Division of Public Health Science, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, University of Washington, Seattle, WA.
Division of Public Health Science, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Value Health. 2021 Aug;24(8):1111-1117. doi: 10.1016/j.jval.2021.02.009. Epub 2021 Apr 22.
For men with intermediate prostate-specific antigen (PSA) levels (4-10 ng/mL), urine-based biomarkers and multiparametric magnetic resonance imaging (MRI) are increasingly used as reflex tests before prostate biopsy. We assessed the cost effectiveness of these reflex tests in the United States.
We used an existing microsimulation model of prostate cancer (PCa) progression and survival to predict lifetime outcomes for a hypothetical cohort of 55-year-old men with intermediate PSA levels. Urine-based biomarkers-PCa antigen (PCA3), TMPRSS2:ERG gene fusion (T2:ERG), and the MyProstateScore (MPS) for any PCa and for high-grade (Gleason score ≥7) PCa (MPShg)-were generated using biomarker data from 1112 men presenting for biopsy at 10 United States institutions. MRI results were based on published sensitivity and specificity for high-grade PCa. Costs and utilities were sourced from literature and Medicare reimbursement schedules. Outcome measures included life years, quality-adjusted life years (QALYs), and lifetime medical costs per patient. Incremental cost-effectiveness ratios were empirically calculated on the basis of simulated life histories under different reflex testing strategies.
Biopsying all men provided the most life years and QALYs, followed by reflex testing using MPShg, MPS, MRI, T2:ERG, PCA3, and biopsying no men (QALY range across strategies 15.98-16.09). Accounting for costs, MRI and MPShg were dominated by other strategies. PCA3, T2:ERG, and MPS were likely to be the most cost-effective strategy at willingness-to-pay thresholds of $100 000/QALY, $125 000/QALY, and $150 000/QALY, respectively.
Using PCA3, T2:ERG, or MPS as reflex tests has greater economic value than MRI, biopsying all men, or biopsying no men with intermediate PSA levels.
对于前列腺特异性抗原（PSA）水平处于中间范围（4-10ng/ml）的男性，尿液生物标志物和多参数磁共振成像（MRI）越来越多地被用作前列腺活检前的反射性检测。我们评估了这些反射性检测在美国的成本效益。
我们使用现有的前列腺癌（PCa）进展和生存的微观模拟模型，预测一组假设的 55 岁 PSA 水平处于中间范围的男性的终生结局。使用来自美国 10 个机构的 1112 名接受活检的男性的生物标志物数据，生成尿液生物标志物-前列腺癌抗原（PCA3）、TMPRSS2:ERG 基因融合（T2:ERG）和 MyProstateScore（MPS）用于任何 PCa 和用于高级别（Gleason 评分≥7）PCa（MPShg）-。MRI 结果基于高级别 PCa 的敏感性和特异性的发表数据。成本和效用均来自文献和医疗保险报销时间表。结果测量包括寿命、质量调整寿命年（QALY）和每位患者的终生医疗费用。根据不同的反射性测试策略下的模拟生活史，经验性地计算增量成本效益比。
对所有男性进行活检提供了最多的寿命和 QALY，其次是使用 MPShg、MPS、MRI、T2:ERG、PCA3 和不进行活检的反射性测试（策略之间的 QALY 范围为 15.98-16.09）。考虑到成本，MRI 和 MPShg 被其他策略所主导。PCA3、T2:ERG 和 MPS 可能分别在愿意支付 100000 美元/QALY、125000 美元/QALY 和 150000 美元/QALY 的阈值下成为最具成本效益的策略。
与 MRI、对所有 PSA 水平处于中间范围的男性进行活检或不对这些男性进行活检相比，使用 PCA3、T2:ERG 或 MPS 作为反射性检测具有更大的经济价值。
