Nice have published draft guidance not recommending ustekinumab (also called Stelara and made by Janssen) for treating moderately to severely active ulcerative colitis in adults.
Ulcerative colitis is a long-term condition that causes inflammation and ulcers in the bowel and rectum which can bleed and produce pus. While surgery can be an effective treatment for some patients, outcomes are variable and abdominal scarring can significantly affect sexual and reproductive function.
NICE already recommends several treatment options for when conventional therapy or a biological agent cannot be tolerated, or the disease has responded inadequately or lost response to treatment.
NICE’s technology appraisal committee were told there is still an unmet need for new, non-surgical treatment options because many people have an inadequate response to current therapies or they stop working. The committee heard that the only option for these people, other than surgery, is long-term corticosteroid use but this is associated with side effects. New medical treatment options would be welcome, the committee said.
Ustekinumab would be used when conventional therapy or a biological agent cannot be tolerated or the disease has responded inadequately or lost response to treatment.
Initial doses of utekinumab are given intravenously. Maintenance treatment is given as a subcutaneous injection. The annual treatment costs are £14,482 in the induction year, and £9,304 per year for maintenance treatment (year two onwards). The company has agreed a confidential pricing arrangement for ustekinumab with the Commercial Medicines Unit.
Clinical trial evidence shows that ustekinumab is more effective than placebo for treating moderately to severely active ulcerative colitis. For induction (the first eight weeks of treatment), indirect comparisons suggest that ustekinumab may be more effective than one of the current therapies – adalimumab – but only for some people. For maintenance treatment, the results of the indirect comparisons are very uncertain.
There is considerable uncertainty about the cost-effectiveness estimates for ustekinumab, which vary from slightly below to above the range normally considered to be a cost-effective use of NHS resources. Therefore, ustekinumab cannot be recommended.
Jennifer Lee, Director of Health Economics, Market Access & Reimbursement (HEMAR) and Advocacy, Janssen-Cilag Limited commented: “If NICE’s decision is upheld, approximately 15,000 people in the UK living with moderately to severely active UC who may be eligible for treatment with ustekinumab, would potentially not have access to an important new treatment option. We firmly believe patients living with ulcerative colitis have the right to treatment choices that improve their lives and address their ongoing needs. This initial guidance reinforces the need for reform of existing NICE technology appraisal processes through the NICE Methods Review. We will continue to collaborate closely with NICE throughout the subsequent stages of this appraisal as we believe ustekinumab should become routinely available as an alternative treatment option.”
The draft guidance is subject to consultation. Consultees and commentators can have their say at nice.org.uk until 11th February 2020.