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通过参与加拿大国家癌症研究所临床试验组的III期临床试验对药物成本节约和病理成本节约的估计。

Estimation of drug cost avoidance and pathology cost avoidance through participation in NCIC Clinical Trials Group phase III clinical trials in Canada.

作者信息

Tang P A, Hay A E, O'Callaghan C J, Mittmann N, Chambers C R, Pater J L, Leighl N B

机构信息

Tom Baker Cancer Centre, University of Calgary, Calgary, AB;

ncic Clinical Trials Group, Kingston, ON;

出版信息

Curr Oncol. 2016 Feb;23(Suppl 1):S7-S13. doi: 10.3747/co.23.2861. Epub 2016 Feb 29.

DOI:10.3747/co.23.2861
PMID:26985151
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4780589/
Abstract

BACKGROUND

Cost avoidance occurs when, because of provision of a drug therapy [drug cost avoidance (dca)] or a pathology test [pathology cost avoidance (pca)] during trial participation, health care payers need not pay for standard treatments or testing. The aim of our study was to estimate the total dca and pca for Canadian patients enrolled in relevant phase iii trials conducted by the ncic Clinical Trials Group.

METHODS

Phase iii trials that had completed accrual and resulted in dca or pca were identified. The pca was calculated based on the number of patients screened and the test cost. The dca was estimated based on patients randomized, the protocol dosing regimen, drug cost, median dose intensity, and median duration of therapy. Costs are presented in Canadian dollars. No adjustment was made for inflation.

RESULTS

From 1999 to 2011, 4 trials (1479 patients) resulted in pca and 17 trials (3195 patients) resulted in dca. The total pca was estimated at $4,194,849, which included testing for KRAS ($141,058), microsatellite instability ($18,600), and 21-gene recurrence score ($4,035,191). The total dca was estimated at $27,952,512, of which targeted therapy constituted 43% (five trials). The combined pca and dca was $32,147,361.

CONCLUSIONS

Over the study period, trials conducted by the ncic Clinical Trials Group resulted in total cost avoidance (pca and dca) of approximately $7,518 per patient. Although not all trials lead to cost avoidance, such savings should be taken account when the financial impact of conducting clinical research is being considered.

摘要

背景

在试验参与期间,由于提供了药物治疗[药物成本避免(dca)]或病理检查[病理成本避免(pca)],医疗保健支付方无需为标准治疗或检测付费,此时即发生了成本避免。我们研究的目的是估算参与由加拿大国家癌症研究所临床试验组开展的相关Ⅲ期试验的加拿大患者的总dca和pca。

方法

确定已完成入组且产生dca或pca的Ⅲ期试验。pca根据筛查患者数量和检测成本计算得出。dca根据随机分组的患者、方案给药方案、药物成本、中位剂量强度和中位治疗持续时间估算得出。成本以加元表示。未对通货膨胀进行调整。

结果

1999年至2011年期间,4项试验(1479例患者)产生了pca,17项试验(3195例患者)产生了dca。总pca估计为4,194,849加元,其中包括KRAS检测(141,058加元)、微卫星不稳定性检测(18,600加元)和21基因复发评分检测(4,035,191加元)。总dca估计为27,952,512加元,其中靶向治疗占43%(5项试验)。pca和dca的总和为32,147,361加元。

结论

在研究期间,加拿大国家癌症研究所临床试验组开展的试验导致每位患者的总成本避免(pca和dca)约为7518加元。尽管并非所有试验都能实现成本避免,但在考虑开展临床研究的财务影响时,应考虑到此类节省。

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