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Validity and Reliability of Value Assessment Frameworks for New Cancer Drugs.新型癌症药物价值评估框架的有效性和可靠性
Value Health. 2017 Feb;20(2):200-205. doi: 10.1016/j.jval.2016.12.011. Epub 2017 Feb 10.
2
Three Sets of Case Studies Suggest Logic and Consistency Challenges with Value Frameworks.三组案例研究揭示了价值框架在逻辑和一致性方面存在的挑战。
Value Health. 2017 Feb;20(2):193-199. doi: 10.1016/j.jval.2016.11.012.
3
Evaluating Frameworks That Provide Value Measures for Health Care Interventions.评估为医疗保健干预措施提供价值衡量的框架。
Value Health. 2017 Feb;20(2):185-192. doi: 10.1016/j.jval.2016.11.013.
4
Evaluation of the ASCO Value Framework for Anticancer Drugs at an Academic Medical Center.评估学术医疗中心的抗癌药物 ASCO 价值框架。
J Manag Care Spec Pharm. 2017 Feb;23(2):163-169. doi: 10.18553/jmcp.2017.23.2.163.
5
Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received.更新美国临床肿瘤学会价值框架:针对收到的评论进行的修订与思考
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N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.
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American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options.美国临床肿瘤学会声明:评估癌症治疗方案价值的概念框架。
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Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer.纳武单抗与多西他赛治疗晚期鳞状细胞非小细胞肺癌的疗效比较
N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.
10
Enzalutamide in metastatic prostate cancer before chemotherapy.恩杂鲁胺治疗化疗前转移性前列腺癌。
N Engl J Med. 2014 Jul 31;371(5):424-33. doi: 10.1056/NEJMoa1405095. Epub 2014 Jun 1.

患者-提供者互动的价值框架:ASCO 价值框架与 NCCN 证据块在肿瘤学中确定价值的比较。

Value Frameworks for the Patient-Provider Interaction: A Comparison of the ASCO Value Framework Versus NCCN Evidence Blocks in Determining Value in Oncology.

机构信息

1 Touro University California College of Pharmacy, Vallejo, California, and Ipsos Healthcare, San Francisco, California.

2 Touro University California College of Pharmacy, Vallejo, California.

出版信息

J Manag Care Spec Pharm. 2017 Jun;23(6-a Suppl):S13-S20. doi: 10.18553/jmcp.2017.23.6-a.s13.

DOI:10.18553/jmcp.2017.23.6-a.s13
PMID:28535103
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10408426/
Abstract

BACKGROUND

To address the rising concern about oncology drug costs, the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) recently developed unique tools to help providers and patients make informed decisions about the value of an anticancer regimen. The ASCO Value Framework (AVF) allows users to generate a net health benefit (NHB) score along with drug acquisition costs for oncology regimens that have been compared in a prospective randomized clinical trial. In contrast, the NCCN Evidence Blocks (NEB) derives ratings from an expert panel assessment in the categories of efficacy, safety, quality and consistency of evidence, and affordability.

OBJECTIVE

To compare the results of the AVF and NEB by applying each tool to the same clinical scenarios.

METHODS

We evaluated 2 regimens using the AVF and NEB scores: (1) enzalutamide for treatment of metastatic castration-resistant prostate cancer and (2) nivolumab versus docetaxel in treatment of advanced squamous and nonsquamous non-small cell lung cancer (NSCLC).

RESULTS

Enzalutamide generated a total NHB score of 44.8 (range 0-180) for use before chemotherapy and 70.8 for use after chemotherapy with a monthly cost of $8,495 in the AVF. The NEB scored enzalutamide 4 (very effective) for efficacy, 4 (occasionally toxic) for safety, and 2 (expensive) for affordability in the no visceral metastases block. It scored 3 (moderately effective) for efficacy, 4 for safety, and 2 for affordability in the visceral metastases block. Nivolumab in advanced nonsquamous NSCLC scored 36.0 and 73.2 in advanced squamous NSCLC, with a monthly cost of $7,010 in the AVF. The NEB gave nivolumab a score of 4 for efficacy and safety and 1 (very expensive) for affordability in the NEB in advanced nonsquamous and advanced squamous NSCLC.

CONCLUSIONS

The AVF and NEB are novel tools that take different approaches in assessing the value of an oncology treatment regimen. From this study, it is clear that the findings generated by these tools are distinct. The AVF provides a summary score for treatments across all clinical benefit and toxicity categories, whereas the NEB provides component scores for treatment efficacy, safety, quality and consistency of evidence, and affordability. Both tools are novel and come with their own challenges.

DISCLOSURES

No outside funding supported this study. Shah-Manek is also employed by Ipsos Healthcare, a consulting firm. The authors have no conflicting interests to report. Study concept and design were contributed by Shah-Manek and Ignoffo. Galanto and Nguyen collected the data, and data interpretation was performed by all the authors. All the authors contributed to writing the manuscript, which was revised primarily by Shah-Manek, along with Galanto, Nguyen, and Ignoffo. This research was previously presented as a poster and podium presentation at the Academy of Managed Care Pharmacy Nexus 2016 held October 3-6 in National Harbor, Maryland.

摘要

背景

为了解决人们对肿瘤药物费用不断上涨的担忧,美国临床肿瘤学会(ASCO)和美国国家癌症综合网络(NCCN)最近开发了独特的工具,帮助医疗服务提供者和患者了解抗癌方案的价值。ASCO 价值框架(AVF)允许用户为已在前瞻性随机临床试验中进行比较的肿瘤治疗方案生成净健康收益(NHB)评分和药物获得成本。相比之下,NCCN 证据块(NEB)根据疗效、安全性、证据质量和一致性以及可负担性的专家组评估得出评分。

目的

通过将每种工具应用于相同的临床情况,比较 AVF 和 NEB 的结果。

方法

我们使用 AVF 和 NEB 评分评估了 2 种方案:(1)恩扎鲁胺治疗转移性去势抵抗性前列腺癌,(2)纳武单抗对比多西他赛治疗晚期鳞状和非鳞状非小细胞肺癌(NSCLC)。

结果

在 AVF 中,恩扎鲁胺在化疗前的总 NHB 评分为 44.8(0-180 分),化疗后的 NHB 评分为 70.8,每月费用为 8495 美元。在没有内脏转移块中,NEB 对恩扎鲁胺的评分是 4(非常有效)用于疗效,4(偶尔有毒)用于安全性,2(昂贵)用于可负担性。在有内脏转移块中,NEB 对恩扎鲁胺的评分是 3(中等有效)用于疗效,4 用于安全性,2 用于可负担性。在晚期非鳞状 NSCLC 中,纳武单抗的评分是 36.0 和 73.2,在晚期鳞状 NSCLC 中,评分是 36.0 和 73.2,在 AVF 中每月费用为 7010 美元。NEB 在晚期非鳞状和晚期鳞状 NSCLC 中对纳武单抗的疗效和安全性评分为 4,可负担性评分为 1(非常昂贵)。

结论

AVF 和 NEB 是评估肿瘤治疗方案价值的两种新工具,它们采用不同的方法。从这项研究中可以清楚地看出,这两种工具的结果是不同的。AVF 为所有临床获益和毒性类别提供了治疗的综合评分,而 NEB 则为治疗的疗效、安全性、质量和一致性证据以及可负担性提供了组成部分的评分。这两种工具都是新的,都有自己的挑战。

披露

本研究没有外部资金支持。Shah-Manek 还受雇于咨询公司 Ipsos Healthcare。作者没有利益冲突需要申报。Shah-Manek 和 Ignoffo 为研究概念和设计做出了贡献。Galanto 和 Nguyen 收集了数据,所有作者都对数据进行了解释。所有作者都参与了撰写手稿,主要由 Shah-Manek 与 Galanto、Nguyen 和 Ignoffo 共同修改。这项研究之前曾作为海报和演讲在 2016 年 10 月 3 日至 6 日在马里兰州国家港举行的管理式医疗药房协会 Nexus 2016 上展示。