IQWiG publishes new version of its General Methods
the new basis for the scientific work of the institute
The Institute for Quality and Efficiency in Health Care (IQWiG) had already published the first draft of version 6.0 of the methods paper at the end of 2019. The Institute received 40 comments from pharmaceutical companies, medical societies and various stakeholders of the German health care system. Some comments and suggestions were (partially) followed in the final version - others were rejected with a corresponding rationale. IQWiG is fully transparent in this process: comprehensive documentation is available on its website.
Especially the section on the assessment of clinical relevance was considered controversial and sometimes arbitrary in the comments received by IQWiG. With a fixed scale range of 15 %, IQWiG has for the first time, determined specifically from when responder analyses are to be considered within the dossier assessment. Responder analyses are commonly used to assess the clinical relevance of a therapeutic difference. Here, the extent to which a therapeutic difference is clinically relevant for the patient is crucial: the minimal important difference (MID). According to IQWiG, a fixed scale range of 15 % is now supposed to "provide clarity for manufacturers and prevent arbitrary responder analyses based on incomprehensible responder definitions".
At SKC, we take into account any changes in the legal basis, codes of procedures and any working guidelines of all stakeholders in the German health care system directly in our consulting activities for our clients. It remains to be seen to what extent the respective sections in the General Methods 6.0 will replace "old" precedents in future benefit assessment procedures with the Federal Joint Committee (G-BA): With regard to the new criterion of a fixed responder threshold of 15 % of the scale rank, a number of previously accepted "MIDs" will no longer be considered for the assessment of the added benefit.
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M. Sc. Life Science
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