Evaluation on the first 2 years of the positive list system in South Korea.

Objective: The South Korean positive list system in pharmaceutical reimbursement was introduced by the Health Care System Reform Act implemented in December 2006. This study introduces this positive list system (PLS), and reports on an evaluation of two years of operation. In addition, decision-making factors are evaluated and current issues and solutions discussed.

Methods: We analyzed 91 submissions with reimbursement decisions completed by December 31, 2008. Submission characteristics and relevant factors related to decision criteria were identified by the decision outcomes (recommended/rejected).

Results: Under the new system, Health Insurance Review and Assessment service (HIRA) recommended 64 submissions for reimbursement and rejected 27 submissions. For recommended submissions, 59 met all criteria and 5 were recommended based on the rule of rescue. The primary reason for rejection was unacceptable cost-effectiveness. The likelihood of recommendation was found to be significantly elevated if a drug was superior to its comparator, if treatment cost was not greater than that of its comparator, or if the number of recommended decisions made by other committees increased.

Conclusions: The South Korean PLS has stabilized during the 2 years after its introduction. The recommended submissions were qualified in all decision-making criteria used. Among the various decision criteria, clinical benefit and cost-effectiveness were the main drivers of reimbursement decisions. In addition, there is a certain degree of consistency between the reimbursement decisions of HIRA and other countries.