Registry-data of sufficient quality are suitable for the extended benefit assessment of drugs, says IQWiG

Rapid report shows how routine practice data should be used and processed. Therefore, first data from high-quality registries will presumably soon be considered in benefit assessment of drugs, says Germany’s Institute for Quality and Efficiency in Health Care (IQWiG)

Particularly in the case of accelerated drug approvals and drugs for rare diseases (orphan drugs), the evidence available at the time of market access is often insufficient for the early benefit assessment of drugs. Often, the studies are too short or no data on patient-relevant outcomes were collected. Comparisons with the German standard of care are also often lacking. In order to close such evidence gaps, in future, routine practice data are also to be included in early benefit assessments of drugs.

But how must the data be collected and processed so that they can be used by the Federal Joint Committee (G-BA) for benefit assessments in Germany? In order to answer this question, the G-BA commissioned the IQWiG to develop scientific concepts for the generation of routine practice data and their analysis for benefit assessments of drugs – especially with regard to the option of quantifying the added benefit of a new drug. According to the “Gesetz für mehr Sicherheit in der Arzneimittelversorgung” (GSAV, Law for More Safety in the Supply of Medicines), the G-BA may in future commission the collection of routine practice data on selected drugs to support the quantification of added benefit.