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在美国未经治疗的慢性淋巴细胞白血病患者中,12 个月固定治疗持续时间 Venetoclax 联合 Obinutuzumab 的预算影响。

Budget Impact of 12-Month Fixed Treatment Duration Venetoclax in Combination with Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia Patients in the United States.

机构信息

University of Southern California School of Pharmacy, Los Angeles, USA.

AbbVie Inc., North Chicago, IL, USA.

出版信息

Pharmacoeconomics. 2020 Sep;38(9):941-951. doi: 10.1007/s40273-020-00919-1.

DOI:10.1007/s40273-020-00919-1
PMID:32383129
Abstract

OBJECTIVES

This study aimed to assess the total cost of care (TCC) and budget impact of introducing 12-month fixed duration venetoclax + obinutuzumab (VEN+G) as first-line treatment for chronic lymphocytic leukemia (CLL) from the perspective of a US health plan with 1,000,000 (1M) members.

METHODS

The 3-year model included the following comparators: fludarabine + cyclophosphamide + rituximab (FCR), bendamustine + rituximab (BR), obinutuzumab + chlorambucil (GClb), ibrutinib (Ibr), and Ibr+Rituximab/obinutuzumab [Ibr+R/Ibr+G]). TCC included US-specific costs associated with treatment (i.e., drug, administration, and wastage), adverse events, routine care, and monitoring. Dosing and safety data were drawn from clinical trials and US package inserts. Budget impact outcomes were presented on an absolute and per-member per-month (PMPM) basis. Sensitivity analyses explored uncertainty in influential parameters, including scenarios testing the duration of treat-to-progression agents.

RESULTS

Over the 3-year time horizon, introducing VEN+G in a 1M-member health plan resulted in total cost savings of $1,550,663 (PMPM - $0.04), compared to a scenario without VEN+G. The fixed 12-month duration of VEN+G contributed to this cost saving by reducing cumulative treatment costs compared with Ibr-based regimens. By year 3, the cumulative difference in TCC of VEN+G compared with Ibr, Ibr+G, and Ibr+R amounted to - $300,942, - $367,001, and - $369,784, respectively. Extensive sensitivity analyses supported the base case findings.

CONCLUSIONS

Introducing VEN+G among first-line CLL treatments to a US health plan resulted in cost savings compared to a plan with chemoimmunotherapies and Ibr-based therapies only. Economic benefits of VEN+G, a novel agent with fixed treatment duration, coupled with proven clinical benefits should help inform formulary adoption decisions and treatment recommendations.

摘要

目的

本研究旨在评估从拥有 100 万(1M)名成员的美国健康计划的角度来看,采用 12 个月固定疗程 venetoclax+obinutuzumab(VEN+G)作为慢性淋巴细胞白血病(CLL)一线治疗的总医疗成本(TCC)和预算影响。

方法

3 年模型纳入以下对照方案:氟达拉滨+环磷酰胺+利妥昔单抗(FCR)、苯达莫司汀+利妥昔单抗(BR)、obinutuzumab+chlorambucil(GClb)、伊布替尼(Ibr)和 Ibr+利妥昔单抗/obinutuzumab(Ibr+R/Ibr+G)。TCC 包括与治疗相关的美国特定成本(即药物、管理和浪费)、不良事件、常规护理和监测。剂量和安全性数据来自临床试验和美国药品说明书。预算影响结果以绝对值和每名成员每月(PMPM)为基础呈现。敏感性分析探讨了影响参数的不确定性,包括测试进展性药物治疗持续时间的情景。

结果

在 3 年的时间内,在拥有 1M 名成员的健康计划中引入 VEN+G 可节省总医疗成本 1550663 美元(PMPM-0.04),而不引入 VEN+G 的方案则会增加成本。VEN+G 固定的 12 个月疗程通过与基于 Ibr 的方案相比降低累积治疗成本,有助于节省成本。到第 3 年,与 Ibr、Ibr+G 和 Ibr+R 相比,VEN+G 的 TCC 累计差异分别为-300942 美元、-367001 美元和-369784 美元。广泛的敏感性分析支持基础案例的发现。

结论

与仅使用化疗免疫疗法和基于 Ibr 的疗法相比,在美国健康计划中引入 VEN+G 作为一线 CLL 治疗方法可节省成本。新型固定疗程药物 VEN+G 的经济效益,加上其已被证实的临床获益,应有助于为药品目录的采用决策和治疗建议提供信息。

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