title: National reimbursement listing determinants of new cancer drugs: a retrospective analysis of 58 cancer treatment appraisals in 2007-2016 in South Korea.
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.
  
  
  CONCLUSIONS
  Clinical improvement, cost-effectiveness, and RSA application are critical to successful national reimbursement listing.
authors.affiliation: a School of Pharmacy , Sungkyunkwan University , Suwon , South Korea.
authors.forename: Eun-Sook
authors.identifier: http://orcid.org/0000-0002-1559-2868
authors.initials: ES
authors.lastname: Kim
authors.affiliation: a School of Pharmacy , Sungkyunkwan University , Suwon , South Korea.
authors.forename: Jung-Ae
authors.identifier: http://orcid.org/0000-0003-4369-2978
authors.initials: JA
authors.lastname: Kim
authors.affiliation: a School of Pharmacy , Sungkyunkwan University , Suwon , South Korea.
authors.forename: Eui-Kyung
authors.initials: EK
authors.lastname: Lee
mesh_terms: D000970:Antineoplastic Agents / Q000191:economics*; D003362:Cost-Benefit Analysis; D003657:Decision Making; D016527:Drug Costs; D017850:Economics, Pharmaceutical; D006297:Health Services Accessibility / Q000191:economics; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000191:economics*; D007356:Insurance, Pharmaceutical Services / Q000191:economics; D016015:Logistic Models; D015999:Multivariate Analysis; D009369:Neoplasms / Q000188:drug therapy* / Q000191:economics; D012051:Reimbursement Mechanisms / Q000191:economics; D056910:Republic of Korea; D012189:Retrospective Studies; D020414:Risk Sharing, Financial
chemical_list: D000970:Antineoplastic Agents
keywords: Cancer; oncology; positive list system; reimbursement; risk-sharing agreements