Authors' objectives: To assess the available evidence on the efficacy, safety and coverage related issues regarding the use of fingolimod in patients with RRMS.

Authors' recommendations: There is evidence, although scarce, showing that fingolimod would have slightly better benefits than INF and glatiramer acetate. However, most studies use placebo as comparator and the systematic reviews are based on indirect methods to evaluate the efficacy of fingolimod versus the active treatment. It is worth mentioning that the cost of this treatment is high when compared to the benefits and adverse effects observed, and in some countries its use is not recommended. In other countries, its use in patients with RRMS is limited to the price/discount the manufacturer may give, in addition to monitoring its effectiveness in the patients treated to evaluate continuous treatment. On the other hand, there is concern about its safety due to the cardiovascular events and deaths reported since its long-term safety profile is unknown. Fingolimod is proposed as oral monotherapy and disease modifying drug in patients with highly active RRMS and who are refractory to IFN-Beta therapy.

Project Status: Completed

Year Published: 2012

URL for published report: https://www.iecs.org.ar/home-ets/?cod_publicacion=1387&origen_publicacion=publicaciones

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)