Cost-effectiveness of mirabegron and tolterodine for the treatment of overactive bladder in Japan - Which drug is more cost-effective if used as the first-line treatment?
IUGA Academy. Yamanishi Y. Jun 30, 2018; 212783
Topic: Overactive Bladder
Yuriko Yamanishi
Yuriko Yamanishi

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Cost-effectiveness of mirabegron and tolterodine for the treatment of overactive bladder in Japan - Which drug is more cost-effective if used as the first-line treatment?

Yamanishi, T1;Yamanishi, Y2; Tajima, H3; Ikeda, S4

1: Continence Center, Dokkyo Medical University; 2: Department of Pharmacy, Toho University Omori Medical Center; 3: Department of Pharmacy, Yokohama Sakae Kyosai Hospital; 4: Department of Public Health, School of Medicine, International University of Health and Welfare

Introduction: Mirabegron (Mira), a Beta3-adrenoceptor agonist, is expected to be the first choice of treatment as well as anticholinergic drugs. However, pharmaco-econnomic study for this drug has not been performed in Japan.

Objectives: To evaluate the cost-effectiveness of Mira 50mg/day relative to tolterodine extended release (Tol) 4mg/ day, an antimuscarinic (anti-M) drug, if used as the first-line treatment in patients with overactive bladder (OAB) in Japan.

Methods: A Markov model was developed to simulate the cost effectiveness of these drugs taken for 5 years from the randomized European-Australian phase III study of Mira (SCORPIO trial), and single technology appraisal assessment report by the NICE (STA report). For the study of transition of treatment status, our analytical model was established based on the transitions of the following two parameters; “transition of treatment status” and “transition of OAB symptoms based on treatment efficacy. After treatment discontinuation, the probability was set at 26.1% for switch to second-line treatment, and 73.9% for switch to no treatment. The probability of treatment restart after switch to no treatment was set at 5.6% from the STA report; the percentage of restart was set at 33.3% for first-line treatment and 66.7% for second-line treatment. The incremental cost-effectiveness ratio (ICER) was calculated with utility value by Quality-Adjusted Life Year (QALY) with cost using the medical fee and the drug price tariff in 2016. For the study of transition of OAB symptoms based on treatment efficacy, the cycle length was set at 1 month, and there were 60 transition cycles in 5years. The mean numbers of micturition episodes per day and incontinence episodes per day were combined to define the severity state of OAB. The severity states were classified into 25states from A to Y. The transition probabilities of severity states were calculated based on the probabilities for the mean numbers of incontinence episodes per day and micturition episodes per day in Mira-treated and Tol-treated patients in the STA report.

Results: The 5-year expected effect per patient was 3.860 QALYs for Mira 1st and 3.839 QALYs for Tol 1st. The 5-year expected cost per patient was 526,191 yen for Mira 1st, and 472,390 yen for Tol 1st. In first-line mirabegron therapy compared with first-line tolterodine therapy, the ICER was 2,565,927 yen/QALY. This ICER remained below the generally accepted willingness-to-pay threshold of five million yen /QALY. In T and Y of severer states based on the mean number of micturition episodes per day, the ICER exceeded 5million yen. The ICER was below this threshold in other severity states.

Conclusions: First-line Mira at 50 mg/day appeared to be more cost-effective than first-line Tol at 4 mg/day in Japan. In patients with severe symptoms, the ICER of first-line mirabegron exceeded 5 milion yen/QALYs, and Mira 1st was not economically preferable in these patients.


Work supported by industry: no.

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