2 The technology
Tocilizumab (RoActemra, Roche) is a humanised monoclonal antibody that inhibits cytokine interleukin‑6 (IL‑6). Reducing the activity of IL‑6 may reduce inflammation in the joints, prevent long-term damage, improve quality of life and function, and relieve certain systemic effects of rheumatoid arthritis. Tocilizumab, in combination with methotrexate, has a UK marketing authorisation for the treatment of moderate to severe active rheumatoid arthritis in adults whose disease has not responded adequately to, or who were intolerant to, previous therapy with one or more DMARDs or TNF-alpha antagonists. In these people, tocilizumab can be given as monotherapy in case of intolerance to methotrexate or if continued treatment with methotrexate is inappropriate. Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X‑ray and to improve physical function when given in combination with methotrexate.
Tocilizumab is contraindicated in people with active, severe infections. The summary of product characteristics (SPC) lists the following as the most commonly reported adverse drug reactions associated with tocilizumab treatment: upper respiratory tract infections, nasopharyngitis, headache, hypertension and increased alanine transaminase. For full details of side effects and contraindications, see the SPC.
Tocilizumab is administered as an intravenous infusion, given over 1 hour. The recommended dosage is 8 mg/kg, given once every 4 weeks. For people whose body weight is more than 100 kg, doses exceeding 800 mg per infusion are not recommended. Tocilizumab is available in three vial sizes, which are priced at £102.40 for an 80-mg vial, £256 for a 200-mg vial and £512 for a 400-mg vial ('British national formulary' [BNF] edition 59, excluding VAT). The cost for tocilizumab as reported by the manufacturer is £9295 per year for a patient weighing approximately 70 kg. Costs may vary in different settings because of negotiated procurement discounts.
The Department of Health and the manufacturer have agreed that tocilizumab will be available to the NHS with a patient access scheme in which a discount from the list price is applied to original invoices. The level of the discount is commercial in confidence (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.