PDF(Pubmed)
Abstract：
UNASSIGNED: Oncology clinical trial enrollment is strongly recommended for patients with cancer who are not eligible for established and approved therapies. Many trials are specific to biomarker-targeted therapies, which are typically managed as specialty pharmacy services. Comprehensive genomic profiling (CGP) of advanced cancers has been shown to detect biomarkers, guide targeted treatment, improve outcomes, and result in the clinical trial enrollment of patients, which is modeled to offset pharmacy costs experienced by US payers, yet payer policy coverage remains inconsistent. A common concern limiting coverage of CGP by payers is the potential of identifying biomarkers beyond guideline-recommended treatments, which creates a perception that insurance companies are being positioned to \"pay for research.\" However, these biomarkers can increase clinical trial eligibility, and specialty pharmacy management may have an interest in maximizing the clinical trial enrollment of members.
UNASSIGNED: To investigate if clinical trial enrollment following liquid biopsy CGP for non-small cell lung cancer (NSCLC) is clinically and/or economically impactful from a payer claims perspective.
UNASSIGNED: Clinical and economic outcomes were studied using a real-world clinical genomic database (including payer claims data) from patients with NSCLC who enrolled in clinical trials immediately following liquid biopsy CGP (using Guardant360) and matched NSCLC patient controls also tested with liquid biopsy CGP.
UNASSIGNED: Real-world overall survival was significantly (log-rank P < 0.0001) better for patients enrolled in clinical trials with similar costs of care, albeit with more outpatient encounters among those enrolled compared with matched controls.
UNASSIGNED: The results, together with previous analyses, suggest that, in addition to the clinical benefits associated with targeted therapies directed by CGP and other testing approaches, payers and specialty pharmacy managers may consider clinical trial direction and enrollment as a clinical and economic benefit of liquid biopsy CGP and adopt this into coverage decision frameworks and formularies.
UNASSIGNED: To investigate if clinical trial enrollment following liquid biopsy CGP for non-small cell lung cancer (NSCLC) is clinically and/or economically impactful from a payer claims perspective.
UNASSIGNED: Clinical and economic outcomes were studied using a real-world clinical genomic database (including payer claims data) from patients with NSCLC who enrolled in clinical trials immediately following liquid biopsy CGP (using Guardant360) and matched NSCLC patient controls also tested with liquid biopsy CGP.
UNASSIGNED: Real-world overall survival was significantly (log-rank P < 0.0001) better for patients enrolled in clinical trials with similar costs of care, albeit with more outpatient encounters among those enrolled compared with matched controls.
UNASSIGNED: The results, together with previous analyses, suggest that, in addition to the clinical benefits associated with targeted therapies directed by CGP and other testing approaches, payers and specialty pharmacy managers may consider clinical trial direction and enrollment as a clinical and economic benefit of liquid biopsy CGP and adopt this into coverage decision frameworks and formularies.
摘要：
■对于不符合既定和批准治疗条件的癌症患者，强烈建议进行肿瘤临床试验。许多试验是针对生物标志物靶向治疗的，通常作为专业药房服务进行管理。晚期癌症的综合基因组分析（CGP）已被证明可以检测生物标志物，引导针对性治疗,改善结果，并导致患者的临床试验登记，这是为了抵消美国付款人经历的药房成本而建模的，然而，付款人的保单覆盖范围仍然不一致。限制付款人对CGP覆盖的一个普遍关注是识别超出指南推荐治疗的生物标志物的潜力。这产生了一种看法，即保险公司正被定位为“为研究付费”。\"然而,这些生物标志物可以提高临床试验的合格性，和专业药房管理可能对最大化成员的临床试验注册感兴趣。
■从付款人索赔的角度，调查非小细胞肺癌（NSCLC）液体活检CGP后的临床试验注册是否具有临床和/或经济影响。
■使用真实世界的临床基因组数据库（包括付款人索赔数据）研究了NSCLC患者的临床和经济结果，这些患者在液体活检CGP（使用Guardant360）和匹配的NSCLC患者对照也用液体活检CGP进行了测试。
■参加临床试验且护理费用相似的患者的真实世界总生存率显著提高（log-rankP<0.0001），尽管与匹配的对照组相比，这些参与者的门诊就诊次数更多。
■结果，加上以前的分析，建议，除了与CGP和其他测试方法指导的靶向治疗相关的临床益处外，付款人和专业药房经理可以将临床试验方向和注册视为液体活检CGP的临床和经济效益，并将其纳入承保决策框架和处方集。
■从付款人索赔的角度，调查非小细胞肺癌（NSCLC）液体活检CGP后的临床试验注册是否具有临床和/或经济影响。
■使用真实世界的临床基因组数据库（包括付款人索赔数据）研究了NSCLC患者的临床和经济结果，这些患者在液体活检CGP（使用Guardant360）和匹配的NSCLC患者对照也用液体活检CGP进行了测试。
■参加临床试验且护理费用相似的患者的真实世界总生存率显著提高（log-rankP<0.0001），尽管与匹配的对照组相比，这些参与者的门诊就诊次数更多。
■结果，加上以前的分析，建议，除了与CGP和其他测试方法指导的靶向治疗相关的临床益处外，付款人和专业药房经理可以将临床试验方向和注册视为液体活检CGP的临床和经济效益，并将其纳入承保决策框架和处方集。
