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2 Information about ustekinumab

Marketing authorisation indication

2.1 The marketing authorisation for ustekinumab 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 Induction treatment is administered intravenously as a weight-based dose of about 6 mg per kg.

2.3 Maintenance treatment is administered as a subcutaneous injection of a fixed dose of 90 mg, with the first dose given at week 8 after induction. After this, dosing every 12 weeks is recommended. Patients who have not had an adequate response 8 weeks after the first subcutaneous dose (week 16) may have a second subcutaneous dose at this time, to allow for delayed response. Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks. Patients may subsequently have ustekinumab every 8 weeks or every 12 weeks according to clinical judgement.


2.4 The list price is £2,147 per 130‑mg vial of concentrate for solution for infusion, and £2,147 per 90‑mg vial of solution for injection (excluding VAT; British national formulary online accessed January 2020).

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

2.6 The company has agreed a confidential pricing arrangement for ustekinumab with the Commercial Medicines Unit.