Objectives: To suggest a framework and managing requirements for the temporary approval of new health technology (TANHT) that can meet the needs of patients who have suffered from rare diseases.
Methods: We investigated the Korean healthcare insurance and overseas policies for clinical trials and Coverage with Evidence Development (CED) through a literature review and interviews with experts. Subsequently, using these interviews and literature, we developed a frame work and a detailed procedure for the TANHT.
Results: We suggested a framework and detailed procedure for the TANHT that allows conditional approval of the research-phase health technology, which lacks clinical evidence but shows promise. We also provided related amendments of enforcement rules, a process of enacting related regulations, guidelines for patient safety, the disclosure of conflict of interest, and the authoring qualifications and ownership rights to research results.
Conclusions: This study is the first attempt to devise a framework, management requirements, and guidelines for the TANHT. Through this elaborative system, high-quality and reliable evidence necessary for new health technology assessments will be generated earlier than before.
Prof. Dr. Bilal BİLGİN