Globalise the evidence, Localise the decision ‘’A comparative analysis of factors responsible for differences in cost effectiveness of Relapsing Remitting Multiple Sclerosis therapy between Norway and its price referenced countries’’

As a result of the centralised marketing authorisation of pharmaceutical therapies by EMA, with which Quality, Safety and Efficacy is assessed as the primary criteria, it is assumed that the biological effect of such therapy should be the same across countries where patients are being treated with the said therapy. However, there are factors that are unique to the individual countries such as the characteristics of patient homogeneity and differences in epidemiology, methods with which the healthcare is designed, the analytic approach and methodological requirements etc. These mentioned factors contradict EMA centralised assumptions, which prompt 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 of the therapy across the individual countries varies. These variations eventually lead to a probable health inequality, whereby about 15% of patients suffering from Relapsing Remitting of Multiple Sclerosis ‘’RRMS’’in Norway are denied treatment, because the therapy in question is not cost effective. Unlike other previous MS treatments that can only treat about 85% of patients suffering from Primary Progressive form of Multiple Sclerosis ‘’PPMS’’, Ocrevus, a new treatment manufactured by Roche Pharmaceuticals with an active ingredient Ocrelizumab treats both RRMS and PPMS. Even though Norwegian neighbouring Nordic states like Sweden and Denmark and a few other Norwegian price referenced countries like Germany, the UK and Ireland already reimbursed or are at the verge of reimbursement. However, Ocrelizumab does not have market access and reimbursement in Norway, because Rituximab, an off label cancer treatment used as a standard treatment and it’s fourteen times cheaper than Ocrelizumab. In other words, Ocrelizumab is not cost effective.