Reason for request



Clinical Benefit



Clinical Added Value

no clinical added value

In the absence of a superiority study versus an active treatment, TECFIDERA does not provide an improvement in actual benefit (Level V, non-existent) in the treatment of relapsing remitting multiple sclerosis.
The results of the network meta-analysis showing, through an indirect comparison, a reduction in the annualised relapse rate with TECFIDERA 240 mg x 2/day compared with interferon beta, glatiramer acetate and teriflunomide can not be considered as sufficient to draw any conclusions concerning the superior efficacy of TECFIDERA at a dose of 240 mg x 2/day compared with these treatments.
The Transparency Committee recognises the benefit of the availability of an additional oral proprietary medicinal product indicated as disease modifying therapy in relapsing remitting multiple sclerosis.