2 Information about tofacitinib

2 Information about tofacitinib

Marketing authorisation

Tofacitinib (Xeljanz, Pfizer) is indicated for 'the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent'.

Dosage in the marketing authorisation

The recommended dosage of tofacitinib for induction is 10 mg taken orally twice daily for 8 weeks, then 5 mg taken twice daily for maintenance.

If adequate therapeutic benefit is not achieved by week 8 the induction dose can be taken for an additional 8 weeks (16 weeks in total). Induction therapy should be stopped if there is no evidence of therapeutic benefit by week 16.

For patients whose disease has responded inadequately to tumour necrosis factor antagonist therapy, consider continuing the 10-mg twice-daily dose for maintenance in order to maintain therapeutic benefit.

If response decreases to tofacitinib 5 mg taken twice daily as maintenance therapy, consider increasing the dose to 10 mg taken twice daily.

When the disease has responded adequately to tofacitinib, corticosteroids may be reduced or stopped in accordance with standard care.

Price

The list price of a 56‑tablet pack of 5-mg tofacitinib is £690.03; the list price of a 56‑tablet pack of 10-mg tofacitinib is £1,380.06 (excluding VAT; British national formulary [BNF] online 2018). The average cost per patient for the first year is estimated at £10,350.45 and for the subsequent year is estimated at £8,970.39.

The company has a commercial arrangement. This makes tofacitinib available to the NHS with a discount. The size of the discount is commercial-in-confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)