1. Processes of cost effectiveness evaluation
The Chuikyo discusses the price of a new medicine or medical device. If judged acceptable, use of the product can be covered by public health insurance. Then, if this product meets the selection criteria of cost-effectiveness evaluation, the manufacturer has to prepare and submit economic data to Chuikyo (actually, C2H) within 9 months after selection. However, the analysis data submitted by the manufacturer will not be directly used. The analysis data will be reviewed by academic groups on behalf of C2H. If deemed necessary, re-calculation of the incremental cost effectiveness ratio (ICER) will be conducted (re-analysis). This process is called “public analysis” and is indispensable for obtaining scientifically valid cost-effectiveness data.
Both the manufacture’s and the public analysis data are submitted to the Expert Committee of Cost-Effectiveness Evaluation of the Chuikyo. This committee is made up of health economists, epidemiologist, clinical experts and so on. The experts discuss on the validity, uncertainty and other properties of the analysis. In UK, the similar organization is called as the appraisal committee.
The results of the discussions will be reported to the Chuikyo, where a final decision is made. In this way, the policy on price adjustment is adopted. These processes take about 15-18 months.
2. Roles of C2H in these processes
During the above-mentioned processes, C2H controls the public analyses. That is, C2H has the role of conducting review and re-analysis of the analysis data submitted by manufactures. C2H makes the data more appropriate from the scientific points of view. While cooperating with experts in health economics and clinical epidemiologists belonging to academia, C2H attempts to conduct scientifically high-quality analyses.
In addition to review and re-analysis, C2H provides consultation to manufacturers after the selection of the product (preliminary consultation). This is because it is more efficient to conduct analysis through communication with manufactures. For example, this can avoid cases where the clinical data collected through investigation requiring much labor cannot be actually utilized because of discrepancy in views.
Meanwhile, C2H members participate in the Expert Committee on Cost-Effectiveness Evaluation to provide explanations about the public analyses. In this sense, C2H plays the role of bridging manufactures to Chuikyo.
3. Why should C2H implement this?
C2H is a department of a national “National Institute of Public Health (NIPH).” In many foreign countries also, such review process seem to be conducted by national institutes.
This is intended to secure the fairness and reliability of cost-effectiveness evaluation. Many researchers belonging to universities are conducting research with the funding paid by manufactures. They are providing consultation to manufactures while receiving personal rewards. These activities are not always undesirable.
However, it does not seem appropriate that the researchers receiving funding from manufactures are involved in the public analysis. We cannot rule out the influence of conflicts of interests or personal relationships on the evaluation. Furthermore, when viewed from outside, such conduct could invite ungrounded misunderstanding or doubts. From the viewpoint of conflicts of interests, it is considered appropriate that public analyses are conducted at national institutes having no relationship to the private sector.