2 The technology
2.1 Infliximab (Remicade, Schering-Plough Ltd) is a tumour necrosis factor alpha (TNF-α) inhibitor and has a UK marketing authorisation for the treatment of moderately to severely active ulcerative colitis. Infliximab is indicated for intravenous use in adults whose ulcerative colitis has responded inadequately to conventional therapy (including corticosteroids and 6-mercaptopurine or azathioprine), or who are intolerant of or have medical contraindications to such therapies. The recommended dose of infliximab for the treatment of ulcerative colitis is 5 mg/kg body weight infused intravenously over a 2-hour period followed by additional 5 mg/kg infusions at 2 and 6 weeks after the first infusion, then every 8 weeks. The summary of product characteristics (SPC) states that continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.
2.2 The most common adverse events reported during infliximab therapy, for all indications, include viral infections, serum sickness-like reaction, headache, vertigo, dizziness, flushing, lower and upper respiratory tract infections, abdominal pain, diarrhoea, nausea, dyspepsia, increased transaminases, urticaria, rash, pruritus, hyperhidrosis, dry skin, infusion-related reactions, chest pain, fatigue and fever. Infliximab is contraindicated in people with moderate or severe heart failure and active infections. Before starting treatment, people must be screened for both active and inactive tuberculosis. The SPC lists a number of uncommon but serious adverse events related to infliximab's immunomodulatory activity. For full details of side effects and contraindications, see the SPC.
2.3 Infliximab (vial with powder for reconstitution) is available at a net price of £419.62 for a 100-mg vial (excluding VAT; 'British national formulary' [BNF] edition 55). The drug cost varies from patient to patient because the dose is adjusted to each patient's body weight. For example, for a person weighing 73 kg the cost per infusion (if no vial sharing is assumed) would be £1678.48, corresponding to four vials of 100 mg for a dose of 365 mg. Therefore, for a 'course' of infliximab, assuming three doses, the drug cost is £5035.44. Costs may vary in different settings because of negotiated procurement discounts.