Critical analysis of the prescription and evaluation of monoclonal antibodies approved in Germany for the outpatient setting from 2010-2021.

Monoclonal antibodies (mAbs) are increasingly being launched on the German market and account for a growing share of total drug costs every year. In 2021 alone, eleven monoclonal antibodies were among the 30 best-selling drugs, accounting for 9.91% of total drug costs. In contrast, a considerable additional benefit of the newly introduced monoclonal antibodies is not predominantly demonstrable. Therefore, our objective was to analyze the drug prescriptions and associated costs in comparison to the benefit assessment of the Federal Joint Committee (GBA). This paper analyzes 62 monoclonal antibodies that were approved by the European Medicines Agency in the period from 2010 to 2021 and newly launched on the German market. The data basis is provided by the Drug Prescription Report (AVR) and the Statutory Health Insurance (SHI) Drug Index for outpatients. The SHI index is compiled by the Wissenschaftliches Institut der AOK (WIdO). The GBA provides a further data basis for the assessment of additional benefits. The relevant parameters used for each drug include the number of prescriptions, net costs, defined daily doses (DDD) and costs of the defined daily doses (DDD costs) at the time of the year of approval and as of 2021. There is only a slight correlation between the number of DDDs, prescriptions and net costs of the respective drug and the additional benefit assessed by the GBA. There is a certain correlation between the advertisements in the journal "Oncology Research and Treatment" and the drug benefit. In summary, the high costs of monoclonal antibodies cannot be justified by the additional benefit assessed by the GBA, as no overriding significant additional benefit can be proven for the drugs analyzed. More precise regulation of drugs with little or no additional benefit, as well as regulation of the price of drugs with considerable additional benefit, is crucial to ensure a better balance between costs and benefits.