2.1 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.
2.2 The summary of product characteristics lists the following adverse effects for teriflunomide: diarrhoea, alopecia, nausea and increased levels of alanine aminotransferase. For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.3 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.