Abstract
Health technology assessment was first introduced to the Republic of Korea in 2006 by amending the Medical Services Act. The Committee of New Health Technology Assessment (CNHTA) is the ministerial committee that has the responsibility of reviewing the safety and effectiveness of new health technology. CNHTA review plays a gatekeeping role for new health technology in Korea, which can increase the burden on patients in Korea, either by out-of pocket payments or co-pays for National Health Insurance covered service. This kind of gatekeeping is a function of the healthcare system in many countries where no financial cap such as a fixed budget or diagnosis-related group payment is applied. However, it has been argued that gatekeeping works against industrial promotion policy. The one-stop service introduced in 2014 is a system similar to US parallel review between the US Food and Drug Administration and Centers for Medicare and Medicaid Services. This service provides a simultaneous process of regulatory review by the Ministry of Food and Drug Safety, identification of existing technology by the Health Insurance Review and Assessment Services, and new health technology assessment by the National Evidence-based Healthcare Collaborating Agency and the Ministry of Health and Welfare. This service is expected to reduce the total review process by 3 to12 months. A limited health technology appointment service was introduced in April 2014. This service designates orphan health technologies and health technologies for rare and incurable diseases and supports evidence development at designated hospitals. Several countries have similar systems: US Coverage with Evidence Development, Canadian Conditionally Funded Field Evaluation, UK Only in Research, and many others. The future direction of Health technology assessment should focus on the life cycle management of health technology. A consistent, continuous, and transformative mechanism to manage from the research and development of health technology to delisting obsolete technology to make room for new innovative technology is warranted.