In final guidance the National Institute for Health and Care Excellence (NICE) has recommended the use of Genzyme's multiple sclerosis drug teriflunomide (also called Aubagio). The NHS now has a legal obligation to begin funding this treatment for eligible patients within the next 3 months.

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

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: "Current treatments all need to be injected, and can be associated with unpleasant side effects. As an oral treatment with a different side-effect profile, teriflunomide offers a new option for treating relapsing-remitting multiple sclerosis, which could have a substantial impact on quality of life for people with relapsing-remitting multiple sclerosis."

Teriflunomide is recommended 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 teriflunomide with the discount agreed in the patient access scheme.

Nick Rijke, Director for Policy & Research at the MS Society, said: "We've been waiting a long time for a tablet to be available for early stage MS, so this is excellent news. As well as making another valuable treatment available for people with MS, many people will be delighted to have the option of a tablet rather than regular injections, which can be difficult to manage."

ENDS

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Notes to Editors

About the guidance

1. Teriflunomide (Aubagio, Genzyme) is an immunomodulatory disease-modifying therapy. It has a UK marketing authorisation for 'the treatment of adult patients with relapsing remitting multiple sclerosis'. It is anti-inflammatory and works by blocking proliferation of stimulated lymphocytes. The exact mechanism of action for teriflunomide is not fully understood. It is thought to reduce the number of activated lymphocytes, which would cause inflammation, and damage myelin in the central nervous system. Teriflunomide is taken orally as a 14 mg tablet once daily.

2. The manufacturer has stated that the list price of teriflunomide is £1037.84 per 28-tablet pack (excluding VAT). The length of teriflunomide treatment may vary because it is anticipated to be used continuously until a joint decision is made between the patient and clinician to stop treatment. Based on the list price, the manufacturer has estimated the annual cost of teriflunomide to be £13,529 per patient per year. Costs may vary in different settings because of negotiated procurement discounts. The manufacturer of teriflunomide 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. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS. The manufacturer has agreed that the patient access scheme will remain in place until any review of this NICE technology appraisal guidance is published.

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