Enzing Joost J, Knies Saskia, Engel Jop, IJzerman Maarten J, Sander Beate, Vreman Rick, Boer Bert, Brouwer Werner B F
Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands.
Zorginstituut Nederland, Diemen, The Netherlands.
Cost Eff Resour Alloc. 2022 Aug 31;20(1):46. doi: 10.1186/s12962-022-00383-y.
Drug reimbursement decisions are often made based on a price set by the manufacturer. In some cases, this price leads to public and scientific debates about whether its level can be justified in relation to its costs, including those related to research and development (R&D) and manufacturing. Such considerations could enter the decision process in collectively financed health care systems. This paper investigates whether manufacturers' costs in relation to drug prices, or profit margins, are explicitly mentioned and considered by health technology assessment (HTA) organisations.
An analysis of reimbursement reports for cancer drugs was performed. All relevant Dutch HTA-reports, published between 2017 and 2019, were selected and matched with HTA-reports from three other jurisdictions (England, Canada, Australia). Information was extracted. Additionally, reimbursement reports for three cases of expensive non-oncolytic orphan drugs prominent in pricing debates in the Netherlands were investigated in depth to examine consideration of profit margins.
A total of 66 HTA-reports concerning 15 cancer drugs were included. None of these reports contained information on manufacturer's costs or profit margins. Some reports contained general considerations of the HTA organisation which related prices to manufacturers' costs: six contained a statement on the lack of price setting transparency, one mentioned recouping R&D costs as a potential argument to justify a high price. For the case studies, 21 HTA-reports were selected. One contained a cost-based price justification provided by the manufacturer. None of the other reports contained information on manufacturer's costs or profit margins. Six reports contained a discussion about lack of transparency. Reports from two jurisdictions contained invitations to justify high prices by demonstrating high costs.
Despite the attention given to manufacturers' costs in relation to price in public debates and in the literature, this issue does not seem to get explicit systematic consideration in the reimbursement reports of expensive drugs.
药品报销决策通常基于制造商设定的价格做出。在某些情况下，这一价格引发了公众和科学界对于其价格水平相对于成本（包括研发和生产成本）是否合理的争论。这些考量可能会进入公共融资医疗系统的决策过程。本文调查了卫生技术评估（HTA）机构是否明确提及并考虑了制造商的药品成本或利润率与药品价格的关系。
对癌症药物的报销报告进行了分析。选取了2017年至2019年间发布的所有相关荷兰HTA报告，并与其他三个司法管辖区（英格兰、加拿大、澳大利亚）的HTA报告进行匹配。提取了相关信息。此外，还深入研究了荷兰定价辩论中突出的三种昂贵的非溶瘤孤儿药的报销报告，以考察对利润率的考量。
共纳入了66份关于15种癌症药物的HTA报告。这些报告均未包含有关制造商成本或利润率的信息。一些报告包含了HTA机构将价格与制造商成本相关联的一般性考量：6份报告中有关于价格设定缺乏透明度的陈述，1份报告提到收回研发成本是证明高价合理的一个潜在论据。对于案例研究，选取了21份HTA报告。其中1份包含了制造商提供的基于成本的价格合理性说明。其他报告均未包含有关制造商成本或利润率的信息。6份报告包含了关于缺乏透明度的讨论。来自两个司法管辖区的报告邀请通过证明高成本来为高价进行辩护。
尽管在公开辩论和文献中都关注了制造商成本与价格的关系，但在昂贵药品的报销报告中，这个问题似乎并未得到明确的系统考虑。
