LAUSR

INTRODUCTION: Historically, patient access processes of new and innovative medical devices including in-vitro diagnostics are made in the sequence of regulatory approval, new Health Technology Assessment (nHTA) approval, reimbursement coverage and coding finally reaching the pricing approval stage in South Korea. Although the individual patient access process has its own distinct objective and perspective, there are still opportunities for the authorities or agencies in charge to streamline their processes by working together to promote earlier patient access of new and innovative medical devices to patients without impacting their own decision making. METHODS: This research examined and analyzed the current policies about: patient access processes with a holistic viewpoint, industry-wide survey about patient access practices; case studies of two innovative medical devices for patient access in South Korea and also proposed new or alternative programs which can contribute to patient access harmonization efforts with a holistic approach. RESULTS: Historically, health authorities play defensive strategies by delaying the adoption of new and innovative medical devices and implementing certain periods (that is, 2 to 5 years) for a patient's out-of-pocket payment scheme. It is well illustrated with the statistic that only twenty-nine percent of new and innovative medical technologies which have successfully gone through the nHTA process were determined for reimbursement coverage in the past 7 years. The survey by the medical device industry to determine the patient access lead-time of innovative medical devices with a holistic perspective indicated significantly delayed patient access even considerabley exceeding the legally required decision-making lead time. The in-depth case studies with two innovative devices indicated the disadvantageous patient access processes to the innovator in terms of both final approval timing and the price level. CONCLUSIONS: The concurrent review process for reimbursement coverage decision making for medical procedures, medical devices and reimbursement coverage payment guidelines committed within the Health Insurance Review and Assessment Service shall be created. New programs to deal with uncertainty in reimbursement coverage decision making shall be considered such as coverage with evidence development, performance-based risk-sharing arrangement, multi-criteria decision analysis and economic evaluation.