Presentation (CTI)

OBJECTIVES: The reimbursement criteria must first be established in order for a new anticancer drug to be listed. Recently, concerns have been raised about patient access as many drugs fail to pass this initial stage. This study analyzes the current status of reimbursement criteria decisions.
METHODS: Since October 2021, the government has been disclosing the outcomes of reimbursement criteria decisions for anticancer drugs. This study analyzed the approval rate of reimbursement criteria based on 89 cases disclosed up to March 2025. Factors examined for their influence on decision-making included whether the case was the first application submitted, cancer type, type of pharmaceutical company, and whether the therapy involved combination. Additionally, the study calculates the time required from regulatory approval to the setting of reimbursement criteria and final listing.
RESULTS: Among the 89 cases, 36(40.5%) were for hematologic cancers, 74(83.2%) involved global companies, 17(19.1%) were combination therapies, and 61(68.5%) were initial submissions. The approval rate was 37.7% for initial submissions, which was lower than the 53.6% for resubmitted(p=0.175). Domestic companies had a slightly higher rate than global(46.7% vs. 41.9%), solid tumors had a higher than hematologic cancers(43.4% vs. 41.7%), and monotherapies fared better than combination(43.1% vs. 41.2%); however, none of these differences were statistically significant. The median time from regulatory approval to the first Cancer Reimbursement Criteria(CRC) meeting was 195 days(Q1-Q3: 145-442), and the median duration from CRC to listing was 334 days(Q1-Q3: 172-391).
CONCLUSIONS: For new anticancer drugs, 62% failed to pass the reimbursement criteria stage on the first attempt, preventing progression to full reimbursement assessment. In many cases, reimbursement criteria were only approved after two to three submissions. Even after the criteria are set, it takes approximately one year until listing. Therefore, improving the success rate at the reimbursement criteria stage is essential to ensure timely patient access.