Center for Health Outcomes and PharmacoEconomic Research and Department of Pharmacy Practice and Science, College of Pharmacy, University of Arizona, Tucson, and University of Arizona Cancer Center, Tucson.
Matrix45, Tucson, AZ.
J Manag Care Spec Pharm. 2022 Apr;28(4):435-448. doi: 10.18553/jmcp.2022.21379. Epub 2022 Jan 31.
Chemotherapy-induced myelosuppression, which commonly manifests as neutropenia, anemia, and/or thrombocytopenia, is a frequent and severe complication of standard treatment regimens for patients with extensive-stage small cell lung cancer (ES-SCLC). Trilaciclib is a first-in-class myeloprotective therapy indicated to decrease the incidence of chemotherapy-induced myelosuppression when administered prior to a platinum-/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. To estimate the budget impact of administering trilaciclib prior to chemotherapy to manage chemotherapy-induced myelosuppression in adults with ES-SCLC from a US payer perspective. A budget impact model was developed to assess the impact of introducing trilaciclib to a hypothetical 1 million-member health insurance plan. The model compared 2 market scenarios: a current scenario of standard treatments for ES-SCLC without trilaciclib, and an alternative scenario of standard treatment plus trilaciclib. Population, clinical, and cost inputs were derived from published literature and trilaciclib clinical trial data. Model outcomes included the number of myelosuppressive adverse events (AEs), costs of treatment, costs of AE management, total cost, and per-member per-month (PMPM) costs. The budget impact of trilaciclib was calculated as the difference in cost (2021 US dollars) between the 2 scenarios over a 1- to 5-year time horizon. Scenario and deterministic sensitivity analyses were conducted to assess uncertainty around key model inputs. An estimated total of 301 patients were eligible for treatment with trilaciclib over a 5-year period. The use of trilaciclib was estimated to reduce the number of myelosuppressive AEs over a 5-year period (events avoided included 108 for neutropenia, 7 for febrile neutropenia, 23 for anemia, and 46 for thrombocytopenia) compared with the scenario without trilaciclib. The adoption of trilaciclib was associated with a cost saving of $801,254 ($0.013 PMPM) over 5 years. The acquisition cost for trilaciclib ($3,704,199) was offset by the reduction in AE management cost ($4,282,748) and reduction in prophylactic granulocyte colony-stimulating factor use ($222,704). The cost savings associated with trilaciclib began in year 1 (total $34,388; $0.003 PMPM) and accrued over time. The acquisition cost of trilaciclib is projected to be offset by a reduction in the costs of managing AEs related to myelosuppression when added to standard chemotherapy regimens for ES-SCLC. The net budget impact of trilaciclib is estimated to be a cost saving. This research was funded by G1 Therapeutics, Inc., and implemented by ZS Associates, an independent consultancy that collated the model inputs and performed the budget impact analysis. The study sponsor was involved in the study design; collection, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. The journal open access fee was funded by G1 Therapeutics, Inc. Moran, Chioda, and Huang are employed by G1 Therapeutics, Inc. Chioda and Huang report stocks and stock options for G1 Therapeutics, Inc. Goyal and Deniz are employed by ZS Associates. Goyal reports consulting fees from G1 Therapeutics, Inc. Abraham reports consulting fees from Coherus, G1 Therapeutics, Inc. (unrelated to this study and manuscript), Mylan/Viatris, and Sandoz and participation on a data safety monitoring board or advisory board for G1 Therapeutics, Inc. MacDonald reports consulting fees from Coherus, G1 Therapeutics, Inc. (unrelated to this study and manuscript), Mylan/Viatris, and Sandoz. Deniz reports no disclosures. A synopsis of the current study was presented in poster format at the Virtual AMCP Annual Meeting, April 12-16, 2021.
化疗引起的骨髓抑制,通常表现为中性粒细胞减少症、贫血和/或血小板减少症,是广泛期小细胞肺癌(ES-SCLC)患者标准治疗方案的常见且严重的并发症。 Trilaciclib 是一种首创的骨髓保护疗法,当与含铂/依托泊苷的方案或拓扑替康联合用于 ES-SCLC 时,可降低化疗引起的骨髓抑制的发生率。 从美国支付者的角度估算在化疗前使用 Trilaciclib 管理 ES-SCLC 成人化疗引起的骨髓抑制的预算影响。 开发了一个预算影响模型,以评估在假设的 100 万成员医疗保险计划中引入 Trilaciclib 的影响。该模型比较了两种市场情景:一种是没有 Trilaciclib 的 ES-SCLC 标准治疗的当前情景,另一种是标准治疗加 Trilaciclib 的替代情景。人口、临床和成本投入来自已发表的文献和 Trilaciclib 临床试验数据。模型结果包括骨髓抑制不良事件(AE)的数量、治疗成本、AE 管理成本、总成本和每位成员每月(PMPM)成本。通过在 1 至 5 年内比较两种方案的成本差异(2021 年美元)来计算 Trilaciclib 的预算影响。进行了情景和确定性敏感性分析,以评估关键模型投入的不确定性。 在 5 年内,估计共有 301 名患者有资格接受 Trilaciclib 治疗。与没有 Trilaciclib 的方案相比,使用 Trilaciclib 估计可以减少 5 年内骨髓抑制性 AE 的数量(避免的事件包括中性粒细胞减少症 108 例、发热性中性粒细胞减少症 7 例、贫血 23 例和血小板减少症 46 例)。采用 Trilaciclib 可在 5 年内节省 801,254 美元(0.013 PMPM)。Trilaciclib 的采购成本(3704199 美元)被 AE 管理成本(4282748 美元)和预防使用粒细胞集落刺激因子的成本(222704 美元)的减少所抵消。与 Trilaciclib 相关的成本节约从第 1 年(总计 34388 美元;0.003 PMPM)开始,并随着时间的推移而累积。 Trilaciclib 的采购成本预计将通过降低与骨髓抑制相关的 AE 管理成本来抵消添加到 ES-SCLC 的标准化疗方案的成本。Trilaciclib 的净预算影响预计将节省成本。 这项研究由 G1 Therapeutics, Inc. 资助,并由 ZS Associates 实施,后者汇集了模型投入并进行了预算影响分析。研究赞助商参与了研究设计;数据的收集、分析和解释;报告的编写;以及提交报告供出版的决定。该研究的期刊开放获取费用由 G1 Therapeutics, Inc. 资助。Moran、Chioda 和 Huang 受雇于 G1 Therapeutics, Inc. Chioda 和 Huang 报告了 G1 Therapeutics, Inc. 的股票和股票期权。Goyal 和 Deniz 受雇于 ZS Associates。Goyal 报告了来自 G1 Therapeutics, Inc. 的咨询费(与本研究和手稿无关)、Coherus、G1 Therapeutics, Inc.(与本研究和手稿无关)、Mylan/Viatris 和 Sandoz 以及 G1 Therapeutics, Inc. 的数据安全监测委员会或咨询委员会的参与。MacDonald 报告了来自 Coherus、G1 Therapeutics, Inc.(与本研究和手稿无关)、Mylan/Viatris 和 Sandoz 的咨询费。Deniz 报告没有任何披露。本研究的概要以海报形式在 2021 年 4 月 12 日至 16 日举行的虚拟 AMCP 年度会议上展示。