2 The technology

2 The technology

Tofacitinib (Xeljanz, Pfizer)

Marketing authorisation

Tofacitinib in combination with methotrexate has a marketing authorisation in the UK for the 'treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs'. Tofacitinib can be given as monotherapy in patients who are intolerant to methotrexate or when treatment with methotrexate is inappropriate.

Recommended dose and schedule

The recommended dose of tofacitinib is 5 mg twice daily. A dose of 5 mg once daily is appropriate for patients with severe renal impairment (creatinine clearance less than 30 ml/min). A dose of 5 mg once daily is appropriate for patients with moderate hepatic impairment (Child–Pugh B). Tofacitinib should not be used in patients with severe hepatic impairment (Child–Pugh C). Tofacitinib should be interrupted if a patient develops a serious infection, until the infection is controlled.

Price

The list price of a 56‑tablet pack of 5 mg tofacitinib is £690.03 (excluding VAT; British national formulary [BNF] online [2017]). The average cost per patient for the first 6 months is estimated at £4,050.60 based on the list price. The average cost per patient for subsequent years is estimated at £9,001.19 based on the list price.

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of tofacitinib, 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.

  • National Institute for Health and Care Excellence (NICE)