ABSTRACT
Background: Since the positive-list system was introduced, concerns have been raised over restricting access to new cancer drugs in Korea. Policy changes in the decision-making process, such as risk-sharing agreement and the waiver of pharmacoeconomic data submission, were implemented to improve access to oncology medicines, and other factors are also involved in the reimbursement for cancer drugs. The aim of this study is to investigate the reimbursement listing determinants of new cancer drugs in Korea.
Methods: All cancer treatment appraisals of Health Insurance Review and Assessment during 2007–2016 were analyzed based on 13 independent variables (comparative effectiveness, cost-effectiveness, drug-price comparison, oncology-specific policy, and innovation such as new mode of action). Univariate and multivariate logistic analyses were conducted.
Results: Of 58 analyzed submissions, 40% were listed in the national reimbursement formulary. In univariate analysis, four variables were related to listing: comparative effectiveness, drug-price comparison, new mode of action, and risk-sharing agreement. In multivariate logistic analysis, three variables significantly increased the likelihood of listing: clinical improvement, below alternative’s price, and risk-sharing arrangement. Cancer drug’s listing increased from 17% to 47% after risk-sharing agreement implementation.
Conclusion: Clinical improvement, cost-effectiveness, and RSA application are critical to successful national reimbursement listing.
Acknowledgments
We would like to thank Jin-Hyun Nam for consultation in statistical analysis.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Supplemental data
Supplemental data for this article can be accessed here.