2 Information about ustekinumab

Marketing authorisation indication

2.1 Ustekinumab (Stelara, Janssen) has a marketing authorisation that includes the following indication: 'treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies'.

Dosage in the marketing authorisation

2.2 The dosage schedule is available in the summary of product characteristics. Induction treatment is administered intravenously as a weight-based dose using 130 mg concentrate for solution for infusion. Maintenance treatment is administered as a subcutaneous injection using solution for injection in a vial or pre-filled syringe.


2.3 The list price of ustekinumab is £2,147 per 130‑mg vial of concentrate for solution for infusion, and £2,147 per 90‑mg solution for injection in a pre-filled syringe (excluding VAT; BNF online accessed February 2020).

2.4 The annual treatment costs are £14,482 in the induction year, and £9,304 per year for maintenance treatment (year 2 onwards).

2.5 The company has agreed a nationally available price reduction for ustekinumab with the Commercial Medicines Unit. The prices agreed through the framework are commercial in confidence.

  • National Institute for Health and Care Excellence (NICE)