PHP9 - Accessibility of Orphan Drugs in Korea: Reimbursement and Supply Refusal Example

Abstract

To enhance accessibility of orphan drugs in Korea, various policies such as risk sharing agreement, the Introduction of the benefit enhancement plan (IBEP) for the four major conditions, have been implemented in Korea since 2013. The purpose of this study is to describe accessibility of orphan drugs in Korea by comparing the reimbursement and supply status of orphan drugs. Reimbursement status was defined by referring to the Health Insurance Review and Assessment Service(HIRA) and National Health Insurance Service(NHIS) from 2010 till 2017. Supply stability was assessed by comparing the list of non-supplied orphan drugs at the Korea Orphan & Essential Drug Center with the list of approved orphan drugs at the Ministry of Food and Drug Safety. The orphan drug expenditure for outpatient setting increased from 258 million USD in 2010 to 438 million USD in 2017, and the growth rate is higher than that observed in the general population. 293 drugs designated as orphan drugs by the MFDS, and 116 (38.4 %) of them were not supplied in 2013, where 83 of supply refusals were listed by the Korean NHI. In 2018, 129(32.5%) out of 397 orphan drugs were not supplied and 44 of the supply refusals were listed by the NHI. The rate of overall orphan drug supply refusal fell 5.9 % and the rate in reimbursed orphan drugs was cut by 17.3 %, more than half. The supply stability of orphan drugs are improving in Korea with the introduction of various schemes, yet further study is needed to understand factors related with the observations