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KMID : 1146320180060010033
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Journal of Health Technology Assessment
2018 Volume.6 No. 1 p.33 ~ p.42
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Moon Care and Preliminary Benefit Program in South Korea: Innovative Strategies in Post-Market Evidence Generation for Medical Devices
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Lee Sang-Soo
Holbrook Reece
Choi Hyun-Sook
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Abstract
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Objectives: The President Moon administration was launched in May 2017. The “Benefit Expansion” of the National Health Insurance (NHI) system has emerged as the core policy of the new government. It provides an overview of the health policies and programs announced by the Moon administration and suggests health policy operation for a successful and effective “Preliminary Benefit” program specific to medical devices which is one of the main drivers in the new health policies.
Methods: A description of the new health policies, namely “NHI Benefit Enhancement Measures” and “Preliminary Benefit” program and a review of foreign strategies in post-market evidence generation for medical devices which provides insight for evidence generation applicable in South Korea.
Results: Registries are strategic instruments to generate evidence under “Preliminary Benefit” for those medical devices which do not have sufficient evidence at the time of market entry and subsequent post-market stage. As demonstrated in the transcatheter valve therapy registry and Micra coverage with evidence development study, there are even more effective and cost-saving methods for evidence generation. There are several strategies and elements that can be considered in performing efficient medical device registries: 1) quality measure and pay-for-performance, 2) registry linking with claims datasets, 3) funding and resource provision for registry, and 4) participation in international registries.
Conclusion: The “Preliminary Benefit” program under “Moon Care” is epoch-making in the benefit expansion history of NHI system. Registries are one of the promising strategies to pursue health technology reassessment required in the “Preliminary Benefit” program. The success of “Preliminary Benefit” depends on the reassessments, and the evidence generation of medical devices required for reassessment can be resolved by registries. The development of and investment in registries, and even more innovative evidence generation approaches as seen in the foreign cases, should be made for the “Preliminary Benefit” program.
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KEYWORD
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Moon care, Preliminary benefit, Medical device, Registry, Coverage with evidence development, Claims datasets, South Korea
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