[Analysis of costs and consequences related to the persistence of Mirabegron and antimuscarinic treatments and their impact on quality of life in patients with overactive bladder in Spain: Results of a probabilistic model.] / Análisis de costes y consecuencias relacionados con la persistencia del tratamiento con Mirabegrón y los fármacos antimuscarínicos y su impacto sobre la calidad de vida en los pacientes con vejiga hiperactiva en España: resultados de un modelo probabilístico.

OBJECTIVE: To evaluate whether the lower dropout rate of the treatment of overactive bladde r(OAB) with mirabegron could generate cost savings to the National Health System (NHS) and lead to quality-adjusted life years (QALYs) gains, compared to the most commonly prescribed antimuscarinics (AM) in Spain (tolterodine, fesoterodine, oxybutynin, solifenacin). METHODS: A probabilistic model (second order Monte Carlo simulation) in a hypothetical cohort of 1,000 patients with OAB and a time horizon of 1 year was carried out. Discontinuation and persistence rates for both mirabegron and AM were obtained from a Spanish observational study in 1798 patients. Unit costs (€ 2018) and utility loss associated with treatment discontinuation were obtained from Spanish public prices and literature, respectively. RESULTS: Persistence rates in patients treated with mirabegron were twice as high compared to AM, leading to a QALY gain of 0.0151 ± 0.0007 per year. Treatment with mirabegron could generate savings of 80.74 ±4.61 € per patient per year compared to AM, assuming 100% probability of saving. The hypothetical substitution of AM treatment for mirabegron could potentially generate savings of 6.6 million euros (95% CI 3.9-10.1 million euros) to the NHS and 1,238 QALYs gains (CI95%731; 1,885 QALYs) within a period of 1 year. CONCLUSIONS: The probabilistic model presented showed a greater persistence in patients treated with mirabegron compared to AM, leading to a positive impactin patients quality of life, as well cost savings to the NHS in Spain.

OBJETIVO: Evaluar si la menor tasa de abandonos del tratamiento de la vejiga hiperactiva (VH) con mirabegrón podría generar ahorros para el Sistema Nacional de Salud (SNS) y ganancia de años de vida ajustados por calidad (AVACs), en comparación con los fármacos antimuscarínicos (AM) (tolterodina, fesoterodina, oxibutinina, solifenacina).MÉTODOS: Modelo probabilístico (simulación de Monte Carlo de segundo orden) en una cohorte hipotética de 1.000 pacientes con VH y un horizonte temporal  de 1 año. Las tasas de abandono/persistencia del tratamiento con mirabegrón y AM se obtuvieron de un estudio observacional español en 1.798 pacientes. Los costes unitarios (€ 2018) y la pérdida de utilidades ligada al abandono del tratamiento se obtuvieron de precios públicos españoles y de la literatura, respectivamente. RESULTADOS: En cada paciente tratado con mirabegrón se duplica la tasa de persistencia en comparación con los AM, ganándose anualmente 0,0151 ±0,0007 AVACs, frente a AM. Con mirabegrón se generaría un ahorro anual por paciente de 80,74 ± 4,61 € en comparación con los AM, con una probabilidad de ahorro del 100%. La sustitución hipotética de los AM por mirabegrón, generaría en el plazo de 1 año un ahorro para el SNS de 6,6 millones de euros (IC 95%3,9-10,1 millones de euros) y se ganarían 1.238 AVAC (IC95% 731; 1.885 AVAC). CONCLUSIONES: El modelo probabilístico muestra una mayor persistencia en pacientes tratados con mirabegrón en comparación con los AM, generando un impacto positivo sobre la calidad de vida de los pacientes así como ahorros para el SNS.

[Cost effectiveness of Mirabegron and antimuscarinic drugs in patients with hiperactive bladder.] / Coste-efectividad de mirabegrón y los antimuscarínicos en pacientes con vejiga hiperactiva.

OBJECTIVE: To evaluate the costeffectivenessof mirabegron in comparison to theantimuscarinic drugs tolterodine, solifenacin andfesoterodine, in the treatment of urgency, increasedmicturition frequency and urinary incontinence in patientswith overactive bladder (OAB). MATERIAL AND METHODS: A Markov model in Excel,with a time horizon of 5 years was developed fromthe National Health System and societal perspective.Clinical effectiveness was estimated from a clinical trial(SCORPIO) and a network meta-analysis. Unit costswere obtained from Spanish sources. The effectivenessof the treatments was measured as quality adjusted lifeyears(QALY). Deterministic and probabilistic sensitivityanalyses were performed. RESULTS: For the 5-year time horizon, the incrementalcost per patient with mirabegron 50 mg versustolterodine was € 195.52 and € 157.42, from theNational Health System (NHS) and societal perspectivesrespectively, with a gain of 0.0127 QALY withmirabegron. Consequently, the cost of gaining a QALYwith mirabegron versus tolterodine was 15,432 € and12,425 € respectively. The probability that mirabegronwould be cost-effective at a willingness to pay thresholdof € 30,000 was: 70% (NHS) and 71% (society)versus tolterodine; 94% (NHS and society) versussolifenacin 5 mg; 84% (NHS) and 84.5% (society)versus solifenacin 10 mg; 96% (NHS and society)versus fesoterodine 4 mg; 98% (NHS) and 99% (society)versus fesoterodine 8 mg. The highest probability thatmirabegron would be cost-effective at a willingness topay threshold of € 20.000 and € 25.000 per QALYgained, is obtained versus fesoterodine 4 mg and 8 mgfrom both NHS and society perspectives. CONCLUSIONS: The treatment of patients with OABwith mirabegron 50 mg is likely to be cost-effectivecompared to treatment with antimuscarinics.

OBJETIVO: Evaluar el coste-efectividad de mirabegrón frente a los fármacos antimuscarínicos tolterodina, solifenacina y fesoterodina, en el tratamiento sintomático de la urgencia, el aumento de la frecuencia miccional y la incontinencia de urgencia en los pacientescon vejiga hiperactiva (VH).MÉTODOS: Modelo de Markov en Excel, con un horizonte temporal de 5 años, desde la perspectiva del Sistema Nacional de Salud y de la sociedad. La efectividad clínica se obtuvo de un ensayo clínico frente a tolterodina y de un metaanálisis. Los costes unitarios se obtuvieron de fuentes españolas. La efectividad de los tratamientos se midió como años de vida ajustados por calidad de vida (AVAC). Se realizaron análisis de sensibilidad determinísticos y probabilísticos. RESULTADOS: Para el horizonte temporal de 5 años, el coste incremental por paciente con mirabegrón 50 mg frente a tolterodina es de 195,52 € y 157,42 €, desde las perspectivas del Sistema Nacional de Salud (SNS) y social, respectivamente, con una ganancia de 0,0127 AVAC con mirabegrón. El coste de ganar un AVAC con mirabegrón frente a tolterodina sería de 15.432 € y de 12.425 €, respectivamente. La probabilidad de que mirabegrón sea coste-efectivo frente a tolterodina, sería del 70% y del 71%, respectivamente. Para el SNS, la probabilidad de coste-efectividad de mirabegrón frente a solifenacina 5 y 10 mg sería del 84% y del 84,5%, respectivamente y en comparación con fesoterodina 4 y 8 mg sería del 96% y 98%, respectivamente. CONCLUSIONES: El tratamiento de los pacientes con VH con mirabegrón 50 mg es probablemente coste- efectivo en comparación con el tratamiento con antimuscarínicos.

Development and feasibility assessment of a 3 day electronic bladder diary as an app for smart-phone.

AIMS: To develop a 3 day bladder diary (BD) as an easy-to-use application for smart-phone (eDM3d). To test its feasibility and acceptance in a reduced number of patients. METHODS: An external agency developed the eDM3d following the structure of the Spanish validated 3 day BD (DM3d©), which includes a frequency-volume chart, the assessment of the grade of urgency, the incontinence events and fluid intake. The eDM3d consisted in a main interface of four buttons ("wake up," "go to bed," "urinate," "drink") which had to be clicked to create an event. Results were automatically transferred to an internet server to obtain an electronic report. We recruited 25 patients with overactive bladder syndrome or nocturia and previous experience on paper BD. They were asked to complete the eDM3d. Finally, a direct question about satisfaction was answered: "If you had to complete a BD again, would you choose the paper or the app version?" RESULTS: Three patients (12%) did not complete the eDM3d, 1 patient (4%) completed 2 days of the eDM3d and did not register volumes of micturition nor fluid intake, 1 patient (4%) completed all 2 days variables and 20 patients (80%) completed all 3 day variables. Regarding satisfaction, 19 patients (86.4%) would choose the app version, 2 patients (9.1%) would choose a paper version and 1 patient (4.5%) would choose either indistinctly. CONCLUSIONS: The eDM3d is a useful tool easily filled in by patients with a high satisfaction rate. Adequate validation of the eDM3d is required.

Assessment of treatment-seeking behavior and healthcare utilization in an international cohort of subjects with overactive bladder.

UNLABELLED: Abstract Objective: To assess the association between incontinence severity, treatment-seeking behavior, and healthcare resource utilization (HRU) among participants with overactive bladder (OAB) in eight countries. RESEARCH DESIGN AND METHODS: A cross-sectional online survey of subjects ≥18 years old in Australia, Europe, and North America, who had a past OAB diagnosis and/or experienced ≥1 urinary incontinence (UI) episode in the preceding 12 months, were eligible to participate. Subjects contacted for the survey were primarily from a voluntary medication monitoring registry, MediGuard. Predominantly stress incontinence subjects were excluded. Incontinence severity was assessed by the number of UI episodes over 3 days and grouped as 0 ('dry'), 1-2, 3-4, and ≥5 UI episodes/day. Subject demographics, employment status, comorbidities, treatment-seeking behavior (past OAB diagnosis; spoken to healthcare provider [HCP]), and HRU (diagnostic tests; HCP visits in 6 months before screening) were analyzed by incontinence severity. RESULTS: Overall, 1341 subjects with OAB (mean age 54.5 years; 70.7% female) were surveyed; 20.2%, 47.7%, 18.8%, and 13.3% of subjects reported 0, 1-2, 3-4, and ≥5 UI episodes/day, respectively. Employment status and comorbidities were significantly (p < 0.05) associated with incontinence severity. The two measures of treatment-seeking behavior were significantly (p < 0.05) associated with incontinence severity groups; the proportion of subjects with a past diagnosis of OAB were 35.8%, 44.8%, 52.4%, and 64.0% in the 0, 1-2, 3-4, and ≥5 UI episodes/day groups, respectively; and 59.0%, 63.6%, 65.9%, and 78.1% of subjects in the respective UI severity groups talked to a HCP about their OAB symptoms. Multivariate linear regression analyses showed a positive and consistent association between incontinence severity and HRU; subjects reported a mean of 2.7, 4.1, 4.4, and 7.7 diagnostic tests overall (p < 0.001), and a mean of 1.4, 2.2, 2.7, and 4.0 HCP visits in the 0, 1-2, 3-4, and ≥5 UI episodes/day groups, respectively (p < 0.001). A potential limitation of the study is the cross-sectional survey methodology which limits the ability to draw causal inferences from the results. Additionally, since this is a web-based survey it is possible respondents who have access to/are familiar with technology were more likely to be enrolled. CONCLUSIONS: Incontinence severity was positively associated with both treatment-seeking behavior and HRU among subjects with OAB.