2023 Volume 72 Issue 2 Pages 152-160
In Japan, cost-effectiveness evaluation was officially introduced to the pricing system in April 2019. The results of cost-effectiveness are used to adjust the official prices of drugs, medical devices, and regenerative medical products. The official guideline for cost-effectiveness evaluation was published, which describes the methodological issues. The guideline must be referred to when manufacturers submit cost-effectiveness data and researchers review them. The guideline consists of 14 chapters, which, especially, Chapters 3 (target population) and 4 (comparator(s)), attract users’ attention because they directly relate to “frameworks of analysis” and their influence on the results of cost-effectiveness. In this paper, we focus on both chapters and explain the background of the description. In our view, the idea that a comparator should be selected from the most replaceable ones is not appropriate if we consider the current Japanese cost-effective evaluation system. In addition, when the results of subgroup analysis are interpreted, we always consider the limitation of the analysis, for example, the inflation of α error and β error, and not discussed based on the P value only. The results, including the clinical views, are deliberately appraised by the committee.
