Budget Impact Analysis of Fingolimod in Relapsing Remitting Multiple Sclerosis

Objectives: In recent years, fingolimod and natalizumab - though expensive - have brought significant improvements in second-line treatment of Multiple Sclerosis (MS). In Italy, fingolimod was acknowledged in 2011 the therapeutic innovation criterion which exempts the manufacturer from a mandatory discount of 5% on the ex-factory price for a three-year period. Since the innovation period is soon expiring and in order to assess the affordability of this therapy for the National and Regional Healthcare Systems (HSs), we performed a Budget Impact Analysis (BIA) of fingolimod in second-line treatment of MS, enclosed an ethical assessment of justice issues.