[ARTICLE] Cost-Effectiveness of Treating Upper Limb Spasticity Due to Stroke with Botulinum Toxin Type A: Results from the Botulinum Toxin for the Upper Limb after Stroke (BoTULS) Trial – Full Text

Abstract

Stroke imposes significant burdens on health services and society, and as such there is a growing need to assess the cost-effectiveness of stroke treatment to ensure maximum benefit is derived from limited resources. This study compared the cost-effectiveness of treating post-stroke upper limb spasticity with botulinum toxin type A plus an upper limb therapy programme against the therapy programme alone. Data on resource use and health outcomes were prospectively collected for 333 patients with post-stroke upper limb spasticity taking part in a randomized trial and combined to estimate the incremental cost per quality adjusted life year (QALY) gained of botulinum toxin type A plus therapy relative to therapy alone. The base case incremental cost-effectiveness ratio (ICER) of botulinum toxin type A plus therapy was £93,500 per QALY gained. The probability of botulinum toxin type A plus therapy being cost-effective at the England and Wales cost-effectiveness threshold value of £20,000 per QALY was 0.36. The point estimates of the ICER remained above £20,000 per QALY for a range of sensitivity analyses, and the probability of botulinum toxin type A plus therapy being cost-effective at the threshold value did not exceed 0.39, regardless of the assumptions made.

1. Introduction

Stroke is a major cause of mortality and morbidity and imposes a significant burden on both health services and society [1,2,3]. In the United Kingdom (UK) it is estimated that the annual direct costs of stroke are approximately £4 billion, which constitutes around 5.5% of the total UK expenditure on health care [3]. If the costs of lost productivity and informal care are taken into account, the total annual societal costs of stroke are estimated to be around £9 billion [3]. In England, over 900,000 people are living with the consequences of stroke, 300,000 of whom are moderately or severely disabled [4]. As the proportion of older people in society increases, so the burden of stroke is likely to grow.

Upper limb spasticity after stroke is an important clinical problem and its identification and treatment are key components of stroke rehabilitation [5]. Upper limb spasticity may cause deformity, reduced function and pain [6]. Botulinum toxin type A, which when given by intramuscular injection causes temporary local muscle paresis by blocking neuromuscular transmission [7], has become an established treatment for spasticity due to stroke. Randomised controlled trials have shown that botulinum toxin reduces muscle tone [8] and improves the performance of basic upper limb functional tasks such as hand opening for cleaning and ease of dressing [9,10,11]. However, the impact on active upper limb function (e.g., reaching and grasping) and the efficacy of repeated treatment is less clear.

The BoTULS trial was a pragmatic multi-centre randomised controlled trial to evaluate the clinical and cost-effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity. The clinical results indicated that botulinum toxin type A did not improve active upper limb function (as measured by the Action Research Arm Test (ARAT)), but that there may be benefits in terms of decreased muscle tone, improved upper limb strength, improved ease of performance of basic upper limb functional activities and reduction in pain [12]. This article describes the results of the cost-effectiveness analysis. […]

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