Implementation and Application of the Physician Information System (Arztinformationssystem, AIS) in Germany

OBJECTIVES:

Since July 2020, detailed information on German benefit assessments of medicinal products provided by the physician information system (Arztinformationssystem, AIS) must be included in practice management softwares. For this purpose, the G-BA publishes a machine-readable version of the decisions available as a regularly updated XML file twice a month. The objective of this analysis was to present the content of the XML file and possible applications of this data for the AIS and other purposes.

METHODS:

After extraction and implementation of the data from the XML file in the IQVIA Insights Builder, we use the example of orphan drugs to show which information can be visualized and combined for a comfortable access of the information.

RESULTS:

Of 828 benefit assessments completed to date (13.06.2022), 153 are of orphan drugs. The assessments of orphan drugs include 151 decisions with an additional benefit. Of these, 54 assessments had a quantifiable additional benefit. Between 01.01.2020 and 13.06.2022 17 orphan dossiers achieved a quantifiable additional benefit. The justification for the decision of a quantifiable additional benefit with regards to outcomes was based on superiority versus the study comparator (independent of appropriate comparator therapy) exclusively on primary endpoints (4 cases), exclusively on secondary endpoints (7 cases) and on primary and secondary endpoints (6 cases). In one case the safety profile was sufficient to achieve a quantifiable additional benefit.

CONCLUSIONS:

The implementation of the AIS in Germany helps physicians to access information from the benefit assessment procedures efficiently and improves the possibility of supporting the individual decision of the physicians in the treatment of patients with evidence-based information. In this analysis we show in which way the information can be visualized and combined for a convenient access.