Evidence-based healthcare and the need of conditional decision

ABSTRACT

The decision making for reimbursement has become more difficult than before because of the high cost innovative new technologies and limitation of healthcare resources. Evidence-based healthcare system has been introduced in Korea since 2007. Not infrequently, however, decision makers have been confronted with uncertainties caused by lack of information related to comparative effectiveness, real world outcomes, off-label drug use, combination therapy and cost-effectiveness. Under these circumstances, the decision making of whether or not to reimburse is inadequate because undesirable results may be induced. Managed entry agreement has been introduced globally. This kind of decision is conditional and linked with monitoring and following the results and adjusting the policy according to the results. Especially access with evidence development is a form of prospective data correction with conditional coverage in the case of existing uncertainties of effectiveness and safety. In Korea, there have been several examples including off-label drug use in oncologic drugs, new healthcare intervention and re-evaluation of existing drugs. Even though there has been some conflict and confusion because of inadequate systematization, it is strongly recommended to establish the conditional decision making system in Korea since this is a unique answer to manage the uncertainty in maintaining development of health science, keeping patients' right and using healthcare resources rationally.