背景:在医疗费用控制的背景下,2016年3月24日的法令对高成本药品的注册程序和条款进行了修订。本研究旨在建立这一措施的经济影响。
方法:于2015年7月1日至2015年12月31日在法国大学医院进行了为期六个月的回顾性研究。对于为癌症患者开具的每种可注射的高成本抗癌药物,治疗适应症,研究了其与上市许可相关的状况以及相关的实际健康益处的改善。这些治疗的总成本,每种指示类型的成本,在营销授权指示的情况下,考虑到所有受法令影响的药物都将被取消,因此评估了实际健康福利的每次改善成本。
结果:超过六个月,开出了4416种高成本的可注射抗癌药物,总费用为420万欧元。实际收益略有改善或不存在改善的药物成本,并且比较者不是繁重的557,564欧元。
结论:繁重药物清单上的登记方式的改革对卫生机构来说是一笔巨大的额外费用(我们医院为110万欧元),并提出了癌症患者获得这些治疗的问题。
BACKGROUND: In the context of health expenses control, reimbursement of high-cost medicines with a \'minor\' or \'nonexistent\' improvement in actual health benefit evaluated by the Haute Autorité de santé is revised by the decree of March 24, 2016 related to the procedure and terms of registration of high-cost pharmaceutical drugs. This study aims to set up the economic impact of this measure.
METHODS: A six months retrospective study was conducted within a French university hospital from July 1, 2015 to December 31, 2015. For each injectable high-cost anticancer drug prescribed to a patient with cancer, the therapeutic indication, its status in relation to the marketing authorization and the associated improvement in actual health benefit were examined. The total costs of these treatments, the cost per type of indication and, in the case of marketing authorization indications, the cost per improvement in actual health benefit were evaluated considering that all drugs affected by the decree would be struck off.
RESULTS: Over six months, 4416 high-cost injectable anticancer drugs were prescribed for a total cost of 4.2 million euros. The costs of drugs with a minor or nonexistent improvement in actual benefit and which comparator is not onerous amount 557,564 euros.
CONCLUSIONS: The reform of modalities of inscription on the list of onerous drugs represents a significant additional cost for health institutions (1.1 million euros for our hospital) and raises the question of the accessibility to these treatments for cancer patients.