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

BMC Urology, May 2015

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.

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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

Nazir et al. BMC Urology 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 Jameel Nazir Lars Heemstra Anke van Engen Zalmai Hakimi Cristina Ivanescu 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. Benign prostatic hyperplasia; Cost-effectiveness; Fixed-dose combination; Incremental cost-effectiveness ratio; Lower urinary tract symptoms; Quality adjusted life years; Solifenacin; Tamsulosin; Tolterodine - Background The term ‘lower urinary tract symptoms’ (LUTS) is used to describe a condition that encompasses storage, voiding and post-micturition symptoms [1,2]. The aetiology of LUTS can be multifactorial [2,3], but BPH is a common cause in men. Storage symptoms (e.g. urgency, frequency, urgency incontinence and nocturia) and voiding symptoms (e.g. weak or intermittent urinary stream, straining, hesitancy, terminal dribbling and incomplete emptying) are common and frequently co-exist in men with LUTS [4,5]. Storage symptoms represent the most troublesome LUTS, reported in up to 42% of men aged ≥75 years [4]. Storage symptoms are also reported to be the most bothersome LUTS [6]. Overall, the recommended treatment options for men with moderate-to-severe LUTS include α-blockers, 5αreductase inhibitors (in those with a large prostate, 30 g or 40 mL) and antimuscarinic (in those with predominant storage symptoms) [2,4,7]. In addition, α-blocker plus antimuscarinic combination treatment should be considered for patients not adequately responding to monotherapy of either drug [2,4]. However, the majority of men with moderate-to-severe LUTS associated with BPH receive α-blocker monotherapy only [8], whilst less than 25% are reported to receive an antimuscarinic [8,9]. Additionally, α-blocker monotherapy is reported to improve voiding and storage symptoms in men with LUTS/BPH [10,11]. However, storage symptoms may persist in some men after receiving α-blocker monotherapy, epitomised by data from Lee et al. that reported only 35% of men with storage symptoms were sufficiently controlled by this treatment strategy [12]. Several trials have demonstrated that α-blocker plus antimuscarinic combination treatment is more effective than α-blocker monotherapy for men with moderate-tosevere LUTS and documented storage symptoms [13-19]. The most recent phase 3 trial (NEPTUNE), which included 1,334 men with LUTS/BPH who had moderate-to-severe storage symptoms and voiding symptoms, showed that solifenacin 6 mg plus an oral controlled absorption system (OCAS™) formulation of tamsulosin (TOCAS) improved storage symptoms and quality of life compared with TOCAS alone [18]. The combination treatment was also well tolerated and exhibited an adverse event profile similar to that reported for the individual monotherapies. A once-daily, FDC tablet of solifenacin 6 mg plus TOCAS 0.4 mg aimed at treating both storage and voiding sy (...truncated)


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Jameel Nazir, Lars Heemstra, Anke van Engen, Zalmai Hakimi, Cristina Ivanescu. 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, BMC Urology, 2015, pp. 41, 15, DOI: 10.1186/s12894-015-0031-8