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带状疱疹重组疫苗的临床和经济影响逐渐增加:预算影响模型中的真实世界数据。

Incremental clinical and economic impact of recombinant zoster vaccination: real-world data in a budget impact model.

机构信息

GSK, Philadelphia, PA.

RTI Health Solutions, Research Triangle, NC.

出版信息

J Manag Care Spec Pharm. 2020 Dec;26(12):1567-1575. doi: 10.18553/jmcp.2020.20251. Epub 2020 Oct 12.

DOI:10.18553/jmcp.2020.20251
PMID:33043821
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10391059/
Abstract

BACKGROUND

In 2017, the FDA approved the adjuvanted recombinant zoster vaccine (RZV) for the prevention of herpes zoster (HZ) in immunocompetent adults aged 50 years and older. RZV joined zoster vaccine live (ZVL) as U.S.-marketed vaccines against HZ. The Advisory Committee on Immunization Practices preferentially recommended use of RZV over ZVL. In order to inform population-based decision makers (PBDMs) about the incremental clinical and economic impact of RZV adoption, budget impact (BI) models may be used. Populating such models with national data can inform PBDMs about the incremental value of RZV adoption nationally; however, heterogeneity across health plans requires the inclusion of plan-specific data to ensure the relevance of modeling outcomes for plan-specific decision makers.

OBJECTIVE

To investigate the clinical and economic outcomes associated with the adoption of RZV in nationally representative populations with commercial and Medicare coverage and to demonstrate the effect of the heterogeneity of health plans using real-world data from a large, integrated delivery network (IDN).

METHODS

We used a publicly available BI model. The model accounts for national and IDN-collected population characteristics (size, age distribution) and epidemiological data (incidence of HZ and complications, HZ recurrence rate), vaccine characteristics from randomized controlled trials and observational studies (efficacy, waning, second dose compliance for RZV, adverse event rate), national costs (vaccine, direct medical for HZ, complications, and vaccine adverse events), and current and anticipated vaccine coverage. We assessed incremental clinical (HZ cases and complications) and economic (per-member-per-month [PMPM] costs) impact at 5-year to 15-year time horizons, comparing scenarios where RZV is solely implemented with one where only ZVL is utilized.

RESULTS

Following the adoption of RZV, the incremental HZ cases avoided over 5 and 15 years were estimated to be 1,800 and 15,000 for a commercial plan, 3,800 and 21,000 for a Medicare plan, and 8,600 and 71,000 for a specific IDN. The incremental PMPM budget impact over the same time horizons was estimated to be $0.42 and $0.31, respectively, for a commercial plan, $0.35 and $0.10 for a Medicare plan, and $0.39 and $0.25 for a specific IDN. The differences in results across plans resulted from the population age distribution, the vaccine copay (applied in the Medicare scenario only), the vaccine coverage in the plan, and other plan-specific factors affecting disease epidemiology and costs per case of HZ.

CONCLUSIONS

Model projections indicated that RZV adoption avoided HZ cases and related complications, with the PMPM budget impact dependent on plan-specific factors. As health gains increased over time, the incremental costs incurred were found to decrease as the shorter-term costs of adopting the new vaccine were increasingly offset by the longer-term benefits of vaccination.

DISCLOSURES

GlaxoSmithKline Biologicals SA funded this study (GSK study identifier: HO-17-18378) and was involved in all stages of study conduct, including analysis of the data. GlaxoSmithKline Biologicals SA also paid all costs associated with the development and publication of this manuscript. Patterson, Van Oorschot, and Curran are employees of the GSK group of companies and hold shares in the GSK group of companies. Herring, Carrico, and Zhang are employees of RTI Health Solutions, which received funding via a contractual agreement with the GSK group of companies to perform the work contributing to this research. Ackerson, Bruxvoort, Sy, and Tseng are employees of Kaiser Permanente Southern California, which was contracted by the GSK group of companies for the conduct of this study and were members of the KPSC study team. Ackerson, Bruxvoort, Sy, and Tseng report research contracts with the following pharmaceutical companies unrelated to this study: Dynavax (Ackerson, Bruxvoort, and Sy); the GSK group of companies (Ackerson, Bruxvoort, Sy, and Tseng); Novavax (Ackerson, Sy, and Tseng); and Seqirus (Ackerson, Bruxvoort, Sy, and Tseng). Tseng reports having served as a paid consultant for the GSK group of companies. The authors declare no other financial and nonfinancial relationships and activities. Findings from this study were presented at AMCP Nexus 2019; October 29-November 1, 2019; National Harbor, MD.

摘要

背景

2017 年,美国食品药品监督管理局(FDA)批准了佐剂重组带状疱疹疫苗(RZV)用于预防免疫功能正常的 50 岁及以上成人带状疱疹(HZ)。RZV 与带状疱疹减毒活疫苗(ZVL)一起成为美国市场上针对 HZ 的疫苗。免疫实践咨询委员会(ACIP)优先推荐使用 RZV 而不是 ZVL。为了向基于人群的决策者(PBDMs)提供有关 RZV 采用的增量临床和经济影响的信息,预算影响(BI)模型可能会被使用。使用国家数据填充这些模型可以为 PBDMs 提供关于全国范围内采用 RZV 的增量价值的信息;然而,由于健康计划之间存在异质性,需要纳入计划特定的数据,以确保建模结果与特定计划决策者的相关性。

目的

调查在具有商业和医疗保险覆盖的代表性人群中采用 RZV 的临床和经济结果,并使用来自大型综合交付网络(IDN)的真实世界数据来展示健康计划异质性的影响。

方法

我们使用了一个公开的 BI 模型。该模型考虑了全国性和 IDN 收集的人口特征(规模、年龄分布)和流行病学数据(HZ 和并发症的发病率、HZ 复发率)、来自随机对照试验和观察性研究的疫苗特征(疗效、衰减、RZV 的第二剂依从性、不良事件发生率)、全国性成本(疫苗、直接医疗用于 HZ、并发症和疫苗不良事件)以及当前和预期的疫苗覆盖率。我们在 5 年至 15 年的时间范围内评估了增量临床(HZ 病例和并发症)和经济(每会员每月[PMPM]成本)影响,比较了仅实施 RZV 和仅实施 ZVL 的情况。

结果

在采用 RZV 后,预计商业计划和医疗保险计划的 5 年和 15 年累计 HZ 病例数分别减少 1800 例和 15000 例,特定 IDN 计划分别减少 8600 例和 71000 例。在同一时间范围内,预计商业计划、医疗保险计划和特定 IDN 计划的 PMPM 预算影响增量分别为 0.42 美元和 0.31 美元、0.35 美元和 0.10 美元、0.39 美元和 0.25 美元。计划之间的结果差异源于人口年龄分布、疫苗共付额(仅在医疗保险计划中适用)、计划中的疫苗覆盖率以及影响 HZ 疾病流行病学和每例 HZ 成本的其他计划特定因素。

结论

模型预测表明,采用 RZV 可避免 HZ 病例和相关并发症,PMPM 预算影响取决于计划特定因素。随着健康收益的增加,随着新疫苗的短期成本越来越多地被疫苗接种的长期效益所抵消,增量成本也随之降低。

披露

葛兰素史克生物制品有限公司(GSK)资助了这项研究(GSK 研究标识符:HO-17-18378),并参与了研究的所有阶段,包括数据分析。GSK 生物制品有限公司还支付了与该研究相关的所有开发和出版费用。Patterson、Van Oorschot 和 Curran 是 GSK 集团公司的员工,并持有 GSK 集团公司的股份。Herring、Carrico 和 Zhang 是 RTI 健康解决方案公司的员工,该公司通过与 GSK 集团公司的合同协议获得资金,以开展为这项研究做出贡献的工作。Ackerson、Bruxvoort、Sy 和 Tseng 是 Kaiser Permanente Southern California 的员工,该公司受 GSK 集团公司委托进行这项研究,是 KPSC 研究团队的成员。Ackerson、Bruxvoort、Sy 和 Tseng 报告与这项研究无关的以下制药公司的研究合同:Dynavax(Ackerson、Bruxvoort 和 Sy);GSK 集团公司(Ackerson、Bruxvoort、Sy 和 Tseng);Novavax(Ackerson、Sy 和 Tseng);和 Seqirus(Ackerson、Bruxvoort、Sy 和 Tseng)。Tseng 报告曾担任 GSK 集团公司的付费顾问。作者声明没有其他财务和非财务关系和活动。本研究的结果在 2019 年 AMCP Nexus 会议上提出;2019 年 10 月 29 日至 11 月 1 日;马里兰州国家港。

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