Mirabegron or tolterodine for the treatment of overactive bladder in Japan: Which drug is more cost-effective as the first-line treatment?

OBJECTIVES: To assess the cost-effectiveness of mirabegron 50 mg relative to tolterodine extended release 4 mg for the treatment of overactive bladder if used as the first-line treatment in Japan. METHODS: A Markov model was developed to simulate the cost-effectiveness of the mirabegron first-line treatment (and tolterodine second-line) versus tolterodine first-line treatment (and mirabegron second-line) taken for 5 years from the randomized European-Australian study (SCORPIO trial) and single technology appraisal assessment report by the National Institute for Health and Care Excellence. The incremental cost-effectiveness ratio was calculated with utility value by quality-adjusted life year with cost using the medical fee and the drug price tariff in 2016. For the study of transition of treatment status, our analytical model was established. The transition probabilities of severity states were calculated based on the probabilities for the mean numbers of incontinence episodes/day and micturition episodes/day in mirabegron-treated and tolterodine-treated patients in the single technology appraisal assessment report. RESULTS: The 5-year expected effect per patient was 3.860 quality-adjusted life years for first-line mirabegron and 3.839 quality-adjusted life years for first-line tolterodine. The 5-year expected cost per patient was ¥526 191 for first-line mirabegron, and ¥472 390 for first-line tolterodine. The incremental cost-effectiveness ratio was ¥2 565 927/quality-adjusted life year. This value was below the willingness-to-pay threshold of ¥5 million/quality-adjusted life year. In more severe states, the incremental cost-effectiveness ratio exceeded ¥5 million. CONCLUSIONS: First-line mirabegron appears to be more cost-effective than first-line tolterodine. In patients with severe symptoms, first-line mirabegron is not economically preferable.

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.

Cost-effectiveness of a fixed-dose combination of solifenacin and oral controlled adsorption system formulation of tamsulosin in men with lower urinary tract symptoms associated with benign prostatic hyperplasia.

BACKGROUND: Storage symptoms, associated with benign prostatic hyperplasia (BPH), often co-exist with voiding symptoms in men with lower urinary tract symptoms (LUTS). Storage symptoms are likely to be most bothersome, and may not be adequately resolved by treatment with α-blocker or antimuscarinic monotherapy. A recent randomised controlled phase 3 trial (NEPTUNE) demonstrated that a fixed-dose combination (FDC) of solifenacin 6 mg plus an oral controlled absorption system (OCAS™) formulation of tamsulosin (TOCAS, 0.4 mg) improved storage symptoms, as well as quality of life, compared with TOCAS alone in men with moderate-to-severe storage symptoms and voiding symptoms. This analysis aimed to assess the cost-effectiveness of a FDC tablet of solifenacin 6 mg plus TOCAS relative to tolterodine plus tamsulosin given concomitantly, from the perspective of the UK National Health Service (NHS). METHODS: A Markov model was developed for men aged ≥45 years with LUTS/BPH who have moderate-to-severe storage symptoms and voiding symptoms. The model calculated cost-effectiveness over an analytical time horizon of 1 year and estimated total treatment costs, quality adjusted life years (QALYs) and incremental cost-effectiveness ratio. RESULTS: The FDC tablet of solifenacin 6 mg plus TOCAS was associated with lower total annual costs (£860 versus £959) and increased QALYs (0.839 versus 0.836), and was therefore dominant compared with tolterodine plus tamsulosin. Time horizon, discontinuation or withdrawal rates, drug cost and utility values were the main drivers of cost-effectiveness. The probability that the FDC tablet of solifenacin 6 mg plus TOCAS is cost-effective was 100% versus tolterodine plus tamsulosin, at a willingness-to-pay threshold of £20,000/QALY gained. CONCLUSIONS: The FDC tablet of solifenacin 6 mg plus TOCAS provides important clinical benefits and is a cost-effective treatment strategy in the UK NHS compared with tolterodine plus tamsulosin for men with both storage and voiding LUTS/BPH.

Use of health care resources and associated costs in non-institutionalized vulnerable elders with overactive bladder treated with antimuscarinic agents in the usual medical practice.

OBJECTIVE: To evaluate the use of resources and health costs in vulnerable elderly institutionalized patients with overactive bladder (OAB) treated with fesoterodine, tolterodine or solifenacin in routine medical practice. MATERIAL AND METHODS: A multicenter retrospective study, from the records of patients treated during 2008-2010 in three geographical locations and starting treatment with antimuscarinic (fesoterodine, solifenacin and tolterodine) for OAB. The attribute of vulnerability was based on collecting at least 3 of the Vulnerable Elders Survey criteria-13, age>75 years, poor/average age for health and difficulty in at least one daily physical activity. MAIN MEASURES: morbidity, persistence and resource use and costs. Monitoring of patients was conducted over 52 weeks. A general linear model with covariates and bootstraping (1000) at random was used to construct the 95% CI of the cost differences between drugs. RESULTS: Records of 552 patients (50.8% women, mean age: 80.2 years) were analyzed. Treated with fesoterodine (N=58), solifenacin (N=252) or tolterodine (N=212). The use of absorbent was 20.7%, 29.4% and 33.0% (P=.186), respectively. Persistence to treatment was slightly greater with fesoterodine. The patient healthcare costs/year were lower with fesoterodine, €1,775 (1550-2014) vs. solifenacin €2,062 (1911-2223) and tolterodine €2,149 (1,978-2,307), P=.042, as a result of lower utilization visits and concomitant medication. CONCLUSIONS: Despite the potential limitations of the study, the vulnerable elderly non institutionalized patients with OAB treated with fesoterodine, compared to solifenacin or tolterodine were associated with lower resource utilization and healthcare costs.