OBJECTIVES : Analyzing the impact of multiple sclerosis modifying treatments approved by the European Medicines Agency (EMA) using real-world data from the Valencia University Clinical Hospital for 2013-2018.

METHODS : A database of 324,497 people resident in a health district of Valencia (Spain) was used. Each patient register contained the following information: age, diagnostic, type of treatment (start; continuation; modification; suspension), start date and end date of treatment, treatment description and posology. Cost of treatments was calculated according to the sale price of the laboratory plus VAT by using the 3% discount rate, commonly accepted for Spain. The analysis was made from the payer perspective.

RESULTS : During 2013-2018, 115 patients started treatment for multiple sclerosis in the Valencia University Clinical Hospital. The economic impact of these innovative drugs amounted to 437,972.14 euros. 28.10% of treatments where glatiramer, followed by interferon beta-1a (17.15%), teriflunomide (13.14%), fingolimod (12.04%), dimethyl fumarate (11.31%), interferon beta-1b (4.74%), rituximab (3.65%), alemtuzumab (3.28%), natalizumab (2.92%), peginterferon beta-1a (2.55%), ocrelizumab (0.73%) and claridribine (0.36%). 43% of treatments where a starting, 33% continuation, 21% modification and 3% suspension due to adverse events or patient desire. About gender, 30.4% were male with an average age of 42 years old while 69.6% were female with an average age of 43. First-line therapeutic drugs (glatiramer, interferons, teriflunomide and dimethyl fumarate) represented the 77% of treatments and the 56% of costs while second-line drugs signified the 23% of treatments and the 44% of costs.

CONCLUSIONS : The results support what has been published in the literature regarding incidence and distribution by gender. Despite having a low participation in the volume of treatments, second-line therapeutic drugs are close to first-line in terms of economic impact. An exhaustive analysis of health outcomes is required to assess the cost effectiveness in real population to conduct prescriptions towards the most efficient therapies.