OBJECTIVES:

The Institute for Quality and Efficiency in Health Care (IQWiG) is an independent, scientific institution that supports evidence-based decision making in the German health care system. IQWiG publishes their General Methods, which describe principles and scientific tools for document preparation, such as health technology assessments (HTA). In 2015, the Health Care Strengthening Act (HCSA), which promotes integrated care and the type and scope of potential evaluations in the statutory health insurance system, was passed and updates to the Fifth Book of the Social Insurance Code (SGB V) made, necessitating an update to the General Methods. The objective was to compare IQWiG’s General Methods version 5.0 which replaces version 4.2.

METHODS:

An overlay of IQWiG´s General Methods 4.2 and 5.0 was created in Word to identify the replacements and additions.

RESULTS:

The General Methods 5.0 includes new language to support a systematic approach to the evaluation of medical devices in high risk categories, which HCSA envisioned.

Para. §139b SGB V was changed to include HTA reports based on public proposals. The General Methods 5.0 detail the topic choice and selection, as well as quality assurance. The HTA report should include benefit and risk assessment of an intervention, as well as economic, ethical, social, legal and organizational aspects, following international HTA definitions.

The chapter on information acquisition was restructured and extended, detailing the approach in conducting systematic literature reviews. The General Methods 5.0 now detail when to perform a comprehensive or a targeted review, respectively search strategy development and data assessment.

Minor changes in the meta-analyses section were implemented, in particular regarding the methodology choices following assessment of study heterogeneity.

CONCLUSIONS: IQWiG’s General Methods 5.0 include new paragraphs that align procedures and methodology with changes in German law. Expanded details are provided for the conduct of systematic literature review and meta-analyses.