Trend Analysis of Listing And Budget Impact For Orphan Drugs In Korea

Abstract

Orphan drugs refer to drugs used in rare diseases(~1 in 20,000 persons in Korea) and it is often difficult to be recommended in reimbursement due to lack of evidence. In recent years, some efforts have been made to improve the access of orphan drugs in Korea through P&R schemes such as economic evaluation exemption track. This study aims to estimate the historical trend of orphan drug listing and the annual budget impact of orphan drugs in Korea between 2010 and 2015 and future trend. Reimbursement list of orphan drugs approved by Korean MFDS was derived to identify the number of orphan drugs situation annually from 2010 to 2015. HIRA claims data (2010~2015) was used to estimate the historical trend of the orphan drugs expenditure and total pharmaceutical expenditure respectively and also future trend analysis. Between 2010 and 2015, number of orphan drugs listed have been increased from 91 (88) to 117(102). Regards to budget impact, expenditure for orphan drug summed up 86 billion KRW(73 million USD) in 2010 and increased to 229 billion KRW(195 million USD) in 2015, representing 0.687-1.646% of total Korean pharmaceutical expenditure. CAGR for orphan drugs (17.7%) are much bigger than those for total Korean pharmaceutical expenditure(1.8%). Assuming linearity, orphan drug expenditure will account for 1.9%~ 3.4% of total expenditure in the future(2016-2020). Although the number of available orphan drugs are increasing slightly and the budget impact for orphan drugs is quite very small compared to total pharmaceutical expenditure, budget impact of orphan drugs are increasing very fast annually. It seemed due to the impact of some policy to improve the access of orphan drugs in Korea. This study suggests that it might be needed to manage the budget impact of orphan drugs in the future, considering both access of drugs and financial sustainability.