我们小组最近的一项分析（https://pubmed.ncbi.nlm.nih.gov/37014400/）显示，2015年至2019年批准的20种肿瘤蛋白激酶抑制剂的巨额成本很大程度上是由额外增加的药物造成的。益处尚未得到证实。我们更新了分析，添加了 2020 年和 2021 年新批准的蛋白激酶抑制剂。根据 2021 年和 2022 年 Arzneiverordnungsreport (AVR)，我们扩大了分析范围，纳入了欧洲药品管理局新批准的总共 9 种蛋白激酶抑制剂(EMA) 将于 2020 年和 2021 年进行。结果，我们确定了 29 种蛋白激酶抑制剂，用于更新我们的分析。对于这 29 种药物，我们对 Gemeinsamer Bundesausschus (GBA) 发布的所有额外效益评估进行了分析。 GBA 的额外效益评估与欧洲肿瘤内科学会 (ESMO)、德国血液学和肿瘤学协会 (DGHO，德国血液学和肿瘤学协会) 和 Arzneimittelkommission der deutschen ärzteschaft (Akdä，德国医学会药物委员会）。此外，还对2022年《肿瘤研究与治疗》杂志上发表的总共91个药品广告进行了分析。 GBA 无法发现额外益处的蛋白激酶抑制剂数量正在增加，而能够发现相当大额外益处的药物数量却在减少。因此，在大湾区当前的 2022 年额外效益（重新）评估中，50% 的药物没有发现额外效益（2020 年为 46%）。 19% 的受访者获得了较小的额外福利（2020 年，18%），19% 的受访者获得了相当大的额外福利（2020 年，27%）。对于 12% 的药物，GBA 无法量化额外收益（2020 年，9%）。其他医学会的效益评估往往与大湾区的效益评估存在显着差异，这主要是由于对各种终点参数的评估不同。此外，越来越多的蛋白激酶抑制剂被批准为孤儿药。然而，在大多数情况下（78%），大湾区无法量化它们的额外收益。肿瘤学期刊的广告中有 38% 宣传蛋白激酶抑制剂，这显示了这些药物的药物经济学重要性。综上所述，德国目前的附加福利评估程序非常值得商榷，迫切需要进行改革以维持德国医疗体系的稳定性，而德国医疗体系正因药品成本过高而受到损害，尤其是那些附加福利尚未得到重视的药物。已证明。© 2024。作者。

A recent analysis from our group ( https://pubmed.ncbi.nlm.nih.gov/37014400/ ) has shown that the immense costs of the 20 protein kinase inhibitors for oncology approved from 2015 to 2019 are largely caused by drugs whose additional benefit has not been proven. We updated our analysis by adding the newly approved protein kinase inhibitors of the years 2020 and 2021. Based on the 2021 and 2022 Arzneiverordnungsreport (AVR), we expanded our analysis to include a total of nine protein kinase inhibitors newly approved by the European Medicines Agency (EMA) in 2020 and 2021. As a result, 29 protein kinase inhibitors were identified for an update of our analysis. For these 29 drugs, all additional benefit assessments published by the Gemeinsamer Bundesausschuss (GBA) were analyzed. The additional benefit assessments of the GBA were compared with the corresponding assessments of the European Society for Medical Oncology (ESMO), the Deutsche Gesellschaft für Hämatologie und Onkologie (DGHO, German Society for Hematology and Oncology) and the Arzneimittelkommission der deutschen Ärzteschaft (AkdÄ, Drug Commission of the German Medical Association). In addition, a total number of 91 drug advertisements published in the journal Oncology Research and Treatment in 2022 were analyzed. The number of protein kinase inhibitors for which no additional benefit can be found by the GBA is increasing, whereas the number of drugs for which a considerable additional benefit can be found is decreasing. Thus, in the current 2022 (re)assessment of additional benefit by the GBA, no additional benefit was identified for 50% of the drugs (2020, 46%). Nineteen percent were assessed with a minor additional benefit (2020, 18%) and also 19% with a considerable additional benefit (2020, 27%). For 12% of the drugs, the additional benefit could not be quantified by the GBA (2020, 9%). The benefit assessments by other medical societies often differ significantly from those of the GBA, mainly due to different evaluations of various endpoint parameters. In addition, more and more protein kinase inhibitors are being approved as orphan drugs. However, their additional benefit cannot be quantified by the GBA in most cases (78%). In 38% of the advertisements of an oncology journal, protein kinase inhibitors are promoted, which shows the pharmacoeconomic importance of these drugs. In summary, the current additional benefit assessment procedure in Germany is very questionable, and reforms are urgently needed to maintain the stability of the German healthcare system, which is being undermined by the high cost of medicines, particularly for drugs whose additional benefits have not been proven.© 2024. The Author(s).