Evidence-based healthcare and the need of conditional decision

Silvia Park; Sang Moo Lee

doi:10.5124/jkma.2011.54.12.1319

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Park and Lee: Evidence-based healthcare and the need of conditional decision

Healthcare Policy

Journal of the Korean Medical Association

Journal of the Korean Medical Association 2011; 54(12): 1319-1329.

Published online: 13 December 2011

DOI: https://doi.org/10.5124/jkma.2011.54.12.1319

Evidence-based healthcare and the need of conditional decision

Silvia Park, PhD¹, Sang Moo Lee, MD²

¹Korea Institute for Health and Social Affairs, Seoul, Korea.

²National Evidence-based Healthcare Collaborating Agency, Seoul, Korea.

Corresponding author: Sang Moo Lee, lsm@neca.re.kr

Received 16 November 2011 Accepted 25 November 2011

(open-access):

This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Keywords: Evidence-based medicine, Decision making, Conditional decision

Figures and Tables

Figure 1

Pipeline from evidence generation to practice and dealing with uncertainties.

Figure 2

Stage of regulation and decision process for adoption of new health technology and need for conditional decision with evidence generation. KFDA, Korean Food and Drug Administration; CnHTA, Committee for New Health Technology Assessment; HIRA, Health Insurance Review and Assessment Service; MoHW, Ministry of Health and Welfare, Korea.

Table 1

Concerning points for performing access with evidence development

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