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Supplements The Clinical, Social, and Economic Implications of Neurogenic Bladder in Managed Care: Optimizing Pa

Managed Care Aspects of Managing Neurogenic Bladder/Neurogenic Detrusor Overactivity

William J. Cardarelli, PharmD
Neurogenic bladder (NGB) and neurogenic detrusor overactivity (NDO) manifesting in urinary incontinence (UI) can present substantial treatment challenges to clinicians managing patients with underlying neurologic disorders such as multiple sclerosis, Parkinson’s disease, spinal cord injury, spina bifida, and stroke. Although the clinical disease burden alone is difficult for patients and those managing their disorders, the significant negative impact that NGB/NDO and UI can have on health-related quality of life and the economic costs surrounding these disorders can be devastating for patients already burdened with neurologic disorders. Careful clinician assessment of these quality-of-life issues and the economic impact of NGB/NDO with UI is needed to appropriately assess the burden these disorders place on patients and their management and to assist clinicians to design the most clinically, socially, and economically effective individualized management plans to optimize patient outcomes.

(Am J Manag Care. 2013;19:S205-S208)
The Problem of Neurogenic Bladder and Neurogenic Detrusor Overactivity

Neurogenic bladder (NGB) is a form of lower urinary tract dysfunction created by a loss of voluntary control of bladder function due to nervous system injury or neurologic disease such as multiple sclerosis (MS), Parkinson’s disease (PD), spinal cord injury (SCI), or spina bifida.1 This loss of bladder control may result from involuntary bladder contractions during the filling and storage phases of the process of urination, a phenomenon termed neurogenic detrusor overactivity (NDO).2 NDO results in sustained high bladder pressure and urinary incontinence (UI) or sphincter-detrusor dyssynergia, leading to a loss of coordination of bladder function.1,3 Among the substantial complications patients with NGB can experience are urinary tract infections (UTIs) with risk of progression to sepsis, urinary retention, chronic vesicoureteral reflux, and kidney hydronephrosis with risk of progression to overt renal failure due to high intravesical pressures. Secondary changes of the bladder wall may occur. UI itself can be difficult to manage in patients with NGB as a result of restricted mobility created by their underlying neurologic disease.1 NDO and accompanying UI can create physical complications such as skin decubiti, urethral erosions, and upper urinary tract damage. UI itself can result in diminished quality of life (QoL) for patients with NGB/NDO, manifesting as embarrassment, depression, and social isolation and sexual dysfunction. UI can create significant health and lifestyle burdens for patients with neurologic disorders.4

Overactive bladder (OAB) develops in a variety of patient types, including the elderly, women post-childbirth or who are post-menopausal, and men with prostatic enlargement.1,5 Although patients with NGB and OAB share some characteristics and symptoms, the economic burden and impact on QoL of OAB have been well studied and characterized, whereas those of NGB are not as well known and understood. Because of their underlying neurologic abnormalities, patients with NGB and NDO and related UI may view their urinary symptoms differently from their healthy counterparts. A better understanding of the negative effects of lower urinary tract dysfunction on the healthcare utilization, economic outcomes, and QoL in patients with neurologic disorders is crucial to assist clinicians in optimizing patient assessment and therapy, leading to better outcomes and health-related quality of life (HRQoL) for these patients.1,2

The Healthcare Utilization Impact of Neurogenic Bladder

Manack and colleagues published a study in 2011 evaluating the epidemiology and healthcare utilization patterns of patients with NGB dysfunction related to incontinence using a United States insurance claims database. The purpose of the study was to characterize the profile of patients with NGB, their medication utilization, and their healthcare visits/encounters surrounding NGB dysfunction specifically related to incontinence. A total of 46,271 patients were in the main NGB cohort. Subcohorts including 9315 patients with MS and 4168 patients with SCI were also assessed. Medical and pharmacy claims were retrospectively analyzed for a 1-year period. Demographic data, concomitant diseases, and use of oral medications for bladder overactivity (OAB drugs) were summarized as part of the study. The mean age of the patients studied was 62.5 years.1

Results of the study demonstrated a high frequency of UTIs (range of 29% to 36% of patients), obstructive uropathies (6% to 11%), and urinary retention (9% to 14%) in the patients with NGB. A smaller proportion of patients were diagnosed with upper urinary tract infections (1.4% to 2.2%). Some serious systemic conditions were found, specifically sepsis (including septicemia, range of 2.6% to 4.7%) and episodes of acute renal failure (0.8% to 2.2%). Approximately 33,100 patients (71.5%) studied were using an oral OAB medication, with oxybutynin and tolterodine the drugs most frequently used (39.0% and 36.9% of patients, respectively). The mean number of days on OAB drug calculated to 201.9 days, with the average length of time on drug at 209.1 days. The percentage of patients using OAB drugs who discontinued their medications and did not restart them was 30.5%.

Analysis of use of healthcare resources demonstrated that during the 1-year follow-up period, 39% of patients with NGB visited a urologist, and 31.7% underwent consultation with a neurologist. More than half of patients with MS and almost one-fifth of those with SCI visited a neurologist (52.6% and 18.5%, respectively). Healthcare encounters were measured using the number of patients with NGB who were hospitalized (33.3%), treated in the emergency department (ED) (23.4%), or who resided in a nursing home (14.4%). More patients in the SCI subcohort (42.3%) were hospitalized than in the overall NGB cohort (33.3%) and the MS subcohort (21.4%). Similarly, more patients with SCI underwent ED treatment than in the main cohort or MS subcohort (25.9% vs 23.4% and 19.9%, respectively) and resided in nursing care facilities (15.0% vs 14.4% and 6.8%, respectively). More than 21% of those patients hospitalized in all cohorts were diagnosed with lower UTIs, with approximately 8% being treated for sepsis/septicemia. Of those hospitalized, 5.6% were diagnosed with urinary retention, and 5.4% were found to have obstructive uropathies. Overall, patients with NGB averaged 16 office and 0.5 ED visits annually.1

The authors of the study commented that the most striking finding was the high frequency of lower UTIs, urinary obstruction, and retention in all of the NGB cohorts, all of which led to increased healthcare services utilization. UTIs and urinary retention are of special concern because they can progress to upper tract involvement and serious renal and systemic complications and hospitalization.1,6 Obstructive uropathies can also lead to severe kidney damage, including renal failure.1,7 In this study, 22% of patients with NGB and lower UTIs were hospitalized, as were 46% of patients with upper UTIs. Approximately 17% of those with obstructive uropathies underwent hospitalization, and although there were proportionally fewer patients diagnosed with acute renal failure, more than 66% of these patients were hospitalized. The fact that these statistics represent only a 1-year period must be taken into consideration, as it is probable that more serious chronic and systemic complications would develop over a longer period of time.1 Patients with NGB were noted to have multiple diagnoses on record and were receiving several different classes of medications, suggesting a substantial level of other comorbidities associated with their primary disorder. Although overall and indirect costs have been calculated for patients with OAB (cost data from the year 2000 were calculated at approximately $12.02 billion), a direct comparison of healthcare utilization and costs has not been performed surrounding NGB.1,8 However, the high number of complications, comorbidities, specialist consultations, and medication usage in the Manack epidemiologic study suggests a proportionately higher cost per patient for management of NGB compared with OAB.1

One other important factor surrounding healthcare utilization in NGB is patient adherence to therapy. One retrospective analysis of a pharmacy claims database evaluated therapy adherence in 515 patients taking immediate-release oxybutynin and 505 patients using tolterodine, common antimuscarinic therapies approved by the US Food and Drug Administration and prescribed for NDO. The results demonstrated that less than one-third of patients on either treatment had 6 months of continuous therapy. Prescriptions were not refilled by 68% of those taking oxybutynin and 55% of those prescribed tolterodine.1,9 Considering that 71.5% of patients studied in Manack et al received 1 or more OAB oral agent, data strongly suggest that patients with NGB are not managing their disorder optimally considering the high rate of discontinuation of first-line therapies.1 Another study showed that patients on extended-release medication actually had a higher nonpersistence rate than those on immediate-release drugs.10 Adherence is an important factor in therapy and patient management, especially when considering that combination therapy using 2 or more drugs may be needed in many patients with NGB to improve outcomes.11

One could speculate that the reason for this lack of adherence is related to the undesirable adverse effects associated with OAB agents, including dry mouth, constipation, and blurred vision. It also might be related to the patient’s perceived benefit of therapy (or lack thereof).12 Another consideration is the patient’s out-of-pocket cost, although even the elimination of copays does not seem to have a positive effect on adherence.10

Manack et al conducted a large observational study to characterize the epidemiology and healthcare utilization of patients with NGB. The results demonstrated the high rates of comorbidities and complications these patients experience and their high utilization of healthcare resources. The data suggest that these patients are experiencing suboptimal management of their NGB, indicated by both their excessive rate of urinary tract complications and high rates of hospitalization. Future studies will be needed to assist in developing more effective treatment pathways for these patients to assist clinicians in optimizing their management and adherence to therapy.1

The Health-Related and Economic Impact of Urinary Incontinence Associated With Neurogenic Detrusor Overactivity

In a study by Tapia et al, published in 2013, the primary objective was to assess HRQoL and economic burden in patients with neurologic disorders and urgency UI due to NDO in countries in North America, the European Union, Asia, and Australia. Systematic literature searches and review of English language articles published between January 2000 and February 2011 were performed. Studies assessing the impact of UI on HRQoL in patients with underlying neurologic disorders (MS, PD, SCI, spina bifida, and stroke) were included in the analysis. Economic studies in urgency UI were also included. Final delineation of sources provided a total of 27 relevant articles, of which 16 presented HRQoL data and 11 information on economic burden in these patients.2

 
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