Health Policy and Market Access Working Group of Section C of the German Cancer Society, Berlin, Germany.
Value & Access Oncology, Amgen GmbH, Riesstrasse 24, 80992, Munich, Germany.
J Cancer Res Clin Oncol. 2023 Jun;149(6):2637-2645. doi: 10.1007/s00432-022-04379-2. Epub 2022 Oct 1.
2021 marks the tenth anniversary of the AMNOG process and brought with it a new German administration-two good reasons to take stock of where we stand today, what has been achieved so far, and how the path of early benefit assessments in Germany should continue.
From the perspective of manufacturers of cancer drugs, the AMNOG process, as a constantly evolving system, has for the most part proved itself-which does not mean that there is no longer room for improvement. Significant improvements have been achieved in the area of early consultation of medical societies regarding the selection of the appropriate comparator therapy as well as in the reimbursement of biomarker diagnostic tests in the outpatient sector. However, there is still a need for improvement, especially in the areas of patient-relevant outcomes accepted by the G-BA, the inclusion of real-world data in evidence assessments, or the transfer of evidence from certain patient groups to others.
The current AMNOG structures were developed for the most part at a time when no one saw immuno-oncology or gene and cell therapies coming, when there were no multi-tumor drug approvals, and when few imagined that within a few years, the established tumor entities would be broken down into dozens of sub-entities on the basis of molecular genetic markers. Society wants these and other advances, and the HTA process must, therefore, take this into account in a healthcare system based on solidarity.
2021 年标志着 AMNOG 进程的十周年，同时迎来了新的德国政府——这是对我们目前所处的位置、迄今为止取得的成就以及德国早期效益评估的路径应如何继续进行评估的两个很好的理由。
从癌症药物制造商的角度来看，作为一个不断发展的系统，AMNOG 进程在大多数方面已经证明了自己——这并不意味着没有改进的空间。在早期咨询医学协会选择适当的比较治疗方法以及在门诊部门报销生物标志物诊断测试方面取得了重大进展。然而，仍有改进的空间，特别是在 G-BA 认可的与患者相关的结果、将真实世界数据纳入证据评估中或从某些患者群体向其他群体转移证据等方面。
目前的 AMNOG 结构在大多数情况下是在没有人看到免疫肿瘤学或基因和细胞疗法、没有多肿瘤药物批准以及很少有人想象在短短几年内，基于分子遗传标志物，将现有的肿瘤实体分解成数十个子实体的时候制定的。社会希望这些和其他进展能够实现，因此，在基于团结的医疗保健系统中，HTA 流程必须考虑到这一点。
