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
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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)