2 The technology
2.1 Vedolizumab (Entyvio, Takeda UK) is a humanised IgG1 monoclonal antibody derived from a newly engineered cell line. It is targeted against α4β7 integrin, which is expressed on certain white blood cells. α4β7 integrin is responsible for recruiting these cells to inflamed bowel tissue. It is administered by intravenous infusion.
2.2 Vedolizumab has a marketing authorisation in the UK for 'the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor‑alpha antagonist'. The summary of product characteristics states that the recommended dosage of vedolizumab for treating Crohn's disease is 300 mg at 0, 2 and 6 weeks, then every 8 weeks thereafter. It further notes that people who have not shown a response may benefit from a dose at week 10. If no evidence of therapeutic benefit is seen by week 14, vedolizumab should not be continued.
2.3 Vedolizumab's summary of product characteristics lists nasopharyngitis (inflammation of the nose and throat), headache and arthralgia (joint pain) as very common adverse reactions. For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.4 The list price of vedolizumab is £2050 per 300 mg vial (excluding VAT; British National Formulary, accessed online July 2015). The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of vedolizumab 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.