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dimethyl fumarate (Tecfidera)

Advice

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 Details

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.
BNF Category:
Sub Category: 8.2 Drugs affecting the immune response
Submission Type: Full submission
Status: Accepted
Date Advice Published: 7 April 2014

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