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27 August 2014

NICE recommends new treatment option for multiple sclerosis (Dimethyl fumarate)

In final guidance, the National Institute for Health and Care Excellence (NICE) has recommended the use of Biogen Idec’s multiple sclerosis drug, dimethyl fumarate (also called Tecfidera).

The NHS now has a legal obligation to begin funding this treatment for eligible patients within the next 3 months.

Dimethyl fumarate is recommended as a treatment option for adults with relapsing–remitting multiple sclerosis. This is a chronic, disabling, neurological condition that, as it progresses, can be life altering and have a substantial negative impact on quality of life and activities of daily living.

The independent Appraisal Committee, which developed the guidance on behalf of NICE, considered evidence from the manufacturer, clinical experts and patient representatives.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “We are very pleased to be able to recommend dimethyl fumarate as an option for adults with relapsing-remitting multiple sclerosis.

“Evidence has shown that this drug is more effective in reducing relapse rates and just as effective in delaying disability progression compared with current similar treatments.

“Another advantage of dimethyl fumarate is that it is an oral treatment. It will be more convenient for patients to take than other currently available treatments, which must all be injected. It will help more people with multiple sclerosis to live a normal life.”

Dimethyl fumarate is recommended as an option for treating adults with active relapsing-remitting multiple sclerosis (normally defined as 2 clinically significant relapses in the previous 2 years), only if:

  • they do not have highly active or rapidly evolving severe relapsing–remitting multiple sclerosis and
  • the manufacturer provides dimethyl fumarate with the discount agreed in the patient access scheme.

Ends

Notes to Editors

The final guidance can be found on the NICE website.

About the guidance

  1. Dimethyl fumarate is taken orally. The recommended dosage is 120 mg twice daily in the first week of treatment and 240 mg twice daily thereafter, and treatment continues as long as patients benefit clinically, or until they experience unacceptable adverse reactions.
  2. The prices of a pack of 120-mg tablets (14 tablets per pack) and 240-mg tablets (56 tablets per pack) are £343 and £1373 respectively (excluding VAT; manufacturer’s submission). Costs may vary in different settings because of negotiated procurement discounts.
  1. The manufacturer of dimethyl fumarate has agreed a patient access scheme with the Department of Health. This is a simple discount scheme, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

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We are very pleased to be able to recommend dimethyl fumarate as an option for adults with relapsing-remitting multiple sclerosis.

Professor Carole Longson, Director of NICE Health Technology Evaluation Centre