In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG) updated its general methods on benefit assessment. An important recommendation, within this update, was the inclusion of considering the score scale range of an instrument when defining a threshold to designate important individual-level changes. Specifically, the threshold should be at least 15% of the scale range.

The ISPOR Clinical Outcome Assessment Special Interest Group has developed a paper discussing the possible implications of this recommendation, such as not taking into account clinical practice standards, contradicting with regulatory recommendations, raising the bar for patients to get access to preferred medicines and reducing the scientific value of established minimal important difference (MID) research for 20 years.

This forum will begin with Dr. Wieseler presenting the rationale and the advantages of this unique definition of small but relevant individual-level changes applied to all PROs. The forum will then discuss pros and cons from different perspectives: with Dr. Bjorner discussing an instrument developer’s perspective and Dr. Bennett, the industry perspective.