2 The technology
2.1 Tocilizumab (RoActemra, Roche Products) is a humanised monoclonal antibody that inhibits the cytokine interleukin-6 (IL-6). Reducing the activity of IL-6 can reduce inflammation in the joints, prevent long-term damage, and improve quality of life and function. Tocilizumab has a marketing authorisation for the treatment of active systemic juvenile idiopathic arthritis (JIA) 'in patients aged 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids'. Tocilizumab can be given as monotherapy (in patients intolerant to methotrexate or if treatment with methotrexate is inappropriate) or in combination with methotrexate.
2.2 Upper respiratory tract infection, with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache, is one of the most common side effects of tocilizumab. Other reported side effects include rash, urticaria, diarrhoea, epigastric discomfort and arthralgia. Infusion-related reactions that can be considered serious and life-threatening (such as angioedema) have also been reported. For full details of side effects and contraindications, see the summary of product characteristics.
2.3 Tocilizumab is administered as an intravenous infusion over 1 hour and treatment is repeated at 2-week intervals. The recommended dose is 8 mg/kg in patients weighing 30 kg or more, and 12 mg/kg in patients weighing less than 30 kg. The dose should be calculated based on the patient's body weight at each administration. A change in dose should only be based on a consistent change in the patient's body weight over time. The cost of 80 mg in a 4 ml vial is £102.40 (excluding VAT; 'British national formulary' [BNF] edition 61). The average cost of treatment is £7987.20 per year for a 30 kg patient and £9984 per year for a 25 kg patient, assuming no wastage. The manufacturer of tocilizumab (Roche Products) has agreed a patient access scheme with the Department of Health which makes tocilizumab available with a discount applied to all invoices. The level of the discount is commercial-in-confidence (for further details see section 5.2). 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.