NICE rejects Janssen’s Stelara for moderate to severe ulcerative colitis

Image of man and woman sat in waiting room holding their stomachs to show NICE rejects Janssen's Stelara for moderate to severe ulcerative colitis

The National Institute for Health and Care Excellence (NICE) has not recommended ustekinumab, Janssen’s Stelara, for treating moderately to severely active ulcerative colitis in adults.

Ulcerative colitis causes inflammation and ulcers in the bowel and rectum. While surgery can be effective for some patients, outcomes vary and abdominal scarring can significantly affect sexual and reproductive function.

A number of treatment options are already recommended by NICE including for when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment.

Although NICE’s technology appraisal committee said new medical treatment options would be welcome for this group, Ustekinumab, which would be used in these circumstances, wasn’t recommended due to uncertainties over its cost-effectiveness.

Initial doses of utekinumab are given intravenously with maintenance treatment (year two onwards) given as a subcutaneous injection. The annual treatment costs are £14,482 in the induction year, and £9,304 per year for maintenance treatment. Janssen has agreed a confidential pricing arrangement with the Commercial Medicines Unit.

The NICE Guidance says that clinical trial evidence shows that ustekinumab is more effective than placebo for treating moderately to severely active ulcerative colitis. For induction (the first 8 weeks of treatment), indirect comparisons suggest that ustekinumab may be more effective than adalimumab for some people. For maintenance treatment, the results of the indirect comparisons are very uncertain.

The cost-effectiveness estimates vary from slightly below to above the range normally considered to be a cost-effective use of NHS resources. And the Committee said that there is considerable uncertainty about these estimates. Therefore, ustekinumab cannot be recommended.

Janssen has responded saying that whilst it is disappointed by the recommendation set out within the Appraisal Consultation Document, the company is committed to continue collaborating closely with NICE throughout the subsequent stages of this appraisal.

The draft guidance is subject to consultation. Consultees and commentators can have their say at until 11th February 2020.

In October, Janssen released new clinical trial data for Stelara demonstrating the efficacy and safety of ustekinumab through two years of treatment in adults with moderately to severely active ulcerative colitis.