6．Potential Contribution of Real World Data for Health Technology Assessment from the Standpoint of CRO / 薬剤疫学

ABSTRACT

Health Technology Assessment (HTA) of healthcare technologies including drugs, medical devices, and interventions is expected to be fully implemented into the pricing evaluation system. Under this circumstance, it is crucial to show not only clinical but also economic benefits in the healthcare technology. Real World Evidence (RWE) obtained from Real World Data (RWD) can be useful input from clinical practice since economic evaluation needs various information including effectiveness, epidemiology, costs, and utilities in long-term follow-up. According to GetReal report from IMI initiatives, in the assessment phase, epidemiology data such as incidence and prevalence, and resource use data were generally accepted by most of HTA agencies in major European countries. However, treatment effects by RWD were considered to be used under specific circumstances. In the appraisal phase, treatment effects on the basis of RWD was regarded as complementary data while other parameters such as epidemiology data, costs, and resource use were regarded as fundamental and reliable. In Japan, Health Economics and Outcomes Research (HEOR) using RWD is emerging rapidly and the volume of input data collected for economic evaluation from RWD is expected to increase. There are limited descriptions on RWD in the cost-effectiveness guideline issued by Chuikyo in Japan. Considering RWD to be an important source of economic evaluation, it is helpful to have information on what kind of RWD can be used as RWE for economic evaluations in HTA policy and guidelines in Japan. Further development of HTA policy and guidelines reflecting RWD element is desired.