1 Priority Health, Grand Rapids, Michigan, and Oakland University William Beaumont School of Medicine, Rochester, Michigan.
2 Priority Health, Grand Rapids, Michigan.
J Manag Care Spec Pharm. 2019 May;25(5):601-611. doi: 10.18553/jmcp.2019.18309. Epub 2019 Jan 11.
Comprehensive genomic profiling (CGP) is a next-generation sequencing-based methodology that detects 4 classes of genomic alterations, as well as gene signature biomarkers such as microsatellite instability and tumor mutational burden. In the context of precision oncology, CGP can help to direct treatment to genomically matched therapies.
To describe the results of a 3-year observational analysis of patients undergoing testing with CGP assays (either FoundationOne or FoundationOne Heme) at a community oncology practice after a regional health plan implemented a medical policy that enabled coverage of CGP.
A retrospective analysis of medical records was completed at the oncology practice from November 2013 to January 2017; this date range was chosen to coincide with the regional health plan's medical policy implementation of CGP. The medical policy provided coverage of CGP for patients with advanced solid and hematologic cancers. A medical record review assessed all previous and current molecular test results, matched therapy or clinical trial enrollment, and clinical outcomes (clinical benefit or disease progression). The potential cost diversion, from payer to study sponsor, for patients who enrolled in clinical trials was explored.
There were 96 patients in the community oncology practice who received CGP over the 3-year period, 86 of whom had clinically relevant genomic alterations. Of the 86, 15 patients were treated with genomically matched therapy, and 6 patients enrolled in clinical trials based on CGP results. In a subset of 32 patients who previously underwent conventional testing, most (84%) had clinically relevant genomic alterations detected by CGP that conventional testing did not identify, and a portion of these patients subsequently received treatment based on the CGP results. In the separate cost diversion analysis of 20 patients who enrolled in phase 1 clinical trials, an estimated $25,000 per-patient cost-benefit may have been accrued to the payer.
This observational analysis characterized the use of CGP in a large community oncology practice among a group of patients insured by a regional health plan. Clinical trial enrollment was facilitated by CGP use in the community setting and may have contributed to cost diversion from the payer to study sponsors.
No separate study-related funding was provided by or to Priority Health, Foundation Medicine, and Cancer and Hematology Centers of West Michigan. Data analysis by Reitsma was conducted as part of an internship funded by Priority Health. Reitsma and Fox are employed by Priority Health. Anhorn, Vanden Borre, Cavanaugh, Chudnovsky, and Erlich are employed by Foundation Medicine.
全面基因组分析（CGP）是一种基于下一代测序的方法，可检测 4 类基因组改变，以及微卫星不稳定性和肿瘤突变负担等基因特征生物标志物。在精准肿瘤学方面，CGP 有助于将治疗指向基因组匹配的疗法。
描述在区域健康计划实施一项医疗政策以覆盖 CGP 后，在社区肿瘤学实践中对接受 CGP 检测（FoundationOne 或 FoundationOne Heme）的患者进行为期 3 年的观察性分析结果。
对 2013 年 11 月至 2017 年 1 月期间在肿瘤学实践中完成的病历进行回顾性分析；该日期范围选择与区域健康计划的 CGP 医疗政策实施时间一致。该医疗政策为患有晚期实体瘤和血液恶性肿瘤的患者提供 CGP 覆盖。病历审查评估了所有以前和当前的分子检测结果、匹配的治疗或临床试验入组情况以及临床结果（临床获益或疾病进展）。还探讨了入组临床试验的患者从支付方到研究赞助商的潜在成本转移。
在 3 年期间，社区肿瘤学实践中有 96 名患者接受了 CGP，其中 86 名患者具有临床相关的基因组改变。在这 86 名患者中，有 15 名患者接受了基因组匹配的治疗，有 6 名患者根据 CGP 结果入组临床试验。在之前接受常规检测的 32 名患者的亚组中，大多数（84%）患者的 CGP 检测到常规检测未发现的具有临床意义的基因组改变，其中一部分患者随后根据 CGP 结果接受了治疗。在对 20 名入组 1 期临床试验的患者进行的单独成本转移分析中，估计每位患者的支付方可能获得了 25000 美元的成本效益。
这项观察性分析描述了在区域健康计划承保的一组患者中，在一家大型社区肿瘤学实践中使用 CGP 的情况。在社区环境中使用 CGP 有助于入组临床试验，并可能导致支付方向研究赞助商的成本转移。
优先健康、Foundation Medicine 和密歇根西部癌症和血液病中心没有为这项研究提供专门的研究相关资金。Reitsma 的数据分析是由优先健康公司资助的实习的一部分。Reitsma 和 Fox 受雇于优先健康公司。Anhorn、Vanden Borre、Cavanaugh、Chudnovsky 和 Erlich 受雇于 Foundation Medicine。
