OBJECTIVES: Since the introduction of the positive listing system(PLS) in 2007, reimburseability of a new drug has been evaluated on the target patient group after establishing the reimbursement scope. However, there have been increasing concerns for decreased patient accessibility for innovative anticancer drugs due to the frequent failure in setting the reimbursement scope. This study analyzes the reimbursement scope approval status for anticancer drugs.

METHODS: We conducted a survey pharmaceutical companies to assess the need for improvement in determining th reimbursement scope for anticancer drugs by the Cancer Disease Review Committee(CDRC). The reimbursement scope approval rate was analyzed based on HIRA’s publicly disclosed CDRC results from January 2022 to June 2023. The approval rate was determined based on drugs which were assigned reimbursement scope among all products submitted for review, and any duplicate drugs were treated as individual, and for multiple indications, reimbursement scope was deemed approved if any indication was assigned a scope.

RESULTS: A total of 56 respondents participated in the survey, and 83.9% responded that improvements are necessary. 32 drugs were included in the analysis of the reimbursement scope approval rate, and the approval rate during the analyzed period was 41%. Among these, 31%(=10/32) drugs underwent duplicate reviews, and 25%(=8/32) had multiple indications. The time from regulatory approval to submission for the 1^st CDRC review took a median of 183 days(range: 41-5,489), and the median time from reimbursement scope approval to listing was 337 days(range: 199-402).

CONCLUSIONS: PLS is a system that selectively lists new drugs which prove cost-effectiveness. In order to assess cost-effectiveness, it is necessary to determine the target patient population, however, evaluations are frequently stalled due to the failure to set reimbursement scope. To improve patient accessibility, there is a need for standardizing the evaluation criteria for better predictability and increased approval rate.