teriflunomide (Aubagio)

following a full submission

teriflunomide (Aubagio®) is accepted for restricted use within NHS Scotland.

Indication under review: treatment of adults with relapsing remitting multiple sclerosis (MS).

SMC restriction: as an alternative to treatment with interferon beta or glatiramer acetate. Teriflunomide is not expected to be used for the treatment of patients with highly active disease.

In two phase III, randomised, double-blind, placebo-controlled, parallel-group studies in adult patients with relapsing MS, teriflunomide significantly reduced the annualised relapse rate.  In a phase III, randomised, single-blind, parallel-group study, teriflunomide showed similar efficacy to interferon beta.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of teriflunomide. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.