临床试验中的免费药物及其对国民保健制度潜在的成本节约影响：意大利的回顾性成本分析。

Free drugs in clinical trials and their potential cost saving impact on the National Health Service: a retrospective cost analysis in Italy.

机构信息

IRCCS Azienda Ospedaliera Universitaria San Martino IST - Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.

出版信息

Lung Cancer. 2013 Aug;81(2):236-40. doi: 10.1016/j.lungcan.2013.03.021. Epub 2013 May 4.

DOI:10.1016/j.lungcan.2013.03.021

PMID:23648072

Abstract

BACKGROUND

The cost of new anti-cancer drugs has dramatically increased in recent years, and countermeasures are required in order to limit pharmaceutical expenses. Sponsored clinical trials that provide drugs free of charge may be a useful tool in order to reduce drug costs. The aim of this analysis is to evaluate the effect of clinical trials on pharmaceutical expenditure savings.

METHODS

We evaluated the cost of drugs administered in clinical practice and in clinical trials (considering only the standard regimens that were administered also in clinical practice) in 2010 at the Lung Cancer Unit of the National Institute for Cancer Research in Genoa, Italy. The cost of drugs was calculated on the price charged at our Institute in 2010. The supposed cost of experimental treatment replacing standard therapy was converted in the cost of the treatments that would have been chosen in clinical practice, considering histology, line of treatment and number of administered cycles.

RESULTS

From 1/1/2010 to 12/31/2010, 196 patients affected by lung cancer or pleural mesothelioma were treated. 152 patients (78%) received treatment in clinical practice or in non-sponsored trials (18 patients in 4 trials), while 44 (22%) were treated in one of the 12 sponsored clinical trials recruiting in 2010. Globally, 606 cycles of treatment would have been administered to patients, of which 436 (72%) were administered in clinical practice or in non-sponsored trials and 170 (28%) were administered in pharmaceutical company sponsored clinical trials. The overall cost of those anti-neoplastic drugs, based on the prices charged at our Institute in 2010, was €799 803. The cost of drugs administered in clinical practice or in non-sponsored trials was €556 649 (70%), whereas the cost of standard drugs administered in clinical trials was €243 154 (30%). The grants provided by pharmaceutical companies were evaluated and amounted to €235 965.

CONCLUSIONS

The participation in sponsored clinical trials in which drugs are provided free of charge offers substantial cost savings for the National Health Service; moreover, the grants received for each enrolled patient produced additional income.

摘要

背景

近年来，新抗癌药物的成本大幅上升，因此需要采取措施限制药品支出。提供免费药物的赞助临床试验可能是降低药品成本的一种有用工具。本分析旨在评估临床试验对药品支出节省的影响。

方法

我们评估了意大利热那亚国家癌症研究所肺癌科 2010 年临床实践和临床试验中使用的药物成本（仅考虑在临床实践中也使用的标准方案）。药物成本是根据我们研究所 2010 年的收费计算的。替代标准治疗的实验治疗的假定成本被转换为在临床实践中会选择的治疗成本，考虑组织学、治疗线和给予的周期数。

结果

从 2010 年 1 月 1 日至 12 月 31 日，196 名肺癌或胸膜间皮瘤患者接受了治疗。152 名患者（78%）在临床实践或非赞助试验中接受治疗（在 4 项试验中 18 名患者），而 44 名患者（22%）在 2010 年招募的 12 项赞助临床试验之一中接受治疗。总体而言，将向患者给予 606 个周期的治疗，其中 436 个（72%）在临床实践或非赞助试验中给予，170 个（28%）在制药公司赞助的临床试验中给予。根据我们研究所 2010 年的收费，这些抗癌药物的总费用为 799803 欧元。在临床实践或非赞助试验中给予的药物的成本为 556649 欧元（70%），而临床试验中给予的标准药物的成本为 243154 欧元（30%）。评估了制药公司提供的赠款，金额为 235965 欧元。