Abstract
ObjectivesThe South Korean government required the submission of economic evidence when it implemented the Positive-List System in December 2006. This study investigates the key factors that influenced actual public insurance reimbursement decisions, including the role of economic evidence, after 10 years of decision practice under compulsory health technology assessment (HTA) for new drugs.MethodLogistic regression analysis was used to estimate the impact of the variables involved, including cost-effectiveness ratio as a key variable, on reimbursement decisions. The latter were defined as “yes” or “no” at a submitted price and indication. Only cases (n = 91) that present a cost-effectiveness ratio, and that have been reviewed based on this ratio from January 2007 to December 2016, were included in the analysis.ResultsCases with higher cost-effectiveness ratios were less likely to be accepted. In addition, drugs that were used to treat severe diseases and drugs with no substitute were more likely to be recommended. The probability of acceptance declined along with the level of uncertainty in the submitted evidence. The acceptance rate for severe-disease drugs has increased since 2013, when the government introduced several policies that lowered the existing barriers to positive reimbursement. However, such an increase was not statistically significant.ConclusionsCost-effectiveness is one of the most influential factors in drug-reimbursement decisions. However, inclusion of other explanatory variables, in addition to the cost-effectiveness ratio, predicted the results of decisions more accurately.
Highlights
South Korea was the first Asian country to adopt the cost-effectiveness model when the positive list system came into effect in 2006 [1]
Since Australia first mandated the submission of economic evaluation data for reimbursement decision-making in 1993, many European countries and some Canadian provinces began implementing similar policies [2,3,4], which later spread to other continents as well [5,6,7,8]
If a company submits the dossiers for coverage, the Health Insurance Review and Assessment service (HIRA) reviews them, and makes a coverage decision based on the Pharmaceutical Benefit Coverage Advisory Committee’s (PBCAC) recommendation
Summary
South Korea was the first Asian country to adopt the cost-effectiveness model when the positive list system came into effect in 2006 [1]. Since Australia first mandated the submission of economic evaluation data for reimbursement decision-making in 1993, many European countries and some Canadian provinces began implementing similar policies [2,3,4], which later spread to other continents as well [5,6,7,8]. The UK, for example, uses it to identify the most cost-effective use of technology within approved indications. Australia, Canada, and other European countries use economic evidence to support their coverage decisions: whether to reimburse or not, and at what price [5, 9]. Some countries require the submission of economic evidence for all drugs, whereas others only require it for drugs that meet the conditions in their country [5, 10]
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