PMD44 PRICING AND REIMBURSEMENT, AND MARKET ACCESS OF THERAPEUTIC MATERIALS (MEDICAL DEVICES/DIAGNOSTICS/BIOMARKERS) IN SOUTH KOREA.

Abstract

This study aims to introduce South Korean health systems for medical device developers to access the market in terms of market access, pricing and reimbursement (P&R), focusing on cancer biomaker diagnostics. Literature review and in-depth interviews were performed. Guidelines and publications on health technology assessment were searched and reviewed. To complement the literature review, key opinion leaders including reimbursement decision makers and medical doctors experienced with pricing and reimbursement decision making were identified and interviewed. While the ministry of health and welfare (MoHW) is a decision-making body in finalizing the pricing and reimbursement (P&R), the health insurance review and assessment service (HIRA) and national evidence-based healthcare collaborating agency (NECA) play pivotal roles in assessing the eligibility and appropriateness of market access and P&R of therapeutic materials such as medical devices, diagnostics, biomarker tests. These technologies are paid for under fee-for-service (FFS) or diagnosis-related group (DRG)-based schemes, however DRG is not applied to all disease areas. Basically, South Korean health system operates under the FFS system and thus, new technologies need to be reviewed by HIRA to see if there are any equivalent technologies existent in South Korea and to which FFS activity is relevant. Meanwhile, NECA is responsible for new technology assessment (nHTA), where no comparable technologies exist in South Korea. NECA makes a recommendation based on safety, efficacy, and effectiveness of new technologies using the method of systematic literature review. The level of P&R is determined against that of existing technologies listed in the same functional category (indication for use, physical characteristics) and in most cases, it is priced at a lower price or 90% of the highest ceiling price within the same functional category. However, if the technology considered to be significantly superior, it can be determined under the value appraisal schemes.