Vallejo-Aparicio Laura Amanda, Peces-Barba Germán, Gil Alicia, Huerta Hernandez Alicia
Market Access, GlaxoSmithKline, Tres Cantos, Madrid, Spain,
IIS-Fundación Jiménez Díaz. CIBERES, Madrid, Spain.
Clinicoecon Outcomes Res. 2018 Sep 5;10:501-510. doi: 10.2147/CEOR.S169154. eCollection 2018.
The Salford Lung Study in Chronic Obstructive Pulmonary Disease (SLS COPD) is a 12-month, open-label randomized clinical trial comparing clinical effectiveness and safety of initiating once-daily fluticasone furoate/vilanterol (FF/VI) 92/22 mcg with continuing usual care (UC) in patients with COPD followed in primary care in the UK. The objective of this analysis is to estimate the economic impact of these results when applied to Spain.
An Excel-based cost-consequence model with a one-year time horizon was populated with SLS COPD results, adopting the Spanish National Health System (NHS) perspective. Patients analyzed were diagnosed COPD patients ≥40 years old, currently managed with maintenance treatment and with a history of exacerbations (total number estimated from Spanish data). Mean least squares annual rates of moderate/severe exacerbations after 1 year for the intention-to-treat population from SLS COPD were included in the model (1.50 [FF/VI] and 1.64 [UC]); serious adverse events were excluded from the analysis as no differences between treatment arms were found. Medication and exacerbation management costs in euros were estimated from Spanish public sources for 2016. Model base-case analysis assumed an increased usage of FF/VI from 4% to 10% within 1 year, and a 100% proportion of days covered with study medications. Deterministic sensitivity analyses were performed for mitigating uncertainty.
At base case, within 50,522 COPD patients analyzed, substitution of UC with FF/VI 92/22 mcg was associated with reduced medication and exacerbation management costs, leading to potential total annual savings of €353,623. Deterministic sensitivity results ranged from €218,333 up to €1,532,366 potential cost savings associated with FF/VI, showing the robustness of base-case results.
The decreased rate of exacerbations with FF/VI 92/22 mcg compared with UC observed in SLS COPD could be translated into potential health care savings for the Spanish NHS. These results may be useful to inform decision-making processes.
索尔福德慢性阻塞性肺疾病肺部研究(SLS COPD)是一项为期12个月的开放标签随机临床试验,比较在英国初级医疗中接受治疗的慢性阻塞性肺疾病(COPD)患者中,起始每日一次使用糠酸氟替卡松/维兰特罗(FF/VI)92/22微克与继续常规治疗(UC)的临床有效性和安全性。本分析的目的是评估将这些结果应用于西班牙时的经济影响。
采用西班牙国家卫生系统(NHS)视角,构建了一个基于Excel的成本后果模型,时间跨度为一年,模型数据来源于SLS COPD研究结果。分析的患者为年龄≥40岁、目前接受维持治疗且有加重病史的COPD确诊患者(总数根据西班牙数据估算)。模型纳入了SLS COPD意向性治疗人群1年后中度/重度加重的平均年最小二乘发生率(FF/VI组为1.50,UC组为1.64);由于各治疗组之间未发现差异,严重不良事件被排除在分析之外。2016年西班牙公共资源估算了以欧元计的药物和加重治疗管理成本。模型基础病例分析假设FF/VI的使用量在1年内从4%增加到10%,且研究药物覆盖天数比例为100%。进行了确定性敏感性分析以降低不确定性。
在基础病例中,在分析的50522例COPD患者中,用FF/VI 92/22微克替代UC与药物和加重治疗管理成本降低相关,每年潜在节省总计353623欧元。确定性敏感性分析结果显示,与FF/VI相关的潜在成本节省范围从218333欧元到1532366欧元,表明基础病例结果具有稳健性。
在SLS COPD中观察到,与UC相比,FF/VI 92/22微克降低了加重发生率,这可能为西班牙NHS带来潜在的医疗保健节省。这些结果可能有助于为决策过程提供信息。