Khoudigian-Sinani S, Blackhouse G, Levine M, Thabane L, O'Reilly D
Department of Health Research, Methods, Evidence and Impact, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
PATH Research Institute, St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
Health Econ Rev. 2017 Oct 2;7(1):35. doi: 10.1186/s13561-017-0170-6.
Approximately half of oral cancers are detected in advanced stages. The current gold standard is histopathological assessment of biopsied tissue, which is subjective and dependent on expertise. Straticyte™, a novel prognostic tool at the pre-market stage, that more accurately identifies patients at high risk for oral cancer than histopathology alone. This study conducts an early cost-effectiveness analysis (CEA) of Straticyte™ and histopathology versus histopathology alone for oral cancer diagnosis in adult patients.
A decision-analytic model was constructed after narrowing the scope of Straticyte™, and defining application paths. Data was gathered using the belief elicitation method, and systematic review and meta-analysis. The early CEA was conducted from private-payer and patient perspectives, capturing both direct and indirect costs over a five-year time horizon. One-way and probabilistic sensitivity analyses were conducted to investigate uncertainty.
Compared to histopathology alone, histopathology with Straticyte™ was the dominant strategy, resulting in fewer cancer cases (31 versus 36 per 100 patients) and lower total costs per cancer case avoided (3,360 versus 3,553). This remained robust when Straticyte™ was applied to moderate and mild cases, but became slightly more expensive but still more effective than histopathology alone when Straticyte™ was applied to only mild cases. The probabilistic and one-way sensitivity analyses demonstrated that incorporating Straticyte™ to the current algorithm would be cost-effective over a wide range of parameters and willingness-to-pay values.
This study demonstrates high probability that Straticyte™ and histopathology will be cost-effective, which encourages continued investment in the product. The analysis is informed by limited clinical data on Straticyte™, however as more data becomes available, more precise estimates will be generated.
大约一半的口腔癌在晚期才被发现。当前的金标准是对活检组织进行组织病理学评估，这是主观的且依赖于专业知识。Straticyte™是一种处于上市前阶段的新型预后工具，它比单纯的组织病理学更能准确识别口腔癌高危患者。本研究对Straticyte™联合组织病理学与单纯组织病理学用于成年患者口腔癌诊断进行了早期成本效益分析（CEA）。
在缩小Straticyte™的范围并定义应用路径后构建了一个决策分析模型。通过信念诱导法、系统评价和荟萃分析收集数据。从私人支付者和患者的角度进行早期CEA，在五年时间范围内计算直接和间接成本。进行单向和概率敏感性分析以研究不确定性。
与单纯组织病理学相比，Straticyte™联合组织病理学是主要策略，癌症病例更少（每100例患者中分别为31例和36例），避免每例癌症的总成本更低（分别为3360美元和3553美元）。当Straticyte™应用于中度和轻度病例时，这一结果仍然稳健，但当Straticyte™仅应用于轻度病例时，成本略有增加，但仍比单纯组织病理学更有效。概率和单向敏感性分析表明，将Straticyte™纳入当前算法在广泛的参数和支付意愿值范围内具有成本效益。
本研究表明Straticyte™联合组织病理学具有成本效益的可能性很高，这鼓励对该产品持续投资。然而，该分析所依据的Straticyte™临床数据有限，但随着更多数据的可得，将能得出更精确的估计。
