DATA REQUIREMENTS FOR COST EFFECTIVENESS ANALYSIS IN KOREA AND AUSTRALIA- A COMPARISON
Author(s)
Yoon Y1, Lee Y2, Kim H31Sanofi-Aventis Korea Co., Ltd., Seoul, South Korea, 2Bristol-Myers Squibb, Seoul, South Korea, 3Bristol-Myers Squibb, Noble Park, Victoria, Australia
Presentation Documents
OBJECTIVES: Both Korea and Australia have stringent pharmaco-economic (PE) guidelines outlining the data requirements for cost effectiveness analysis (CEA). The requirements for regulatory approval in both countries are clear and mainly rely on multinational clinical trials with the addition of relative small bridging studies in Korea. It seems, however, to be different for reimbursement submission where CEAs are presented.The purpose of this study is to uncover the data requirements for CEA from an industry perspective. METHODS: Firstly a literature search was performed to find any relevant publications. Moreover website of decision maker’s were searched for past reimbursement decisions. Finally a qualitative comparison was made of the PE guidelines for Korea and Australia. RESULTS: The literature search revealed very little published literature on CEAs as part of drug reimbursement submissions in Korea and Australia. Decision makers in both countries publish reimbursement decisions on their respective website. However the information disclosed rarely reveals what input data was used for CEAs. The PE guidelines for the respective countries showed remarkable similar data requirements. The main difference is surrounding local resource data. In Korea this usually retrieved through information gathering exercises like cost and utilisation studies. It is quite different in Australia where most information is available either through a government website or as IMS data. CONCLUSIONS: Both Korea and Australia has specific requirements for CEAs however the local data needed for each country differs significantly. Acquiring cost and utilisation data in Australia seems straight forward in most cases, whereas the situation is different in Korea. Not only does it have an impact on time to market for new innovative pharmaceuticals but it also increases the uncertainty surrounding the result of the CEA making it more difficult for decision makers to make a decision.
Conference/Value in Health Info
2012-09, ISPOR Asia Pacific 2012, Taipei, Taiwan
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PRM9
Topic
Economic Evaluation
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies
Disease
Multiple Diseases