2 The technology
2.1 Vedolizumab (Entyvio, Takeda) is a humanised monoclonal antibody. It targets α4β7 integrin, which is expressed in certain white blood cells that are found in the gut. α4β7 integrin is responsible for recruiting these cells to inflamed bowel tissue. Vedolizumab therefore specifically targets the gut. The marketing authorisation states that vedolizumab is indicated 'for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, or lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor‑alpha antagonist'. The recommended dosage of vedolizumab is 300 mg given by intravenous infusion at 0, 2 and 6 weeks and then every 8 weeks thereafter. Continued therapy for people with ulcerative colitis should be carefully reconsidered if no evidence of therapeutic benefit is observed by week 10.
2.2 The most common adverse reactions experienced with vedolizumab are nasopharyngitis (inflammation of the nose and throat), headache and joint pain. For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.3 The NHS list price of vedolizumab is £2050 per 300 mg vial (excluding VAT; 'British national formulary' [BNF] edition 69). 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.