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利益相关者对ICER证据报告草案公众意见的参与情况分析。

Analysis of Stakeholder Engagement in the Public Comments of ICER Draft Evidence Reports.

作者信息

Gerlach Jean A, Snow Brian, Prioli Katherine M, Vertsman Ronald, Patterson Julie, Pizzi Laura T

机构信息

PharmD Candidate, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ.

Biologic Programs Associate, Regeneron Pharmaceuticals, Tarrytown, PA.

出版信息

Am Health Drug Benefits. 2020 Sep;13(4):136-142.

Abstract

BACKGROUND

Health technology assessment is becoming increasingly important to healthcare payers' decision-making. The Institute for Clinical and Economic Review (ICER) is the most established US-based research group performing value assessments. ICER provides opportunities for stakeholder engagement, including a window of opportunity for public comments on the draft evidence report. Those public comments were reviewed in this study.

OBJECTIVES

To determine which stakeholders are most often commenting on ICER technology appraisal reports and to examine what aspects of the reports are the topics of these comments.

METHOD

We reviewed 7 ICER reports, which were used to extract stakeholder comments. All the identified comments were evaluated by 2 trained reviewers independently for stakeholder type, comment nature (positive or negative), and focus of comments (eg, methodology, data, real-world experience). Statistical analyses were used to analyze the reports for any associations between the frequency of the comments and the stakeholder type by therapeutic area.

RESULTS

A total of 463 comments were identified within the 55 letter submissions identified across the 7 ICER reviews that were included in the study. The quantity of the comments generally reflected the quantity of therapies that were included in the review. Drug manufacturers (63.1%), patients or patient advocacy groups (18.1%), and providers or provider groups (9.7%) were the stakeholders most often engaged in the public comments. The comments most often addressed the methodology of the value assessment (53.8%). Comments about missing data (14%), general criticism (8.2%), and general support (2.2%) were less common.

CONCLUSION

ICER is committed to engaging stakeholders in their value assessment process and adapting their strategies to improve such communications. Although ICER aims to influence payer decision-making, drug manufacturers were the most involved stakeholder in the assessment process, and they were most concerned with ICER's methodology. These results show the impact that ICER may have on decision-making in healthcare, emphasize the incentives that ICER drives for certain stakeholders, and highlight areas for further investigation.

摘要

背景

卫生技术评估对医疗保健支付方的决策变得越来越重要。临床与经济评论研究所(ICER)是美国最成熟的进行价值评估的研究团体。ICER为利益相关者参与提供了机会,包括对证据报告草案进行公众评论的机会窗口。本研究对这些公众评论进行了审查。

目的

确定哪些利益相关者最常对ICER技术评估报告发表评论,并检查这些评论所针对的报告方面。

方法

我们审查了7份ICER报告,用于提取利益相关者的评论。所有识别出的评论由2名经过培训的评审员独立评估利益相关者类型、评论性质(正面或负面)以及评论重点(例如,方法、数据、实际经验)。使用统计分析来分析报告中评论频率与治疗领域利益相关者类型之间的任何关联。

结果

在纳入研究的7份ICER审查中确定的55份信件提交中,共识别出463条评论。评论数量总体上反映了审查中所涵盖疗法的数量。药品制造商(63.1%)、患者或患者倡导团体(18.1%)以及提供者或提供者团体(9.7%)是最常参与公众评论的利益相关者。评论最常涉及价值评估的方法(53.8%)。关于数据缺失的评论(14%)、一般性批评(8.2%)和一般性支持(2.2%)则较少见。

结论

ICER致力于让利益相关者参与其价值评估过程,并调整其策略以改善此类沟通。尽管ICER旨在影响支付方的决策,但药品制造商是评估过程中参与度最高的利益相关者,他们最关注ICER的方法。这些结果显示了ICER可能对医疗保健决策产生的影响,强调了ICER对某些利益相关者的激励作用,并突出了需要进一步调查的领域。

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