Table 5.

The Comparison of Challenge Application (CA) and Conditional Selective Benefit (CSB).

Category	CA in Japan	CSB in South Korea
Authority in charge	MHLW	MoHW/HIRA
Applicant	Manufacturers	MoHW/HIRA
Target of evaluation	STMs	New procedures and medical technologies
Responsibility of evidence generation (data collection)	Manufacturers	Healthcare providers
Reevaluation period	Depending on protocol*	Designated by the MoHW/HIRA (usually 3-5 years)**
Patient financial burden (patient copayment)	Relatively low (e.g., 30%)	High (e.g., 80% patient copayment rates)
Expected administrative measures after reevaluation	Create new functional category and premium pricing	Relieve patient copayment rates or reduced prices

MHLW, Ministry of Health, Labour and Welfare; MoHW, Ministry of Health and Welfare; HIRA, Health Insurance Review and Assessment Service; STMs, Special Treatment Materials

*Although reevaluation period varies depending on protocol, periodic report on CA program is needed to be submitted at least every 2 years.

**According to the administration rule (standard for designation and implementation etc. of Selective Benefit), the designated period is determined a year after the designation of CSB.