Germany’s IQWiG opens consultation on methods for routine practice data collection in drug benefit assessment 

The Institute for Quality and Efficiency in Health Care (IQWiG) has published a preliminary rapid report outlining methodological considerations for collecting routine practice data on new drugs in Germany. Stakeholders have until 19 August 2025 to submit comments. 

The German Federal Joint Committee (G-BA) has tasked IQWiG with developing a scientific concept for the generation and analysis of routine practice data in the context of “routine practice data collection.” This process is used when studies comparing a new drug with the therapeutic standard have not been conducted, particularly for medicines targeting rare diseases or approved under special regulatory pathways. 

IQWiG noted that, under current legal requirements, these data collections “can currently only be conducted as non-randomized comparative studies.” The preliminary rapid report, commissioned on 28 January 2025, examines the available scientific knowledge on key methodological areas and proposes quality standards for their implementation. 

The report addresses seven topics that are considered critical to the conduct of non-randomized comparative studies in routine practice settings. These include the identification and selection of so-called confounders, determining the start of the observation period, collecting patient-reported outcomes, and handling missing values. By reviewing current scientific knowledge in these areas, the rapid report draws conclusions on the quality standards necessary for effective implementation of routine practice data collection. IQWiG’s aim is to ensure that future studies are designed and conducted in a way that produces valid, reliable evidence for use in benefit assessment under §35a of the German Social Code Book V (SGB V). 

Commenting procedure now open 

The commenting period for IQWiG’s preliminary rapid report is open until 12:00 CEST on 19 August 2025. According to IQWiG, “Interested persons, institutions and (professional) societies can submit comments” via the institute’s online form.  

Following the written comment period, IQWiG will hold a scientific debate on 16 September 2025 to discuss outstanding questions. Feedback from this hearing “may lead to changes and/or supplements to the preliminary report,” ensuring that the final version reflects stakeholder input and clarifies methodological guidance where needed. 

Role in benefit assessment 

Routine practice data collection is a relatively new but increasingly useful tool in Germany’s benefit assessment framework. It provides an evidence generation pathway when conventional randomized controlled trials are not available or feasible, such as for small patient populations or accelerated approvals. 

IQWiG’s work on this topic aims to standardize methodological approaches and provide clear guidance for researchers, regulators, and manufacturers. By specifying quality requirements for data sources, confounder adjustment, outcome measurement, and data completeness, the institute seeks to improve the robustness of non-randomized comparative studies used in health technology assessment (HTA). 

Next steps 

Once the comment period and subsequent hearing are complete, IQWiG will finalize its report and submit it to the G-BA. The conclusions are expected to inform both future policy and the practical conduct of routine practice data collection studies, supporting transparent and evidence-based decision-making on new medicines in Germany.