Ten years of AMNOG from an oncological perspective: new horizons and continuing expansion

Abstract

Purpose: 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.

Results: 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.

Conclusion: 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.

Keywords: AMNOG; Drugs; Germany; HTA; Oncology.

Fig. 1

Flowchart of early benefit assessment based on AMNOG. Modified from Trümper and Wörman (2021)

Fig. 2

Oncology is the field with most new drugs and indication extensions within the German benefit assessment system. The category “significant additional benefit” is granted in oncological benefit assessments at an above-average rate. Modified from Trümper and Wörman (2021), Dabisch et al. (2014) and Federal Joint Committee (2021a)