Forest Research Institute, Jersey City, NJ, USA.
J Med Econ. 2011;14(6):805-15. doi: 10.3111/13696998.2011.623204. Epub 2011 Oct 12.
To conduct a cost-effectiveness analysis comparing roflumilast/tiotropium therapy vs tiotropium monotherapy in patients with severe-to-very severe COPD.
The economic evaluation applied a disease-based Markov cohort model with five health states: (1) severe COPD, (2) severe COPD with a history of severe exacerbation, (3) very severe COPD, (4) very severe COPD with a history of severe exacerbation, and (5) death. Within a given health state, a patient may have a mild/moderate or severe exacerbation or die. Data from roflumilast clinical trials and published literature were used to populate model parameters. The model calculated health outcomes and costs for roflumilast/tiotropium therapy vs tiotropium monotherapy over a 5-year horizon. Incremental cost and benefits were then calculated as cost-effectiveness ratios, including cost per exacerbation avoided and cost per quality adjusted life year ($/QALY).
Over a 5-year horizon, the estimated incremental costs per exacerbation and per severe exacerbation avoided were $589 and $5869, respectively, and the incremental cost per QALY was $15,815. One-way sensitivity analyses varying key parameters produced an incremental cost per QALY ranging from $1963-$32,773.
A number of key parameters used in the model were obtained from studies in the literature that were conducted under different contexts. Specifically, the relative risk estimate for severe COPD patients originates from a small trial not designed to demonstrate the impact of roflumilast on frequency of exacerbations. In addition, the model extrapolates the relative risk estimates over periods of 5-30 years, even though the estimates were only observed in trials that spanned less than a year.
The addition of roflumilast to tiotropium is cost-effective for the treatment of severe to very severe COPD patients.
对罗氟司特/噻托溴铵治疗与噻托溴铵单药治疗重度至极重度 COPD 患者的成本效益进行分析。
该经济学评价采用了基于疾病的 Markov 队列模型，共有五个健康状态：（1）重度 COPD；（2）重度 COPD 且有重度加重史；（3）极重度 COPD；（4）极重度 COPD 且有重度加重史；（5）死亡。在给定的健康状态中，患者可能会经历轻度/中度或重度加重，或者死亡。模型参数使用了罗氟司特临床试验和已发表文献的数据。该模型计算了罗氟司特/噻托溴铵治疗与噻托溴铵单药治疗在 5 年期间的健康结果和成本。然后，计算了增量成本和效益，作为成本效益比，包括避免每次加重的成本和每质量调整生命年的成本（/QALY）。
在 5 年期间，避免每次加重和每次重度加重的增量成本分别为 589 美元和 5869 美元，每 QALY 的增量成本为 15815 美元。对关键参数进行的单因素敏感性分析产生了每 QALY 增量成本 1963-32773 美元的范围。
模型中使用的许多关键参数是从文献中的研究中获得的，这些研究是在不同的背景下进行的。具体而言，重度 COPD 患者的相对风险估计来自一个不是为了证明罗氟司特对加重频率影响而设计的小型试验。此外，该模型将相对风险估计外推到 5-30 年的时间段，即使这些估计仅在持续不到一年的试验中观察到。
对于重度至极重度 COPD 患者，罗氟司特联合噻托溴铵的治疗具有成本效益。
