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This study aims to analyze the policy and its effects as they apply to new orphan drug (OD) and the budget impact after reimbursement listing in South Korean National Health Insurance (NHI). We analyzed 198 new drugs listed by South Korea’s NHI from July 2007 to March 2017. A comparison of the time to listing for ODs and non-orphan drugs (NODs) was conducted via the Mann–Whitney U test. The budget impact of ODs was analyzed by the NHI claim data from the listing date of new drugs until 31 December 2018. An analysis of the time shows that the period (median) for NOD (13.2 months) was shorter than for OD (17.4 months) (Mann–Whitney U test: p = 0.018). The annualized budget impact of OD was 4,967,049 US$/year and that of NOD was 7,800,924 US$/year. Additionally, the percentage of oncology orphan drugs in the total pharmaceutical expenditure was 1.1%; as such, the percentage of non-oncology orphan drug was only 0.9%. There has been no significant evidence for patient accessibility improvement regarding new ODs. The proportion of ODs in South Korea’s NHI total pharmaceutical expenditure is not high and the proportion of ODs among new drugs is even lower.

Pricing and reimbursement policy for new orphan drugs in South Korea: focused on patient accessibility and budget impact