Johansson Gunnar, Andreasson Emma B, Larsson Per E, Vogelmeier Claus F
Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.
Pharmacoeconomics. 2006;24(7):695-708. doi: 10.2165/00019053-200624070-00008.
Budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy (SMART) is an effective and well tolerated treatment option for patients with asthma. We compared the cost effectiveness from a societal perspective of this one-inhaler regimen with that of maintenance salmeterol/fluticasone propionate (Seretide) plus salbutamol (albuterol) as needed (Seretide) Fixed Combination [SFC]).
A cost-effectiveness analysis was performed based on effectiveness and resource-utilisation data collected prospectively in a randomised, 12-month study performed in 2143 patients in 16 countries. Resource utilisation data were pooled and unit costs (euro, year 2003 values) from Italy, France, the UK and Germany were used to generate estimates of direct and total costs per patient per year and cost per severe exacerbation avoided.
Adolescents and adults with asthma (n = 2143; mean forced expiratory volume in 1 second [FEV(1)] 73% predicted; mean inhaled corticosteroid [ICS] dose 884 microg/day) were randomised to SMART or SFC. The effectiveness measure used was the number of severe exacerbations per patient per year. Direct costs included medication use (budesonide/formoterol 160microg/4.5microg or salmeterol/fluticasone 50microg/100microg, 50microg/250microg or 50microg/500microg plus salbutamol) and nonmedication-related resource use, including days in hospital, emergency room visits, specialist or primary care physician visits and other healthcare provider contacts. Indirect costs, including the number of days when the patient or their carer was unable to attend to their normal daily activities, were also assessed. The study assumed a European societal perspective (i.e. including direct and indirect costs).
Treatment with SMART resulted in significantly fewer severe exacerbations per patient per year compared with SFC (0.24 vs 0.31 events per patient per year; p = 0.0025). Resource use was low in both groups. Medication costs accounted for the majority of the total costs. The increased effectiveness of SMART was achieved at a reduced or similar cost compared with SFC. SMART dominated when German unit costs were applied (i.e. there was a statistically significant reduction in both costs and number of exacerbations). In all other countries, the incremental cost-effectiveness ratios showed that there was a reduction in mean total cost per exacerbation avoided; however, this difference was not statistically significant.
This analysis demonstrates that, compared with SFC, SMART may be cost effective from a societal perspective for the treatment of patients with asthma in Italy, Germany, France and the UK. SMART provided a reduction in the number of severe exacerbations per patient per year, at no statistically significant increase in cost - or even at a lower cost - compared with SFC plus as-needed reliever salbutamol.
布地奈德/福莫特罗（信必可）维持和缓解治疗（SMART）是一种对哮喘患者有效且耐受性良好的治疗方案。我们从社会角度比较了这种单吸入器疗法与按需使用沙美特罗/丙酸氟替卡松（舒利迭）加沙丁胺醇（沙丁胺醇）固定复方制剂（SFC）的成本效益。
基于在16个国家的2143例患者中进行的一项为期12个月的前瞻性随机研究收集的有效性和资源利用数据进行成本效益分析。汇总资源利用数据，并使用来自意大利、法国、英国和德国的单位成本（2003年欧元值）来估算每位患者每年的直接成本和总成本以及避免每次严重加重发作的成本。
哮喘青少年和成人（n = 2143；一秒用力呼气容积[FEV₁]平均为预测值的73%；吸入糖皮质激素[ICS]平均剂量为884微克/天）被随机分为SMART组或SFC组。所使用的有效性指标是每位患者每年的严重加重发作次数。直接成本包括药物使用（布地奈德/福莫特罗160微克/4.5微克或沙美特罗/丙酸氟替卡松50微克/100微克、50微克/250微克或50微克/500微克加沙丁胺醇）以及与药物无关的资源利用，包括住院天数、急诊就诊、专科或初级保健医生就诊以及与其他医疗服务提供者的接触。还评估了间接成本，包括患者或其护理人员无法进行正常日常活动的天数。该研究采用欧洲社会视角（即包括直接和间接成本）。
与SFC相比，SMART治疗使每位患者每年的严重加重发作次数显著减少（每位患者每年0.24次发作与0.31次发作；p = 0.0025）。两组的资源利用都较低。药物成本占总成本的大部分。与SFC相比，SMART在成本降低或相似的情况下提高了有效性。应用德国单位成本时，SMART占主导地位（即成本和加重发作次数均有统计学显著降低）。在所有其他国家，增量成本效益比表明，避免每次加重发作的平均总成本有所降低；然而，这种差异无统计学意义。
该分析表明，与SFC相比，从社会角度看，SMART在意大利、德国、法国和英国治疗哮喘患者可能具有成本效益。与SFC加按需使用缓解药物沙丁胺醇相比，SMART使每位患者每年的严重加重发作次数减少，且成本无统计学显著增加，甚至成本更低。
