Analysis Group, Inc., Menlo Park, CA, USA.
Duke Cancer Institute, Durham, NC, USA.
J Med Econ. 2022 Jan-Dec;25(1):817-825. doi: 10.1080/13696998.2022.2080463.
Use of comprehensive genomic profiling (CGP) in metastatic colorectal cancer (mCRC) is limited. We estimated impacts of expanded 1 L CGP, using the Tempus xT test, on detection of actionable alterations and testing budgets in a modeled US health plan over two-years.
A decision analytic model was developed to estimate the impact of replacing 20% of usual testing (a mix of CGP and non-CGP) with Tempus xT CGP. Actionable alterations for matched treatments or clinical trial included , , , , deficient mismatch repair (dMMR)/microsatellite instability (MSI), , , , , , and . Costs included initial and repeat testing, physician-associated and administrative costs.
In a hypothetical five-million-member plan, 50% Medicare and 50% commercial, 1,112 new cases of mCRC were expected per year. Of these, 566 (51%) would undergo 1 L molecular testing, with 55 re-tested upon progression. Based on current testing rates, there were an expected 521 missed opportunities for genomically informed treatment (47% of new cases), with 442 missed due to lack of testing and 79 due to testing without CGP. Replacing 20% of usual testing with Tempus xT CGP was associated with up to a $0.003 per member per month testing cost increase (net total cost of $202,102 for the five-million-member plan) and 15.5 additional patients with an opportunity for genomically informed care (12.7 patients for treatment and 2.8 for clinical trial). The testing total cost (initial test, repeat test, biopsy and physician services, and administrative cost) to put one additional patient with mCRC on matched therapy or matched clinical trial was estimated to be $13,005. Number needed to test to identify one actionable alteration with Tempus xT CGP versus usual testing was 7.8 patients.
Conservative assumptions were made for inputs with limited evidence. Based on high concordance rates with dMMR/MSI status, tumor mutational burden (TMB) status was not calculated separately.
Replacing 20% of usual testing with Tempus xT CGP was associated with a small incremental testing cost and can identify meaningfully more actionable alterations.
在转移性结直肠癌（mCRC）中，综合基因组分析（CGP）的应用受到限制。我们使用 Tempus xT 测试，估计在两年内，对美国健康计划中扩展的 1L CGP 检测，对检测到的可操作改变和检测预算的影响。
开发了一个决策分析模型，以估计用 Tempus xT CGP 替代 20%的常规检测（CGP 和非 CGP 的混合）的影响。匹配治疗或临床试验的可操作改变包括、、、、缺陷错配修复（dMMR）/微卫星不稳定性（MSI）、、、、、、和。成本包括初始和重复检测、医生相关和管理成本。
在一个假设的五百万人的计划中，预计每年有 1112 例新的 mCRC。其中，566 例（51%）将接受 1L 分子检测，55 例在进展时重复检测。根据目前的检测率，预计有 521 次错过基于基因组信息的治疗机会（新病例的 47%），其中 442 次是由于缺乏检测，79 次是由于没有 CGP 检测。用 Tempus xT CGP 替代 20%的常规检测，与每月每会员增加 0.003 美元的检测成本（五百万会员计划的总检测成本为 202102 美元）和 15.5 名额外的有机会进行基于基因组的治疗的患者相关联（12.7 名患者用于治疗，2.8 名患者用于临床试验）。将一名额外的 mCRC 患者置于匹配治疗或匹配临床试验中的检测总成本（初始检测、重复检测、活检和医生服务以及管理成本）估计为 13005 美元。用 Tempus xT CGP 检测出一个可操作改变的检测人数比用常规检测检测出一个可操作改变的检测人数少 7.8 人。
输入的保守假设是基于有限的证据。基于与 dMMR/MSI 状态的高一致性，肿瘤突变负担（TMB）状态没有单独计算。
用 Tempus xT CGP 替代 20%的常规检测与小的增量检测成本相关，可以识别出更多有意义的可操作改变。
