dimethyl fumarate (Tecfidera)
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.
|Drug Name:||dimethyl fumarate (Tecfidera)|
|SMC Drug ID:||886/13|
|Manufacturer:||Biogen Idec Ltd|
|Indication:||for the treatment of adult patients with relapsing remitting multiple sclerosis.|
|Sub Category:||8.2 Drugs affecting the immune response|
|Submission Type:||Full submission|
|Date Advice Published:||7 April 2014|