following a full submission:
dimethyl fumarate (Tecfidera®) is accepted for use within NHS Scotland.
Indication under review: treatment of adult patients with relapsing remitting multiple sclerosis.
Two phase III, placebo-controlled studies demonstrated significantly superior efficacy for dimethyl fumarate compared to placebo for the primary end-points of proportion of patients relapsed at two years (in one study) and the annualised relapse rate (in the other study).
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of dimethyl fumarate. 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.
Download detailed advice215KB (PDF)
Medicine details
- Medicine name:
- dimethyl fumarate (Tecfidera)
- SMC ID:
- 886/13
- Indication:
- for the treatment of adult patients with relapsing remitting multiple sclerosis.
- Pharmaceutical company
- Biogen Idec Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 07 April 2014