| dc.description.abstract | Abstract Background; as a result of the centralized marketing authorization of pharmaceutical therapies by EMA, whereby Quality, Safety and Efficacy is assessed, it is assumed that the biological effect of therapy are the same across countries. However, there are factors that are unique to the individual countries such as differences in epidemiology, differences in analytic Approach and Methodological requirement etc. These mentioned factors contradict EMA centralized assumptions, which prompts the individual countries to require a cost effectiveness study before such therapy is granted market access and reimbursement. In other words, as a result of these factors, the cost effectiveness therapies across the individual countries vary. These variations eventually are one of the reasons why Ocrelizumab, a new and only authorized treatment for MS patients ‘’85% RRMS and 15% PPMS’’ is not reimbursed in Norway. Objective; the objective of this research is a comparative analysis of these factors between Norway and the price referenced countries to see how these factors vary among them to refute EMA assumption, what could be transferred and if Norway decision not to reimburse would change or not in light of new evidence. Methods; the method used is to compare and contrast the factors that limit transferability of economic evaluation data as published by Drummond and Pang. To enable use the method, a clear problem statement of why Ocrelizumab is not reimbursed in Norway is stated. In addition, the problem statement is further broken down in series of questions that enable how those factors vary among countries. Hence, how it impacts the cost effectiveness study of Ocrelizumab. The focus of the research is only on RRMS patients. Result; after careful and thorough analysis, research findings shows that, as a result of the variation among those factors and its impact on their respective cost effectiveness study, as well as the fact that economic evaluation interpretation is subjective and sometimes seen as a tool of manipulation, generalizability assumption assumed by EMA is indeed not valid across countries. Finally, research also shows that cost effectiveness result does not always capture values, perhaps Norway should rethink the decision not to reimburse. | eng |