syndrome in Russia. Based on previous clinical studies, formal mathematical model for the development of OAB have been suggested, taking into account the concomitant symptoms (urinary incontinence), and complications (urinary tract infections, skin infections, depression and fractures). The model considers the direct medical and non-medical costs, as well as indirect social costs, arising from the traditional management of patients with OAB syndrome (no medication) and the use of solifenacin. As a result, it was found that the use of solifenacin is economically feasible option for the management of patients with OAB within 1 year, the difference in costs between these strategies per patient is 2,385 rubles. The use of solifenacin ceases to be a resource-saving if the cost of incontinence pads will reduced by more than half of the basic price included in the calculations, or if the effectiveness of solifenacin would be 15% lower than the value used in the basic model.

Cost-effectiveness of test phase implantation strategies for InterStim® sacral neuromodulation.

OBJECTIVE: Sacral neuromodulation with InterStim can be performed with staged implants or peripheral nerve evaluation followed by a combined stage I/II procedure. In both, unilateral or bilateral leads can be placed for the testing phase. Our objective was to determine the cost-effectiveness of these strategies in patients with refractory overactive bladder. METHODS: A cost-effectiveness model compared 6 strategies, namely, unilateral and bilateral testing for both stage I and peripheral nerve evaluation, combined stage I/II, and no treatment. Costs were derived from a societal perspective using Medicare physician fee schedules and published studies. Quality-adjusted life-years (QALYs) were assigned using utility values. Results were reported using incremental cost-effectiveness ratios. Model robustness was assessed using probabilistic sensitivity analysis. Monte Carlo analysis sampled statistical distributions for each variable to examine the effects of varying all values simultaneously. RESULTS: No InterStim treatment was the least expensive but also the least effective option. Unilateral and bilateral stage I were the only cost-effective options with incremental cost-effectiveness ratios of $3533 and $7600, respectively. Because bilateral stage I was more effective, it is preferred. Probabilistic sensitivity analysis showed bilateral stage I was most likely to be cost-effective at willingness-to-pay thresholds greater than $6000 per QALY. At lower thresholds, no treatment was more economically acceptable. CONCLUSIONS: Bilateral and unilateral stage I lead placement were the only cost-effective strategies. Bilateral stage I was preferred due to greater effectiveness. In probabilistic sensitivity analysis, bilateral stage I was the most likely cost-effective strategy at all willingness-to-pay thresholds greater than $6000 per QALY confirming model robustness.

Cost-effectiveness analysis of newer anticholinergic drugs for urinary incontinence vs oxybutynin and no treatment using data on persistence from the Swedish prescribed drug registry.

UNLABELLED: Study Type - Therapy (cost effectiveness). Level of Evidence 2a. What's known on the subject? and What does the study add? Anticholinergic drugs are a common treatment alternative in urinary incontinence, which results in large costs for caregivers. So far, most cost-effectiveness analyses of anticholinergic drugs have focused on small putative differences between the newer anticholinergics. This study takes a novel approach by treating the clinical effects of the newer alternatives as similar and evaluating them as a group in relation to no treatment and oxybutynin (immediate release). It also uses registry data to account for persistence. OBJECTIVE: • To analyse the cost-effectiveness of newer anticholinergic drugs in relation to oxybutynin immediate release (IR) and no treatment for patients with urgency urinary incontinence. PATIENTS AND METHODS: • A decision analytic model was constructed. • Results were collected from randomized trials and combined with registry data on persistence of medicine use and estimated number of severe adverse events. • The setting corresponds to Swedish clinical practice. • The costs and effects of the treatment options were analysed over a period of 1 year. Costs included drug costs, treatment costs and costs for pad use. Patients' utilities were based on treatment effect and the lack or presence of adverse events. RESULTS: • No treatment was the least costly treatment but also resulted in the fewest number of quality adjusted life years (QALYs). • Treatment with newer anticholinergic drug medications is the most costly option but also the most efficient treatment. Sensitivity analyses showed that the results were robust. • Treatment with newer anticholinergics resulted in a cost per QALY gained of €21 045 compared with no treatment and no effect and €65 435 compared with no treatment and placebo effect. Compared with oxybutynin IR, the cost per QALY gained was €37 119. These calculations are based on relatively low pad costs, resulting in higher costs per QALY for the original drugs. CONCLUSIONS: • The newer anticholinergic medications are likely to be cost effective in relation to oxybutynin IR. • The cost-effectiveness of the newer anticholinergics compared with no treatment depends on assumptions of the effect of no treatment, the severity of the treated condition and the treated individual's risk of adverse events. • Treatment is less likely to be cost effective for elderly persons or for persons otherwise at higher risk for adverse events.

Urinary incontinence: pharmacotherapy options.

The impact of incontinence is felt by millions of people worldwide, with tremendous decrement in quality of life and enormous cost reaching billions of dollars. Urinary incontinence is defined as 'involuntary leakage of urine' and is categorized into two main types: urgency urinary incontinence (UUI) and stress urinary incontinence (SUI). Behavioral modifications and pharmacologic therapies, primarily antimuscarinic agents, are the mainstay of treatment for UUI. These drugs are moderately efficacious but have troublesome side-effects, the combination resulting in poor compliance and persistence with therapy. There are several agents on the market today, each with some variation in pharmacologic properties. Whether these translate into meaningful differences in clinical efficacy and tolerability remains a matter of debate. Treatment of SUI has seen little success with pharmacologic therapy. In Europe, duloxetine is approved for treatment of SUI with marginal success rates; this drug, although available in the United States for treatment of depression, is not approved for SUI. The search for newer and better pharmacologic options and novel therapies is on-going, fueled primarily by the high prevalence of bothersome incontinence and the tremendous number of health care dollars spent on current therapy. This review addresses pharmacologic options for treatment of urinary incontinence.

Cost-effectiveness of sacral neuromodulation versus intravesical botulinum A toxin for treatment of refractory urge incontinence.

PURPOSE: We determined the cost-effectiveness of sacral neuromodulation vs intravesical botulinum toxin A for the treatment of refractory urge incontinence. MATERIALS AND METHODS: We developed a Markov decision model using a societal perspective to compare costs (2008 U.S. dollars) and effectiveness (quality adjusted life-years) of sacral nerve stimulation and botulinum toxin A. Our primary outcome was the incremental cost-effectiveness ratio, which was defined as (sacral nerve stimulation cost - botulinum toxin A cost)/(sacral nerve stimulation quality adjusted life-year - botulinum toxin A quality adjusted life-year). Sensitivity analyses were performed to assess the impact of varying efficacy, costs and adverse event rates over the range of reported values. RESULTS: In the base case scenario sacral nerve stimulation was more expensive ($15,743 vs $4,392) and more effective (1.73 vs 1.63 quality adjusted life-years) than botulinum toxin A during a 2-year period. The incremental cost-effectiveness ratio was $116,427 per quality adjusted life-year. Using conventional incremental cost-effectiveness ratio thresholds of $50,000 and $100,000 per quality adjusted life-year, sacral nerve stimulation was not cost-effective. In sensitivity analyses intravesical botulinum generally remained cost-effective. CONCLUSIONS: During a 2-year period botulinum toxin A was cost-effective compared to sacral neuromodulation for the treatment of refractory urge incontinence. Additional data regarding time to failure after botulinum toxin A injections, long-term efficacy with repeat botulinum toxin A injections and long-term complications with both therapies will be helpful for future cost-effectiveness studies.

The total economic burden of overactive bladder in the United States: a disease-specific approach.

OBJECTIVE: To employ results from a recent US population-based survey to calculate disease-specific total costs of overactive bladder (OAB). STUDY DESIGN: Disease-specific total cost-of-illness method using population prevalence estimates. METHODS: Cases were identified as community-dwelling adults reporting the presence of urinary urgency or urgency urinary incontinence. Two OAB classifications were used based on Likert scale responses of OAB symptoms: "often" (base case) or "sometimes" (alternative). The study estimates disease-specific total costs of OAB from the societal perspective and using an average costing method. A population-based survey, a claims data analysis, and the published literature provided the prevalence and resource utilization data. RESULTS: The prevalence of OAB as defined in the base case (alternative) was 18.6% (28.7%) in the adult US population, accounting for 42.2 million (65.1 million) community-dwelling adults. The disease-specific total cost of OAB is estimated at $24.9 billion for the base case and $36.5 billion for the alternative case. Total direct costs were $22.3 billion in the base case and $33.5 billion in the alternative case. Costs were higher among adults younger than 65 years of age, compared with adults 65 years or older. This relative cost burden was lower for the base case compared with the alternative case in the full sample, with a larger gap among men. CONCLUSION: The total cost of OAB among community-dwelling adults is significant and varies with demographic groups. Future research is needed to determine whether the differential cost burden is robust to alternate cost-of-illness estimation methods.