Impact of urinary incontinence on healthcare resource utilization, health-related quality of life and productivity in patients with overactive bladder.

OBJECTIVE: To evaluate the impact of urinary incontinence (UI) on healthcare resource utilization (HRU), health-related quality of life (HRQoL) and productivity measures in patients with overactive bladder (OAB). PATIENTS AND METHODS: This retrospective, cross-sectional study used data from the Adelphi OAB/UI Disease Specific Programme, a multinational survey of patient- and physician-reported data, fielded between November 2010 and February 2011. The primary patient groups of interest were those with OAB, both with and without UI. Health-related quality of life and productivity measures were derived from the EuroQoL-5D, the Incontinence Quality of Life questionnaire, the Overactive Bladder Questionnaire, and the Work Productivity and Activity Impairment Questionnaire. Measures of HRU included OAB-related surgeries, OAB-related hospitalizations, incontinence pads, anticholinergic use and physician visits. Multivariate linear regression models and literature-based minimal clinically important differences were used to assess statistically significant and clinically meaningful differences in HRQoL and productivity measures between patients with OAB with UI and those without UI. RESULTS: A total of 1 730 patients were identified, with a mean age of 60.7 years, and 77.0% of them were women, 84.2% were non-Hispanic whites, and 71% were incontinent. Bivariate analyses showed that HRU was significantly higher among patients with OAB with UI than among those without UI in all categories except for the number of OAB-related physician visits. In both bivariate and multivariate analyses, incontinent patients presented with clinically and statistically significantly lower HRQoL and productivity measures with respect to all study endpoints, except for percentage of work time missed due to their OAB/UI. CONCLUSIONS: Urinary incontinence was associated with significantly higher HRU and lower HRQoL and productivity in this population of patients with OAB from five different countries. In addition to clinical considerations, the economic and humanistic impact of UI should be taken into account when evaluating treatment options for patients with OAB.

Economic and humanistic consequences of preventable bladder tumor recurrences in nonmuscle invasive bladder cancer cases.

PURPOSE: Perioperative intravesical chemotherapy following transurethral resection of bladder tumor has been underused despite level 1 evidence supporting its performance. The primary objective of this study was to estimate the economic and humanistic consequences associated with preventable recurrences in patients initially diagnosed with nonmuscle invasive bladder cancer. MATERIALS AND METHODS: Using population based estimates of nonmuscle invasive bladder cancer incidence, a 2-year model was developed to estimate the number of preventable recurrences in eligible patients untreated with perioperative intravesical chemotherapy. Therapy utilization rates were obtained from a retrospective database analysis and a chart review study of 1,010 patients with nonmuscle invasive bladder cancer. Recurrence rates of nonmuscle invasive bladder cancer were obtained from a randomized clinical trial comparing transurethral resection of bladder tumor with or without perioperative mitomycin C. Costs were estimated using prevailing Medicare reimbursement rates. Quality adjusted life-year estimates and disutilities for complications were obtained from the literature. RESULTS: The model estimated that 7,827 bladder recurrences could be avoided if all patients received immediate intravesical chemotherapy. It estimated an economic savings of $3,847 per avoidable recurrence, resulting in an aggregate savings of $30.1 million. The model also estimated that 1,025 quality adjusted life-years are lost every 2 years due to preventable recurrences, resulting in 0.13 quality adjusted life-years (48 quality adjusted days) lost per avoidable recurrence. This translates into 0.02 quality adjusted life-years (8.1 quality adjusted days) lost per patient not receiving immediate intravesical chemotherapy. CONCLUSIONS: Greater use of immediate intravesical chemotherapy in the United States has the potential to substantially decrease the economic and humanistic burdens of nonmuscle invasive bladder cancer.

Estimating the cost-effectiveness of onabotulinumtoxinA for neurogenic detrusor overactivity in the United States.

BACKGROUND: Urinary incontinence (UI) secondary to a neurogenic pathology, including spinal cord injury and multiple sclerosis, is termed neurogenic detrusor overactivity (NDO). Patients with NDO experience decreased quality of life and are at risk for upper urinary tract damage. Two recent trials demonstrated that onabotulinumtoxinA significantly reduced UI, improved urodynamic parameters, and improved quality of life relative to placebo. However, the economic impact of onabotulinumtoxinA treatment for UI due to NDO in the United States remains unknown. OBJECTIVE: The objective of this analysis was to evaluate whether the benefit observed in NDO patients receiving onabotulinumtoxinA provides good value for money. METHODS: We developed a Markov state transition model to estimate population outcomes and costs for anticholinergic-refractory NDO patients who received either onabotulinumtoxinA or best supportive care (use of incontinence pads with either an anticholinergic drug, clean intermittent self-catheterization, or both). Nonresponding patients (<50% reduction in UI episodes at 6 weeks) were eligible to receive invasive procedures, including augmentation cystoplasty or sacral neuromodulation. Patients could transition through 6 health states, 3 defined based on response to initial treatment, 2 capturing patients who underwent invasive procedures, and death. Time in each health state was adjusted for patient quality of life and summed to estimate quality-adjusted life-years (QALYs). The model included direct medical costs related to initial and subsequent drug and invasive treatments, physician visits, and catheterization. Outcomes and costs were summed and compared across intervention groups by using the incremental cost-effectiveness ratio (ICER; cost per QALY). The time horizon of the model was 3 years, and results were discounted at 3%. Scenario, 1-way, and probabilistic sensitivity analyses were performed to test the robustness of the model results. RESULTS: In the base case, onabotulinumtoxinA increased QALYs by 0.059 and costs by $1466 compared with best supportive care, which resulted in an estimated ICER of $24,720/QALY. OnabotulinumtoxinA also decreased mean UI episodes per person-year by 398, resulting in a cost of $4 per UI episode avoided. Model results were most sensitive to the probability of treatment response. The probabilistic sensitivity analysis indicated that at a willingness to pay of $50,000/QALY, onabotulinumtoxinA has a 97% probability of being cost-effective. In subgroup analyses of each etiology, onabotulinumtoxinA yielded an ICER of $32,268/QALY in multiple sclerosis and $2182 in spinal cord injury. CONCLUSION: OnabotulinumtoxinA seems to be a cost-effective intervention for UI due to NDO compared with best supportive care.

Surveillance and treatment of non-muscle-invasive bladder cancer in the USA.

Seventy percent of newly diagnosed bladder cancers are classified as non-muscle-invasive bladder cancer (NMIBC) and are often associated with high rates of recurrence that require lifelong surveillance. Currently available treatment options for NMIBC are associated with toxicities that limit their use, and actual practice patterns vary depending upon physician and patient characteristics. In addition, bladder cancer has a high economic and humanistic burden in the United States (US) population and has been cited as one of the most costly cancers to treat. An unmet need exists for new treatment options associated with fewer complications, better patient compliance, and decreased healthcare costs. Increased prevention of recurrence through greater adherence to evidence-based guidelines and the development of novel therapies could therefore result in substantial savings to the healthcare system.

A1C and cardiovascular outcomes in type 2 diabetes: a nested case-control study.

OBJECTIVE: Type 2 diabetes is associated with increased cardiovascular risk. The role of aggressive glycemic control in preventing cardiovascular events is unclear. A nested case-control study design was used to evaluate the association between average A1C and cardiovascular outcomes. RESEARCH DESIGN AND METHODS: Adults with type 2 diabetes were identified among members of Kaiser Permanente Southern California. Type 2 diabetes was identified based on ICD-9 diagnosis codes and either A1C >7.5% or prescriptions for hypoglycemic agents. Case subjects were defined based on nonfatal myocardial infarction, nonfatal stroke, or death attributed to cardiovascular events during a 3-year window. Four type 2 diabetes control subjects were matched to each case subject based on age, sex, and index date for the corresponding case. A conditional logistic regression model was used to estimate the odds ratio of cardiovascular events and compare three patient groups based on average A1C measured in the preindex period (≤6, >6-8, >8%). RESULTS: A total of 44,628 control subjects were matched to 11,157 case subjects. Patients with an average A1C ≤6% were 20% more likely to experience a cardiovascular event than the group with an average A1C of >6-8% (P < 0.0001). Patients with an average A1C >8% experienced a 16% increase in the likelihood of a cardiovascular event (P < 0.0001). We found evidence of statistical interaction with A1C category and LDL level (P = 0.0002), use of cardiovascular medications (P = 0.02), and use of antipsychotics (P = 0.001). CONCLUSIONS: High-risk patients with type 2 diabetes who achieved mean A1C levels of ≤6% or failed to decrease their A1C to <8% are at increased risk for cardiovascular events.