Nielsen Rune, Kankaanranta Hannu, Bjermer Leif, Lange Peter, Arnetorp Sofie, Hedegaard Morten, Stenling Anna, Mittmann Nicole
Institute of Medicine, University of Bergen, Jonas Lies vei 65, N-5021 Bergen, Norway; Department of Thoracic Medicine, Haukeland University Hospital, Jonas Lies vei 65, N-5021 Bergen, Norway.
Respir Med. 2013 Nov;107(11):1709-21. doi: 10.1016/j.rmed.2013.06.007. Epub 2013 Jul 13.
Assess the cost effectiveness of budesonide/formoterol (BUD/FORM) Turbuhaler(®)+tiotropium (TIO) HandiHaler(®) vs. placebo (PBO)+TIO in patients with chronic obstructive pulmonary disease (COPD) eligible for inhaled corticosteroids/long-acting β2-agonists (ICS/LABA).
The cost-effectiveness analysis was based on the 12-week, randomised, double-blind CLIMB trial. The study included 659 patients with pre-bronchodilator forced expiratory volume in 1 s ≤ 50% and ≥1 exacerbation requiring systemic glucocorticosteroids or antibiotics the preceding year. Patients received BUD/FORM 320/9 μg bid + TIO 18 μg qd or PBO bid + TIO 18 μg qd. Effectiveness was defined as the number of severe exacerbations (hospitalisation/emergency room visit/systemic glucocorticosteroids) avoided. A sub-analysis included antibiotics in the definition of an exacerbation. Resource use from CLIMB was combined with Danish (DKK), Finnish (€), Norwegian (NOK) and Swedish (SEK) unit costs (2010). The incremental cost-effectiveness ratios (ICERs) for BUD/FORM + TIO vs. PBO + TIO were estimated using descriptive statistics and uncertainty around estimates using bootstrapping. Analyses were conducted from the societal and healthcare perspectives in Denmark, Finland, Norway and Sweden.
From a societal perspective, the ICER was estimated at €174/severe exacerbation avoided in Finland while BUD/FORM + TIO was dominant in the other countries. From the healthcare perspective, ICERs were DKK 1580 (€212), €307 and SEK 1573 (€165) per severe exacerbation avoided for Denmark, Finland and Sweden, respectively, while BUD/FORM + TIO was dominant in Norway. Including antibiotics decreased ICERs by 8-15%. Sensitivity analyses showed that results were overall robust.
BUD/FORM + TIO represents a clinical and economic benefit to health systems and society for the treatment of COPD in the Nordic countries. (ClinicalTrials.gov Identifier: NCT00496470).
评估布地奈德/福莫特罗（BUD/FORM）都保®联合噻托溴铵（TIO）吸乐®对比安慰剂（PBO）联合TIO用于符合吸入性糖皮质激素/长效β2受体激动剂（ICS/LABA）治疗条件的慢性阻塞性肺疾病（COPD）患者的成本效益。
成本效益分析基于为期12周的随机双盲CLIMB试验。该研究纳入了659例支气管扩张剂使用前1秒用力呼气容积≤50%且前一年有≥1次需要全身使用糖皮质激素或抗生素的加重发作的患者。患者接受BUD/FORM 320/9μg bid + TIO 18μg qd或PBO bid + TIO 18μg qd治疗。有效性定义为避免的严重加重发作（住院/急诊就诊/全身使用糖皮质激素）次数。一项亚分析将抗生素纳入加重发作的定义中。CLIMB研究中的资源使用情况与丹麦（丹麦克朗）、芬兰（欧元）、挪威（挪威克朗）和瑞典（瑞典克朗）的单位成本（2010年）相结合。使用描述性统计方法估计BUD/FORM + TIO对比PBO + TIO的增量成本效益比（ICER），并通过自抽样法评估估计值的不确定性。从丹麦、芬兰、挪威和瑞典的社会和医疗保健角度进行分析。
从社会角度来看，芬兰避免每例严重加重发作的ICER估计为174欧元，而在其他国家BUD/FORM + TIO具有优势。从医疗保健角度来看，丹麦、芬兰和瑞典避免每例严重加重发作的ICER分别为1580丹麦克朗（212欧元）、307欧元和1573瑞典克朗（165欧元），而在挪威BUD/FORM + TIO具有优势。将抗生素纳入计算后，ICER降低了8 - 15%。敏感性分析表明结果总体稳健。
对于北欧国家的卫生系统和社会而言，BUD/FORM + TIO在治疗COPD方面具有临床和经济效益。（ClinicalTrials.gov标识符：NCT00496470）
