4．How Should We Consider Several Factors Other Than Cost-Effectiveness Analysis? ーProblems Regarding ‘Appraisal’ (Comprehensive Evaluation) Process
- VernacularTitle:4．How Should We Consider Several Factors Other Than Cost-Effectiveness Analysis? ーProblems Regarding ‘Appraisal’ (Comprehensive Evaluation) Process
- Author:
Shinya SAITO
1
Author Information
- Keywords: health technology assessment; HTA; cost-effectiveness analysis; cost-effectiveness evaluation; appraisal
- From:Japanese Journal of Pharmacoepidemiology 2018;23(1):29-39
- CountryJapan
- Language:Japanese
- Abstract: In Japan, cost-effectiveness evaluations for medicines and medical devices are scheduled to be introduced in April, 2019 in a full-scale mode, following 2-year trial. The whole process of the “Cost-Effectiveness Evaluation (Japanese HTA：Health Technology Assessment)” is divided into three steps that are “Assessment” , “Appraisal” , and “Decision” . In the process of the “Appraisal”, the results of cost-effectiveness analysis (CEA) are evaluated along with the several factors other than CEA, such as social and ethical elements. The Special Committee on Cost-Effectiveness Evaluation (SCCEE) of Central Social Insurance Medical Council (CSIMC) has determined four factors that should be considered during the “Appraisal” process, as follows. 1) Benefit from the standpoint of public health (e.g. measures for infectious diseases), 2) Additional costs which are not included in public health insurance (e.g. long-term care costs, productivity costs), 3) Life-prolonging therapy for long-standing severe diseases, 4) Treatment for the diseases in which alternative treatment is not sufficiently present. Special attention for ‘Innovation’ used to be discussed in SCCEE, however, they decided not to employ it as a considerable factor for the “Appraisal” , since it had already received ‘Innovation premium’ at an initial pricing process. It is controversial whether the Japanese HTA agency should ask the pharmaceutical companies to present another CEA model that includes public health view or indirect costs, or just consider 1) and/or 2) factors as qualitative or semi-quantitative ones during “Appraisal” process. As for 3), they should pay attention for the special situation of the patients with end of life stage. SCCEE has declared that they will use the results of HTA just for adjusting the price of medicines or devices, not for insurance covering decision, while UK uses it for the latter purpose. It will be necessary further discussion on problems regarding “Appraisal” process, considering the difference of purpose for utilizing HTA results between Japan and UK.
