Turcu-Stiolica Adina, Subtirelu Mihaela-Simona, Bumbea Ana-Maria
Department of Pharmacoeconomics, Faculty of Pharmacy, University of Medicine and Pharmacy of Craiova, Craiova, Romania.
Department of Physical Medicine and Rehabilitation, Faculty of Medicine, University of Medicine and Pharmacy of Craiova, Craiova, Romania.
Front Pharmacol. 2020 Jan 16;10:1516. doi: 10.3389/fphar.2019.01516. eCollection 2019.
In Romania, the strokes' incidence is of 61,500 per year and improving upper limb function is the essence in rehabilitation after a stroke to maximize the patient quality of life and reduce disability. In this study, it is compared the cost-effectiveness of the treatment of post-stroke upper limb spasticity with incobotulinumtoxin-A (INCO), with or without electromyographic control, against the conventional therapy programme alone (CON). A Markov state transition model was developed to effectuate a cost-utility analysis (CUA). Measurements of health-related quality of life were derived from relevant clinical trials. Utility values for quality of life by response status were derived from the Short-Form-12 (SF-12) Health Survey data from a published study. The incremental cost-effectiveness ratio (ICER) of INCO (fixed, every 12 weeks) against CON was calculated in Ron per quality-adjusted life-year (QALY) gained for both therapies. Costs and outcomes were discounted using different scenarios at 3% and 5% per year with a time horizon of 3 and 5 years because Romanian legislative norms don't specify the discount rates and time horizon for pharmacoeconomic analysis. Probabilistic sensitivity analyses (PSA) were managed on the base case with distributions attributed to the frequency of repeat dosing and utility valuation of the responder and the non-responder for health utilities derived from both mental and physical health state. Compared with CON, in all 4 scenarios, therapy with INCO had an incremental cost-effectiveness ratio (ICER) of less than 950 Euro per QALY gained (1 Euro = 4.7 Ron). INCO proved to be more favorable treatment option than CON in the treatment of upper limb spasticity in Romania. Despite costs being higher for patients treated with INCO, this treatment has more advantageous Incremental Cost-Effectiveness Ratio. This therapy should be taken into account when considering rehabilitation options because it is highly cost-effective at < EURO 1,000/QALY gained, a very low WTP (Willingness To Pay) threshold. INCO proved to be a disruptive innovation because it is a new and more effective treatment, and, in the end, much higher in quality of life for patients with post-stroke upper limb spasticity.
在罗马尼亚，中风的年发病率为61,500例，改善上肢功能是中风后康复的关键，可最大限度地提高患者生活质量并减少残疾。在本研究中，比较了使用因可必特（INCO）（无论有无肌电图控制）治疗中风后上肢痉挛的成本效益与单纯传统治疗方案（CON）的成本效益。开发了一个马尔可夫状态转换模型来进行成本效用分析（CUA）。健康相关生活质量的测量数据来自相关临床试验。根据已发表研究中的简短健康调查问卷（SF-12）数据得出按反应状态划分的生活质量效用值。计算了INCO（固定剂量，每12周一次）相对于CON的增量成本效益比（ICER），以每获得一个质量调整生命年（QALY）的罗马尼亚列伊（Ron）数来表示两种治疗方法的情况。由于罗马尼亚立法规范未规定药物经济学分析的贴现率和时间范围，因此在3%和5%的不同贴现率以及3年和5年的时间范围内，使用不同情景对成本和结果进行贴现。在基础案例上进行概率敏感性分析（PSA），将分布归因于重复给药频率以及从心理健康和身体健康状态得出的健康效用的反应者和非反应者的效用估值。与CON相比，在所有4种情景中，使用INCO治疗的增量成本效益比（ICER）均低于每获得一个QALY 950欧元（1欧元 = 4.7罗马尼亚列伊）。在罗马尼亚治疗上肢痉挛方面，INCO被证明是比CON更有利的治疗选择。尽管接受INCO治疗的患者成本更高，但这种治疗具有更有利的增量成本效益比。在考虑康复方案时应考虑这种治疗方法，因为它在每获得一个QALY成本低于1000欧元时具有很高的成本效益，这是一个非常低的支付意愿（WTP）阈值。INCO被证明是一项突破性创新，因为它是一种新的、更有效的治疗方法，最终，对于中风后上肢痉挛患者的生活质量有很大提高。
