Pitfalls in Reimbursement Decisions for Oncology Drugs in South Korea: Need for Addressing the Ethical Dimensions in Technology Assessment

This study aimed to discover to what extent ethical issues are considered in the reimbursement decision processbased on health technology assessment (HTA) in Korea, especially for oncology medications. Public summarydocuments (PSDs) published by the Health Insurance Review and Assessment Service (HIRA) were analyzedfor empirical and normative factors. For external comparison, PSDs presented by corresponding institutions ofAustralia and the United Kingdom were employed. Furthermore, the opinions of eight expert oncologists wereobtained regarding the accountability of the evidence in PSDs. Among 7 oncology drugs, there were differencesin the final decisions and empirical factors considered, such as selected comparators and interpretation ofevidencebetween the PSDs from the three institutions. From an ethical viewpoint, the following matters weredeficient in the HTA decision-making process for oncology drugs: clear and reasonable standards; identifyinga nd evaluating ethical values; and public accountability for reasonableness about decisions and due process.