University of Washington, Seattle, WA 98195-7630, USA.
J Med Econ. 2011;14(5):609-16. doi: 10.3111/13696998.2011.602160. Epub 2011 Jul 11.
Personalized medicine requires diagnostic tests that stratify patients into distinct groups that may differentially benefit from targeted treatment approaches. This study compared the costs and benefits of two approaches for identifying those at high risk of developing type 2 diabetes for entry into a diabetes prevention program. The first approach identified high risk patients using impaired fasting glucose (IFG). The second approach used the PreDx Diabetes Risk Score (DRS) to further stratify IFG patients into high-risk and moderate-risk groups.
A Markov model was developed to simulate the incidence and disease progression of diabetes and consequent costs and quality-adjusted life expectancy (QALY), comparing alternative approaches for identifying high-risk patients. We modeled direct medical costs, including the costs of the stratification testing, over a 10-year time horizon from a US payer perspective.
Stratification of IFG patients by the DRS method leads to improved identification and prevention among those at highest risk. At 5 years, the number needed to treat (NNT) in the IFG-only approach was 39 patients to prevent one case of diabetes compared to an NNT of 15 in the IFG + DRS approach. When compared to IFG alone, the IFG + DRS approach results in an incremental cost-effectiveness ratio (ICER) of $17,100/QALY gained at 5 years and would become cost saving in 10 years. In contrast and as compared to no stratification, the IFG-only approach would produce an ICER of $235,500/QALY gained at 5 years and $94,600/QALY gained at 10 years. The study findings are limited by the generalizability of the DRS validation study and uncertainty regarding the long-term effectiveness of diabetes prevention.
The analysis indicates that the cost-effectiveness of diabetes prevention can be improved by better identification of patients at highest risk for diabetes using the DRS.
个性化医学需要诊断测试，将患者分为不同的组别，这些组别可能会从靶向治疗方法中获益。本研究比较了两种方法的成本和效益，这两种方法用于识别那些有发展为 2 型糖尿病风险的患者，以便进入糖尿病预防计划。第一种方法使用空腹血糖受损（IFG）来识别高危患者。第二种方法使用 PreDx 糖尿病风险评分（DRS）将 IFG 患者进一步分为高危和中危组。
采用 Markov 模型模拟糖尿病的发病和疾病进展，以及相应的成本和质量调整生命期望（QALY），比较了两种识别高危患者的替代方法。我们从美国支付者的角度，在 10 年的时间内，对分层检测的直接医疗成本进行了建模。
通过 DRS 方法对 IFG 患者进行分层，可以提高高危人群的识别和预防效果。在 5 年时，IFG 单一方法的治疗需要人数（NNT）为 39 人，以预防一例糖尿病病例，而 IFG+DRS 方法的 NNT 为 15 人。与 IFG 单一方法相比，IFG+DRS 方法在 5 年时的增量成本效益比（ICER）为 17100 美元/QALY，在 10 年内将节省成本。相比之下，与不进行分层相比，IFG 单一方法在 5 年时的 ICER 为 235500 美元/QALY，在 10 年时的 ICER 为 94600 美元/QALY。研究结果受到 DRS 验证研究的普遍性和糖尿病预防长期效果的不确定性的限制。
分析表明，通过使用 DRS 更好地识别糖尿病风险最高的患者，可以提高糖尿病预防的成本效益。
