Heijnsdijk Eveline A M, Denham Dwight, de Koning Harry J
Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands.
Global Health Economics and Reimbursement, Beckman Coulter Inc., Brea, CA, USA.
Value Health. 2016 Mar-Apr;19(2):153-7. doi: 10.1016/j.jval.2015.12.002. Epub 2016 Jan 14.
Clinical trial results suggested that prostate-specific antigen (PSA) screening can reduce prostate cancer mortality. Nevertheless, because the specificity of the PSA test for cancer detection is low, it leads to many negative biopsies. The Beckman Coulter Prostate Health Index (PHI) testing demonstrates improved specificity compared with the PSA-only screening and therefore may improve the cost-effectiveness of prostate cancer detection.
To examine the cost-effectiveness of adding PHI testing to improve cancer detection for men with elevated serum PSA.
A microsimulation model, based on the results of the European Randomized Study of Screening for Prostate Cancer trial, was used to evaluate the effects of PSA screening and PHI reflex testing. We predicted the numbers of prostate cancers, negative biopsies, deaths, quality-adjusted life-years gained, and cost-effectiveness of both PSA (cutoff 3 ng/mL) and PHI (cutoff 25) testing methods for a European population, screened from age 50 to 75 years at 4-year intervals.
When the PHI test was added to the PSA screening, for men with a PSA between 3 and 10 ng/mL, the model predicted a 23% reduction in negative biopsies. This would lead to a 17% reduction in costs for diagnostics and 1% reduction in total costs for prostate cancer. The cost-effectiveness (3.5% discounted) was 11% better. Limitations found were the modeling assumptions on the sensitivity and specificity of PHI by tumor stage and cutoff values.
Compared with PSA-only screening, the use of a PHI test can substantially reduce the number of negative biopsies and improve the cost-effectiveness of prostate cancer detection.
临床试验结果表明，前列腺特异性抗原（PSA）筛查可降低前列腺癌死亡率。然而，由于PSA检测用于癌症检测的特异性较低，导致许多活检结果为阴性。与仅进行PSA筛查相比，贝克曼库尔特前列腺健康指数（PHI）检测显示出更高的特异性，因此可能提高前列腺癌检测的成本效益。
研究增加PHI检测以改善血清PSA升高男性癌症检测的成本效益。
基于欧洲前列腺癌筛查随机研究的结果，使用微观模拟模型评估PSA筛查和PHI反射检测的效果。我们预测了欧洲人群中前列腺癌的数量、阴性活检结果、死亡人数、获得的质量调整生命年，以及PSA（临界值3 ng/mL）和PHI（临界值25）两种检测方法的成本效益，该人群年龄在50至75岁之间，每4年筛查一次。
当在PSA筛查中加入PHI检测时，对于PSA在3至10 ng/mL之间的男性，模型预测阴性活检结果减少23%。这将使诊断成本降低17%，前列腺癌总成本降低1%。成本效益（贴现率3.5%）提高了11%。发现的局限性在于模型对不同肿瘤分期和临界值下PHI敏感性和特异性的假设。
与仅进行PSA筛查相比，使用PHI检测可大幅减少阴性活检结果的数量，并提高前列腺癌检测的成本效益。
