Palimaka Stefan, Blackhouse Gord, Goeree Ron
Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph's Healthcare, Hamilton, ON, Canada.
Programs for Assessment of Technology in Health (PATH) Research Institute, St. Joseph's Healthcare, Hamilton, ON, Canada ; Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
Ont Health Technol Assess Ser. 2015 Jul 1;15(15):1-43. eCollection 2015.
Colorectal cancer is a leading cause of mortality and morbidity in Ontario. Most cases of colorectal cancer are preventable through early diagnosis and the removal of precancerous polyps. Colon capsule endoscopy is a non-invasive test for detecting colorectal polyps.
The objectives of this analysis were to evaluate the cost-effectiveness and the impact on the Ontario health budget of implementing colon capsule endoscopy for detecting advanced colorectal polyps among adult patients who have been referred for computed tomographic (CT) colonography.
We performed an original cost-effectiveness analysis to assess the additional cost of CT colonography and colon capsule endoscopy resulting from misdiagnoses. We generated diagnostic accuracy data from a clinical evidence-based analysis (reported separately), and we developed a deterministic Markov model to estimate the additional long-term costs and life-years lost due to false-negative results. We then also performed a budget impact analysis using data from Ontario administrative sources. One-year costs were estimated for CT colonography and colon capsule endoscopy (replacing all CT colonography procedures, and replacing only those CT colonography procedures in patients with an incomplete colonoscopy within the previous year). We conducted this analysis from the payer perspective.
Using the point estimates of diagnostic accuracy from the head-to-head study between colon capsule endoscopy and CT colonography, we found the additional cost of false-positive results for colon capsule endoscopy to be $0.41 per patient, while additional false-negatives for the CT colonography arm generated an added cost of $116 per patient, with 0.0096 life-years lost per patient due to cancer. This results in an additional cost of $26,750 per life-year gained for colon capsule endoscopy compared with CT colonography. The total 1-year cost to replace all CT colonography procedures with colon capsule endoscopy in Ontario is about $2.72 million; replacing only those CT colonography procedures in patients with an incomplete colonoscopy in the previous year would cost about $740,600 in the first year.
The difference in accuracy between colon capsule endoscopy and CT colonography was not statistically significant for the detection of advanced adenomas (≥ 10 mm in diameter), according to the head-to-head clinical study from which the diagnostic accuracy was taken. This leads to uncertainty in the economic analysis, with results highly sensitive to changes in diagnostic accuracy.
The cost-effectiveness of colon capsule endoscopy for use in patients referred for CT colonography is $26,750 per life-year, assuming an increased sensitivity of colon capsule endoscopy. Replacement of CT colonography with colon capsule endoscopy is associated with moderate costs to the health care system.
结直肠癌是安大略省导致死亡和发病的主要原因之一。大多数结直肠癌病例可通过早期诊断和切除癌前息肉来预防。结肠胶囊内镜检查是一种用于检测结直肠息肉的非侵入性检查。
本分析的目的是评估在因计算机断层扫描(CT)结肠成像而转诊的成年患者中,实施结肠胶囊内镜检查以检测晚期结直肠息肉的成本效益及其对安大略省卫生预算的影响。
我们进行了一项原创性成本效益分析,以评估因误诊导致的CT结肠成像和结肠胶囊内镜检查的额外成本。我们从基于临床证据的分析中生成诊断准确性数据(单独报告),并开发了一个确定性马尔可夫模型,以估计因假阴性结果导致的额外长期成本和生命年损失。然后,我们还使用安大略省行政来源的数据进行了预算影响分析。估计了CT结肠成像和结肠胶囊内镜检查的一年成本(替换所有CT结肠成像程序,以及仅替换前一年结肠镜检查不完全的患者的那些CT结肠成像程序)。我们从支付方的角度进行了这项分析。
根据结肠胶囊内镜检查和CT结肠成像之间的头对头研究的诊断准确性点估计值,我们发现结肠胶囊内镜检查假阳性结果的额外成本为每位患者0.41美元,而CT结肠成像组的额外假阴性结果导致每位患者增加成本116美元,每位患者因癌症损失0.0096个生命年。与CT结肠成像相比,结肠胶囊内镜检查每获得一个生命年的额外成本为26,750美元。在安大略省,用结肠胶囊内镜检查替换所有CT结肠成像程序的总一年成本约为272万美元;仅替换前一年结肠镜检查不完全的患者的那些CT结肠成像程序,第一年的成本约为740,600美元。
根据获取诊断准确性的头对头临床研究,结肠胶囊内镜检查和CT结肠成像在检测晚期腺瘤(直径≥10毫米)方面的准确性差异无统计学意义。这导致经济分析存在不确定性,如果诊断准确性发生变化,结果会非常敏感。
假设结肠胶囊内镜检查的敏感性提高,对于因CT结肠成像而转诊的患者,结肠胶囊内镜检查的成本效益为每生命年26,750美元。用结肠胶囊内镜检查替换CT结肠成像会给医疗保健系统带来适度成本。