Health Economics, Market Access & Reimbursement, Janssen-Cilag GmbH, Pharmaceutical Companies of Johnson & Johnson, Neuss, Germany.
Institute for Health Services Management and Research, Universität Duisburg-Essen, Essen, Germany.
Health Econ Policy Law. 2024 Apr;19(2):216-233. doi: 10.1017/S1744133123000117. Epub 2023 Aug 14.
Since 2011, the prices for all new drugs in Germany are negotiated based on a benefit assessment. The purpose of this study was to analyze the price regulation of drugs with unproven additional benefit.
Benefit assessment procedures from 2011 to 2020 were reviewed and selected through AMNOG Monitor and Lauer Taxe. Negotiated annual therapy costs, the annual costs of the most cost-efficient appropriate comparative therapy (ACT) and the potential budget impact for 33 included procedures were calculated.
55% of the included drugs achieved a negotiated price higher than the most cost-efficient ACT, 3% were identified as equal and 42% showed lower negotiated prices. The potential savings exceeded expenditures by around EUR 523.5 m. After price flexibility was adopted by the legislator in 2017, the overall potential savings still outweighed the expenditures by around EUR 62 m.
Our analysis shows that making price negotiations more flexible by law does not undermine the fundamental aim of the AMNOG, which is to avoid additional expenditure without increased patient benefit. The regulation can thus fulfill the objective provided by the legislature of keeping drugs without proven additional benefits in the German healthcare system.
自 2011 年以来，德国所有新药的价格都基于效益评估进行谈判。本研究的目的是分析尚未证明具有额外效益的药物的价格管制。
通过 AMNOG Monitor 和 Lauer Taxe 审查并选择了 2011 年至 2020 年的效益评估程序。计算了 33 项纳入程序的谈判年度治疗费用、最具成本效益的适当比较治疗（ACT）的年度成本和潜在预算影响。
纳入的药物中有 55%的药物达成的谈判价格高于最具成本效益的 ACT，3%的药物被认为是相等的，42%的药物显示出较低的谈判价格。潜在节省额超过支出约 5.235 亿欧元。2017 年立法者采用价格灵活性后，总体潜在节省仍超过支出约 6200 万欧元。
我们的分析表明，通过法律使价格谈判更加灵活不会损害 AMNOG 的基本目标，即避免在没有增加患者受益的情况下增加支出。因此，该法规可以实现立法者的目标，即在德国医疗保健系统中保留没有证明具有额外效益的药物。
