Evidence-based decision-making and health technology assessment in South Korea.

South Korea’s social security system is a social insur-ance system similar to those in France, Germany,Japan, and Taiwan [1]. By law, South Korean citizensare covered by health insurance. In addition, health-care providers must contract with the National HealthInsurance Corporation. This uniﬁed social healthinsurance system provides almost all South Koreanswith health insurance.During the last 50 years, medical breakthroughsand signiﬁcant health-care advances have improvedthe quality of health care and the management ofdisease and chronic illness. With this progress hascome markedly increased health-care costs. Currently,these expenditures are exceeding Korea’s economicgrowth rate [2]. Consequently, there has been a signiﬁ-cant amount of research on the rational use of health-care resources and interest in other countries’ means ofcontrolling costs [3]. Prioritizationofreimbursementhasbecomeamajorissue within South Korea’s national health insurancesystem. The current presiding principle behind reim-bursement is that all medically necessary health-careservices are covered and reimbursed with the exceptionof those on the negative or noncovered list of health-care technologies.Health-care policymakers decide whether a technol-ogy is medically appropriate for patients and thereforereimbursed as daily practice or not. Health-caredecision-making for what are considered medicallyappropriate health-care services has been based onopinion or opinion-based information. Because reim-bursement decisions are opinion-based, they are notonly subjective, but can be signiﬁcantly delayed bydissenting opinion [4]. Consequently, evidence-based medicine consistingof clinical expertise and patient preferences or valuescombined with clinical research is being introduced tomake health-care decisions reasonably, objectively, andclearly as well as to reduce conﬂicts among stakehold-ers [5–7]. This process, combined with considera-tion of affordability, should improve reimbursementdecisions.The Health Insurance Review & AssessmentService (HIRA) also utilizes scientiﬁc evidence in thedecision-making process. HIRA’s goal is to maintainand improve national health through health-carereview and quality assessment. HIRA is responsiblefor reviewing medical fees and evaluating at whatlevel and cost health-care services are delivered tobeneﬁciaries [8]. In addition to health-care servicesreview and evaluation, HIRA supports governmentcoverage decisions and pricing.Since 2006, the evidence-based decision-makingsystem has been introduced progressively. An EvidenceBased Review Manual, with methods of appropriatequestioning, searching, extracting data, classiﬁcationof articles, and presentation, has been used by HIRAfor policy coverage.Another challenging issue for policymakers is theuncertainty with regard to how much improvementin health-care quality can be expected with the intro-duction of expensive new health technology. Toaddress this issue, the South Korean National Assem-bly passed legislation that allows heath technologyassessment of new health technologies, with theexception of medications. Because this legislation isnot part of the Health Insurance Act, health-careproviders are not obligated to apply health technol-ogy assessment (HTA) to new technologies, but ifHTA reports become mandatory for reimbursement,it is likely to become a requirement.The legislature is establishing an advisory commit-tee for new health technology assessment review(NHTAC) and a special subcommittee responsible forsystemic literature review and draft reports. NHTACwill conduct the ﬁnal review of the new technologyand state the results of assessment based on its twomajor criteria for health technology assessment, safetyand effectiveness.For medications, Korean FDA (KFDA) focuses onsafety and efﬁcacy. Although there is a strong need fordrug evaluation based on effectiveness and cost-effectiveness, the review process for new health tech-nologies does not include new medications. However,South Korea has introduced pharmacoeconomicanalysis for drug evaluation in the health insurancedecision-making process.South Korea has a relatively higher cost and growthrate of pharmaceutical expenditure than other coun-