Tofacitinib is recommended, within its marketing authorisation, as an option for treating moderately to severely active ulcerative colitis in adults when conventional therapy or a biological agent cannot be tolerated or the disease has responded inadequately or lost response to treatment. It is recommended only if the company provides tofacitinib with the discount agreed in the commercial arrangement.
Why the committee made these recommendations
Clinical trial evidence shows that tofacitinib is more effective than placebo for treating moderately to severely active ulcerative colitis. An indirect comparison suggests that for people who have not had a TNF-alpha inhibitor, tofacitinib is more effective than adalimumab and golimumab as maintenance treatment. For people who have had a TNF-alpha inhibitor, tofacitinib is more effective than adalimumab as induction treatment. No other statistically significant differences between tofacitinib and biological therapies were identified.
Based on the health-related benefits and costs compared with conventional therapy and biologicals, tofacitinib is recommended as a cost-effective treatment for moderately to severely active ulcerative colitis in adults whose disease has responded inadequately to, or who cannot tolerate, conventional or biological therapy.