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In South Korea the new Health Technology Assessment (nHTA) program for medical technologies, including in-vitro diagnostics, was introduced in 2007. Although the nHTA program has made a positive and important contribution to the healthcare system, its introduction provoked unnecessary misunderstanding and conflict between stakeholders, due in large part to poor communication between parties, but also because the program had two distinct, and to a degree conflicting, objectives to fulfill: management of the national health insurance budget and promotion of the Korean health technology industry. The recent revisions of the nHTA program have led to a fairer, more objective and predictable decision-making process, which is very encouraging, however further improvements are required: in particular, a clear definition of what constitutes ‘new medical technology’ is essential; a more robust ‘coverage with evidence development’ process for promising technology is desirable; the ‘Conditional nHTA Approval’ program could be expanded to include reimbursement, and improved with guidelines for how the evidence generated will be utilized in subsequent nHTA assessment. These improvements to the nHTA program will ensure that the Korean community receives access to safe and effective innovations in technology, the health system budget is managed in a sustainable manner and the correct encouragement and guidance is given to the local medical technology industry, to help it compete in the global marketplace.

Market Access for New Medical Technology in South Korea: A Case Study in Health Technology Assessment Policy Development and Implementation